#or one time in my local pharmacy when getting my covid booster

[atalana]

you know in this age of calorie counting and fad diets, where admitting to sometimes consuming sugar especially for woman might as well be a death sentence, it's surprisingly refreshing as someone prone to fainting in medical situations to have a nurse just shove an entire packet of super glucose jellybeans at you and go "eat."

[odinsblog]

idgi wasn’t the white house begging anti vaccination people to get vaccinated? how is that eugenics? explain!?

[re: this post]

I … can’t? Apparently I’m not a very good explainer.

Look, I’ll try one more time. Where I live is affluent and blindingly, overwhelmingly white. So when the vaccines were first being given out (for free! to anyone who met the age requirements!) I saw them practically everywhere. In mall parking lots, grocery stores, and at the local pharmacies. I took note, but I was too young to get a shot in the beginning, because shots were being rationed out to the vulnerable, the elderly and others who were likely to be more susceptible to COVID. Again, to me, that seems like the opposite of “eugenics” and targeting at risk groups, but wtf do I know, right?

Now please don’t get me wrong, whiter more affluent counties/countries did get (and still have) more access to the coronavirus vaccine. I don’t dispute that, but I got all three of my shots on the south side (poorer/Blacker/more diverse) of town, because someone who worked in a senior assisted living facility called me to let me know that a mobile, pop up vaccination site had administered as many shots as they could, but had leftover doses that they didn’t want to expire. (the medication had to be kept at or below a certain temperature, or it would spoil and have to be trashed - and it didn’t have a long shelf life, so any doses that weren’t administered by day’s end would have to be thrown away).

Anyway, that’s how I got my first shot. I had to get my second shot at a different location because the pop up van didn’t have enough people requesting the vaccine to justify returning. The place where I got my second shot was still on the south side, less than 10 minutes away from the assisted living facility where I received my first shot, at a Black cultural center that had been refitted to do nothing but administer shots. Again, I wanna emphasize that this was in a very .… rough …. part of town. But you would hardly know that because of all the white people lined up there to get the vaccine. I eventually got my booster shot there too. It was well organized and super easy. Both times I was in and out in less than 30 minutes, and 15 of those minutes was me waiting in an observation area.

Look, I said all of that to say this: anon you have put me in the unenviable position of having to actually say something nice about Biden. He’s broken a shit load of his campaign promises to progressives—vaccine patent waivers; $15 minimum wage; reforming ICE; $2k monthly payments; student loan cancellation; overfunding the police; etc etc etc—but he did do a competent job of handling the vaccine rollout. It was easy af to get a shot, if you wanted it. I’ll circle back and link to it if I can find the post, but when I got my first shot, I blogged about how there was an older cat there who refused to get vaccinated. But he was Black and looked old enough to have been a young man during the Tuskegee “Experiment” so I cut him some slack. But that was back in the very early days of the pandemic. Nearly two years ago now. (And it’s worth noting that a disproportionately large percentage of people currently refusing to get vaccinated are white conservatives.) Yet, almost two years into the pandemic, even as a more contagious strain, Omicron, has appeared, we still have proudly, willfully, ignorant antivaxxers who flatly refuse to be vaccinated, even though the vaccine is readily available AND FREE (for now, anyway). Antivaxxers aren’t refusing the vaccine because it’s hard to access, they’re refusing because they’re making a political statement. And the government isn’t refusing to administer vaccines, they’re BEGGING people to get vaccinated.

Idk how all that is “eugenics.”

To answer your question, I don’t fucking know how anyone conflates giving away vaccines for free! and imploring people to get vaccinated,… I’m not sure how anyone manages to confuse that with eugenics. I mean, words actually mean things. Right? The last time I checked, taking a stern tone while begging and pleading with people to pretty please get vaccinated is not eugenics.

Is vaccine apartheid a real thing between western nations vs poorer nations in the global south? Yes. Absolutely.

Is there even more that could be done to accommodate people who want the vaccine but cannot get it? Yes. We should always strive to do better. (SN: I personally drove a few of my great aunts to get vaccinated, so it occurs to me that maybe providing busses to vaccination centers might be helpful for those who want to be vaccinated? I know Uber was offering free rides at one point, but I’m unsure if that’s still a thing now)

Does America have a problem with hoarding the vaccine and not waiving patent rights for less wealthy countries? Yes! Hell yeah it does.

But …… when you have the federal government practically begging antivaxxers to pretty please get vaccinated or you may get sick and die, and when those people are somehow trying to turn themselves into victims? Of eugenics? Sorry, but they completely lose me there.

Calling the White House statement “eugenics” isn’t just ignorant, it’s mad disrespectful. It makes light of the horrors that eugenics really was.

[misadventuresofthatoregongirl]

Getting a job in Oregon

Getting a job here is a giant groveling fest its more like ok who do I have to know, or fuck, to get this job. Everyone says they're hiring but they want 100% open availability, take it or leave it do you want to hire me then fire me in a week when you schedule me when I don't have a babysitter? If the job is above minimum wage (which I could afford a house when minimum wage was $8 an hour 10 years ago now that they have raised it to $13 I cant afford anything no one can, the state just takes more taxes out of everyone's paycheck too, win win for them they look good for “raising the minimum wage” along with prices on everything and pocket more money) be prepared to beg and beg and beg and answer some of the most ridiculous questions. “What do your old coworkers think of you?” I don’t fucking know I don’t go to work worrying about what others thing call them and ask I go to do my job, I assure you this has nothing with my ability to stack boxes, do taxes, fill out forms or count money. “Well with that attitude its no wonder” friends and family will say, yeah I just walk into every job interview like that (sarcasm). I walk in smiling phony and fake and they ask me the same question reworded differently 5 fucking times. I also have a mill, for a receptionist position, hand me a misfeed count paper and ask me “What would you do if the misfeed count is off?” Now these sheets, I have seen many of my relatives fill out. There is literally nothing anyone can do it has to do with how many pieces of wood goes through the machine and how many are doubled up or miscounted etc. The receptionist has NOTHING to do with it. I said turn it into the supervisor “give me a different answer” what do you want from me lady? The job is processing payroll, not bitching at field employees about their feed count. The people I know who worked at that same mill, when I told them they said why are they even asking you that we turn that into the supervisor at the end of our shift if the count is off we cant change it. Yeah, duh. Why should I have to constantly beg so much when they are the ones needing people and I will see the same places post the same job over and over so obviously whoever they're hiring is not working out. I can’t get a bank teller job, I can’t get a receptionist job, even with 8 years of accounting, customer service, cash handling and a year of business and law classes I still can not get a job here. Half of these companies too have recruiters from out of state call you ask redundant questions already on your resume, and then say “Ok I will forward this to the local office” can’t the local office look at resumes anyways? Why do we live in such a stupid fucking society? All jobs should have WORKING INTERVIEWS like let me work a day for free, then I will show you I can do the job. I am not trying to be a speaker of the house ok. Oh, and as soon as I get a job I lose health coverage for my child so first ER trip, fucked. I will get into healthcare in another post. Another reason, they are still gung ho on the masks and vaccine mandates in this state. Every single healthcare worker even pharmacy workers are required to wear a mask. To be a receptionist at the VA you have to agree to get covid boosters every 6 months and flu shots once a year. A, fucking, receptionist. I don’t know a single person, who gets all these shots that is healthier than me. Those shots are not even proven to prevent it “may lessen symptoms” is not “immunity”. Natural immunity is completely disregarded. As a result everywhere is short staffed like pharmacies I know I'm not the only one sick of this shit. They’re moving to other states, wit better pay because despite the high minimum wage here everything barely pays minimum wage, that don’t force tyrannical mandates on them. I am still waiting for an explanation as to why all the states who had no mandates the entire time, have no higher fatality rates the way these people act, you’d think every person who didn't wear a mask and get 5 shots was dead. Lol. I am just so incredibly over this shithole I have watched this state be ran into the ground I cant even take my kid to the park because there are massive homeless camps everywhere and I don't even live in a big city! I live in rural southern Oregon! The entire I5 corridor, besides the places that are not near a city for example the area between Grants Pass and Roseburg, then again from Roseburg to Eugene, looks like a giant homeless camp. Be careful in the bushes and public bathrooms might find a used needle (not joking I don’t use public restrooms ever here anymore). People really do not realize what a nightmare the entire west coast has become. 

[atlanticcanada]

N.B.'s COVID-19 booster eligibility expands to those aged 18 and over, some areas experiencing high demand

New Brunswick public health opened up booking Monday for anyone over the age of 18 looking to get their third dose of an approved COVID-19 vaccine.

People can book their shot through one of the regional health authorities or a local pharmacy.

At Ford’s Family Pharmacy in Moncton, N.B., a steady stream of people were doing just that.

“We were anticipating this was going to happen probably this week so we ordered lots of Moderna. We’ve got lots of stock, we’ve got more stuff coming in again tomorrow,” said owner and practicing pharmacist, Peter Ford.

When Ford arrived at work around 10:30 a.m., his employees informed him the pharmacy phones were ringing off the hook earlier in the day.

“From 9 to 9:30 a.m., we had 12 lines coming in here, we didn’t even have enough staff to answer all the phone calls, but then it just stopped, which is kind of weird,” said Ford.

The wait time for online bookings Monday morning was surprisingly short as well, with the majority of people experiencing between a 15 to 30 minute wait.

Some, however, had reservations regarding the province’s ability to provide the shots in a timely fashion.

JC D’Amours, the MLA for Edmundston-Madawaska Centre, sent out a tweet earlier in the morning claiming there were no available appointments for booster shots in the Zone 4 area.

“As of today, GNB is opening up booster doses to 18-49 year olds. Where are the appointments available? Zone 4: no availability in Edmundston and Grand Falls. #GNB #organized,” read the tweet.

CTV News reached out to D’Amours for comment but did not receive a reply.

When asked about the tweet, New Brunswick Liberal Party Leader Roger Melanson said he worries public health does not have the capacity to provide the number of appointments needed.

“If you want to book an appointment for a booster shot it takes time and too much time. It takes four or five weeks to get an appointment, so it comes back to capacity,” said Melanson.

Health Minister Dorothy Shephard said she has heard more positive feedback.

“I’ve been hearing more of the 10 to 14 days and I think I want to assure New Brunswickers that if we need more clinics in certain areas, those are being worked on now to try and open it up, but we also have pharmacies helping us,” said Shephard.

According to New Brunswick’s COVID-19 online dashboard, 194,816 out of 750,000 people, or 26 per cent of the eligible population, has received their third dose.

“As of yesterday, we had 32,000 vacant appointments for our now 18 plus, and we had about 9,000 that’s been booked today so far,” said Shephard.

Nova Scotia’s COVID-19 online dashboard is reporting 19.9 per cent of the eligible population has received a booster dose. 

Wayne Marcotte said he stood in line with more than 100 other people for his shot at the Captain William Spry Community Centre in Spryfield, N.S.

“I wanted to get the Pfizer. I was booked for the other one, Moderna, but I wanted to get my Pfizer because the first two was Pfizer,” said Marcotte.

Ford says he cautions people about being fussy over Pfizer, adding that any approved mRNA vaccine is a good choice.

“There are people on the fence about getting Moderna versus Pfizer, but they forget that every day their immunity is going down. So, you wait another three months, that’s nine months; you’ve probably got no immunity at that point, so get Moderna,” said Ford.

Shephard adds that both regional health authorities, as well as the province, have been reaching out to more pharmacies across New Brunswick, asking them to assist in administering vaccinations.

“We understand that December is a difficult time for pharmacies to be doing vaccines, and I know that we have more coming on board,” said Shepard.

As of Jan. 10, New Brunswick is reporting that a total of 1,500,679 doses of vaccine have been administered.

from CTV News - Atlantic https://ift.tt/3zH29Hr

[not-your-damsel]

Um, I’ve just let something fully sink in and I’m finding myself getting angrier and angrier the more I think about it.

I just got off of FaceTime with my little sister. She called me having just gotten home, to tell me that she’s being induced for labor tomorrow. This is her second child, and with her having Lupus, she’s high risk. I was there for the birth of my niece 2 years ago, especially since there wasn’t a little one to worry about anywhere else. But I knew that this time around would be different because of the fact my niece needs to be taken care of and with Covid still a thing along with her lapdog variants, no one is dumb enough to bring her to a hospital for her little brother to be born.

My sister was crying and she was essentially telling me she loves me, and that if anything happens to her or the baby to please take care of my niece as though she were my own, as if that was ever going to be out of the question because I would already die and kill for her as if I did birth her myself. There’s just zero question on the topic. We shed some tears, and I was in the middle of just having finished cooking, on top of having my door being knocked on because my medicines from my local pharmacy were also being delivered at the same time so what she confessed next didn’t fully sink in initially.

“I wasn’t going to tell you that I was going to be induced this week, let alone tomorrow. I texted you that it was happening next week but that was a lie.”

Me - 🤨 “Wait what?” 🤔

“We were worried about stressing you to the point that you’d end up in the hospital, so we weren’t gonna tell you.”

Me - That would’ve sucked if something serious were to happen to you and my nephew. I never would’ve been able to see or speak to you.

“That’s why I’m telling you now, in case something happens to me or us.”

😦

Now that the convo is over, the more I think about this, I’m really floored. This isn’t the first time that I’ve been left in the dark about her health during this pregnancy. Or how sometimes I find out after the fuckin’ fact that our mother (who also has Lupus) was in the hospital and no one thought to tell me about it knowing I would want to check in on her or my sister.

So now I’m thinking, how in the hell would this have been handled had she stayed lying to me? Would I have found out about my nephew the next time I went to the house? Or would I find out after she birthed him? Even worse, that I receive a call from our mom, informing me of the loss of my little sister or my little sister and nephew? Or would the beans have spilled when I need to accompany our mom and my niece to the supermarket so I can stay in the car with her so she’s not exposed to people? Would my mom have told me then? And that’s another thing, the fact that our mom was going along with this!

I’ve been on the phone with mom so very much these last 5 days because my booster shot site itself reacted so terribly, I couldn’t even lift my arm, and my pharmacy made a mistake in where I was without my pain medication for 5 days. Anyone on chronic pain medication knows how dangerous it is to just stop taking them since you risk seizures, as well as starting to go through withdrawals, which was/is happening to me currently. Thank goodness they came today so I’m combating that awful feeling right now.

FAside from all that, they know how angry I get when I’m kept out of shit as important as health. I’m not looking to be informed about everything, they’re grown ass adults, but when my family is going to the hospital and not telling me when anything can happen? Especially since I’m the poster child for anything can happen by going in for one thing and on day 3 of my stay, I’m having a fuckin’ stroke and a brain bleed, being told I’m gonna need brain surgery. There’s 2 hours of my life back when that happened in 2020 that are still to this day unaccounted for. The only reason I know something is amiss to begin with is because the next time I went back, I had people hugging me, telling me “You’re alright?!”, “You had us very scared there while we were waiting for the ambulance to transport you to an even better facility.” and I don’t recognize those people at all. I didn’t know I had a team around my bed, my blood was being taken, nothing. I still appreciate them all just the same - with my life.

But shit, TELL ME!!! I’m owed at least that fuckin’ much! I’d expect more from them on this knowing how many unfair times they’ve been thrown for a nerve wracking loop on if I’m gonna live through one of my episodes or not. If this was the other way around, my family would be so angry with me if I kept from them the times I have to go in the hospital, knowing that it’s a very real possibility that it’s the last time they see/speak to me. We’ve been through too much shit to be playing with visits to the hospital as though it’s a trip to a motel with free WiFi and drugs 🙄. This shit actually hurt me and it takes a lot to hurt me nowadays.

🌩 When it’s time to check out, that’s it. We don’t get a free phone call in the afterlife to phone our loved ones on the fact that we’ve passed. Please don’t do this to your loved ones.

[gordonwilliamsweb]

Pfizer CEO to Public: Just Trust Us on the Covid Booster

Pfizer CEO Albert Bourla was confident in June about the ability of his company’s vaccine to protect against the highly contagious delta variant, as it marched across the globe and filled U.S. hospitals with patients.

“I feel quite comfortable that we cover it,” Bourla said.

Just weeks later, Pfizer said it would seek authorization for a booster shot, after early trial results showed a third dose potentially increased protection. At the end of July, Pfizer and BioNTech announced findings that four to six months after a second dose, their vaccine’s efficacy dropped to about 84%.

Bourla was quick to promote a third dose after the discouraging news, saying he was “very, very confident” that a booster would increase immunity levels in the vaccinated.

There’s one hitch: Pfizer has not yet delivered conclusive proof to back up that confidence. The company lacks late-stage clinical trial results to confirm a booster will work against covid variants including delta, which now accounts for 93% of new infections across the U.S.

Pfizer announced its global phase 3 trial on a third dose in mid-July. That trial’s completion date is in 2022. Phase 3 results generally are required before regulatory approval.

“We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that,” Jerica Pitts, Pfizer’s director of global media relations, said Monday. The financial stakes are enormous: Pfizer announced in July that it expects $33.5 billion in covid-19 vaccine revenue this year.

Meanwhile, Pfizer recently said that if a third dose couldn’t combat the delta or other variants, the drugmaker is poised to come up with a “tailor-made” vaccine within 100 days.

All of this has sown a sense of confusion about what exactly will work, and when. The pharmaceutical industry’s rush to recommend boosters for the public is “a little frustrating,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and Food and Drug Administration. Even if a booster is found to be safe, he said, the U.S. effort should focus on “vaccinating people who are unvaccinated.”

In any case, decisions about boosters do not rest with vaccine makers, he said.

“Pharmaceutical companies aren’t public health agencies, it’s really not theirs to determine when or whether there should be booster dosing,” Offit said. “That is the purview of the CDC.”

Indeed, the Centers for Disease Control and Prevention and the FDA ― the federal agencies overseeing the authorization of covid vaccines ― said in July that fully vaccinated Americans do not need a booster shot. Currently authorized vaccines ― from Pfizer, Moderna and Johnson & Johnson ― are working as they should: All three lower the risk of covid severe enough to hospitalize or kill a person.

If hospitalization and death rates increase among the vaccinated, then it would be time to talk about boosters, Offit said, but “we’re not there, yet.”

The White House has added to the mixed messaging: Spokesperson Jan Psaki confirmed that the U.S. will buy an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.

Natalie Dean, a biostatistician at Emory University in Atlanta, said the confusion is not necessarily the fault of any one institution but rather “there is genuine scientific uncertainty about how well [existing] vaccines work against the new variant.”

Scientists are piecing together information from observational studies, outbreak investigations and analyses of antibody responses.

For many Americans ― especially those who struggled six months ago to find any dose, frantically hiring vaccine hunters and driving hours-long distances for their first jab ― the confusion has set off a feverish search for an illicit third dose just in case it’s necessary.

“I snuck in a dose of Pfizer last week,” Angie Melton, a 50-year-old mother of four, shared on Facebook. Melton received the one-dose Johnson & Johnson shot at a mass vaccination site in April and feared the highly contagious delta variant could infect her and, then, her unvaccinated 10-year-old son, who has asthma.

After consulting friends and doctors and seeing reports about mix-and-match approaches in Europe, Melton signed onto a local pharmacy site and made an appointment to get a Pfizer shot. She’s scheduled for a second shot as well.

“I’m trying to keep my family safe,” Melton said.

The CDC advisory panel was set to meet Friday to consider updates on whether additional vaccine doses are necessary for immunocompromised people. A presentation about boosters is also on the agenda.

Immunocompromised patients like Sarah Keitt, who has multiple sclerosis and Crohn’s disease, expressed relief that federal regulators planned to recommend a third dose. Keitt, a disability rights activist who lives in Connecticut, said her neurologist told her to get a booster even after she had received two doses of Moderna. On Thursday, she said she was eager to get another dose but still frustrated about a lack of confidence in how much protection it would offer.

“If someone could definitely say there is a 95% chance you are protected” by a booster, Keitt said, “I would love it.”

Despite widespread media reports of “breakthrough cases,” a recent data analysis by KFF found that hospitalizations and deaths are extremely rare among the fully vaccinated ― well below 1%.

Offit points to a recent outbreak in Provincetown, Massachusetts, in which only four of the 346 fully vaccinated people infected with covid were hospitalized, two of whom had underlying medical conditions. And no one died. “This vaccine still does an excellent job in the face of the delta variant at protecting people against severe, critical disease,” he said.

Yet the effectiveness of the Pfizer vaccine against variants is still under debate. This month a new preprint study by the Mayo Clinic found that the product’s effectiveness against infection dropped to 42% from January to July ― as the delta variant’s prevalence markedly increased.

Pfizer and partner BioNTech announced they are developing an updated version of their vaccine in Germany to target the genomic features of the delta variant.

However, the idea that a new formulation could work better is “mostly hypothetical at this point,” said Vaughn Cooper, a professor of microbiology and molecular genetics at the University of Pittsburgh.

Dr. Vincent Rajkumar, a hematologist at the Mayo Clinic who closely studies his patients’ immune responses and antibody levels, said trying both strategies of using the current vaccine and testing a new version sounds reasonable.

There is one hypothesis that if “breakthrough” infections are due to a drop in antibody levels, boosting those levels will be enough, Rajkumar said. But the more worrisome hypothesis is that the delta variant, or any other variant, might respond considerably differently ― and be less threatened ― by the antibodies the current vaccine generates.

“So unless you boost [antibodies] with a vaccine that is specific to delta, it won’t work,” Rajkumar said. Rajkumar said testing both hypotheses is the “right thing to do in the interest of time.”

At the same time, though, the push for giving booster shots to healthy populations is premature, said Dr. Sadiya Khan, an epidemiologist and cardiologist at Northwestern University Feinberg School of Medicine. That’s because even if those already fully vaccinated do get a third dose or booster, the virus is still circulating among millions of unvaccinated people.

“The overwhelming majority of infections and hospitalizations and deaths are occurring among those who are unvaccinated,” Khan said.

“Giving up on that greater strategy of vaccinating the population is going to lead to continued surges,” she said. “The potential for harm is quite large.”

KHN editor Arthur Allen contributed to this report.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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This story can be republished for free (details).

Pfizer CEO to Public: Just Trust Us on the Covid Booster published first on https://nootropicspowdersupplier.tumblr.com/

[differentnutpeace]

Coronavirus FAQs: What Should I Do With My Vaccine Card? Is Choir Practice OK Now?

Each week, we answer "frequently asked questions" about life during the coronavirus crisis. If you have a question you'd like us to consider for a future post, email us at goatsandsoda@npr.org with the subject line: "Weekly Coronavirus Questions." หวย บอล เกมส์ คาสิโนออนไลน์

GOATS AND SODA

Coronavirus FAQs: Can I Drink Between Vaccine Doses? What Is 'Vaccine Efficacy'?

I've just had my second dose of the vaccine, and now I have a vaccine card. Um, what do I do with it?

That's a good question. The U.S. version bears this instruction: "Bring this vaccine record to every vaccination or medical visit."

In essence, it's proof that you've gotten the jab (or jabs for the two-dose options).

Beyond that? Yes, there are questions about what purpose it can serve — and how to safeguard it.

In the U.S., the card is a 3 by 4 inches. The document will have your name, birthdate and key information about your vaccine regimen: which brand you got, when you received your dose or doses, and where you were inoculated.

The idea of giving out cards to document a vaccination has been around since the 1930s, says Maureen Miller, an adjunct associate professor of epidemiology at Columbia University's Mailman School of Public Health.

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"As people colonized the world, there were illnesses that were endemic to certain areas," she says. "Using cards saw to it that those diseases could be monitored as individuals crossed borders, like the now internationally recognized yellow fever vaccine cards."

Indeed, the COVID-19 Vaccination Record Card is a valuable document. Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, "urges people to keep [vaccine cards] safe." So-called vaccine passports will likely soon be needed for some international travel, he says — though the concept is still very much in the development stage. One idea is to digitize immunization records into easy-to-trace systems such as scannable bar codes. Until those systems get set up though, you'll likely need to carry your physical card for international travel — even though its size in the U.S., for example, isn't the most wallet-friendly.

The use of the vaccine card may stretch far past air travel, Miller says. You may need it to enter movie theaters, board trains, even sometimes as a condition of employment. In the U.K., for instance, government officials are considering asking individuals to present proof of vaccination to get access to public spaces such as pubs and sporting events — a provision that reportedly more than 70 lawmakers have announced they'll oppose.

As societies begin to reintegrate and have similar conversations, having a vaccine card will likely determine access to certain services. To this end, "people should be guarding vaccine cards very carefully," Miller says.

So what does that mean for you once you receive your vaccine card?

First things first. Miller says it's prudent to take pictures of both sides of your document as soon as you receive it or find a way to scan it, just so you have a personal record. That's what people often do with a driver's license or passport, she notes. While it wouldn't fly to present a phone scan as proof of vaccination, it's good to capture all the data just in case you lose your card.

(A quick tip for iPhone users is to use the built-in Notes app for a close-to-Xerox-looking clean photocopy.)

Miller also suggests laminating your card, as she did. That way, the card feels a bit less like a random scrap of paper and more like the real, official and important document it is. But some worry that lamination might preclude the ability to update a card with potential immunity "boosters" in the future. Adalja says thinking about "boosters" is a bit premature and urges individuals to do what works for them. And if you opt for lamination, you shouldn't have difficulty fulfilling that goal. Office supply stores such as Staples, Office Depot and OfficeMax have agreed to laminate, for free, your vaccine card if you visit one of their stores. Check to make sure the offer is still on before stopping by.

As to where you'd keep the card at home, Miller says she has hers in the folder she uses for medical insurance and health documents. A safe bet would be anywhere you store important records such as passports. Miller emphasizes it's probably better to keep it at home and not in a security deposit box in a bank.

And in the worst-case scenario, what if you lose your card?

"The physical document isn't the only record," Adalja says.

When you get vaccinated, that information enters your state's immunization registry, Adalja says – so no need to call up your primary care doctor or do any other logistical legwork to make it be part of your permanent health record. That process should happen automatically (although it couldn't hurt to call your primary care doctor just to make sure it did).

In the case of losing your card, your best bet is to hit up the pharmacy or clinic or site where you got your vaccine at and ask for a duplicate copy. This will be problematic if you were vaccinated at a local pop-up effort; in that case, Miller suggests contacting your state board of health. You should be able to get a duplicate, but perhaps not without a fair share of moving through bureaucracy, Adalja says.

Eventually, Adalja predicts, more "durable forms of vaccination status" — aka, records that don't just exist on a flimsy piece of cardstock — will emerge. But until then, it's just a matter of being extra careful.

My choir director says that the pandemic is ending soon and that face-to-face, in-person practice is expected to begin in May. Is it true that vaccinated people can safely sing together? Should people still be wearing masks?

Singing indoors is one of the riskiest things you can do during this pandemic — up there with screaming for your March Madness picks in a packed arena. When you sing or scream, you expel air forcefully, which generates lots of respiratory aerosols that can contain SARS-CoV-2, the virus that causes COVID-19.

We all remember that haunting episode from the early days of the pandemic in which 52 of 61 members at a choir rehearsal in Skagit County, Wash., got confirmed or probable cases of COVID-19 after a 2 1/2-hour practice. Three choir members were hospitalized, and two died.

But the vaccines are powerful tools. So, for advice, we tapped one of the co-authors of the International Coalition of Performing Arts Aerosol Study, University of Maryland mechanical engineering professor Jelena Srebric, and Dr. Jill Weatherhead, assistant professor of adult and pediatric infectious diseases at Baylor College of Medicine.

After Srebric had a good chuckle about the choir director's pronouncement that the pandemic is almost over (as much as we may wish, we're not quite there), she explained the study's most recent guidelines, released in December will hold true for a while — even with the additional protection from vaccines. Here's a summary:

Masks should be worn by choir members and anyone playing an instrument. (Cutting a slit in your mask with an X-Acto knife allows you to fit it over a wind instrument.)

Practice outdoors if possible. If indoors, the choir director should make sure there's a good air filtration system.

Singers should be at least 6 feet apart. Practice no more than 30 minutes at a time. The idea is to move away from plumes of air created from singing.

As vaccines become more widely available, Srebric suggests asking as many members to get them as soon as they're eligible.

"Vaccination reduces the risk [of infection] dramatically, especially for vaccinated people, but we still don't have a clear picture on what is going to happen with variants," Srebric explains. "So, it's very prudent to continue to be cautious."

That's why she suggests sticking to the above guidelines even once most of your choir is vaccinated. Instead of changing your habits when you get vaccinated, she suggests changing your thinking: "The vaccine gives you peace of mind," she says. "You can keep the same precaution measures but not worry as much as people used to worry."

Choirs could also wait to resume in-person practice — and definitely performances with audiences — until more people are vaccinated, Weatherhead points out. "Wait until the community transmission comes down. That is the safest plan."

But don't despair that you will have to follow these rules forever. Real-world studies suggest that vaccines may be efficacious against transmission from asymptomatic cases. "That was one of the biggest unknowns because the clinical trials didn't study that," she says.

And an observational study published in Nature showed that the small percentage of people who got infected after a vaccine tended to have much lower viral loads than unvaccinated people who got infected, providing further evidence that the ability to transmit the disease likely diminishes with vaccination.

As more people get vaccinated, choirs should be able to start gradually shifting their protocols, Srebric notes. For example, choirs could practice longer and shorten the breaks, she says.

And yes, all of this also applies to screaming at big concerts and sporting events. But feel free to cheer as much as you like for the UConn Huskies from the privacy of your couch on Friday night!

Will taking a CBD product before my shot affect its efficacy?

In short, avoiding CBD before a shot will probably be the safer approach here. CBD, which stands for cannabidiol, is a chemical component of cannabis. It's been known to have a relaxing and therapeutic effect and is sometimes used to manage pain.

According to Miller of Columbia's Mailman School of Public Health, there's "absolutely no research" that looks at the effect of CBD oil on COVID-19 vaccine efficacy in humans. So it's important to note upfront there's not much that can be said conclusively on the effects of CBD specifically.

That said, Miller points to updated Centers for Disease Control and Prevention guidelines that advise against anti-inflammatories such as Ibuprofen and other painkillers before inoculation — unless those medications are already a part of people's typical medical regime. Miller notes CBD also happens to act as an anti-inflammation tool — though the CDC advisory did not specifically take note of it.

To gain immunity, she emphasizes, your body needs to build up an inflammatory response. So, she reasons, it might be better to be safe than sorry and stay away from using CBD before your shot – just to make sure you're getting your biggest bang for your buck with the vaccine. Unless, of course, CBD is already part of your usual medical routine, Miller says — in which case, you should continue business as usual.

Sheila Mulrooney Eldred is a freelance health journalist in Minneapolis. She's written about COVID-19 for many publications, including Medscape, Kaiser Health News, Science News for Students and The Washington Post. More at sheilaeldred.pressfolios.com. On Twitter: @milepostmedia

Pranav Baskar is a freelance journalist who regularly answers coronavirus FAQs for NPR.

[orbemnews]

Russian Campaign Promotes Homegrown Vaccine and Undercuts Rivals Russian news outlets connected to election disinformation campaigns in the United States have set their sites on a new target: convincing Spanish-speaking countries that the Russian coronavirus vaccine works better than its American competitors, according to researchers and State Department officials. The Russian campaign has focused on Latin American nations, including Mexico, which this week signed a deal to acquire millions of doses of the Russian vaccine, and Argentina, which last month began vaccinating its citizens with it. Conducted on Spanish-language social media and reinforced by the official Twitter account of the Russian embassy in Mexico City, the campaign signaled a new wrinkle in Russian influence operations, promoting Russian industry and scientific cachet over its competitors as governments around the world race to vaccinate their populations. The Russian vaccine, Sputnik V, was named after the first satellite to orbit the earth, which was launched by the Soviet Union in 1957. Sputnik V is considered less expensive and easier to transport than vaccines made by the American companies Pfizer and Moderna. But some researchers say the criticism in Russian outlets of the Western vaccines has been misleading. “Almost everything they are promoting about the vaccine is manipulated and put out without context,” said Bret Schafer, a fellow with the Alliance for Securing Democracy, an advocacy group that tracks Russian disinformation. “Every negative story or issue that has come out about a U.S.-made vaccine is amplified, while they flood the zone with any positive report about the Russian vaccine.” Media outlets backed by the Russian government posted to Facebook and Twitter hundreds of links to news stories that reported potential ties suggesting American vaccines may have had a role in deaths, the researchers said. The accounts left out follow-up reports that found the vaccines most likely played no role in the deaths. “This was a coordinated effort that was part P.R. campaign and part disinformation. It is one of the largest operations we’ve seen to promote a narrative around the vaccine in Latin America, and it appears to have had an effect,” said Jaime Longoria, a disinformation researcher at First Draft, a nonprofit that supports journalists and independent researchers. “Russia steadily seeded a narrative that has grown and been, to some degree, accepted.” Researchers have tracked similar Russian efforts in Eastern European countries that are still negotiating with Russia to buy the vaccine. Disinformation researchers have also monitored Russia spreading similar narratives in a half-dozen languages, targeting countries in central and Western Africa. China has also joined the fray, striking a similar anti-American vaccine tone aimed at a domestic audience, according to disinformation researchers. While Russia and China do not appear to be working together, their shared interests have led to a shared narrative. Last month, a Twitter account dedicated to Sputnik V included a Chinese report that falsely claimed the U.S. media had remained silent on deaths related to Pfizer’s vaccine. Intelligence officials in the United States noticed the first uptick in Russia targeting Spanish-speaking communities in August, when President Vladimir V. Putin announced that he had granted approval to Sputnik V. Since then, Russia’s campaign has intensified, said two intelligence officials who spoke to The New York Times on the condition of anonymity because they were not authorized to speak with reporters. The State Department officials described Russia’s influence campaign as a combination of Russia’s state-backed media outlets highlighting reports that warned about the dangers of the U.S. vaccines, while promoting any reports that were enthusiastic about the Russian-made vaccine. At the State Department, a report circulated last month outlining Russia’s efforts, according to the officials. A department spokeswoman said Russia has tried to promote its own vaccine while “seeking to sow distrust” in the United States about Western vaccines. Analyzing over 1,000 Russian-aligned Twitter accounts, the State Department’s Global Engagement Center found that Spanish-language accounts showed the greatest engagement. Russia’s campaign, the spokeswoman said, “undermines the collective global effort to end the global pandemic.” The influence campaign in Mexico has become the best understood of the efforts by the outlets with ties to the Kremlin. It was different from previous Russian disinformation campaigns, which leaned on posting false and misleading information online. As social media companies have become more aggressive in rooting out disinformation, Russian operations have focused on promoting selective news stories that skirt the truth, rather than reject it. The new approach was particularly effective because the Spanish-language Twitter and Facebook accounts of Russia Today and Sputnik, two state-controlled media outlets, regularly rank among the most influential in Latin America, said researchers at First Draft. Russia Today and Sputnik did not respond to a request for comment. “They have cultivated a large audience and regularly rank in the top 10 of the most-shared stories or links,” said Mr. Longoria. This week, Hugo López-Gatell, Mexico’s deputy health minister, said his government had signed a contract for the Russian vaccine, procuring 24 million doses that will cover 12 million people. The vaccine will be delivered in several stages through May. On Tuesday, the medical journal The Lancet published the results of an independent review of Sputnik V, showing that it had 91.6 percent efficacy and no serious side effects. The news was a boost to the Mexican government’s procurement efforts. In December, Facebook said it had removed a Russian disinformation campaign that posted information in French, English, Portuguese and Arabic about a number of topics, including in support of Russia’s vaccine. “We know influence operations come in different forms, including overt messages promoted through state-controlled media. We put clear labels on these publishers so people know who the information is coming from,” said Liz Bourgeois, a Facebook spokeswoman. She said Facebook had seen clandestine Russian operations mentioning Covid-19 in the past, but it had not found any current campaigns. Posts by the Russian news outlets would not have been considered clandestine and would not have been removed by Facebook. Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? Twitter declined to comment on any Russian operations targeting Spanish-speaking audiences, but said it was still investigating. The Russian campaign relied on cherry-picked news reports, researchers said. On Jan. 17, Russia Today Espanol tweeted that Norway was moving to investigate why 23 older people had died after receiving the Pfizer vaccine. Three weeks earlier, the same account tweeted multiple reports about six people who died during Pfizer’s vaccine trial. The reports did not include context from medical experts who said the deaths most likely had no connection to the vaccine. The accounts shared similar narratives on Facebook. On Jan. 5, Russia Today’s Spanish-language Facebook page shared a story with its 17 million followers claiming that a Portuguese nurse died two days after receiving the Pfizer vaccine. The story implied that the vaccine was responsible, despite doctors and an autopsy concluding the vaccine probably played no role in her death. Russia’s diplomatic corps also used their social media accounts to promote an image that the Russian vaccine was being subjected to unfair scrutiny. The volume of posts was notable, said Mr. Longoria and others who study Russian influence operations. On CrowdTangle, the Facebook-owned tool that analyzes interactions on the site, they found that Russia Today and Sputnik pages targeting Spanish-speaking audiences generated more than 1,000 posts with over six million interactions over the last year with the word “vacuna,” Spanish for vaccine. Researchers said Russia’s earlier efforts focused on other targets, like the Oxford-AstraZeneca vaccine. A Russian effort to undermine confidence in that vaccine — including memes and posts on Facebook, Twitter and elsewhere depicting it as dangerous — peaked over the summer and early fall, according to researchers. The campaign included suggestions that the vaccine would turn people into monkeys because it was developed using a chimpanzee virus. It largely targeted countries that were debating purchases of the British or Russian vaccines, according to a previous report in The Times of London. That campaign abruptly stopped in mid-December, after the drugmakers announced that Russia’s Sputnik V vaccine and the Oxford-AstraZeneca vaccine had reached a deal to test a combination of their vaccines together. “You can see a distinct tipping point, where suddenly the stories about AstraZeneca go from being wholly negative to being wholly positive,” said Mr. Longoria. “It is very stark, and very clear that when the business interests changed, so did the objectives of their influence operation.” Oscar Lopez contributed reporting. Source link Orbem News #campaign #Homegrown #Promotes #Rivals #Russian #Undercuts #Vaccine

[multipleservicelisting]

Biden Inherits a Vaccine Supply Unlikely to Grow Before April

As the Biden administration takes power with a pledge to tame the most dire public health crisis in a century, one pillar of its strategy is to significantly increase the supply of Covid-19 vaccines.

But federal health officials and corporate executives agree that it will be impossible to increase the immediate supply of vaccines before April because of lack of manufacturing capacity. The administration should first focus, experts say, on fixing the hodgepodge of state and local vaccination centers that has proved incapable of managing even the current flow of vaccines.

President Biden’s goal of one million shots a day for the next 100 days, they say, is too low and will arguably leave tens of millions of doses unused. Data collected by the Centers for Disease Control and Prevention suggests that the nation has already reached that milestone pace. About 1.1 million people received shots last Friday, after an average of 911,000 people a day received them on the previous two days.

That was true even though C.D.C. data indicates that states and localities are administering as few as 46 percent of the doses that the federal government is shipping to them. An efficient vaccination regimen could deliver millions more shots.

“I love that he set a goal, but a million doses a day?” said Dr. Paul A. Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of a federal vaccine advisory board.

“I think we can do better,” he said. “We are going to have to if we really want to get on top of this virus by, say, summer.”

The pace of vaccination is critical not just to curbing disease and death but also to heading off the impact of more infectious forms of the virus. The C.D.C. has warned that one variant, which is thought to be 50 percent more contagious, might become the dominant source of infection in the United States by March. Although public health experts are optimistic that the existing vaccines will be effective against that variant, known as B.1.1.7, it may drive up the infection rate if enough people remain unvaccinated.

The current vaccination effort, which has little central direction, has sown confusion and frustration. Some localities are complaining they are running out of doses while others have unused vials sitting on shelves.

Mr. Biden is asking Congress for $20 billion to vastly expand vaccination centers to include stadiums, pharmacies, doctors’ offices and mobile clinics. He also wants to hire 100,000 health care workers and to use federal disaster relief funds to reimburse states and local governments for vaccination costs.

Dr. Mark B. McClellan, the director of Duke University’s health policy center, said those moves should help clear the bottlenecks and “push the number beyond a million doses a day and probably significantly beyond.”

The nation’s vaccine supply in the first three months of the year is expected to substantially exceed what is needed to meet the administration’s goal. According to a senior administration official, Pfizer-BioNTech and Moderna have been ramping up and are now on track to deliver up to 18 million doses a week. Together, they have pledged to deliver 200 million doses by the end of March. A third vaccine maker, Johnson & Johnson, might also come through with more doses. If all of that supply were used, the nation could average well over two million shots a day.

Asked Thursday afternoon by a reporter if one million shots a day was enough, Mr. Biden said: “When I announced it, you all said it’s not possible. Come on, give me a break, man. It’s a good start.”

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

If I live in the U.S., when can I get the vaccine?

While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.

When can I return to normal life after being vaccinated?

Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.

If I’ve been vaccinated, do I still need to wear a mask?

Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.

Will it hurt? What are the side effects?

The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.

Will mRNA vaccines change my genes?

No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

The administration is promising to purchase even more vaccine doses as they become available from the vaccine makers, and to use the Defense Production Act to spur production. But federal health officials and corporate executives said those were longer-term goals because the supply for the first three months of the year was essentially fixed.

The Trump administration invoked the Defense Production Act to force suppliers to prioritize orders from Pfizer, Moderna and other vaccine makers whose products are still in development. Health officials said it was unclear how the new administration could use the law beyond that to boost production.

One senior federal health official involved in the government’s vaccine efforts said that Operation Warp Speed, the Trump administration’s crash development program, had looked at all available manufacturing capacity domestically and globally and that there was little space left to negotiate at this point. The official said that if there had been more doses available to the government in the first quarter, they would have been purchased.

Experts generally agree that the federal government should be locking in purchases of as many doses as possible because no one knows yet how long the vaccines will protect against the coronavirus, whether booster shots will be required and what threats mutations of the virus could pose.

From April and thereafter, the supply outlook brightens. Pfizer and Moderna have each committed to supply another 100 million doses by the end of July, and the companies might be able to provide even more. A week ago, Pfizer and BioNTech, its German partner, increased their global production target to 2 billion doses for the year from 1.3 billion doses.

Pfizer has delayed deliveries to European countries while it retools its Belgium factory to expand production. But at the firm’s factory in Kalamazoo, Mich., which supplies doses for Americans, production has quickened since the federal government ordered suppliers to prioritize Pfizer’s needs. The unexpected discovery that efficient syringes could extract a sixth dose from its vials also upped Pfizer’s estimates.

Moderna has also raised its production targets for the year to 600 million doses, up from 500 million.

Johnson & Johnson is expected to announce results from its vaccine trial within days. If that vaccine proves effective, it could drastically speed up the pace of vaccinations because unlike Moderna’s and Pfizer-BioNTech’s vaccines, it requires only one dose. The company could apply for emergency use authorization from the Food and Drug Administration as soon as the end of the month. While its manufacturing has lagged, Johnson & Johnson is trying to catch up to the goals detailed in the federal contract it signed last year.

The firm is now expected to deliver anywhere from several million to 12 million doses by the end of February, and 10 million to 20 million more doses at the end of March or the first week in April, according to several people familiar with the firm’s manufacturing output. The first batch would be produced at its Dutch factory, and later batches at a factory in Baltimore operated by its manufacturing partner, Emergent BioSolutions.

But to deliver the second batch that quickly, federal regulators may have to agree to delay certain manufacturing reviews of the vaccine from the Baltimore plant, according to people familiar with the situation. Those discussions are now underway.

Johnson & Johnson is also in preliminary talks with Merck, a major American pharmaceutical company, about using its production lines, one of several ideas that federal health officials discussed with the Biden transition team. Federal officials are interested in boosting the nation’s vaccine-making power long-term, and Merck’s facilities may be among the few with remaining manufacturing capability.

But Dr. McClellan, who sits on Johnson & Johnson’s board of directors, said it would take months to adapt Merck’s factory to produce Johnson & Johnson’s vaccine. A senior administration official predicted that it could take until the end of the year.

Other vaccine makers may also come through by midyear. Novavax has worked to iron out what were recently dire manufacturing problems that delayed its clinical trials. Moncef Slaoui, the scientific head of the federal vaccine development program in the Trump administration, said in a recent interview that Novavax could apply for emergency use authorization in late April. The government has already ordered 110 million doses of the Novavax vaccine, to be delivered by the end of June, and Novavax has said it believes it can meet that target.

Mr. Biden has surrounded himself with new health officials assigned to getting vaccines from factories to recipients, including Dr. Bechara Choucair, the former Chicago health commissioner who is the White House’s vaccinations coordinator, and Tim Manning, a former top official at the Federal Emergency Management Agency who is now the supply coordinator. Dr. David Kessler, the former F.D.A. commissioner, will help lead the federal government’s vaccine development program at the Department of Health and Human Services, with special attention to manufacturing.

After both the Pfizer-BioNTech and Moderna vaccines proved to be highly effective in clinical trials late last year, the Trump administration considered whether to rethink its strategy of backing six different vaccine makers and instead throw all of its weight behind the proven producers. One senior administration official described “countless hours of debate” over the issue.

In the end, officials decided it was critical to keep aiming for a broad portfolio of vaccines, in part because no one has figured out which vaccines might work best for children or be most effective against emerging variants. They recommended that the Biden administration do the same.

Katie Thomas and Donald G. McNeil Jr. contributed reporting.

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[orbemnews]

Help! I’m Vaccinated, But What Do I Need to Know to Protect Others? Dear Tripped Up, I’ve had my first vaccination shot and plan to book a flight to California two weeks after my second one. Like so many others, I have not seen my grandchildren for more than 15 months, during which time the baby became a toddler and the preschooler became a young boy. Now that some of us are getting successfully vaccinated and are planning on flying to see our families, I have a few questions that I’m hoping you can clear up. Margot Dear Margot, 1. Is it safe to travel by subway, train, bus or plane after I have been vaccinated? What are the proper protocols for protecting others? Even before the vaccines arrived, mass transit was rarely labeled by health officials with blanket terms like “safe” or “unsafe.” Studies conducted over the summer suggested that when certain criteria are met, subways are safer, from a viral-transmission standpoint, than one might assume. A trove of new research indicates that the chance of contracting the coronavirus while flying is low. For trains and planes alike, the focus is — and will continue to be — concrete, actionable measures that mitigate risk, like high-efficiency air filtration, enhanced disinfection, mask requirements, social distancing and capacity limits. With that in mind, let’s rephrase your first question: “It is safer for her, as the individual, to travel that way, and not herself get sick,” said Keri N. Althoff, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, deliberately emphasizing those italicized words. “We know that vaccines protect the person who has been vaccinated from getting really, really sick to the point of hospitalization or death,” Dr. Althoff said. “But we don’t know whether or not a vaccinated person can still become infected and transmit either asymptomatic infection or very mild unnoticed infection. We’re still waiting for the data.” Only about 8 percent of the United States population has gotten at least one shot, according to the latest numbers, which means you’re in the minority right now; if you’re in line to board a plane, there’s a good chance the person behind you won’t have been jabbed yet. That’s why the second part of your question is so important, and why the basic protocols for protecting others (masks, distancing, hand-washing) haven’t changed. It’s also why airlines and other transportation companies are nowhere close to getting rid of them. In fact, those protocols have only been strengthened in recent weeks by the Centers for Disease Control and Prevention, which has issued a mask mandate for all domestic transportation. “I know it’s frustrating, especially for grandparents, because it almost feels like the goal posts have been moved again,” Dr. Althoff said. “But we’ve always said that you cannot just rip your mask off and run around like it’s 2019 once you’re vaccinated. We’ve all learned not only how important our individual health is, but also how interconnected we are.” 2. Do I need a negative virus test to fly if I have a vaccination card? For the time being, vaccination cards don’t supersede — well, much of anything. Last week, the C.D.C. enacted an order requiring a negative coronavirus test (or documentation of recovery) for all incoming international travelers (ages 2 and older), including United States citizens. The test must be completed within three days of departure and submitted to the airline before boarding, and there are no exceptions for antibody or vaccination status. “It’s directly related to the fact that we don’t know if people who are vaccinated are also protected from infection and cannot transmit,” Dr. Althoff said. “So those guidelines are going to stay in place until the science says differently.” There is currently no federal testing mandate for domestic flights like the one you’re hoping to take, but C.D.C. officials have said they’re “actively looking at it.” (On earnings calls last week, executives from several domestic airlines expressed the concern that such a requirement would further stymie the faltering industry.) Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? As for what those vaccination cards might mean in the future, experts are predicting a surge in third-party “health passports” that store test results, vaccination records and travel guidelines. Some, like CommonPass and the IATA Travel Pass, have already been tested on different routes and airlines and will be further assessed, to eventually be rolled out to the public in the coming months. But for now these apps are information guardians only: Travelers shouldn’t expect them to override testing mandates and other guidelines. 3. Do I need to follow each specific state’s quarantine regulations if I have been fully vaccinated? Such a requirement would make it very difficult to travel. With the exception of New Hampshire, which now allows people who are 14 days past their second shot to skip quarantine, most states are still requiring fully vaccinated people to adhere to quarantine requirements. “States are being conservative and waiting for that data,” Dr. Althoff said. “That’s why the C.D.C. and most public health leaders are not recommending any travel until things calm down. Vaccine or not, there are no silver bullets here.” Sarah Firshein is a Brooklyn-based writer. If you need advice about a best-laid travel plan that went awry, send an email to travel@nytimes.com. Follow New York Times Travel on Instagram, Twitter and Facebook. And sign up for our weekly Travel Dispatch newsletter to receive expert tips on traveling smarter and inspiration for your next vacation. Source link Orbem News #protect #vaccinated

[orbemnews]

Biden and Drug Makers Look to Speed Coronavirus Vaccine Deliveries WASHINGTON — As President Biden winds up his second week in office, a flurry of developments in vaccine production and distribution could mean a bigger boost to coronavirus vaccine supplies than was expected even just days ago. Moderna, one of two developers of federally authorized coronavirus vaccines, is asking U.S. regulators to approve what it says could be a remarkably simple proposal to speed up the immunization of Americans against the coronavirus: Fill empty space in its vials with as many as 50 percent more doses. Moderna currently produces about half of the nation’s vaccine stock. If the change is approved — which could happen in weeks — it could ultimately add tens of millions of more doses to vaccine supplies. At the same time, the White House announced on Tuesday that it was enlisting more retail pharmacies as a channel to distribute vaccines. Jeffrey D. Zients, the White House’s coronavirus response coordinator, said the federal government would send a million doses to around 6,500 retail pharmacies on Feb. 11, the beginning of a federal program that eventually is expected to deliver vaccines directly to 40,000 pharmacies. The White House announcements were clearly intended to show that Mr. Biden was making rapid strides on the vaccine front amid huge frustration in the country over tight supplies and a chaotic, cobbled-together system for administrating the available shots. But the developments also indicated that the government was gradually expanding the way people can get their immunizations and the number of shots available. The prospect of greater supplies offered at least a glimmer of hope that many Americans might not have to wait until midsummer or later to be vaccinated while new variants spread the virus more rapidly and the nation’s death toll, now nearing 445,000 people, grows. For weeks, many health experts inside and outside the federal government have despaired over the United States’ ability to produce more than about 220 million doses that Pfizer and Moderna say they are on track to deliver by the end of next month. The spring is critical because health experts have warned that the nation could be in the grip of even more contagious variants of the virus by then. Because both Pfizer’s and Moderna’s vaccines require two doses, the supply the companies have promised would cover only 110 million of the nation’s 260 million adults eligible to be inoculated. A third vaccine developer, Johnson & Johnson, is expected to seek approval for its vaccine for emergency use soon, but might be able to deliver only as few as seven million doses before April. Fuller vials from Moderna could brighten the outlook. As the company ramped up its manufacturing of its drug over recent weeks, officials said, it realized that the process of filling, capping and labeling millions of tiny vials was a roadblock to increasing output. Were regulators to raise the number of doses that could be put in one vial, Moderna could deliver more vaccine faster, Ray Jordan, a company spokesman, said late Monday. “This just makes a lot of sense,” said Dr. Nicole Lurie, who was the assistant health secretary for preparedness and response under President Barack Obama. If Moderna can use the same size of vial and the same production lines it is already running, she said, “it’s a relatively easy and straightforward fix.” Prashant Yadav, who studies health care supply chains at the Center for Global Development in Washington, said Moderna should be able to make factory adjustments to produce fuller vials fairly quickly. If too many doses are added to a vial, it can break. Moderna officials ran a series of tests and determined the upper limit was 15. Unlike Pfizer, whose manufacturing is geared to a vial limited to about six doses, Moderna’s was big enough to hold the industry standard of 10 doses, in addition to some more, according to people familiar with the companies’ operations. As the Biden administration has searched for any way to bolster production, addressing obstacles in the “fill and finish” phase of manufacturing has increasingly become a focal point. That nuts-and-bolts stage receives less attention than the process of making the vaccine itself, but it has been identified for years as a constraint on production. Company officials have discussed the option of added doses with the Food and Drug Administration, but have not yet submitted data to justify it, they said. Federal regulators might be receptive to the idea but could approve a more modest increase than Moderna is seeking, partly out of concern that too many additional punctures by needles of the rubber covering of the vial could increase the risk of contaminating the vaccine. Asked about Moderna’s proposal, a White House spokesman said only that “all options are on the table.” Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? Among other efforts, Mr. Zients said that the government had now ensured that specialized syringes were shipped out with Pfizer’s vials so practitioners could extract a sixth dose from them. Albert Bourla, Pfizer’s chief executive, told investors Tuesday that the company was now two months ahead of schedule and expected to deliver a total of 200 million doses for Americans by the end of May instead of the end of July. The acceleration is at least partly because the government has decided to count Pfizer vial as six doses instead of five. The introduction of pharmacies will be the start of a new stage in the nation’s vaccination campaign. So far the drive has been centered in hospitals, other health care facilities and big sites like stadiums. Officials hope smaller settings like pharmacies will increasingly play a role. Some states are already delivering doses to a limited number of pharmacies; the federal program will not cut into that supply of doses, officials said. The debut of the program will be slow at first — many pharmacies will not have vaccines at all or will have very limited supply, Mr. Zients said — and it will not expand the still-limited number of high-risk groups that states have deemed to be eligible to receive vaccines. Eligible patients should check pharmacy websites for availability, Mr. Zients said. Mr. Zients said that the federal government would allocate vaccines under the pharmacy program based on the population of each state and jurisdiction, as it has been doing for vaccines distributed through other channels. The Centers for Disease Control and Prevention is also working with states to choose pharmacies in areas that are “harder to reach” and close to people at higher risk of severe cases of Covid-19, Mr. Zients said. He added that the agency would monitor the program to make sure pharmacies were distributing doses efficiently and fairly. Dozens of pharmacies and grocery stores, including both national and regional chains, are participating in the program, but not all will be involved in its initial phase. Among them are CVS, Walgreens, Walmart, Rite Aid, Kroger, Publix, Meijer, Costco, Jewel-Osco and Safeway. The expansion of the vaccine rollout to more retail pharmacies will come with new logistical challenges, as well as many of the same ones that have bedeviled the rollout so far. Pharmacies will have to find space in their stores or other locations to give out vaccines. They will need to carefully document the shots, as well as to remind people to come back for their second doses. Pharmacists and support staff will also need to keep people socially distanced and watch them afterward for side effects — while also handling all the usual demands of a busy drugstore. “It’s not just a matter of drawing up a syringe, you run out, you jab them in the arm, and you come right back,” said Adam Nachand, a Minnesota pharmacist who has spent most of his 20-year career working in retail pharmacies and is currently working for Walgreens giving out vaccines in long-term care facilities. “You have to still be able to manage that with enough time to deliver the care, do the screening, answer their questions, monitor them, etc. — and you still have a pharmacy to run.” Sharon LaFraniere and Noah Weiland reported from Washington, and Rebecca Robbins from Bellingham, Wash. Katie Thomas contributed reporting from Chicago. Source link Orbem News #Biden #coronavirus #deliveries #Drug #Makers #speed #Vaccine

[orbemnews]

Russia’s Vaccine Is Safe and Effective, Published Study Shows MOSCOW — Russia cleared a hurdle in its vaccine rollout on Monday with the publication in the respected British medical journal The Lancet of late-stage trial results showing that the country’s Sputnik V vaccine is safe and highly effective. The publication is sure to buoy the Russian government’s promotion of the vaccine at home and around the world, strengthening the Kremlin’s hand in vaccine diplomacy with a credible endorsement of the product’s safety. Russia drew criticism from Western experts when it approved the vaccine for emergency use in August — before late-stage trials had even begun — and started vaccinations that month. Moscow claimed victory in the vaccine race, as it had decades earlier in the space race with the launch of the Sputnik satellite, though at the time other vaccines were further along in testing. In the end, its politicized rollout only served to deepen skepticism. The peer-reviewed article published Tuesday cleared those doubts. It showed the vaccine had an impressive efficacy rate of 91.6 percent against the virus, and was completely protective against severe forms of Covid-19. “The development of the Sputnik V vaccine has been criticized for unseemly haste, corner cutting, and an absence of transparency,” two independent researchers, Ian Jones of the University of Reading and Polly Roy with the London School of Hygiene and Tropical Medicine, wrote in a commentary published in The Lancet. “But the outcome reported here,” they continued, “is clear and the scientific principle of vaccination is demonstrated.” Their commentary did note that the design of the Russian vaccine, which relies on a genetically modified cold virus and is similar to half a dozen others including those made by Johnson & Johnson and AstraZeneca, is difficult to mass produce. Though quick out of the gate with regulatory approval, Russia has lagged in mass production and actual vaccinations, the process that in fact protects people from illness and death. The Russian financial company promoting the vaccine has said about two million people have been inoculated with Sputnik V worldwide, far fewer than with the Pfizer or Moderna vaccines. The company, the Russian Direct Investment Fund, does not break down the vaccinations by country. But of the two million vaccinations, at least hundreds of thousands have been in countries outside of Russia, suggesting the government has quietly prioritized exports. While beneficial for speeding global immunity to the disease, the policy has also reaped public relations and diplomatic benefits for the Russian government, even as residents of many provincial Russian cities still do not have access to shots. On Monday, for example, the authorities in the Leningrad region in northwest Russia said supplies had run out. So far, 15 other countries, including Argentina, Hungary and Serbia, have approved the Sputnik V vaccine for emergency use. Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? “Publication in The Lancet today really shows that Sputnik V is the vaccine for all mankind,” Kirill Dmitriev, the director of the Russian Direct Investment Fund, said in a statement. “Today is a great victory.” The vaccine is one of three that have completed late-stage trials showing an efficacy rate above 90 percent, along with the shots made by Pfizer and Moderna. The version of the Russian vaccine tested in the trials must be shipped and stored at difficult-to-manage temperatures below about zero degrees Fahrenheit. The Russian ministry of health has also approved a freeze-dried version that can be stored in a refrigerator. Russia is marketing Sputnik V at a price of about $10 per dose for the two-shot vaccine. The clinical trial conducted in Moscow late last year on about 20,000 volunteers showed only side effects commonly associated with vaccines, such as headaches or mild fevers. The researchers determined that no so-called adverse events, or serious medical problems among the trial participants, were associated with the vaccine. In total, they found 70 serious medical episodes in 68 people in the trial, in both the placebo and vaccine group. Notably, two people who were administered the vaccine died of Covid-19 following illnesses that began days after the first injection. The researchers said both people were likely infected before the trial began and fell ill before the vaccine had time to generate antibodies to the coronavirus. The “disease had progressed before any immunity from the vaccine developed,” they wrote. The Russian authors of The Lancet article also noted the trial in Moscow lacked ethnic diversity to ensure the vaccine is safe in nonwhite recipients. A trial of Sputnik V underway now in the United Arab Emirates includes a more diverse study group, the researcher say. Source link Orbem News #effective #Published #Russias #safe #Shows #Study #Vaccine

[orbemnews]

Slow Pace of Vaccinations Pushes Europe Toward Second Economic Slump The new year was supposed to bring improved economic fortunes across Europe, as coronavirus vaccines made their way into the bloodstream. Instead, the eurozone economy shrank at the end of 2020, according to official figures out Tuesday, raising fears of a double-dip recession and demonstrating that the pandemic is likely to remain a force for at least a few more months in the face of the European Union’s pronounced failure to distribute vaccines. Economic output in the 19 countries that belong to the eurozone fell 0.7 percent in the fourth quarter compared with the previous quarter, according to a preliminary estimate by the European Union’s official statistics agency. For the full year, overall output fell 5.1 percent. Europe is now likely to suffer continued economic contraction over the first three months of 2021 and perhaps into the early part of the next quarter, as governments are forced to maintain restrictions on commercial life, according to a report released Tuesday by Oxford Economics in London. “There is definitely a risk that vaccine distribution continues to be disappointing,” said Tomas Dvorak, a eurozone economist with Oxford Economics. “There is risk that the second quarter will also get quite bad.” The failure of European governments to get vaccines to their citizens could create a political backlash, fueling resentment toward Brussels and souring the already uneasy relations among the 27 countries that belong to the European Union. Competition for vaccines has already strained the bloc’s relations with Britain. “We have to watch the potential political consequences,” Holger Schmieding, chief economist at Berenberg Bank in London, said in a note. Previously, Oxford and other economists had forecast stagnation for the first quarter of the year, followed by a marked improvement in the spring. That view was guided by the assumption that vaccines would be distributed widely, allowing authorities to lift restrictions imposed to choke off the spread of the coronavirus. As people returned to shops, restaurants and holiday destinations, and as factories resumed production, economies would again expand. That scenario now appears set for a delay as Europe struggles to secure and distribute vaccines. The eurozone now faces its second recession in six months after its economy shrank in the first half of 2020. European factories have largely adapted to the pandemic and are operating almost normally, but people whose jobs depend on face-to-face contact are suffering. More than half of Germans who work in hotels or restaurants, about 600,000 people, are on government-subsidized furloughs and effectively unemployed, according to the Ifo Institute in Munich, a research organization. Germany managed only meager growth in the fourth quarter of 2020, and the economies of Italy and France declined. All three remain in tight lockdown. Across the 27 states of the European Union, only 2.5 percent of national populations on average have received at least one dose of vaccine, while Germany, Italy, and France are all below that dismal mark. By contrast, Britain — which aggressively purchased vaccines while relying on its national health system to distribute them — has injected at least one dose into more than 13 percent of the population. The United States has vaccinated about 7 percent of its population. Economists assume that the European Union will succeed in substantially ramping up vaccination by spring, allowing restrictions to be gradually lifted. But the potential for further disappointment remains. “The tough Corona restrictions have once again plunged the euro area economy into recession,” Christoph Weil, an economist at Commerzbank, said in a note to clients. He predicted that the downturn in the current quarter will be even steeper. Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? Europeans had hoped for stability after a roller coaster year. In the second quarter of 2020, gross domestic product fell 11.7 percent as the pandemic took hold. Then growth rebounded 12.4 percent in the following quarter, the most on record, as lockdowns eased and firms adjusted to the crisis. Economists do not expect such severe gyrations in 2021, but few expect the eurozone to recover its previous economic strength until 2022. Often maligned for ponderous and bureaucratic ways in the face of crisis, the European Union dickered over contract terms with pharmaceutical companies, allowing more aggressive governments in London, Washington and elsewhere to lock up supplies. Many member states then opted not to purchase their full allocations from the European bloc. If shortages and distribution bottlenecks persist, the economic recovery could be further stymied as governments maintain restrictions even longer. Beyond the timing of the eventual return to economic growth, the botched European vaccination drive also threatens the magnitude of the recovery. As hopes that vaccines would prove transformative give way to a more complex understanding of the continued risks of the pandemic, people may prove more cautious even after governments allow a return to shops, offices and entertainment venues. Companies that have figured out how to substitute Zoom calls for business travel may be slow in putting employees back on airplanes. If an aversion to risk persists, that could limit economic growth even after the pandemic is controlled. Eventually, however, the vaccines will find their way into European arms and the infection rate will slump, allowing a return to places now shunned as vectors for the virus. “I’m wary of saying we’ll get back to normal, because it’s quite hard to pin down what normal is,” Mr. Dvorak said. “But I think it’s reasonable to assume that consumers will resume their spending patterns.” Source link Orbem News #Economic #Europe #pace #Pushes #slow #slump #vaccinations

[orbemnews]

Johnson & Johnson’s Vaccine Offers Strong Protection but Fuels Concern About Variants Johnson & Johnson announced on Friday that its one-dose coronavirus vaccine provided strong protection against Covid-19, potentially offering the United States a third powerful tool in a desperate race against a worldwide rise in virus mutations. But the results came with a significant cautionary note: The vaccine’s efficacy rate dropped from 72 percent in the United States to 57 percent in South Africa, where a highly contagious variant is driving most cases. Studies suggest that this variant also blunts the effectiveness of Covid vaccines made by Pfizer-BioNTech, Moderna and Novavax. The variant has spread to at least 31 countries, including the United States, where two cases were documented this week. Johnson & Johnson said that it planned to apply for emergency authorization of the vaccine from the Food and Drug Administration as soon as next week, putting it on track to receive clearance later in February. “This is the pandemic vaccine that can make a difference with a single dose,” said Dr. Paul Stoffels, the chief scientific officer of Johnson & Johnson. The company’s announcement comes as the Biden administration is pushing to immunize Americans faster even with a tight vaccine supply. White House officials have been counting on Johnson & Johnson’s vaccine to ease the shortfall. But the company may only have about seven million doses ready when the F.D.A. decides whether to authorize it, according to federal health officials familiar with its production, and about 30 million doses by early April. The variant from South Africa, known as B.1.351, could make things even worse for the vaccine push. Given the speed at which the variant swept through that country, it is conceivable that by April it could make up a large fraction of infections in the United States. That would undermine the effectiveness of available vaccines. The fact that four vaccines backed by the federal government seem to be less effective against the B.1.351 variant has unsettled federal officials and vaccine experts alike. Facing this uncertainty, many researchers said it was imperative to get as many people vaccinated as possible — quickly. Lowering the rate of infection could thwart the contagious variants while they are still rare, and prevent other viruses from gaining new mutations that could cause more trouble. “If ever there was reason to vaccinate as many people as expeditiously as we possibly can with the vaccine that we have right now, now is the time,” Dr. Anthony S. Fauci, the government’s top infectious disease expert, said in an interview. “Because the less people that get infected, the less chance you’re going to give this particular mutant a chance to become dominant.” As the United States scrambles to get enough vaccines, the country is turning into something of an evolutionary experiment. The B.1.351 variant is one of several that have arrived in the country or originated here, all with the ability to spread faster than other variants. “The pandemic is a lot more complicated now than it was a couple months ago,” said Dr. Dan Barouch, a virologist at Beth Israel Medical Center in Boston. Vaughan Cooper, an evolutionary biologist at the University of Pittsburgh, said that all the new variants were likely evolving quietly for months before bursting on the scene. “I think we’re going to see many stories like this,” he said. Federal regulators are also still waiting on data from Johnson & Johnson’s new manufacturing facility in Baltimore that prove it can mass-produce the vaccine. The company is counting on that factory to help reach its contractual pledge to the federal government of 100 million doses by the end of June. If Johnson & Johnson can deliver vaccines quickly enough to the United States, it might be able to help drive down cases before variants make things worse. Since the vaccine requires only a single shot — unlike the Moderna and Pfizer-BioNTech vaccines, which require two — that delivery would translate into full coverage for 100 million people. Johnson & Johnson’s vaccine has another advantage that might help speed up the rollout. It can stay viable in a refrigerator for three months, while the two authorized vaccines have to be kept frozen. That gives the company an edge not just in reaching more isolated parts of the United States, but in getting the vaccine to remote areas of the world that could otherwise seed more aggressive mutants. “If you talk about the potential impact on the developing world, I believe it’s much more relevant than here,” Dr. Fauci said. But vaccine makers also have to prepare for the B.1.351 variant or another one surging to dominance and demanding new vaccines. “You’ve got to be nimble enough to be able to adapt by upgrading our vaccines that match the dominant strain,” Dr. Fauci said. Exactly when to make that switch will be a difficult decision, because the viruses are spreading unpredictably, and manufacturing new doses will be a huge undertaking. “The implications of that are big. You would not take that choice lightly,” said John D. Grabenstein, an epidemiologist with the Immunization Action Coalition, a nonprofit organization that disseminates information about vaccines. “It’s not doomsday. It’s just that we are going to need a bigger boat.” Johnson & Johnson’s announcement came one day after Novavax said an early analysis of its 15,000-person trial in Britain had revealed that the two-dose vaccine had an efficacy rate of nearly 90 percent there. But in a small trial in South Africa, the efficacy rate dropped to just under 50 percent. Johnson & Johnson presented only a summary of findings of its clinical trial. The vaccine was 85 percent effective in preventing severe disease in all three regions where the trial was run: the United States, Latin America and South Africa. After 28 days, none of the vaccinated participants who developed Covid-19 had to be hospitalized. The company reported that the vaccine’s protective effect seems to increase with time. But without long-term data on immunity, scientists and regulators do not yet know whether the vaccine’s efficacy peaks at some point before dropping. Dr. Stoffels said the company was still waiting for more data on whether the vaccine can protect against asymptomatic infection. The company is preparing a lengthy briefing document it will submit to the F.D.A. in its application for authorization. The agency’s scientists will review the raw data from the trial and present their own analysis. Unlike the messenger RNA vaccines made by Pfizer-BioNTech and Moderna, Johnson & Johnson uses an adenovirus, which normally causes the common cold. While adenovirus-based vaccines have been investigated for some three decades, they have yet to be licensed for use in the United States. Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? Johnson & Johnson’s Ebola vaccine became the first approved adenovirus-based vaccine for any disease when European regulators gave it the green light last July. Astra-Zeneca and the University of Oxford used a different adenovirus for their coronavirus vaccine, which is now authorized in Britain and other countries. Russian scientists created their Sputnik V vaccine from adenoviruses as well. Johnson & Johnson received $456 million from Operation Warp Speed to support its research. In July, the government agreed to purchase 100 million doses for $1 billion if it proved safe and effective. That same month, the company moved into clinical trials, which found that a single shot produced a strong immune response, consistent with experiments done on monkeys. Johnson & Johnson began the final “Phase 3” trial in September, again using a single dose. It recruited volunteers in the United States, South Africa and Latin America. Half of the volunteers received the vaccine, and half received a placebo. The company then had to wait. Only when enough people in the trial got Covid-19 would an independent board of advisers look at the results to see how many sick volunteers were vaccinated — a process known as unblinding. Late last year, surges of coronavirus infections accelerated the trial toward unblinding. In December, Johnson & Johnson decided it would not need to recruit 60,000 volunteers as it originally planned. It capped the trial at 45,000. Like other vaccine developers, Johnson & Johnson was required by the F.D.A. to also record information about adverse events experienced by the volunteers for the first few months after vaccination. Dr. Barouch, who led the team that designed the vaccine and tested it on animals last year, had to wait for months for the unblinding. “I’m thinking a lot about it,” he said in a Jan. 11 interview. “But, no, I don’t have champagne ready to go.” After he learned the results, Dr. Barouch said he was delighted. “I think this vaccine will have a public health benefit throughout the world,” he said. Johnson & Johnson is also moving forward with other trials of the vaccine to see how it can be improved. In December it began a trial with two doses. Dr. Fauci was optimistic that people who get a so-called prime boost may enjoy even more protection. “If they get a prime boost, it’s entirely conceivable that they can get up to 90-plus percent,” he said. In addition, Dr. Stoffels said that Johnson & Johnson was tailoring a version of its vaccine with a protein patterned after the B.1.351 variant. It could potentially deploy it in countries where that version of the virus was a threat. “Pretty much all vaccine developers now are having that conversation,” said Dr. Peter J. Hotez, a vaccine expert with the Baylor School of Medicine and the creator of a different coronavirus vaccine. Source link Orbem News #concern #fuels #Johnson #Johnsons #Offers #Protection #strong #Vaccine #Variants

[orbemnews]

Pregnant Women Get Conflicting Advice on Covid-19 Vaccines Pregnant women looking for guidance on Covid-19 vaccines are facing the kind of confusion that has dogged the pandemic from the start: The world’s leading public health organizations — the U.S. Centers for Disease Control and Prevention, and the World Health Organization — are offering contradictory advice. Neither organization explicitly forbids or encourages immunizing pregnant women. But weighing the same limited studies, they provide different recommendations. The C.D.C.’s advisory committee urged pregnant women to consult with their doctors before rolling up their sleeves — a decision applauded by several women’s health organizations because it kept decision making in the hands of the expectant mothers. The W.H.O. recommended that pregnant women not receive the vaccine, unless they were at high risk for Covid because of work exposures or chronic conditions. It issued guidance on the Moderna vaccine on Tuesday, stirring uncertainty among women and doctors on social media. (Earlier this month, it published similar guidance on the Pfizer-BioNTech vaccine.) Several experts expressed dismay at the W.H.O.’s stance, saying the risks to pregnant women from Covid were far greater than any theoretical harm from the vaccines. “There are no documented risks to the fetus, there’s no theoretical risks, there’s no risk in animal studies,” from the vaccines, said Dr. Anne Lyerly, a bioethicist at the University of North Carolina, Chapel Hill. “The more that I think about it, the more disappointed and sad I feel about it.” The difference of opinion between the C.D.C. and the W.H.O. is not rooted in scientific evidence, but the lack of it: Pregnant women have been barred from participating in clinical trials of the vaccines, a decision in line with a long tradition of excluding pregnant women from biomedical research, but one that is now being challenged. While the rationale is ostensibly to protect women and their unborn children, barring pregnant women from studies pushes the risk out of the carefully controlled environment of a clinical trial and into the real world. The practice has forced patients and providers to weigh sensitive, worrisome issues with little hard data about safety or effectiveness. Vaccines are generally considered to be safe, and pregnant women have been urged to be immunized for influenza and other diseases since the 1960s, even in the absence of rigorous clinical trials to test them. “As obstetricians we are often faced with difficult decisions about using interventions in pregnancy that have not been properly tested in pregnancy,” said Dr. Denise Jamieson, an obstetrician at Emory University in Atlanta and a member of the Covid expert group at the American College of Obstetrics and Gynecologists. The college strongly advocated including pregnant and breastfeeding women in the vaccine trials. “What many people miss is that there are risks to doing nothing,” Dr. Jamieson said. “Not offering pregnant women the opportunity to be vaccinated and protect themselves, where there are known and severe risks of Covid amplified by pregnancy, is not a wise strategy.” The uncertainty isn’t limited to Covid vaccines: Many if not most medications, including widely used drugs, have never been tested in pregnant women. It can take years or decades for adverse side effects to come to light in the absence of a study with a control group for comparison. “This isn’t a story about the W.H.O. or other people advising against vaccination in pregnancy,” said Carleigh Krubiner, a policy fellow at the Center for Global Development and a principal investigator for the Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies project (PREVENT). “It’s a story about the failure to timely and appropriately include pregnant women in vaccination studies.” Saying she understood the commitment of the W.H.O. and other advisory bodies to rely on scientific studies, Dr. Krubiner added: “The reality is that we don’t yet have the data on these vaccinations in pregnancy, and it’s very difficult without that data to come out and give a full-throated recommendation in support.” The C.D.C. and the W.H.O. have offered dissonant advice many times over the course of the pandemic — most notably on the usefulness of masks and the possibility of the virus traveling by air indoors. In a statement, the C.D.C. said on Thursday that based on how the Pfizer-BioNTech and Moderna vaccines work, “they are unlikely to pose a specific risk for pregnant women.” The C.D.C.’s recommendation may make sense for the United States, where women may easily be able to consult with their health care providers, said Joachim Hombach, a health adviser to the W.H.O. on immunizations. But the W.H.O. provides guidance to many low- and middle-income countries where women do not have access to doctors or nurses, he said. The W.H.O.’s recommendation was also made “in the context of limited supply” of the vaccines, Dr. Hombach said. “I don’t think the language is discouraging, but the language is stating the facts.” Pfizer did not include pregnant women in its initial clinical trials because it followed the policies outlined by the Food and Drug Administration to first conduct developmental and reproductive toxicity studies, said Jerica Pitts, a spokeswoman for the company. Pfizer and Moderna both provided results from toxicity studies in pregnant rats to the F.D.A. in December. Pfizer plans to begin a clinical study in pregnant women in the first half of 2021, Ms. Pitts said. Moderna is establishing a registry to record outcomes in pregnant women who receive its vaccine, according to Colleen Hussey, a spokeswoman for the company. Critics of the companies’ decisions to exclude pregnant women from trials say the reproductive toxicity studies could have been carried out much earlier — as soon as promising vaccine candidates were identified. The companies should have added a protocol to enroll pregnant women once it was clear the vaccines’ benefits outweighed potential harm, Dr. Krubiner said. “It’s hard to understand why that delay is happening and why it wasn’t initiated sooner,” she said. “The bigger issue is, we’re going to have lost months by the time they start them.” Akiko Iwasaki, an immunologist at Yale University who has advocated immunizations for pregnant women questioned the underlying issue that prompted the W.H.O.’s decision. “Whatever it is, I wish the W.H.O. would be more transparent in their reasons behind this recommendation,” she said. “Women’s lives depend on it.” Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? The toxicity data released by Pfizer and Moderna in December found no harmful effects from the vaccines to pregnant rats — evidence cited by the W.H.O. in its guidance. One extreme consequence of a conservative approach to vaccines played out during the Ebola epidemic in the Democratic Republic of Congo, when health workers offered a vaccine for the disease to all frontline workers and contacts of people confirmed to have it — except if they were pregnant or breastfeeding. Without the vaccine, 98 percent of pregnant women who were infected with the Ebola virus died. The rules were changed following a public outcry but, by then, many pregnant women had died, Dr. Lyerly said. Covid-19 has also proved to be dangerous to pregnant women. A large C.D.C. study published in November found that pregnant women with Covid who were symptomatic were significantly more likely to be hospitalized or to die when compared with nonpregnant women who also had Covid symptoms. The evidence prompted agency officials to add pregnancy to the list of conditions that heighten the risk of severe disease and death from Covid. The C.D.C. has set up a smartphone application called v-safe to solicit reports of side effects from immunized people. About 15,000 pregnant women have enrolled in the registry so far, the agency’s immunization committee reported on Wednesday. “I think that’s our best chance of getting safety data rapidly,” Dr. Jamieson said. Britain initially starkly recommended against Covid vaccines for pregnant women, but has since revised its guidance to authorize inoculating pregnant women who are frontline workers or otherwise at high risk. “I’m hoping the W.H.O. will reconsider as well,” Dr. Jamieson said. Some experts said the recommendations are not as divergent as they may appear at first glance. “The C.D.C. is more inclined to say that pregnant women should have access to the vaccine, but should discuss their circumstances with their providers,” said Dr. Ana Langer, a reproductive health expert who leads the Women and Health Initiative at Harvard’s T.H. Chan School of Public Health. “The W.H.O.’s interim recommendation says that women who are at particularly high risk of exposure or getting Covid should get the vaccine. So where’s the big difference here?” Denise Grady contributed reporting. Source link Orbem News #Advice #conflicting #Covid19 #Pregnant #Vaccines #Women

[orbemnews]

Novavax’s Vaccine Works Well — Except on Variant First Found in South Africa Novavax, a little-known company supported by the U.S. federal government’s Operation Warp Speed, said for the first time on Thursday that its Covid-19 vaccine offered robust protection against the virus. But it also found that the vaccine is not as effective against the fast-spreading variant first discovered in South Africa, another setback in the global race to end a pandemic that has already killed more than 2.1 million people. The news was problematic for the United States, which hours earlier reported its first known cases of the contagious variant in two unrelated people in South Carolina. And it came just days after Moderna and Pfizer said that their vaccines were also less effective against the same variant. Novavax, which makes one of six vaccine candidates supported by Operation Warp Speed last summer, has been running trials in Britain, South Africa, the United States and Mexico. It said Thursday that an early analysis of its 15,000-person trial in Britain revealed that the two-dose vaccine had an efficacy rate of nearly 90 percent there. But in a small trial in South Africa, the efficacy rate dropped to just under 50 percent. Almost all the cases that scientists have analyzed there so far were caused by the variant, known as B.1.351. The data also showed that many trial participants were infected with the variant even after they had already had Covid. “We have the first trial — we are the first to conduct an efficacy trial — in the face of a changing virus,” said Stanley Erck, the president and chief executive of Novavax. He said that researchers expected the variants could change the trial results, but “the amount of change has been a bit of a surprise to everyone.” The South Africa trial was relatively small — with just 4,400 volunteers — and was not designed to come up with a precise estimate of how much protection the vaccine provides. Still, the results were striking enough that the company said it would soon begin testing a new vaccine tailored to protect against the variant from South Africa. “You’re going to have to make new vaccines,” Mr. Erck said. While the Pfizer and Moderna vaccines rely on a newer mRNA technology that has not been used in previous vaccines, Novavax’s candidate employs an older, more established method that relies on injecting coronavirus proteins to provoke an immune response. The fact that three vaccines all appeared to show lowered effectiveness against the variant from South Africa is not encouraging, and the results Novavax announced Thursday were the first to occur outside of a laboratory, testing how well a vaccine worked in people infected with a new variant. Johnson & Johnson is also on the cusp of announcing results of its Covid-19 vaccine trials, and has also tested its candidate in South Africa. The announcement from Novavax raises the stakes for Johnson & Johnson. The company was expected to announce its results as early as last weekend, and the delay has triggered speculation among scientists that the firm has also discovered that its vaccine worked less well in South African trial volunteers who were infected with the variant. In an earnings call on Tuesday, Alex Gorsky, the chief executive officer of the company, said they were looking forward to sharing results from their late-stage trial by early next week. The emergence of several highly contagious variants has complicated efforts to bring the pandemic under control, leading world leaders to shut down travel to places like Britain and South Africa even as the variants already appear to have circled the globe. In the United States, researchers have warned that the variant first identified in Britain, which is believed to be more infectious, could become the dominant form of the virus in this country by March. The United States is well behind other countries in testing for such variants, and the one from South Africa has been found in about 30 countries. But experts have also said there are reasons for optimism, noting that the vaccines remain effective. The best way to combat contagious new variants is to continue vaccination and other public health measures, which will slow the virus’s ability to infect new people and mutate further. Drug makers could update their vaccines and offer new shots at regular intervals, similar to the flu vaccine. Covid-19 Vaccines › Answers to Your Vaccine Questions Am I eligible for the Covid vaccine in my state? Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area Is the vaccine free? You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available. Can I choose which vaccine I get? How long will the vaccine last? Will I need another one next year? That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data. Will my employer require vaccinations? Where can I find out more? Novavax’s trial in Britain tested how many volunteers developed symptoms of Covid-19 one week after receiving a second dose. The company said Thursday that its initial analysis showed that out of 62 participants who developed the illness, 56 had received a placebo and 6 had gotten the vaccine. The newer, more contagious variant first identified in Britain was found to have caused about 50 percent of the cases in the trial, Novavax said. If those results were to bear out in the larger clinical trial in the United States and Mexico, which has enrolled about 16,000 out of a goal of 30,000 people, then it would put the vaccine on par with the Moderna and Pfizer-BioNTech vaccines, which were shown to be about 95 percent effective. But the news in South Africa was not as encouraging. Novavax’s smaller trial found the vaccine to have a 49.4 percent efficacy overall. (The company reported that about 6 percent of the trial’s participants were positive for H.I.V., and for those who were not H.I.V. positive, the vaccine had a 60 percent efficacy.) The company said the trial began recording cases of Covid-19 from September through the middle of this month, when the more contagious variant was widely circulating. Novavax said 44 trial participants developed Covid-19, and it sequenced the genetic lineage of 27 cases. Of those, 25 cases were caused by the more contagious version of the virus. The company also said that about one-third of the trial participants in South Africa had previously developed Covid-19 after being infected by the original form of the virus, and that their results showed those previous infections did not protect them against the new variant. The company said its vaccine did provide some protection for those who had previously contracted the disease, but did not include this group in its analysis. Novavax began working on a new version of the vaccine this month to address more contagious variants, which could serve either as a booster shot or which could be given at the same time as their original vaccine. The B.1.351 variant first came to the attention of scientists in December. It contains a number of mutations, including some that change the shape of the surface of the virus and weaken the effectiveness of vaccines. Looking back at older samples, South African scientists found the first evidence of B.1.351 dating back to October. But by December, it had swept across the country, becoming the dominant lineage of the coronavirus in many regions. That alone would make B.1.351 a worrying development. In Britain, researchers found another fast-spreading variant known as B.1.1.7. In Brazil and California, other scientists have found variants that may be more contagious than previous forms of the coronavirus. Source link Orbem News #Africa #Novavaxs #South #Vaccine #Variant #Works