#MODERNA

[dillyt]

Great news for uninsured adults in the USA who want a COVID-19 booster! It now appears that ALL CVS locations are now active participants in the Bridge Access Program. The Bridge Access Program gives out free Covid-19 vaccinations to 18+ adults who otherwise can't afford one, so if you have a CVS near you, please go get one! For others who don't have a CVS near them, please go to vaccines.gov, click on "Find Covid-19 vaccines", fill out which vaccines you prefer (you can mix different vaccines if you have to so i reccomend just marking all of them for the age groups you need), and when the next page loads mark the "Bridge Access Program Participant" option to see only locations that are Bridge Access Program participants. Hopefully, other places that aren't CVS will start participating soon, so just check back every so often to see if there are any updates. The CDC Bridge Access Program website also has more details on what locations will be participating, but only CVS is appearing as an active participant on the vaccines.gov location finder at the moment.

[awesomecooperlove]

BLOOD CLOTHS

💉🌡️🦠

[nimchimpskyphd]

The amount of spam / bot accounts sharing anti-vax sentiment in the tags is frustrating. I'm blocking them all on sight. All the websites seem like a virus waiting to happen which is almost ironic. Reminder not to click on their links so that your devices aren't infected.

If you want, type the headline into a search engine but don't click on random links from people you don't know or trust.

[dosesofcommonsense]

[disease]

MODERNA // DIE4U [THE FUTURE IS AMONG US, MAY 2024]

[pandemic-info]

AMAZING, informative thread by Michael Lin, MD PhD (Assoc. Professor of Neurobiology & Bioengineering @Stanford | https://linlab.stanford.edu/) about the differences between Novavax & mRNA.

& Full thread pasted below:

(P.S. I apologize about the images, Tumblr is not letting me add ALT text for some reason. The original on ThreadReader might be better in that case.)

Flew in from Asia today to learn the exciting news that Novavax's JN.1 booster has been approved! So happy that the delay relative to RNA vaccines is less than a week. People will finally have a choice of RNA vs protein vaccines this fall. What are the differences?

I made this graphic to show how different vaccine types work (back in 2021). We can just look at line 1 (protein vax like Novavax) and line 3 (RNA vax). In protein vax, antigen-presenting cells take up the antigen to activate B cells and Thelper cells....

In RNA vax, your muscles cells take up RNA and translate it into antigen. This process tends to be a bit inflammatory (apparently that's inherent to RNA uptake) so some cells die and release proteins that are also taken up by antigen-presenting cells. The main differences between protein and RNA vax in practice are threefold: 1.  Cellular immunity, meaning CD8 cytotoxic T cell responses: RNA vax elicit this, whereas Novavax CTL responses are minimal.

RNA vax probably do so because having foreign antigens in muscle cells looks like a virus has infected those cells. The antigens are presented on MHC-I (whereas proteins ingested by antigen-presenting cells are expressed on MHC-II), and this is necessary for activating CD8 CTLs. 

Cellular immunity provides a backup and mopping-up function after antibodies have cleared away viruses (note I did not use the term neutralize; more on why later), and lack of cellular immunity may cause prolonged disease. But cellular immunity is long-lived and broad-spectrum... 

If you've had a RNA vax or a SARSCoV2 infection within the last 3 years, then you have cellular immunity. It's broad-spectrum as CTLs recognize many conserved regions of the spike (if you've only been vaccinated and never infected) or other viral proteins if you were infected.

And if you've never had a CTL response (because you only took Novavax vaccines and were never infected — a vanishingly small possibility), then if you get infected you will develop a CTL response in week 1 while antibodies are clearing the virus, after which CTLs help "mop up"

As you can see, I don't think much about keeping CTLs up. Once you have a CTL response (from RNA vax or infection), it stays with you. If you don't have one, you'll develop it during illness. It doesn't help prevent infection and having it ahead of time makes little difference.  

The second difference between protein vax and RNA vax is the peak amplitude of antibodies. Peak antibody levels are higher with RNA vax. This is certainly an advantage of RNA, but it only lasts for 2-6 weeks after inoculation. Titers drop dramatically after that.

This wave is going strong, and does not look like it will peak within 6 weeks. There's a lot of disease going on now, as there was a month ago. It seems likely there will be virus going around at Halloween and Thanksgiving gatherings, and Christmastime-New Year parties too.  

Data on superiority of RNA-boosted Abs in month 1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9576915/ As waves tend to last 3 months (and this one appears might even become 6 months), a 6-week period of somewhat higher protection doesn't seem so useful as how well a vax works over the entire wave, IMO.

And the data do show that in the long-term (measured from 3mo post-vax) Novavax is as good as RNA. Here's one study: https://www.sciencedirect.com/science/article/pii/S0092867422006535

Now if there were no price to pay for having one month of high antibodies, then sure, why not RNA. But that brings us to difference #3 between protein and RNA vaccines: the RNA vax are stronger in their adverse effects on the immune system than any other vaccine we've ever taken.

IgG is the major class of antibodies your B cells make. When they encounter the same antigen repeatedly, often seen in autoimmunity or with parasitic infections, the IgG genes undergo "isotype switching" to IgG4, which lacks any of the "Fc effector" functions of other IgG types. The Fc functions include antibody-mediated recruitment of phagocytic cells to engulf and destroy antibody-coated viral particles. We hear a lot about neutralizing antibodies because it's easy to test how well your blood neutralizes SARSCoV2 from entering cells, but in the body… 

It's more efficient for an antibody to tag a virion, get the virion engulfed and destroyed, and for the antibody to be recycled to repeat the process. If neutralization were the only thing, we'd need more antibody molecules than spike proteins across all virions, a tall order.

An issue that's now well known is that RNA vaccines cause isotype switching to IgG4, which lacks these Fc functions. This was not the case with earlier vaccines, so appears to be the result of the strong B cell stimulation performed by RNA vaccines. https://www.science.org/doi/10.1126/sciimmunol.ade2798

Novavax, likely because its stimulation method is slow and steady, instead of creating a hot and heavy pseudoinfection in your muscles like RNA, does not induce the IgG4 isotype switch. It instead generates more IgG3, with the most Fc effector function. https://www.journalofinfection.com/article/S0163-4453(24)00053-7/fulltext

So those are the 3 differences between Novavax and RNA: (1) CTL responses with RNA, (2) higher peak Abs with RNA, (3) faster conversion to non-catalytic IgG4 with RNA. Actually there's a fourth: Side effects are stronger with RNA than Novavax. Essentially the headache and fatigue we get from RNA vaccines is quite a bit out of line compared with historical flu vaccines, whereas Novavax is more in line with flu vaccines (not surprisingly, as both use proteins). Here's one study; there are others: https://www.mdpi.com/2076-393X/12/7/802

So for those of use who have been following the development of RNA vaccines and watching the Novavax tortoise moving toward the finish line, the major difference has always been clear: RNA vax provide a strong stimulus, stronger than what we are used to in annual vaccines.

Without a doubt, for the initial rounds of vaccination in 2020 and 2021, RNA was a lifesaver. The higher reactogenecity was a small price to pay to avoid hospitalization. Issues with vaccine purity delayed Novavax, so we were lucky to have RNA ready. 

However, now that we are getting into these 3- to 6-month long waves, now that nearly everyone has had COVID-19 and therefore has hybrid humoral and cellular immunity, we can rethink which kind of vaccine is appropriate on an annual basis. 

Essentially now we are fighting off a chronic threat of COVID19. Vaccines are really not effective enough to be the only preventive measure. We'd have to get vaxxed 4 times a year, which is not going to happen. Instead we have to figure out our own behavioral risk/reward ratios. 

For preventing transmission, the situation is similar to flu (a poor analogy as SARSCoV2 outcomes can often be more severe than flu). Perhaps the best we can do is avoid spending too much time in loud crowded indoor setting, and encourage people to test at the first symptoms.

So the vaccines now become a personal choice, and there is no right or wrong answer. But given the differences presented above, my own plan is to get 2 years Novavax (slow and steady baseline) and 1 year Pfizer-BioNTech (for a little CD8 T cell push).

If in a given year, we have a tightly timed surge for just 2 month (say Dec-Jan), then RNA may be worth considering, but that doesn't seem to be happening this year. So might was well do the lesser insult of protein, riding with the tortoise instead of the hare.

That's just me. Not medical advice. YMMV. This is essentially a willingness to take on slightly higher integrated risk of infection for a more balanced immune system.

Forgot to mention, there's a formulation difference between the JN.1 Novavax and the KP.2 Pfizer and Moderna. At the VRBPAC meeting, Novavax made a point that JN.1 was the father to all circulating strains and the antigenic differences were minor compared to the leap from XBB. 

This sounded reasonable to me at the time, because in protein evolution we always evolve on the latest two generations in case the latest one becomes an evolutionary dead-end. The VRBPAC agreed with Novavax, which was why their recommendation was anything in JN.1.

Everyone thought that was settled, except the next day, FDA (withouth asking VRBPAC) announced they would prefer KP.2 which was the rising sublineage at the time. Pfizer and Moderna (who had presented results of KP.2 boosters to VRBPAC) immediately said they'd do it. Hmm, I wonder who might have called their contacts at FDA? But now KP.3 is the one going around. And Novavax's data are that their JN.1 vax neutralizes KP.3 well. Even Moderna shows JN.1-to-KP.3 is better than KP.2-to-KP.3. So Novavax was right.

https://x.com/JUurinmaki/status/1825034073690997055

BTW here's the adverse effect (AE) difference between RNA COVID-19 vax and seasonal influenza vax (SIV), which are protein vax. RNA vax has ~2x higher rates of adverse effects than flu vax. And earlier we saw RNA vax has 2x higher AEs than Novavax. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809119

I've read it asserted in the literature that RNA vax reactogenicity is similar to seasonal flu vax; this is simply not true. Novavax and seasonal flu vax, however, are similar in reactogenicity, as expected as they are similar in mechanism.  

BTW the paper above concluded adding flu to RNA vax doesn't increase reactogenicity, basically assuming readers are taking the RNA vax anyway. But the more interesting comparison is how RNA vax and flu vax compare. The paper never discusses the unfavorable result.

https://www.science.org/doi/10.1126/sciimmunol.adg7327

And here's a thread on RNA-induced IgG4, by the scientist who discovered it. He said harms are unknown, which is still the case, but he believed we didn't have to worry as he couldn't see a need for annual RNA boosters! Maybe reasonable to be cautious. https://threadreaderapp.com/thread/1606002981513662478.html

Also Moderna causes more IgG4 switching than Pfizer-BioNTech, as expected for its larger dose of RNA, eliciting of higher Ab levels, and stronger side effects. So everything correlates.

[cerebrodigital]

Te explicamos como han evolucionado en tiempos recientes:

[mostlysignssomeportents]

The public paid for "Moderna's" vaccine, and now we're going to pay again (and again and again)

Moderna is quadrupling the cost of covid vaccines, from $26/dose to $110–130. Moderna CEO Stephane Bancel calls the price hike “consistent with the value” of the mRNA vaccines. Moderna’s manufacturing costs are $2.85/dose, for a 4,460% markup on every dose:

https://arstechnica.com/science/2023/01/moderna-may-match-pfizers-400-price-hike-on-covid-vaccines-report-says/

If you’d like an essay-formatted version of this thread to read or share, here’s a link to it on pluralistic.net, my surveillance-free, ad-free, tracker-free blog:

https://pluralistic.net/2023/01/24/nationalize-moderna/#herd-immunity

Now, obviously the manufacturing costs are only part of the cost of making a vaccine: there’s also all the high-risk capital that goes into doing the basic research. Whenever a pharma company like Moderna hikes its prices, we’re reminded that the rewards are commensurate with these risks.

But the story of the Moderna vaccine isn’t one of a company taking huge gambles with shareholder dollars. It’s the story of the US government giving billions and billions of dollars to a private firm, which will now charge the US government — and the American people — a 4,460% markup on the resulting medicine.

Writing for The American Prospect, Lily Meyersohn reminds us of the Moderna vaccine’s origin story: the NIH spent $1.4B developing the underlying technology and then the US government bought $8b worth of vaccines at $16/dose, giving Moderna a guaranteed 460% margin on each jab:

https://prospect.org/health/2023-01-23-moderna-covid-vaccine-price-hike-bernie-sanders/

Moderna clearly does not feel that the billions it received in public funds came with any obligation to serve the public interest. The company falsified its patent applications, omitting the NIH scientists who co-developed the vaccine, claiming sole ownership:

https://blog.petrieflom.law.harvard.edu/2022/01/06/nih-moderna-mrna-covid-vaccine-patent/

As Meyersohn writes, this omission allows Moderna to block the NIH from licensing the vaccine to foreign manufacturers — including vaccine manufacturers in the global south, home to many powerhouse producers of vaccines:

https://pluralistic.net/2022/08/24/waivers-for-me-not-for-thee/#vaccine-apartheid

Moderna claims to have capitulated to the NIH on the patent question, but it’s a lie — even as they were publicly announcing they would drop their bid to exclude NIH scientists from their patent application, they quietly filed for a continuance that would let them renew their exclusive claim later, when the heat has died down:

https://www.nytimes.com/2021/12/17/us/moderna-patent-nih.html

This maneuver, combined with Astrazeneca reneging on its promise to open its vaccine — a move engineered by Bill Gates — has deprived billions of the world’s poorest people of access to vaccines. Many of these people were previously blocked from accessing AIDS drugs when the Gates Foundation teamed up to block WTO vaccine waivers:

https://pluralistic.net/2021/04/13/public-interest-pharma/#gates-foundation

These immunucompromised, unvaccinated people are at increased risk of contracting covid, and when they do, they are sick for longer, creating more opportunities for viral mutation and new, more virulent variants.

That was where we stood before Moderna announced its 400% vaccine price-hike. Now, millions of Americans will also be blocked from accessing vaccines, opening the door for rampant, repeated infections, more mutations, and more variants. As Alex Lawson of Social Security Works told Meyersohn, at that price, the US will not be able to achieve herd immunity.

What will Moderna do with the billions it reaps through price-gouging? It won’t be research. To date, the company has spent >20% of its covid windfall profits on stock buybacks and dividends, manipulating its stock price, with more to come:

https://www.levernews.com/how-big-pharma-actually-spends-its-massive-profits/

It’s not an outlier. Big Pharma is a machine for commercializing publicly funded research and then laundering the profits with financial engineering. The largest pharma companies each spend more on stock buybacks than research:

https://www.levernews.com/how-big-pharma-actually-spends-its-massive-profits/

Moderna didn’t have a single successful product for its first decade of operation: it is only a going concern because it got billions in free public research and billions more in public commitments to buy its products at a huge markup.

It wasn’t always this way. Until the 1990s, pharma companies that commercialized public research were bound to license terms that required “reasonable pricing.” NIH inventions were subject to non-exclusive licensing terms, ensuring a competitive market.

The NIH could act to stem Moderna’s profiteering. Moderna’s vaccine (like virtually all mRNA vaccines) uses NIH patent 10,960,070 — though Moderna doesn’t license the ‘070 patent. The NIH could use the threat of a patent infringement suit to force Moderna to put pandemic resilience and access to vaccines over financial engineering and executive bonuses.

When it comes to patent enforcement to protect the public interest, the USG has a long history of channeling King Log, letting companies price-gouge with products built on public research.

https://media.nature.com/original/magazine-assets/d41586-021-03535-x/d41586-021-03535-x.pdf

The states are stepping in where the feds have failed to act, spinning up their own pharma production capacity to create a “public option” for medicine — think of California’s move to produce insulin and other meds:

https://prospect.org/health/its-time-for-public-pharma/

Or Massachusetts’s MassBiologics, the “only non-profit, FDA-licensed manufacturer of vaccines” in the USA, which sells its generic tetanus and diptheria vaccines nationwide:

https://www.umassmed.edu/massbiologics/

The US has a long way to go when it comes to using public production to offer competitive discipline to private pharma. Sweden nationalized its pharma in 1970. Cuba got there in 1960, and is a pharma powerhouse:

https://pluralistic.net/2021/11/28/somos-cuba/#omishambles

Meyersohn closes her excellent article with a warning and a promise: though public covid vaccines are a long way away, new vaccines for RSV and even cancer are in the pipeline, and without “substantial intervention,” Moderna will be a “harbinger…of crises of inequitable access to come.”

[Image ID: Moderna headquarters in Cambridge, Mass. On the left side of the entry, a Jacobin with a guillotine gets ready to decapitate an aristocrat. On the right side of the frame, a cigar-chomping, top-hat wearing ogrish figure makes ready to yank a gilded dollar-sign lever while holding an MRNA molecule disdainfully aloft]

[follow-up-news]

Moderna on Monday said its combination vaccine that targets both Covid-19 and the flu was more effective than existing standalone shots for those viruses in a late-stage trial.  The biotech company is the first to release positive phase three data on a Covid and flu combination shot, giving it a potential lead over rival vaccine makers Pfizer and Novavax.  Moderna plans to file for regulatory approval for its combination jab this summer in the U.S. and hopes it can enter the market in 2025, the company’s CEO Stephane Bancel said in an interview.  Moderna, Pfizer and Novavax have said that combination shots will simplify how people can protect themselves against respiratory viruses that typically surge around the same time of the year. The added convenience is critical as fewer Americans roll up their sleeves to get vaccinated against Covid. 

[a-typical]

What’s the difference between Pfizer/BioNTech, Moderna, and Novavax COVID-19 vaccines?

The Pfizer-BioNTech and Moderna COVID-19 vaccines use mRNA as the active ingredient. The mRNA is converted by our cells into the antigen, in this case, the spike protein of SARS-CoV-2.

The vaccine contains the mRNA, which is synthesized in the lab using a DNA template, the building blocks of RNA, and the enzyme that puts those building blocks together into the right order. mRNA is the molecule template for every protein in every organism. The mRNA sequence is a code for our cells to link amino acids together into functional proteins

mRNA is very fragile, so it is encased in a lipid nanoparticle (LNP) that protects it until it gets into our cells. When the vaccine is administered, the mRNA is released and is used to synthesize the spike protein which is displayed by cells that produced it. That spike protein is recognized by our innate immune cells like dendritic cells and macrophages as well as B cells, which initiates immune response and generation of memory immunity.

In contrast, Novavax is a protein-based vaccine, which contains the prefabricated antigen - the spike protein - instead of the template for it. To make the antigen, we turn cells into protein-producing factories in the lab.

Novavax uses Sf9 cells (moth cells) infected with an insect-specific virus that has been genetically engineered to contain the gene for the spike protein of SARS-CoV-2. These viruses will hijack the cellular machinery of the Sf9 cells to produce lots of spike proteins and baby viruses. Those will continue to reproduce and produce proteins, which will be harvested, purified, and formulated with the other ingredients in the final vaccine.

When the vaccine is injected, the antigen will be recognized by the same innate immune cells listed above, which will trigger the same immune response pathway.

While the vaccines use different technologies, ingredients, and manufacturing processes, the immune responses center around recognition of the spike protein and generating adaptive immune responses targeting that antigen.

[gumjrop]

CDC Recommends Updated 2024-2025 COVID-19 and Flu Vaccines for Fall/Winter Virus Season

Media Statement

For Immediate Release: June 27, 2024 Contact: Media Relations (404) 639-3286

Today [June 27, 2024], CDC recommended the updated 2024-2025 COVID-19 vaccines and the updated 2024-2025 flu vaccines to protect against severe COVID-19 and flu this fall and winter.

It is safe to receive COVID-19 and flu vaccines at the same visit. Data continue to show the importance of vaccination to protect against severe outcomes of COVID-19 and flu, including hospitalization and death. In 2023, more than 916,300 people were hospitalized due to COVID-19 and more than 75,500 people died from COVID-19. During the 2023-2024 flu season, more than 44,900 people are estimated to have died from flu complications.

Updated 2024-2025 COVID-19 Vaccine Recommendation

CDC recommends everyone ages 6 months and older receive an updated 2024-2025 COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 this fall and winter whether or not they have ever previously been vaccinated with a COVID-19 vaccine. Updated COVID-19 vaccines will be available from Moderna, Novavax, and Pfizer later this year. This recommendation will take effect as soon as the new vaccines are available.

The virus that causes COVID-19, SARS-CoV-2, is always changing and protection from COVID-19 vaccines declines over time. Receiving an updated 2024-2025 COVID-19 vaccine can restore and enhance protection against the virus variants currently responsible for most infections and hospitalizations in the United States. COVID-19 vaccination also reduces the chance of suffering the effects of Long COVID, which can develop during or following acute infection and last for an extended duration.

Last season, people who received a 2023-2024 COVID-19 vaccine saw greater protection against illness and hospitalization than those who did not receive a 2023-2024 vaccine. To date, hundreds of millions of people have safely received a COVID-19 vaccine under the most intense vaccine safety monitoring in United States history.

Updated 2024-2025 Flu Vaccine Recommendation

CDC recommends everyone 6 months of age and older, with rare exceptions, receive an updated 2024-2025 flu vaccine to reduce the risk of influenza and its potentially serious complications this fall and winter. CDC encourages providers to begin their influenza vaccination planning efforts now and to vaccinate patients as indicated once 2024-2025 influenza vaccines become available.

Most people need only one dose of the flu vaccine each season. While CDC recommends flu vaccination as long as influenza viruses are circulating, September and October remain the best times for most people to get vaccinated. Flu vaccination in July and August is not recommended for most people, but there are several considerations regarding vaccination during those months for specific groups:

Pregnant people who are in their third trimester can get a flu vaccine in July or August to protect their babies from flu after birth, when they are too young to get vaccinated.

Children who need two doses of the flu vaccine should get their first dose of vaccine as soon as it becomes available. The second dose should be given at least four weeks after the first.

Vaccination in July or August can be considered for children who have health care visits during those months if there might not be another opportunity to vaccinate them.

For adults (especially those 65 years old and older) and pregnant people in the first and second trimester, vaccination in July and August should be avoided unless it won’t be possible to vaccinate in September or October.

Updated 2024-2025 flu vaccines will all be trivalent and will protect against an H1N1, H3N2 and a B/Victoria lineage virus. The composition of this season’s vaccine compared to last has been updated with a new influenza A(H3N2) virus.

For more information on updated COVID-19 vaccines visit: Coronavirus Disease 2019 (COVID-19) | CDC. For more information on updated flu vaccines visit: Seasonal Flu Vaccines | CDC.

The following statement is attributable to CDC Director Dr. Mandy Cohen:

“Our top recommendation for protecting yourself and your loved ones from respiratory illness is to get vaccinated,” said Mandy Cohen, M.D., M.P.H. “Make a plan now for you and your family to get both updated flu and COVID vaccines this fall, ahead of the respiratory virus season.”

[dosesofcommonsense]

Creating new problems needing new solutions. Have they ever cured anything? No. Why would they do that? They’d lose patients.

[pandemic-info]

https://twitter.com/jeffgilchrist/status/1700854098755563660

#Novavax vs mRNA vaccine This thread explains how @Novavax is different from the #Moderna and #Pfizer #mRNA #vaccines and describes some of the benefits such as broadened #variant recognition, more durable #immunity, and fewer side effects.

This is an awesome thread explaining all of the above + recommendations for primary layers of protection like ventilation, filtration, and masking.

Notable:

What about people who had mRNA doses previously but want to consider Novavax? There have been several studies now that found mixing the two, getting mRNA and then Novavax actually gave better results than just mRNA on its own.

One study found that getting Novavax as a booster after mRNA "may enhance the persistence and durability of vaccine-mediated immunity compared to mRNA options" ...with slower decay rate compared to an mRNA booster dose and less side effects than mRNA boosters

While vaccines are important, they should be the last layer of protection to rely on in case all the other layers fail and you get exposed. Vaccines should not be the one and only layer governments all seem to be currently relying on.

This link may be easier to read:

[kelcipher]