#Pfizer COVID-19 bivalent booster

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[mariacallous]

Updated vaccines against Covid-19 are coming, just as hospitalizations and deaths due to the virus are steadily ticking up again.

Today, the US Food and Drug Administration authorized new mRNA booster shots from Moderna and Pfizer, and a panel of outside experts that advises the Centers for Disease Control and Prevention voted to recommend the shots to everyone in the United States ages 6 months and older. Once Centers for Disease Control and Prevention director Mandy Cohen signs off on the recommendations and the vaccines are shipped, people can start getting the boosters.

The recommendation is projected to prevent about 400,000 hospitalizations and 40,000 deaths over the next two years, according to data presented at the meeting by CDC epidemiologist Megan Wallace.

This year’s mRNA vaccines are different from the 2022 booster in a key way. Last year’s shot was a bivalent vaccine, meaning it covered two variants: the original one that emerged in China in 2019, plus the Omicron subvariant BA.5, which was circulating during much of 2022. This fall’s booster drops the original variant, which is no longer circulating and is unlikely to return. It targets just the Omicron subvariant XBB.1.5, which was dominant throughout much of 2023.

Pfizer and Moderna’s vaccines work by introducing a tiny piece of genetic material called messenger RNA, or mRNA, that carries instructions for making SARS-CoV-2’s characteristic spike protein. Once it is injected, cells in the body use those instructions to temporarily make the spike protein. The immune system recognizes the protein as foreign and generates antibodies against it. Those antibodies stick around so that if they encounter that foreign invader again, they will mount a response against it.

Since the start of the Covid-19 pandemic, the virus has acquired new mutations in its spike protein and elsewhere. These mutations result in new variants and subvariants that diverge from the original virus. When enough mutations accumulate, these new versions can more easily evade the antibodies created by previous vaccine doses or infections.

The constantly evolving nature of the virus is the reason health regulators decided last year to update the original mRNA vaccines, which were designed against the version of the virus that first appeared in 2019. This year, once again, the virus has changed enough to warrant an updated booster.

In June, an advisory committee to the FDA recommended that this fall’s booster be a monovalent vaccine—targeting only the then-dominant XBB.1.5 subvariant.

At that meeting, committee members reviewed evidence suggesting that the inclusion of the original variant may hamper the booster’s effectiveness against newer offshoots. “The previous bivalent vaccine contained the ancestral spike and thus skewed immune responses to the old spike,” says David Ho, a professor of microbiology at Columbia University whose research, which is not yet peer-reviewed, was among the evidence the FDA panel reviewed. “This is what we call immunological imprinting, and it results in lack of immune responses to the new spike.” He thinks taking out the old variant should optimize the immune response.

But over the past few months, even newer Omicron offshoots have arrived. Currently, EG.5.1, or Eris, is the dominant one in the United States, United Kingdom, and China. Meanwhile, a variant called BA.2.86, or Pirola, has been detected in several countries. Pirola has raised alarm bells because it has more than 30 new mutations compared to XBB.1.5.

Even though the new boosters were formulated against XBB.1.5, they’re still expected to provide protection against these new variants. “The reason is, while antibodies are important in protection against mild disease, the critical part of the immune response that’s important for protecting against severe disease is T cells,” says Paul Offit, a professor of vaccinology at the University of Pennsylvania and member of the FDA’s vaccine advisory committee.

These cells are a different part of the immune response. Unlike antibodies, which neutralize a pathogen by preventing it from infecting cells, T cells work by eliminating the cells that have already been invaded and boosting creation of more antibodies. Both the Moderna and Pfizer-BioNTech Covid vaccines produce long-lasting T cells in addition to antibodies.

It’s why, Offit says, when the Omicron wave hit in late 2021 and peaked in January 2022, the US didn’t see a dramatic increase in hospitalizations and deaths even as cases rose significantly: People’s T cells kicked into gear, even when their antibodies didn’t recognize the Omicron variant.

“In some ways,” says Offit, when it comes to vaccine booster development, “it almost doesn’t matter what we pick to target” because the coronavirus has yet to evolve away from T cell recognition. “Everything works.”

Scientists think T cells are able to protect against severe Covid because they’re recognizing parts of the virus that have remained unchanged throughout the pandemic. “I suspect that as we continue to vaccinate, there are some conserved regions [of the virus],” says Jacqueline Miller, Moderna’s head of infectious diseases. “So even with the accumulation of mutations, we’re still building on previous immunity.”

People who have hybrid immunity—that is, have had a Covid infection and have also been vaccinated—seem to have the best immune responses to new variants, she says, which suggests that previous exposure shapes and improves immune responses to new variants. Preliminary studies show that antibodies generated by previous infections and vaccinations should be capable of neutralizing Pirola.

Earlier this month, Moderna issued a press release saying that clinical trial data showed that its updated booster generated a strong immune response against Pirola, as well as the more prevalent Eris variant.

In a statement to WIRED, Pfizer spokesperson Jerica Pitts said the company continues to closely monitor emerging variants and conduct tests of its updated monovalent booster against them. Data presented at Tuesday’s CDC meeting showed that Pfizer-BioNTech’s updated booster elicited a strong neutralizing antibody response against both Eris and Pirola.

The FDA expects that Covid-19 vaccines will continue to be updated on an annual basis, unless a completely new variant emerges that requires a different approach. “We will always be a little behind the virus,” says Ho. “In this instance, we won’t suffer too much, but that might not be the case going forward. Surveillance is imperative.”

[darkmaga-returns]

Are Particulates to Blame?

Washed Up Pharmacist Nov 08, 2024

Update Eagle-eyed Jessica Rose noted that the Moderna batch 052D22A is NOT included in the batches identified by the FDA and released. However, batches 050D22A and 051D22A are mentioned so it is possible 052D22A wasn’t actually tested but I would expect to have the same issues as the other batches.

This also gives background as to these early booster bivalent doses Moderna's new booster launch tripped up by production issues at Catalent plant: reports

Evidence supporting early lots of the Pfizer vaccine were toxic than later lots. Dr Peter McCullough just recently summarized the data supporting the increased toxicity of the early lots in the US.

I have noticed in my practice that nearly all of those with serious COVID-19 vaccine syndromes including myocarditis, blood clots, and other live-threatening problems received their first shots either in December 2020 or early 2021. Pfizer’s lots or batches have been evaluated and studied for variation in risk by Schmeling, Manniche, and Jablonowski. All three studies have concluded the earlier batches were more lethal and the variation in risk was considerable from lot to lot. Now Jablonowski and Hooker report:

Here is the paper. Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine in the United States. The conclusion states:

So batches allocated in the first 2 months, sent out to hospitals and universities first. Here are the batches mention in the Jablonowski and Hooker report:

Death: EL0140, EL9261, EL3248, EN9581, EJ1686

Serious AEs: EC4176, EK5730, EH9899, EJ1685

All AE’s: EK5730, EH9888, EK9231, EJ1685

All of these are the purple topped vials formulated in the PBS buffer.

[allthebrazilianpolitics]

Brazilian-developed vaccine against Covid-19 registered by Anvisa

The new vaccine against Covid-19 developed by the Brazilian company Zalika Farmacêutica has been entered into the National Health Surveillance Agency (Anvisa) this week, Agencia Brasil reported. The drug can be used in people aged 12 and over and is to be administered in two doses, 21 days apart, with boosters after 6 months for those over 18 years of age.

The technology used in the Zalika vaccine is called “recombinant” because its molecules are formed by combining two different sources. In this case, the protein S antigen (spike) -capable of promoting a response from the immune system- and the saponin-based adjuvant allow the mixture to enhance the production of antibodies. This form of production brings greater safety to the pharmaceutical industry, Anvisa explained in a statement.

The new immunizer is the sixth to receive definitive individual registration from Anvisa, in addition to Comirnaty Ipfizer/Wyeth, Comirnaty bivalent (Pfizer), Janssen Vaccine (Janssen-Cila), Oxford/Covishield (Fiocruz and Astra-Zeneca) and Spikevax bivalent vaccines have received this type of authorization. Pfizer/Biontech, Astra-Zeneca, Janssen, Moderna, Sinopharm, and Sinovac also have definitive registration in the form of the Covax Facility consortium.

Continue reading.

[xtruss]

We're Having A COVID Summer Surge. Should You Get The Updated Vaccines Now?

The FDA Just Approved an Updated Vaccines, and Officials Say Paxlovid is Still Effective in Preventing Severe Cases.

— By Sanjay Mishra | August 22, 2024

A Colorized Ccanning Electron Micrograph of a Cell (Blue) Infected with the Omicron Strain of the SARS-CoV-2 virus (Yellow). Micrograph By National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes Of Health/Science Photo Library

The summer of 2024—the fifth since the COVID-19 pandemic began—is projected to be the biggest summer wave of COVID infections to date.

Since early May, COVID infections have steadily increased in the United States, Europe, Singapore, New Zealand, and Australia. The U.S. Centers for Disease Control and Prevention estimates that COVID-19 infections are currently increasing in 25 states based on data from emergency department visits. However, hospitalizations and deaths from COVID remain at their lowest levels.

Now, the U.S. Food and Drug Administration has approved updated vaccines to protect against current variants of the virus.

This recent surge has been driven mainly by a new group of closely related Covid subvariants, known collectively as "FLiRT."

As the summer winds down, students across the U.S. will return to school. Traditionally, this also coincides with the season of respiratory viruses, such as flu, RSV, and increasingly COVID.

"Not sure what will happen this fall and winter," says Kei Sato, a virologist at the University of Tokyo. While the FLiRT variants are likely to keep evolving after summer, entirely new subvariants cannot be ruled out. "An Omicron-like event” seems to have occurred every year in the fall since 2021, says Sato.

Here's what you need to know about the new variants and the new vaccines.

What Are FLiRT Variants?

The "FLiRT" variant family includes the majority of currently circulating variants, identified with the letters KP, JN, and the variant LB.1.

The unofficial name "FLiRT" is an acronym for a set of mutations on the spike protein of SARS-CoV-2, the virus that causes COVID-19. The virus uses spike protein to bind with ACE2 receptors in our nose and lung cells to cause infection.

All proteins are made up of amino acids that string together like beads. Mutations can change one amino acid to another, thereby altering the behavior of the protein and making the virus more or less infectious, or able to dodge immunity.

The FLiRT subvariant family members are descended from the JN.1 variant that was dominant in the U.S. in early 2024. JN.1 itself was highly unusual because it acquired 41 mutations that differentiated it from Omicron XBB.1.5, which is the variant upon which the current bivalent COVID booster is based.

Should You Get The New Vaccines?

The two updated mRNA vaccines, manufactured by Pfizer-BioNTech and Moderna, target a FLiRT variant called KP.2. Anyone over the age of 12 can get the new shots, as long as they haven't received a booster in the last two months.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement.

Another vaccine targeting the variant JN.1 and manufactured by Novovax is also under review and could be approved soon.

Previous research also showed that older vaccines based on XBB.1.5, an earlier subvariant of Omicron, were still effective in preventing severe COVID-19. While this vaccine produces antibodies that still target the FLiRT variants, the efficiency is notably reduced. A recent infection from the JN.1 variant also seems to provide strong protection against all the FLiRT variants.

That said, the CDC recommends that everyone six months and older get a COVID vaccine. Those at high risk for serious COVID-19 should get vaccinated with the most recent versions available.

How Alarming Are FLiRT Variants?

Coronaviruses, such as SARS-CoV-2, frequently mutate to avoid recognition by antibodies. The two FLiRT mutations remove the sites on the virus where antibodies bind the SARS-CoV-2 virus.

Additional mutations on the FLiRT variants can either help the virus bind more efficiently to ACE2 receptors making it more infectious, help it evade previous immunity, or both, says Adrian Esterman, an epidemiologist at the University of South Australia, Allied Health & Human Performance in Adelaide, Australia

Early studies show that all existing FLiRT subvariants are very good at dodging previous immunity acquired through multiple COVID vaccinations—including the most recent COVID bivalent booster—or a breakthrough infection from a previous strain of Omicron.

But the good news is that by escaping the antibodies, the FLiRT variants have also seem to lost some ability to infect their target because the virus needed the original antibody-binding sites to bind the ACE2 receptor and enter cells.

"These variants are not yet particularly concerning, even with the new mutations that affect certain aspects of the virus's biology," says Shan-Lu Liu, a virologist at the Ohio State University.

It is common for viruses to acquire mutations that help them dodge immunity, which can affect their ability to infect cells, says Liu. "The viruses can quickly evolve new mutations to restore their infectivity."

But in the meantime, Sato thinks that waning immunity from previous vaccinations and infections, coupled with the FLiRT variant's ability to dodge remaining immunity, are probably the main reason for the recent surge in infections.

Liu also agrees that the currently rising numbers of COVID infections are mostly due to low booster uptake and increased summer travel.

Are COVID Medicines Still Effective?

Emergency department visits, hospitalizations, and deaths have all spiked during this summer but are still much lower compared to earlier waves of the pandemic.

There is no indication that these new FLiRT variants are more dangerous than other Omicron strains.

A study shows that Paxlovid is still effective against FLiRT variants. Other antiviral drugs such as molnupiravir and remdesivir are also expected to work since their mechanism of action is not affected by mutations in the spike protein.

[opspro2005]

Any “parent” that subjects their child to this treatment should be arrested for child-abuse and jailed for not less than 30 years. Every member of the FDA and Pfizer should be arrested for attempted murder and jailed for life with no chance of parole.

[thoughtportal]

June 12 (Reuters) - COVID-19 vaccines being developed and manufactured for the 2023-2024 campaign should target one of the currently dominant XBB variants, the U.S. Food and Drug Administration's (FDA) staff reviewers said on Monday.

The comments were made in documents posted ahead of Thursday's meeting of a panel of FDA's independent experts, who are expected to make recommendations on what strain an updated COVID-19 booster should target.

An advisory group to the World Health Organization (WHO) in May recommended that COVID-19 booster shots for the year should be updated to target XBB subvariants.

Last year's COVID vaccine boosters in the United States featured both the original strain of the vaccine and Omicron in a so-called bivalent shot.

About 17% of people in the United States received a COVID booster shot in the 2022-2023 vaccination season, according to CDC data that was current through early May.

COVID-related deaths in the United States spiked in January, but have mostly fallen since then. They fell 14.3% in the past week.

Regulators say vaccines need to be updated to deal with the unpredictability of the virus.

"There is no indication that SARS-CoV-2 evolution is slowing down, though immunity appears to be mitigating severe clinical outcomes," the FDA's staff said.

The COVID vaccination campaign should feature a monovalent vaccine targeting either the XBB.1.5, XBB.1.16, or XBB.2.3, the FDA's reviewers said.

XBB subvariants accounted for more than 95% of the circulating virus variants in the United States by early June 2023, they added.

COVID-19 vaccine makers like Pfizer/BioNtech (PFE.N), Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating strains.

Reporting by Manas Mishra and Bhanvi Satija in Bengaluru and Michael Erman in New York; Editing by Anil D'Silva

[broadlyepi]

Current MMWR Booster: Effectiveness of Bivalent mRNA COVID-19 Vaccines in Preventing COVID-19–Related Thromboembolic Events Among Medicare Enrollees Aged ≥65 Years and Those with End Stage Renal Disease — United States, September 2022–March 2023

Top 5 Takeaways

Bivalent mRNA COVID-19 Vaccine Effectiveness: The bivalent mRNA COVID-19 vaccine was found to be 47% effective in preventing thromboembolic events in immunocompetent persons aged ≥65 years and 51% effective in adults aged ≥18 years with end stage renal disease (ESRD) receiving dialysis, compared to the original monovalent vaccines.

Study Population and Method: Two retrospective cohort studies were conducted among Medicare fee-for-service enrollees aged ≥65 years and those aged ≥18 years with ESRD on dialysis, using Medicare Parts A and B data from September 2022 to March 2023.

Context of Previous Vaccine Safety Concerns: These findings provide context to a preliminary safety signal regarding ischemic stroke post Pfizer-BioNTech bivalent vaccination in persons aged ≥65, which attenuated over time and was not consistently evident in further studies.

Vaccine Effectiveness Over Time: The effectiveness of the bivalent vaccine appears to wane over time, with lower effectiveness observed ≥60 days post-vaccination compared to 7-59 days post-vaccination.

Public Health Implications: The study emphasizes the importance of staying up to date with COVID-19 vaccinations, particularly for older adults and those with ESRD, to prevent COVID-19-related complications including thromboembolic events.

Full summary link: BroadlyEpi.com

Enjoying these summaries? Check back every day at 8am and 4pm Pacific Time (UTC - 8) for a new MMWR Booster. A reblog would also be greatly appreciated, and thanks to everyone who already has! BroadlyEpi hopes to make Epidemiology and Public Health more approachable to anyone who's interested.

[12nb34]

📆 19 Dec 2023 📰 Wanted: A Covid Booster That Actually Works ✍️ F.D. Flam 🗞 Bloomberg

Pfizer is struggling because not enough people are getting annual Covid shots. The problem is that the boosters aren’t very effective.

... There’s another problem facing Covid booster campaigns: the fast evolution of the virus and the stubborn tendency of our immune systems to insist on fighting the original variant, since that’s what we were first vaccinated against.

This stubborn tendency is called imprinting, and may explain why so many fully vaccinated, multiple-boosted people have gotten omicron not just once but sometimes two or three times. It also explains data showing that the bivalent booster offered in 2022, with components of the initial strain and omicron, didn’t produce any more omicron-neutralizing antibodies than the original booster.

The 2023 boosters don’t have the original strain — they are monovalent and aimed at the omicron sub-variant XBB.1.5, which was dominant earlier in the year. Many scientists say this is a big improvement. A study published last month in Nature showed that repeat exposures to omicron through infection or omicron-only booster shots can start to override the immune imprinting that has our immune systems stuck on the extinct original version of this virus.

Peking University researcher Yunlong (Richard) Cao, who headed the study, said exposure to omicron generates what are called naïve B cells, and over time these become tuned to fight omicron. After two exposures, the body is better able to fight off future exposures to omicron.

As a caveat, he said, this study involved subjects in China who were very rarely exposed to the virus before omicron, and who got a different kind of vaccine called an inactivated virus. Similar studies that followed people who got mRNA shots saw no overriding of the imprinting.

Cao said the mRNA vaccines are more immunogenic than the ones used in China, which can make them more powerful but might render the imprinting effect stronger too. It might take people in the US and elsewhere more exposures to omicron-only boosters or infections to retune their immune systems toward the new version of the virus — though the virus will continue to evolve as well.

[darkmaga-returns]

New study finds Pfizer-BioNTech COVID-19 'vaccinated' children are 159% more likely to be infected with SARS-CoV-2 and 257% more likely to develop symptomatic COVID-19 than unvaccinated peers.

Nicolas Hulscher, MPH

Dec 16, 2024

by Nicolas Hulscher, MPH

A new study was just published in the Journal of the Pediatric Infectious Diseases Society titled, Protection from COVID-19 vaccination and prior SARS-CoV-2 infection among children aged 6 months – 4 years, United States, September 2022–April 2023. The study combined data from three prospective cohort studies (PROTECT, CASCADIA, and CoVE) conducted in the United States from September 1, 2022, to April 30, 2023. Included 614 children aged 6 months to 4 years living in Washington, Oregon, Michigan, Arizona, and Utah.

Here are the key findings:

Increased Risk with Pfizer-BioNTech Vaccination:

Children vaccinated with Pfizer-BioNTech without prior SARS-CoV-2 infection were 159% more likely to get infected and 257% more likely to develop symptomatic COVID-19 compared to unvaccinated children without prior infection:

Hazard Ratio (HR) for infection: 2.59 (95% CI: 1.27–5.28).

HR for symptomatic COVID-19: 3.57 (95% CI: 1.10–11.63).

Prior Infection Offers Robust Protection:

Children with prior SARS-CoV-2 infection (unvaccinated) had a significantly lower risk of reinfection compared to unvaccinated, infection-naïve children:

HR for infection: 0.28 (95% CI: 0.16–0.49).

HR for symptomatic COVID-19: 0.21 (95% CI: 0.08–0.54).

No Protective Effect from Vaccination Alone:

There was no significant reduction in the risk of infection or symptomatic COVID-19 for vaccinated children (Moderna or Pfizer-BioNTech) compared to unvaccinated children:

HR for infection with vaccination alone: 1.23 (95% CI: 0.69–2.16).

HR for symptomatic COVID-19 with vaccination alone: 1.61 (95% CI: 0.65–4.03).

Boosters Show No Significant Protection:

Among children who received at least one bivalent booster dose, there was no significant reduction in infection or symptomatic COVID-19:

HR for infection with a bivalent booster: 0.74 (95% CI: 0.37–1.48).

HR for symptomatic COVID-19 with a bivalent booster: 1.04 (95% CI: 0.37–2.96).

In other words, these injections do the opposite of what they’re supposed to do. Instead of protecting against COVID-19, these genetic injections either fail or increase the risk. The CDC should immediately revoke their recommendations for children aged 6 months and older to receive a COVID-19 booster injection.

[yessadirichards]

Health

WHO recommends new COVID shots should target only XBB variants

GENEVA

A World Health Organization (WHO) advisory group has recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants.

New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.

The group suggested no longer including the original COVID-19 strain in future vaccines, based on data that the original virus no longer circulates in human beings and shots targeting the strain produce "undetectable or very low levels of neutralizing antibodies" against currently circulating variants.

COVID-19 vaccine makers like Pfizer/BioNtech, Moderna Inc and Novavax Inc are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating strains.

The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected.

The bivalent booster shots developed and distributed last year targeted two different strains - the Omicron variant as well as the original virus.

WHO's advisory group, which recommends if changes are needed to the composition of future COVID-19 shots, said currently approved vaccines should continue to be used in accordance with the agency's recommendations.

In late March, WHO had revised its COVID vaccination recommendations and suggested healthy children and adolescents might not necessarily need a shot, but older and high-risk groups should get a booster between six and 12 months after their last vaccine.

The latest recommendations come about two weeks after WHO ended the global emergency status for COVID-19.

[gendronrecherche]

Moderna and Pfizer-BioNTech Vaccines Get Green Light for Second COVID-19 Booster

FDA revises the emergency use authorizations for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines for those with compromised immune systems. http://dlvr.it/SmxdzF