FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

[Photo from Pexels]The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

Get the full story from our sister site, Drug Discovery & Development.

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VRBPAC backs adding omicron-component to COVID-19 boosters

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted today to recommend the use of variant-specific boosters.

Out of 21 voting members, 19 supported the use of a SARS-CoV-2 omicron component for COVID-19 booster vaccines.

“I want to be clear that this doesn’t mean that we are saying that there will be boosters recommended for everyone in the fall, but my belief is that this gives us the right vaccine in preparation for the potential need for boosters in the fall,” said VRBPAC member Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases at CDC.

“Over the coming months, I think we’ll get a sense, and there’ll be plenty of time for debate over who is most appropriate for boosters,” said CBER director Dr. Peter Marks.

Omicron and its subvariants such as BA.2, BA.4 and BA.4 continue to drive the bulk of COVID-19 infections.

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Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11.

The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant and wild-type strain of SARS-CoV-2 compared to two doses. In particular, a sub-analysis of 30 sera from the Phase 2/3 study indicated that a third dose resulted in a 36-fold increase in neutralizing antibody titers for the omicron variant compared to two doses.

The Phase 2/3 clinical trial analysis included data from 140 children aged 5 through 11 years old who received three 10-µg doses of vaccine. In addition, participants received a booster dose approximately six months after a two-dose primary series.

Pfizer and BioNTech intend to seek emergency use authorization (EUA) for a booster dose in the near future and sha…

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FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab

As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week. 

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could hold up to the first omicron subvariant, but the companies have concluded that it is probably ineffective against the BA.2 subvariant. 

The FDA has announced that sotrovimab is not currently authorized in areas where the BA.2 subvariant makes up the majority of COVID-19 infections. These areas include the Northeast, much of the Western part of the country and a portion of the Midwest. 

The FDA has also withdrawn authorization for sotrovimab in Alaska and major U.S. territories, including Puerto Rico. 

Last year, FDA similarly limited the use of Lilly’s bamlanivimab (LY-CoV555)…

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Pfizer-BioNTech vaccine moderately effective against omicron in children

The Pfizer-BioNTech COVID-19 vaccine lowered the incidence of omicron-based SARS-CoV-2 infection by 31% in children aged 5 to 15 in a recent study.

The vaccine was more effective in children between the ages of 12 and 15, lowering the risk of omicron infection by 59%, according to the study from CDC and Abt Associates.

Participants in the study received two doses of the vaccine.

The Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study incorporated real-world data and also gauged vaccine effectiveness against the delta variant.

Studying weekly nasal swab and survey data from 1,346 children in Arizona, Florida, Texas and Utah, researchers were able to capture mild infections.

“Other pediatric vaccine effectiveness studies relied on lab testing data or health records and generally captured only cases where a child had symptoms and received health care,” said Lauren Olsho, the PROTECT study’s principal investi…

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Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq:BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

Get the full story from our sister site, Drug Discovery & Development. 

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Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

Data related to the omicron-specific version are not yet available.

Pfizer also said that clinical trial data involving children under 5 who received three doses of its COVID-19 vaccine would be available in April.

A small Israeli study summarized in Nature last month indicated that a fourth vaccine dose provides a modest increase in antibodies.

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Omicron-specific mRNA vaccine elicited similar protection as original in early primate study 

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine.

In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine. 

The study involved a total of eight macaques who received two initial 100-μg doses of the mRNA-1273 vaccine. Nine months after the second dose, four primates received a dose of the existing vaccine, while the remaining four received the omicron-based version. 

The study authors performed a challenge test, exposing the non-human primates to the omicron variant to gauge their immune response. The researchers ultimately concluded that both…

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Molnupiravir holds up to omicron in lab studies

Merck & Co. (NYSE:MRK) and its partner Ridgeback Biotherapeutics have shared data from six preclinical studies showing that the COVID-19 pill molnupiravir was active against the omicron variant in vitro.

The two companies continue to seek regulatory authorization for the drug internationally, which is currently authorized in more than 10 countries, including the U.S., the UK, Taiwan, Japan, India and Australia.

“Based on its mechanism of action, along with these new findings demonstrating in vitro activity across multiple variants, including omicron, we anticipate that molnupiravir will continue to be active against variants of concern and an important tool in the fight against COVID-19,” said Wendy Holman, Ridgeback Biotherapeutics CEO, in a statement. “We are grateful for the efforts of the investigators and look forward to continuing our work to help address the pandemic.”

The recent lab studies were conducted by independent researchers using cell…

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FDA authorizes expanded use of Pfizer-BioNTech vaccine boosters

With the U.S. facing the biggest surge of COVID-19 infections to date, the FDA has decided to amend the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to cover adolescents aged 12 to 15 and for some immunocompromised children between the ages of 5 and 11. The agency has also reduced the window between the second and third doses from six to five months. 

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19,” said Acting FDA Commissioner Dr. Janet Woodcock.

To arrive at its decision, FDA analyzed real-world data from Israel, including 6,300 individuals between the ages of 12 and 15 who received a booster dose of the BNT162b2 vaccine at least five months after receiving a second dose.  

The authorization for certain immunocompromised child…

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Israel plans to authorize fourth COVID-19 vaccine dose for high-risk populations

Photo by Frank Meriño from Pexels

Mere months ago, health experts were divided on whether COVID-19 boosters were necessary for the broader public. 

Then came delta and then came omicron. 

Now Israel is moving to become one of the first countries to offer a fourth dose of COVID-19 vaccine to people at least 60 years old and those at high risk of severe disease. Countries such as Switzerland and the U.K. have reduced the window of time for booster eligibility from six months down to four and three months, respectively. 

As a result, COVID-19 vaccines from companies such as Pfizer and its partner BioNTech, Moderna and others continue to be a hot commodity. 

A number of companies, including Pfizer and Moderna, are also developing omicron-specific versions of their vaccines. Both of those companies are gearing up for clinical trials in early 2022. 

Earlier this month, Pfizer CEO Dr. Al…

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Sotrovimab wins EU marketing Authorization as an early COVID-19 therapy 

GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab).

The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing severe COVID-19.

This summer, GSK and VIR had reached a joint procurement agreement with the EC involving 220,000 doses of the drug.

“With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients,” said Dr. Hal Barron, chief scientific officer and president R&D of GSK, in a statement.

The two companies also have revealed that preclinical data suggest that sotrovimab retains activity against the Omicron variant, which threatens to become the dominant form of …

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