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How COVID vaccine options stack up for fall 2023

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The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is backing a significant shift in the current COVID-19 vaccine strategy: a move from multivalent to monovalent vaccines focusing on the XBB lineage strains. The advisory committee has set its sights on protecting against XBB.1.5 and has jettisoned is support for vaccines with a Wuhan component, which was included as a component of the bivalent vaccine boosters that debuted in fall 2022. “Continuing to include the original Wuhan strain was unnecessary since early strains are no longer in circulation,” said Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases.

While supporting monovalent vaccines, VRBPAC members acknowledged that the predominant SARS-CoV-2 sublineages could continue to evolve. “We may well find that XBB.1.16 or XBB.2.3 become more dominant than XBB.1…

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

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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 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.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

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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FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

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

FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its pr…

FDA advisory panel to convene to consider second booster dose

[Photo by Daniel Schludi on Unsplash]The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does.

Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster.

Pfizer and its partner BioNTech SE (Nasdaq:BNTX) are seeking authorization for a second booster in adults 65 and older, while Moderna is hoping FDA will authorize a second booster in adults 18 and older.

Get the full story from our sister site, Pharmaceutical Processing World.

FDA advisory panel to convene to consider second booster dose

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster does.

Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster.

Pfizer and its partner BioNTech SE (Nasdaq:BNTX) are seeking authorization for a second booster in adults 65 and older, while Moderna is hoping FDA will authorize a second booster in adults 18 and older.

The VRBPAC does not plan to discuss any product-specific applications, and there is no vote scheduled for the meeting.

Instead, the VRBPAC will discuss broader considerations. In particular, they will focus on the timing and populations for booster doses in the coming months and what criteria might dictate when COVID-19 vaccines need to be updated based on circulating SARS-CoV-2 variants.

“Now is the time to…

FDA hits pause on COVID-19 vaccine for children under 5

FDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years.

The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.

But FDA decided to postpone the meeting until further notice after Pfizer (NYSE:PFE) shared new data related to its emergency use authorization (EUA) request for an ongoing clinical trial testing the Pfizer-BioNTech vaccine in young children.

FDA indicated in a statement that it wants to review data related to a third dose of the vaccine to foster “a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”

The agency noted that evaluating initial data from the clinical trial was “useful,” but “at this time, we believe additional information regarding the ongoing evaluatio…

VRBPAC recommends expanding EUAs to authorize Janssen and Moderna boosters

Image from Sam Moqadam on Unsplash

The U.S. appears to be on the verge of expanding the use of COVID-19 vaccine boosters after an advisory committee backed boosters for the Johnson & Johnson (NYSE:JNJ) and Moderna (NSDQ:MRNA) vaccines.

On October 14 and 15, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) separately voted 19–0 to recommend boosters of both products for high-risk populations.

The committee’s guidance for the two-dose mRNA vaccines from Moderna and Pfizer-BioNTech (NYSE: PFE/NSDQ:MRNA) was to allow boosters six months after completion of a primary series.

Conversely, VRBPAC recommended that recipients of the single-dose Janssen vaccine receive a booster at least two months after the initial dose.

Several panelists balked at the word “booster” in reference to the Janssen vaccine, arguing that would be more accurate to refer to it as a two-dose va…

FDA advisory panel recommends boosters only for older and high-risk individuals

Doses of the COVID-19 vaccine are seen at Walter Reed National Military Medical Center, Bethesda, Md., Dec. 14, 2020. (DoD photo by Lisa Ferdinando)

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19.

The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals 16 years of age and older. A total of 16 panelists voted ‘no’ while two others voted ‘yes.’

“With regard to the extrapolation of data from much older populations to 16- and 17-year-olds, we have no data on the safety in these populations at all that have been presented so far. And that concerns me significantly,” said Dr. Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School. While supporting boosters in older populations…

FDA advisory panel recommends boosters only for older and high-risk individuals

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19.

The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals 16 years of age and older. A total of 16 panelists voted ‘no’ while two others voted ‘yes.’

“With regard to the extrapolation of data from much older populations to 16- and 17-year-olds, we have no data on the safety in these populations at all that have been presented so far. And that concerns me significantly,” said Dr. Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School. While suppo…

Why emergency authorization of COVID-19 therapies could pose thorny regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Further compl…