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.
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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…
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.
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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 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…
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…
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…
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…