Tag: fda advisory committee

FDA Vaccines and Related Biological Products Advisory Committee Meeting May 22, 2025

The meeting of the FDA VRBPAC on the composition of Covid-19 vaccines will be tomorrow, May 22, 2025 at 8:30 am-4:30 pm EST. Some materials have recently become available on the FDA website.

The briefing document indicates that there will be a discussion of the most recent Covid-19 variants and whether the current vaccine needs to be modified as the viral antigenic strain has mutated.

The World Health Organization has formed a new technical advisory group: “Technical Advisory Group on COVID19 Vaccine Composition (TAG-CO-VAC) to review and assess the public health implications of emerging SARS-CoV-2 variants of concern (VOCs) on the performance of COVID-19 vaccines and to provide recommendations to WHO on proposed modifications to COVID-19 vaccine antigen composition. Recently, the TAG-CO-VAC advised that a monovalent JN.1 or KP.2 vaccines remain as appropriate vaccine antigen, while a monovalent LP.8.1 is a suitable alternative vaccine antigen (Ref: https://www.who.int/news/item/15-05-2025-statement-on-the-antigen-composition-of-covid-19-vaccines) to be included in the composition of COVID-19 vaccines (2025-2026 Formula).”

The VRBPAC meeting topics:

“On May 22, 2025, VRBPAC will meet in open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the U.S. The committee will be asked to discuss available evidence on recent and currently circulating SARS-CoV-2 variants, including data from virus surveillance and genomic analyses, antigenic characterization analyses, vaccine effectiveness and clinical immunogenicity studies of current U.S.- authorized/approved COVID-19 vaccines and nonclinical immunogenicity studies of candidate vaccines expressing or containing updated Spike antigens.”

The attendees include:

The TAG-CO-VAC presenter:

Kanta Subbarao, M.B.B.S., M.P.H. Professor Department of Microbiology and Immunology Faculty of Medicine Laval University (Laval University is in Quebec City, Quebec, Canada).

There’s an Iowa City member on the committee roster:

Stanley M. Perlman, M.D., Ph.D. Expertise: Pediatrics, Infectious Diseases Term: 08/23/2022 – 01/31/2026 Professor University of Iowa Distinguished Chair Department of Microbiology and Immunology Carver College of Medicine University of Iowa, Iowa City, IA 52242.

And the acting chair of the meeting will once again be: Arnold Monto, M.D. Expertise: Epidemiology Term: 02/01/2022 – 01/31/2026 Thomas Francis Jr. Collegiate Professor Emeritus of Public Health and Epidemiology School of Public Health University of Michigan Ann Arbor, MI 48109.

Vaccine manufacturer presentations will be from Moderna, Pfizer, Novavax, and Sanofi.

FDA Advisory Committee Meeting to Discuss Future Covid-19 Vaccine Regimens

The FDA 178th Meeting of the Vaccine and Related Biological Products Advisory Committee will meet in open session January 26, 2023 to discuss future Covid-19 vaccination regimens. The meeting will run between 8:30 AM-5:30 PM ET.

CDC Identifies Preliminary Covid-19 Vaccine Safety Signal

The CDC announced that a prelimary Covid-19 Vaccine Safety signal has been identified in a recent update on their website:

“Following the availability and use of the updated (bivalent) COVID-19 vaccines, CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation. Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

  • A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke
  • A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine
  • The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine
  • Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
  • Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines”

The CDC says it’s “very unlikely  that the signal in VSD represents a true clinical risk…” The data and additional analyses will be discussed at the January 26, 2023 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No changes are recommended to the current Covid-19 vaccination practice:

“CDC continues to recommend that everyone ages 6 months of age and older stay up-to-date with COVID-19 vaccination; this includes individuals who are currently eligible to receive an updated (bivalent) vaccine. Staying up-to-date with vaccines is the most effective tool we have for reducing death, hospitalization, and severe disease from COVID-19, as has now been demonstrated in multiple studies conducted in the United States and other countries:

  • Data have shown an updated COVID-19 vaccine reduces the risk of hospitalization from COVID-19 by nearly 3-fold compared to those who were previously vaccinated but have not yet received the updated vaccine.
  • Data have shown that the updated COVID-19 vaccine also reduces the risk of death from COVID-19 by nearly 19-fold compared to those who are unvaccinated.
  • Other preliminary data from outside the U.S. have demonstrated more than 80% protection against severe disease and death from the bivalent vaccine compared to those who have not received the bivalent vaccine.

Overall safety data for the bivalent COVID-19 vaccines are available here.

Once again, no change is recommended in COVID-19 vaccination practice, which can be found here.”

FDA Advisory Committee Approves Adding Omicron component to the Next Covid-19 Vaccine

On June 28, 2022 the FDA Vaccine and Related Biological Products Advisory Committee came to a majority “yes” vote to the question:

“Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States?”

The meeting was recorded and is available for review.

FDA Advisory Committee Meeting on June 7, 2022 for New Covid-19 Vaccine

The FDA Advisory Committee will meet on June 7, 2022, 8:30 AM – 5:00 PM ET to discuss the Novavax Covid-19 vaccine EUA application.

The vaccine is a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2rS) with Matrix-M1 Adjuvant.

Second Covid Vaccine Booster Got Any Mojo?

Tomorrow’s April Fool’s Day and I thought I’d get this post up today so it wouldn’t get confused with a joke.

I’m genuinely a little confused about the FDA and CDC approval of the 2nd Covid vaccine booster. It’s almost like this vaccine is getting a mojo of some kind, at least with some experts.

Although I’m not keen on getting another jab, I’ll do it if there is reasonable evidence to support it. Not everyone on the FDA Advisory committee is for it. Dr. Paul Offit was quoted in a news story as saying, “We’re going to have to learn to live with mild disease at some point.” 

Dr. Offit is the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. I’ve heard him speak at FDA Advisory Committee meetings during public Zoom meetings on the subject and I respect his opinion. He doesn’t think frequent boosting is a reasonable thing to do. I’m inclined to agree with his opinion that most people won’t do it anyway. I’m sure he’ll have more to say at the April 6 FDA Covid Vaccine Advisory Committee meeting.

I was not surprised to learn that of the 90 million Americans who got their initial Covid vaccine series, only about half got the first booster. What kind of mojo is that?

Even the Pfizer drug company CEO, Albert Bourla, says frequent boosting is impractical.

There is some serious doubt in my mind about the booster mojo. Sena says that it would be helpful if more local infectious disease experts would express their own opinions about the direction this vaccination strategy is going. She has a point.

Does the Covid vaccine booster have any mojo? What do you think?

Featured image picture credit: pixydotorg.

FDA Advisory Committee Meeting on Covid Vaccine Boosters Scheduled for April 6, 2022

The FDA Advisory Committee on Vaccines and Related Biological Products has scheduled a meeting on April 6, 2022 “to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants.” The meeting will run from 8:30 AM-5:00 PM ET.

FDA Postpones Meeting to Discuss Pfizer Covid-19 Vaccine for Children Less Than 5 years Old

The FDA announced today that the meeting to discuss Pfizer’s request for authorization of Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age, originally scheduled February 15, 2022, will be postponed. This will give Pfizer time to evaluate a third dose of the vaccine in this age group.

FDA Advisory Meeting on Covid-19 Vaccine for Children Less than 5 years Old

The FDA Advisory Committee will meet February 15, 2022 between 8:30 AM-5:00 PM ET to discuss Pfizer’s proposal to amend the Emergency Use Authorization for administration of the Covid-19 vaccine to children between 6 months through 4 years of age.

Public Notice of Gratitude to FDA & CDC Advisory Committees

I have watched a few YouTube presentations by the CDC and FDA Advisory Committees in the last few weeks. I’m very impressed with the professionalism, sincerity, civility, and dedication of the members of both organizations. The most recent FDA meeting on the extension of the EUA for the Pfizer COVID-19 vaccine to children ages 5-11 was a great example of the best of the best. It’s a tough job. I appreciate them. They also have a pretty good sense of humor, especially when they forget to unmute their microphones.