Unblinding concerns and vaccinating special populations remain issues

WASHINGTON — The FDA had three questions for the members of its Vaccines and Related Biological Products Advisory Committee, but only one of them really mattered, and it was the only one that required a vote: “Based on the totality of the scientific evidence available, do the benefits of the Pfizer vaccine outweigh its risks for use in individuals age ≥16?”

The answer was yes, but it was not unanimous.

The committee responded with a vote of 17-4 in favor of the vaccine at the close of its Dec. 10 meeting, with one member abstaining. If the FDA accepts the committee’s recommendation, Pfizer’s BNT162b2 will become the first Covid-19 vaccine to gain an emergency use authorization in the U.S.

Committee members who voted “No ” were:

  • Michael Kurilla, MD, PhD, a pathologist/infectious disease expert and director of the Division of Clinical Innovation in the National Center for Advancing Translation Sciences at the National Institutes of Health (NIH).
  • Archana Chatterjee, MD, PhD, a pediatrician, infectious disease expert, dean of Chicago Medical School, and vice president for medical affairs at Rosalind Franklin University.
  • A. Oveta Fuller, PhD, a microbiologist/immunologist at the University of Michigan.
  • Capt. David Kim, MD, an infectious disease expert and director of the Division of Vaccines in the Office of Infectious Disease and HIV/AIDS Policy in the Department of Health and Human Services (HHS).

One member decided to abstain from voting: H. Cody Meissner, MD, a pediatrician/infectious diseases expert at Tufts University School of Medicine.

The two other questions, although interesting, were really prompts to trigger discussion and debate. They were:

  • Question 1 – Discuss unblinding: Pfizer has proposed a plan for continuation of blinded, placebo-controlled follow-up in ongoing trials if the vaccine were made available under EUA. Please discuss Pfizer’s plan, including how loss of blinded, placebo-controlled follow-up in ongoing trials should be addressed.
  • Question 2 – Discuss special populations: Discuss any gaps in plans described today, and in the briefing document, for further evaluation of vaccine safety and effectiveness in populations who receive the Pfizer vaccine in the U.S.

Peer-reviewed findings from a multinational phase III trial of BNT162b2 were published earlier today in the New England Journal of Medicine, confirming an efficacy of 95% for the prevention of Covid-19 infection, as reported by BreakingMED.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,190,31,926,192,561,927,151,590,725,925,934