Who’s on the FDA’s Advisory Panel That Will Review Pfizer’s Vaccine?

December 7, 2020

The FDA has had trouble finding members for its vaccine advisory committee that will meet on Dec. 10, to consider recommending Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine candidate — surely one of the most important advisory panel meetings in the agency’s history.

FDA advisory committee members in the past have frequently been the target of heavy politicking by industry representatives of whatever drug they were considering for a recommendation at in-person meetings. That process has been somewhat altered by the fact that during COVID-19, meetings are being held virtually. But it’s likely that behind-the-scenes pressuring still goes on. The industry defends the attempts to influence committee members as simply efforts to best present their case.

One temporary voting member was just added to the panel on Nov. 24 — James Hildreth, president and chief executive officer of Meharry Medical College in Nashville, Tenn. Meharry is an approved site for a trial of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373, being conducted by the NIH as part of Operation Warp Speed. While acknowledging a potential financial conflict of interest, as the college will receive between $500,000 and $750,000 for the Novavax trial, the waiver document asserts that Hildreth’s “strong and significant scientific background in virology and immunology will be critical” to the advisory group’s recommendation.

“It would be impossible to replace Dr. Hildreth (especially in view of previous multiple recusals of invited participants) and excluding him from participation will have a negative effect on the committee deliberations,” said Atreya Prabhakara, the FDA’s director for scientific advisers and consultants within the Center for Biologics, Evaluation and Research.

But who else is on the 15-member advisory committee that usually works far away from the media’s intense scrutiny? It is made up mostly of experts from the academic community, and the current line-up of doctors and researchers from universities, cancer centers and teaching hospitals includes:

  • The committee’s chairperson Hana El Sahly, from Baylor College of Medicine in Houston, Texas;
  • Archana Chatterjee, from Rosalind Franklin University of Medicine and Science in North Chicago, Ill;
  • Hayley Gans, from Stanford University in Stanford, Conn.;
  • Holly Janes, Fred Hutchinson Cancer Research Center in Seattle, Wash.;
  • Myron Levine, from the University of Maryland in Baltimore, Md.;
  • H. Cody Meissner, from Tufts University in Boston, Mass.;
  • Paul Offit, from the Children’s Hospital of Philadelphia, Penn.;
  • Steven Pergam, from the Seattle Cancer Care Alliance, Wash.;
  • Andrea Shane, from Emory University in Atlanta, Ga.;
  • Paul Spearman, from Cincinnati Children’s Hospital, Ohio.; and
  • Geeta Swamy, from Duke University in Durham, N.C.

The HHS representatives, which includes personnel from the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) are:

  • Tammy Beckham, HHS, vaccines and infectious diseases director;
  • Capt. Amanda Cohn, acting chief medical officer for vaccines at the CDC; and
  • Michael Kurilla, director of clinical innovation for advancing translational sciences at NIH.

Paula Annunziato, Merck’s vice president and therapeutic area head for vaccines clinical research, is the non-voting member from industry, but the committee also includes an alternate industry representative, Gregg Sylvester, vice president of medical affairs at N.J.-based Seqirus, a subsidiary of Australian biotech firm CSL.

Representing consumer groups is another non-voting member, health benefits lawyer Sheldon Toubman, a staff attorney at the New Haven Legal Assistance Association in Connecticut.

Each member is chosen by FDA Commissioner Stephen Hahn or a “designee” through a nomination process, with experts solicited via notices published in the Federal Register. Members serve for overlapping terms of no more than four years and are pulled from the fields of: “immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development, allergy, preventive medicine, infectious diseases, pediatrics, microbiology and biochemistry.” ― Jason Scott