Some FDA Advisors Tapped to Review Coronavirus Vaccines Received Payments from Vaccine Companies

Several members of a panel that will be advising the Food and Drug Administration (FDA) on whether to approve potential vaccines for coronavirus have a history of financial relationships with companies developing the vaccines.

The FDA advisors’ ties to the drug companies have taken a variety of forms, including consulting fees and compensation for travel and lodging, according to records reviewed by the Project On Government Oversight (POGO). In some cases, companies have paid them directly. In other cases, companies have paid their organizations for medical studies in which they played a principal role, records show.

The FDA panel, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet tomorrow to discuss for the first time “in general, the development, authorization and/or licensure of vaccines to prevent COVID-19,” according to the meeting agenda.

A federal database shows that, in 2019, advisory committee member Dr. Archana Chatterjee, for instance, received $23,904 from Pfizer (including Pfizer International LLC), $11,738 from Merck, and $11,480 from Sanofi, each of which is in the race for a coronavirus vaccine. Since 2013, she has received more than $200,000 in consulting fees, travel and lodging, and other payments from those companies and others working on coronavirus vaccines, according to the database.

The FDA advisors’ ties to the drug companies have taken a variety of forms, including consulting fees and compensation for travel and lodging.

The newly named acting chairman of the committee, Dr. Arnold Monto, received $54,114 from 2013 through 2019 from vaccine contenders Sanofi, GlaxoSmithKline, Pfizer, and Shionogi, according to the database. He also received $10,657 from Novartis, which has a deal to manufacture a coronavirus vaccine.

Monto’s curriculum vitae says he served as principal investigator from 2007 to 2016 on a study of influenza vaccines funded by Sanofi Pasteur, a unit of Sanofi. He is a professor of epidemiology at the University of Michigan, which has announced that it is partnering with pharmaceutical company AstraZeneca on a clinical trial of a potential COVID-19 vaccine.

Meanwhile, the FDA has indicated that it has granted or is preparing to grant waivers from conflict of interest prohibitions to two new temporary appointees to the committee. One is the president of Meharry Medical College, the approved site for a clinical trial of a potential coronavirus vaccine, an FDA memo says. Meharry, which is in Nashville, will be receiving between $500,000 and $750,000 for conducting the clinical trial, the memo says.

The second waiver recipient, a professor of biostatistics, holds stock valued at $25,000 to $50,000 in Philip Morris, which has a one-third stake in a company “which can be affected by the particular matters before the committee,” another FDA memo says.

The need for the two temporary appointees’ expertise outweighs the potential conflicts, an FDA official asserted in the memos.

The chair of the FDA committee, who specializes in vaccines and infectious diseases at Baylor College of Medicine in Houston, has been recused from the panel’s review of COVID-19 vaccines because she is co-chairing Moderna’s vaccine trial, Baylor spokesperson Dipali Pathak said by email, confirming a September report by Reuters.

See the full story at: https://www.pogo.org/investigation/2020/10/some-fda-advisors-tapped-to-review-coronavirus-vaccines-received-payments-from-vaccine-companies/