Home / Business / Exclusive: top consultants resign alongside FDA-COVID-19 vaccine tests due to possible conflicts

Exclusive: top consultants resign alongside FDA-COVID-19 vaccine tests due to possible conflicts



(Reuters) – A health care professional who heads the influential Vaccine Advisory Board of the U.S. Food and Drug Administration has withdrawn from the board’s review of COVID-19 vaccines because she was conducting a clinical trial for the Moderna Inc candidate has overseen, her spokeswoman told Reuters.

FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which is developing a vaccine against coronavirus disease (COVID-1
9) on May 18, 2020 in Cambridge, Massachusetts, United States. REUTERS / Brian Snyder / File Photo

Hana El Sahly, Associate Professor of Virology and Microbiology at Baylor College of Medicine in Houston, last year became chair of the FDA’s Advisory Committee on Vaccines and Related Biological Products – the panel of external experts that will make recommendations on the approval of coronavirus vaccines.

However, in July, El Sahly was named one of three lead investigators for Moderna’s late-stage COVID-19 vaccine study, creating a potential conflict of interest.

Moderna said there might be enough data to show if the vaccine is safe and effective as early as November. That schedule would make it one of the first drug companies to apply for US approval.

Baylor spokeswoman Dipali Pathak confirmed El Sahly’s rejection. The FDA said it usually publishes the committee’s rosters no later than two business days before a meeting, but didn’t say who would head the vaccination committee in El Sahly’s absence. El Sahly declined to comment and Moderna did not respond to questions.

Expert advisory boards often play a critical role in FDA approval decisions. The advice of these outside experts has become increasingly important on COVID-19 vaccines as the FDA is under pressure from the Trump administration to get a vaccine out ahead of the November 3rd presidential election.

A meeting about COVID-19 vaccine candidates is scheduled for October 22nd. It is highly unlikely that a drug company will have enough data by then to apply for approval, although Pfizer Inc has stated that it may know if its vaccine is working by next month.

FDA officials have promised that the committee will have a “transparent discussion” of clinical trial data on the vaccine candidates prior to possible approval.

The FDA is not required to follow the recommendations of the advisory group. However, should the panel advise against approval – particularly on security concerns – it would be more difficult for the agency to justify further development.

Sheldon Toubman, a Connecticut-based attorney who serves as a consumer advocate on the FDA Vaccine Advisory Board, described El Sahly as “very knowledgeable” and said she did an excellent job leading discussions about other vaccines.

“I am sure that the alternate chair, if chosen from among the existing experts on our committee, will be fully qualified,” said Toubman.

The vaccine advisory board consists of 15 voting members. The agency can also appoint temporary members with specific expertise on the subject under discussion.

The U.S. government has invested nearly $ 11 billion in the development and manufacture of more than half a dozen coronavirus vaccine candidates, which are considered essential to ending a pandemic that killed nearly one million people worldwide.

As part of the protocols for the Moderna study jointly managed by El Sahly, an independent data and safety monitoring committee will examine the data for the first time after infection in 53 study participants. The company estimates this will happen in November.

If the vast majority of those who have contracted COVID-19 are in the group who received a placebo, Moderna will seek emergency authorization (EUA) for its vaccine.

Until last week, Moderna said it had included more than 25,000 of the planned 30,000 participants in the late-stage study.

Earlier this year, the FDA set safety and effectiveness guidelines for issuing an EUA for COVID-19 vaccines. To further address concerns about political pressure, the agency is expected to announce stricter standards soon. Test takers must be monitored for at least two months after receiving a final shot, according to a Washington Post report on Tuesday.

The Secretary for Health and Human Services could override any FDA decision.

Reporting by Dan Levine in San Francisco and Marisa Taylor in Washington; Adaptation by Bill Berkrot


Source link