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COVID Vaccine Standards Questioned at FDA Meeting

Oct. 22, 2020 -- Researchers and several medical groups on Thursday pressed for changes to the FDA’s plans for deciding how to eventually approve vaccines for COVID-19, arguing tougher standards would help bolster confidence in these critical medicines.

The FDA's Vaccines and Related Biological Products Advisory Committee met Thursday for a wide-ranging discussion. The FDA did not ask the panel to weigh in on any particular vaccine. Instead, the FDA asked for the panel's feedback on a series of questions, including considerations for continuing phase III trials if a product were to get a clearance known as an emergency use authorization).

Speakers at the hearing made a variety of requests, including asking for data showing COVID-19 vaccines can prevent serious illness and urging transparency about the agency's deliberations for each product to be considered.

FDA staff are closely tracking the crop of experimental vaccines that have made it into advanced stages of testing, including products from Pfizer, AstraZeneca, Johnson & Johnson, and Moderna.

'Time for a Reset’

Among the speakers at the public hearing was Peter Lurie, MD, who served as an FDA associate commissioner from 2014 to 2017. Now the president of the Center for Science in the Public Interest, Lurie was among the speakers who asked the agency to make its independence clear.

President Donald Trump has for months been making predictions about COVID-19 vaccine approvals that have been overly optimistic. In one example, the president, who is seeking re-election Nov. 3, last month spoke about being able to begin distributing a vaccine in October.

"Until now, the process of developing candidate vaccines has been inappropriately politicized with an eye on the election calendar, rather than the deliberate timeframe science requires," Lurie told the FDA advisory panel. "Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward."

Lurie asked the panel to press the FDA to commit to hold an advisory committee meeting on requests by drugmakers for EUAs. He also asked the panel to demand that informed consent forms and minutes from institutional review board discussions of COVID-19 vaccines trials be made public.

Also among the speakers at the public hearing was Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, who argued that the current trials won't answer the right questions about the COVID-19 vaccines.

"We could end up with approved vaccines that reduce the risk of mild infection, but do not decrease the risk of hospitalization, ICU use, or death — either at all or by a clinically relevant amount," Doshi told the panel.

In his presentation, he reiterated points he had made previously, including in an Oct. 21 article in the BMJ, for which he is an associate editor. Doshi also raised these concerns in a September opinion article in The New York Times, co-authored with Eric Topol, MD, director of the Scripps Research Translational Institute and editor-in-chief of Medscape.

Risks of a 'Rushed Vaccine’

Other complaints about the FDA's approach included criticism of a 2-month follow-up time after vaccination, which was seen as too short. ECRI, a nonprofit organization that works to improve the safety, quality, and cost-effectiveness of medicines, has argued that approving a weak COVID-19 vaccine might worsen the pandemic.

In an Oct. 21 statement, ECRI noted the risk of a partially effective vaccine, which could be welcomed as a way to slow transmission of the virus. But public response and attitudes over the past 9 months in the United States suggest that people would relax their precautions as soon as a vaccine is available.

"Resulting infections may offset the vaccine's impact and end up increasing the mortality and morbidity burden," ECRI said in the brief.

"The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough," ECRI Chief Executive Officer Marcus Schabacker, MD, said in a statement prepared for the hearing.

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