(Reuters) – Influential U.S. The physician, who heads the Food and Drug Administration’s Vaccine Advisory Committee, distanced herself from the panel review of the Covid-19 vaccine because of her role in overseeing the clinical trials of the Moderna Inc. candidate, a spokeswoman told Reuters.
Hannah Al-Sahli, an associate professor of virology and microbiology at the Baylor College of Medicine in Houston, chaired the FDA’s Vaccine and Related Biological Products Advisory Committee last year – to make recommendations on whether to approve coronavirus vaccines.
In July, however, al-Sahli was named as one of the three leading investigators for the trial of the late-stage COVID-19 vaccine in Modern, creating a potential conflict of interest.
Moderna said it may have enough data in November to show whether its vaccine is safe and effective. That timeline would make it one of the first drug manufacturers to receive U.S. approval.
Baylor spokesperson Deepali Pathak has confirmed Al Sahli’s re-visit. The FDA said it usually announces the committee’s rosters two business days before any meeting, but did not say who will chair the vaccination committee in Al Sahli’s absence. Al-Sahli declined to comment, and Moderna did not answer questions.
Expert advisory panels often play a key role ahead of FDA approval decisions. Concerns have been raised under pressure from the Trump administration that the FDA will ship the vaccine before the November 3 presidential election.
Meeting on Covid-1 vaccine candidates Oct Oct. To be held on the 22nd. No drug manufacturer is likely to have enough data to be authorized by then, although Pfizer Inc. said it would know if its vaccine would work until next month.
FDA officials have promised that the committee will have a “transparent discussion” about clinical trial data on vaccine candidates before any possible authorization.
The FDA is not bound to follow the advisory group’s recommendations. However, advising against approval by the panel – especially due to safety concerns – would make it difficult for the agency to do justice to the proceedings.
Connecticut-based attorney Sheldon Toubman, who serves as a consumer advocate on the FDA’s vaccine advisory committee, called al-Sahli “very knowledgeable” and said she had taken the lead in discussing other vaccines.
“I’m sure the replacement chair, if selected from the existing member-experts of our committee, would also be fully qualified,” Tubman said.
The Vaccine Advisory Committee has 15 voting members. The agency may also appoint temporary members with specialized skills in the subject under discussion.
U.S. The government has invested about 11 11 billion to help develop and build more than half a dozen coronavirus vaccine candidates, believed to be needed to help end the epidemic, which has claimed the lives of nearly one million people worldwide.
Under Moderna’s trial protocol, led by Al Sahli, the Independent Data and Safety Monitoring Board will take a first look at the data after 53 trial participants became infected, the company’s estimates said in November.
If the majority of those who contracted COVID-19 were in a group that received a placebo, Moderna said it would take Emergency Use Author Theory (EU) for its vaccine.
As of last week, Moderna said it had registered more than 25,000 participants out of the 30,000 planned in the late-phase study.
Earlier this year, the FDA set safety and efficacy guidelines for giving EUA to COVID-19 vaccines. To allay concerns of political pressure, the agency is expected to issue stricter standards soon, with trial participants being monitored for at least two months after receiving the final shot, the Washington Post reported on Tuesday.
The Secretary of Health and Human Services may overturn any decision of the FDA.
Reported by Dan Levine in San Francisco and Marissa Taylor in Washington; Edited by Bill Burkerot
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