FDA advisory committee recommends emergency use authorization for Moderna vaccine

An independent advisory panel has voted to recommend emergency use authorization for Moderna’s coronavirus vaccine, setting it up to get the green light from the FDA, which would mark the second vaccine available in the U.S.
The Vaccines and Related Biological Products Advisory Committee, which met all day on Thursday, voted 20-0 with one abstention in favor of the EUA after hours of lively discussion.
“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr. James Hildreth, a temporary VRBPAC voting member.
Dr. Arnold Monto, acting VRBPAC chair said, “Our vote was even more overwhelming tonight than last week.”
The prestigious, independent committee convened by the Food and Drug Administration voted that the benefits outweigh the risks for use of the vaccine in adults age 18 and older.
Dr. A. Oveta Fuller, a temporary voting member, said, “I appreciate that Moderna has given us a very transparent and thorough study.”
Data from Moderna confirmed by the FDA shows the vaccine is 94.1% effective and boasts a good safety profile with most common side effects including injection site pain, fatigue, muscle ache and headache.
A new side effect of facial swelling reported in vaccine trial recipients who had previously gotten dermal filler was revealed Thursday.
One ethical issue of importance that resulted in robust discussion during the meeting was whether to unblind Moderna trial participants following issuance of an EUA.
Moderna offered a plan to give placebo recipients a vaccine, saying they wouldn’t be “jumping the line” as there is already supply from the trial that would otherwise go bad if not used.
But the FDA and the committee expressed concern that it cuts the trial short and limits ongoing data collection. The committee did not take up a vote on the matter.
In an addendum to the FDA briefing, new data on reduction in asymptomatic infection was also reported by Moderna, providing a glimpse into the unanswered questions of how a vaccine could impact such patients.
Among baseline participants who tested negative for coronavirus, 14 in the vaccine group and 38 in the placebo group had evidence of infection at the second dose without coronavirus symptoms.
Last week, VRBPAC voted to recommend an EUA for Pfizer’s coronavirus vaccine and the FDA granted the authorization the day after. The same could happen for Moderna.
Emergency use authorization is different from FDA approval, which will likely happen later, but still allows for widespread use.
The United States government has ordered 200 million vaccine doses from Moderna with an option to purchase another 300 million doses. About 20 million doses will be delivered by the end of the month, according to Moderna.

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