A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. Photo: Sarah Silbiger/Getty Images
A Food and Drug Administration advisory panel recommended Wednesday the second vaccine in two days against the respiratory syncytial virus, or RSV, for adults over 60.
Why it matters: If approved by the FDA, the vaccines from GlaxoSmithKline (GSK) and Pfizer would be the first publicly available against a respiratory virus that claims thousands of lives every year.
By the numbers: RSV causes up to 10,000 deaths and as many as 160,000 hospitalizations for adults 65 years and older per year in the U.S., according to the Centers for Disease Control and Prevention (CDC).
Driving the news: The Vaccines, and Biological Products Advisory Committee's decision to endorse GSK's vaccine for adults over age 60 comes a day after it voted to recommend Pfizer's vaccine candidate for the same age group.
- The advisors voted 12-0 on effectiveness and 10-2 on safety for GSK's vaccine. Pfizer's vaccine received 7-4 votes on effectiveness and safety separately.
Yes, but: The FDA flagged concerns about Guillain-Barré risks for both shots before the advisory committee's two-day meeting, which advisors considered before voting.
Thought bubble, via Axios' Tina Reed: The FDA traditionally follows the advice of this key panel. If ultimately approved, this would create the first defense in the U.S. against what is a highly contagious and potentially dangerous virus for older adults.
- We’ll still be waiting, however, for a vaccine for infants and young children, who are also vulnerable to RSV.
Of note: Moderna is also making an mRNA-based vaccine for RSV in older adults that will head to the FDA for approval in the first half of 2023.
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