
Advisory Panel Endorses Pfizer RSV Vaccine for Older Adults

WASHINGTON — A panel of advisors to the Food and Drug Administration narrowly voted on Tuesday to endorse an experimental vaccine from Pfizer to protect older adults against the highly contagious lower respiratory tract ailment RSV.
The advisors voted 7-4 on two questions, the first being whether the vaccine was safe, and the second on whether it was effective.
Pfizer told the panel the vaccine was up to 85.7% effective at preventing a full-blown case with three or more symptoms.
But members still expressed reservations about the vaccine’s “important potential risk” — Guillain-Barré syndrome.
Two adults among the 20,000 vaccine recipients in Pfizer’s phase 3 clinical trial developed symptoms consistent with the rare neurological disorder within nine days of receiving the shot.
The FDA panel is also reviewing another proposed RSV vaccine from GlaxoSmithKline.
It is scheduled to review and vote on GSK’s shot, which is also designed to prevent respiratory disease in adults 60 or older, on Wednesday.
The recommendations are non-binding and an FDA decision on the vaccines is expected by May, well ahead of RSV’s normal winter surge.
Once the FDA acts, the Centers for Disease Control and Prevention will weigh in. It’s the last agency that must give its blessing to the vaccines before they are made available to the public.
RSV is a flu-like illness that increases in severity with age. According to the CDC, it is responsible for an estimated 177,000 hospitalizations and 14,000 deaths per year among adults 65 or older.
Dan can be reached at [email protected] and at https://twitter.com/DanMcCue
In The News
Health
Voting
Health
WASHINGTON — The Environmental Protection Agency, in coordination with the U.S. Justice Department, is seeking potentially millions of dollars in... Read More
WASHINGTON — The Environmental Protection Agency, in coordination with the U.S. Justice Department, is seeking potentially millions of dollars in civil fines from the Norfolk Southern Railway Co. in connection to the Feb. 3 derailment of a train carrying hazardous materials near East Palestine, Ohio. In... Read More
WASHINGTON — Americans starting to think about spring and summer vacations as the weather warms may find their favorite water... Read More
WASHINGTON — Americans starting to think about spring and summer vacations as the weather warms may find their favorite water destinations unsafe for swimming. Thick layers of cyanobacteria — commonly known as blue-green algae — have closed popular local lakes in recent years, and Florida has... Read More
The overwhelming evidence and consensus among global health organizations is that gender-affirming care saves lives. Yet many transgender, nonbinary and... Read More
The overwhelming evidence and consensus among global health organizations is that gender-affirming care saves lives. Yet many transgender, nonbinary and gender non-conforming people lack access to the care they need. Some must wait up to a year to talk to a medical professional about gender-affirming care.... Read More
WASHINGTON — An increased reliance on telehealth services and medications for opioid use disorder by Medicare beneficiaries significantly reduced their... Read More
WASHINGTON — An increased reliance on telehealth services and medications for opioid use disorder by Medicare beneficiaries significantly reduced their risk for fatal overdoses during the COVID-19 pandemic, the National Center for Injury Prevention and Control reported on Wednesday. Published in JAMA Psychiatry, the study is... Read More
In June 2022 the U.S. Supreme Court issued a decision that provided the sought after political fodder to catapult fundraising... Read More
In June 2022 the U.S. Supreme Court issued a decision that provided the sought after political fodder to catapult fundraising efforts heading into the 2022 midterm election cycle. In the June opinion, the court overruled two cases from 1973 and 1992, and returned the matter of... Read More
WASHINGTON — Rep. Nikki Budzinski, D-Ill., has joined the Bipartisan Fentanyl Prevention Caucus and the Bipartisan Mental Health and Substance... Read More
WASHINGTON — Rep. Nikki Budzinski, D-Ill., has joined the Bipartisan Fentanyl Prevention Caucus and the Bipartisan Mental Health and Substance Use Disorder Task Force where, she says, she will work across the aisle on solutions to the ongoing addiction crisis. “Every day, too many of our... Read More