AP

FDA panel narrowly backs Pfizer RSV vaccine for older adults

Feb 28, 2023, 3:21 PM | Updated: 3:51 pm

WASHINGTON (AP) — Federal health advisers on Tuesday narrowly backed an experimental vaccine from Pfizer that could soon become the first shot to protect older adults against the respiratory illness known as RSV.

The Food and Drug Administration panel voted 7-4 on two separate questions of whether Pfizer’s data showed the vaccine was safe and effective against the respiratory virus for people 60 and older. One panelist abstained from voting. The recommendation is non-binding and the FDA will make its own decision on the vaccine in the coming months.

The positive vote came despite concerns about rare potential reactions and questions about how the vaccine fared in people who face the greatest risks from RSV. Pfizer’s shot was more than 85% effective at preventing severe disease in a company study, but panelists noted there were few people with underlying health problems.

“I think the primary endpoint was clearly met here,” said Dr. Daniel Feikin, a respiratory disease consultant who voted in favor of the vaccine. “It’s disappointing we don’t have more data on the high-risk groups and severe outcomes.”

Feikin and other panelists said the FDA should require more data on safety and effectiveness in Pfizer’s planned follow-up study.

The FDA panel is also reviewing another proposed RSV vaccine from GlaxoSmithKline. The FDA panel is scheduled to review and vote on GSK’s shot, which is also designed to prevent respiratory disease in older adults, on Wednesday.

For most healthy people, RSV is a cold-like nuisance. But for the very young, the elderly and people with certain health problems, it can be serious and even life-threatening. The virus can cause infections deep in the lungs, triggering pneumonia.

Efforts to develop RSV vaccines suffered a major setback in the 1960s when one experimental shot was shown to worsen infections in children.

Public interest in a potential vaccine peaked last fall during a surge of cases affecting babies and older Americans. Pfizer and GSK are currently only applying for approval among those who are 60 years old and up.

Much of Tuesday’s meeting centered on two cases of Guillain-Barre syndrome, a rare neurological reaction, diagnosed in two people out of about 20,000 who received Pfizer’s shot. Pfizer said the cases could have been due to other medical factors.

But the FDA said the reaction is “an important potential risk” and would need to be closely tracked and studied, if the vaccine is approved. Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, sometimes causing paralysis that typically is temporary.

Panelists who voted against the vaccine’s safety profile cited the two cases.

“I think we need to do everything we can to make sure that vaccines are safe before we send them out to the public,” said Dr. James Hildreth of Meharry Medical College.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

FILE - Crystal Baziel holds the Pan-African flag Monday, June 19, 2023, during Reedy Chapel A.M.E C...

Associated Press

The beginner’s guide to celebrating Juneteenth

For more than one-and-a-half centuries, the Juneteenth holiday has been sacred to many Black communities. It marks the day in 1865 enslaved people in Galveston, Texas found out they had been freed — after the end of the Civil War, and two years after President Abraham Lincoln’s Emancipation Proclamation. Since it was designated a federal […]

1 day ago

A Boeing 737 Max suffered damage to parts of the plane's structure after it went into a “Dutch ro...

Associated Press

Plane that did ‘Dutch roll’ on flight from Phoenix suffered structural damage, investigators say

A Boeing 737 Max suffered damage to parts of the plane's structure after it went into a “Dutch roll” during a flight from Phoenix last month.

6 days ago

This photo provided by Randy Shannon shows Mooney Falls on the Havasupai reservation outside the vi...

Associated Press

Dozens report illness after trips to waterfalls near Grand Canyon

Dozens of hikers say they fell ill during trips to a popular Arizona tourist destination that features towering blue-green waterfalls deep in a gorge neighboring Grand Canyon National Park.

7 days ago

Mugshot of Rudy Giuliani, who was processed Monday, June 10, 2024, in the Arizona fake electors cas...

Associated Press

Rudy Giuliani posts $10K cash bond after being processed in Arizona fake electors case

Rudy Giuliani, a former New York City mayor and Donald Trump attorney, was processed Monday in the Arizona fake electors case.

9 days ago

FILE - White House former chief of staff Mark Meadows speaks with reporters at the White House, Wed...

Associated Press

Former Trump chief of staff Mark Meadows pleads not guilty in Arizona fake elector case

Former Donald Trump presidential chief of staff Mark Meadows and Trump 2020 Election Day operations director Michael Roman pleaded not guilty Friday in Phoenix to nine felony charges for their roles in an effort to overturn Trump's Arizona election loss to Joe Biden.

13 days ago

deadly heat wave last summer...

Associated Press

After a deadly heat wave last summer, metro Phoenix is changing tactics

Fresh memories of the deadly heat wave last summer have led Arizona authorities to launch new tactics ahead of summer 2024.

23 days ago

Sponsored Articles

...

Sanderson Ford

3 new rides for 3 new road trips in Arizona

It's time for the Sanderson Ford Memorial Day sale with the Mighty Fine 69 Anniversary, as Sanderson Ford turned 69 years old in May.

...

Collins Comfort Masters

Here’s how to be worry-free when your A/C goes out in the middle of summer

PHOENIX -- As Arizona approaches another hot summer, Phoenix residents are likely to spend more time indoors.

...

DESERT INSTITUTE FOR SPINE CARE

Desert Institute for Spine Care is the place for weekend warriors to fix their back pain

Spring has sprung and nothing is better than March in Arizona. The temperatures are perfect and with the beautiful weather, Arizona has become a hotbed for hikers, runners, golfers, pickleball players and all types of weekend warriors.

FDA panel narrowly backs Pfizer RSV vaccine for older adults