Pfizer postpones request with the FDA to approve COVID-19 vaccine for kids under 5


The approval of Pfizer's COVID-19 vaccine for children under five in the United States has hit a snag.
On Friday, Pfizer announced it's postponing its application with the Food and Drug Administration to approve its COVID-19 for children between the ages of 6 months and 4 years, NBC News reports.
Pfizer requested the FDA approve its COVID-19 vaccine for young children earlier this month. But the company said Friday it will wait for data from a study evaluating administering a third dose in this age group two months after the second dose.
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.

Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
"Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," Pfizer and BioNTech said. "This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen."
It's a delay in the timeline after it was previously reported that the vaccine could potentially be available for young kids by February.
At the same time, in what The New York Times described as a "striking reversal," the FDA announced Friday it has postponed a meeting of its Vaccines and Related Biological Products Advisory Committee to consider the Pfizer vaccine, originally scheduled for Feb. 15, as "we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization." The FDA said it will provide an update on the timing of the meeting when it receives the additional data from Pfizer, which Pfizer said is expected in early April.
Sign up for Today's Best Articles in your inbox
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
Brendan worked as a culture writer at The Week from 2018 to 2023, covering the entertainment industry, including film reviews, television recaps, awards season, the box office, major movie franchises and Hollywood gossip. He has written about film and television for outlets including Bloody Disgusting, Showbiz Cheat Sheet, Heavy and The Celebrity Cafe.
-
France and Indonesia promote a contentious bid for an Israel-Palestine two-state solution
Talking Points Both countries have said a two-state solution is the way to end the Middle East conflict
-
Film reviews: Mission: Impossible—The Final Reckoning, Lilo & Stitch, and Final Destination: Bloodlines
Feature Tom Cruise risks life and limb to entertain us, a young girl befriends a destructive alien, and death stalks a family that resets fate's toll.
-
Music reviews: Morgan Wallen and Kali Uchis
Feature "I'm the Problem" and "Sincerely"
-
RFK Jr. scraps Covid shots for pregnant women, kids
Speed Read The Health Secretary announced a policy change without informing CDC officials
-
New FDA chiefs limit Covid-19 shots to elderly, sick
speed read The FDA set stricter approval standards for booster shots
-
US overdose deaths plunged 27% last year
speed read Drug overdose still 'remains the leading cause of death for Americans aged 18-44,' said the CDC
-
Trump seeks to cut drug prices via executive order
speed read The president's order tells pharmaceutical companies to lower prescription drug prices, but it will likely be thrown out by the courts
-
RFK Jr.: A new plan for sabotaging vaccines
Feature The Health Secretary announced changes to vaccine testing and asks Americans to 'do your own research'
-
Unraveling autism: RFK Jr.'s vow to find a root cause
Feature RFK Jr. has vowed to find the root cause of the 'autism epidemic' in months. Scientists have doubts.
-
The sneaking rise of whooping cough
Under the Radar The measles outbreak isn't the only one to worry about
-
RFK Jr. visits Texas as 2nd child dies from measles
Speed Read An outbreak of the vaccine-preventable disease continues to grow following a decade of no recorded US measles deaths