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.
-
Cautious optimism surrounds plans for the world's first nuclear fusion power plant
Talking Point Some in the industry feel that the plant will face many challenges
By Justin Klawans, The Week US Published
-
Explore new worlds this winter at these 6 enlightening museum exhibitions
The Week Recommends Discover the estrados of Spain and the connection between art and chess in various African countries
By Catherine Garcia, The Week US Published
-
2024: the year of Black country artists
In the Spotlight Beyoncé debuted 'Cowboy Carter' at the top of the country charts, shining a spotlight on artists like Shaboozey
By Theara Coleman, The Week US Published
-
Marty Makary: the medical contrarian who will lead the FDA
In the Spotlight What Johns Hopkins surgeon and commentator Marty Makary will bring to the FDA
By David Faris Published
-
California declares bird flu emergency
Speed Read The emergency came hours after the nation's first person with severe bird flu infection was hospitalized
By Rafi Schwartz, The Week US Published
-
Bird flu one mutuation from human threat, study finds
Speed Read A Scripps Research Institute study found one genetic tweak of the virus could enable its spread among people
By Peter Weber, The Week US Published
-
Dark chocolate tied to lower diabetes risk
Speed Read The findings were based on the diets of about 192,000 US adults over 34 years
By Peter Weber, The Week US Published
-
ACA opens 2025 enrollment, enters 2024 race
Speed Read Mike Johnson promises big changes to the Affordable Care Act if Trump wins the election
By Peter Weber, The Week US Published
-
McDonald's sued over E. coli linked to burger
Speed Read The outbreak has sickened at least 49 people in 10 states and left one dead
By Rafi Schwartz, The Week US Published
-
Long Covid: study shows damage to brain's 'control centre'
The Explainer Research could help scientists understand long-term effects of Covid-19 as well as conditions such as MS and dementia
By The Week UK Published
-
Israel, UN agree to Gaza pauses for polio vaccinations
Speed Read Gaza's first case of polio in 25 years was confirmed last week in a 10-month-old boy who is now partially paralyzed
By Rafi Schwartz, The Week US Published