Pfizer Asks FDA To Authorize Its Covid Shot For Kids Under 5

Published 2 years ago
A doctor is injecting a vaccine to a baby boy


Pfizer and BioNTech asked the U.S. Food and Drug Administration to authorize their jointly-developed Covid-19 shot for children under five, the companies announced Tuesday, paving the way for the first vaccine roll out among young children to begin in a matter of weeks.


Pfizer and BioNTech said the companies had initiated a “rolling submission” to the FDA asking it to expand its current Emergency Use Authorization for the companies’ Covid-19 vaccine to include children six months to four years old, and it expects to complete its submission in the coming days.

The companies submitted the data at the FDA’s request, Pfizer and BioNTech said.


The vaccine series for young children is expected to consist of three shots, but data on the third shot’s effectiveness isn’t available yet and will be submitted in the “coming months.”

The FDA could first authorize two shots, which Pfizer CEO Albert Bourla noted would let parents “begin a Covid-19 vaccination series for their children while awaiting potential authorization of a third dose.”

The FDA said in a statement it will meet February 15 to discuss the shots, meaning authorization could come soon after that.

If approved, the shot will be the first authorized for use in children under the age of five in the U.S.



“As hospitalizations of children under five due to Covid-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Bourla said in a statement. “Ultimately, we believe that three doses of the vaccine will be needed for children six months through four years of age to achieve high levels of protection against current and potential future variants.”


Though children are less likely to get seriously unwell from the coronavirus, they play an important role in spreading the virus to more vulnerable people and can, in rare cases, develop life-threatening illness from Covid-19. The FDA has already given Pfizer emergency approval for its shot in children ages five and up—including boosters in those aged 12 to 15 in January—but the company encountered setbacks for its shot in younger age groups after clinical trials showed lower levels of immunity compared to that given to older age groups. The company had reduced the amount of vaccine given to children to stave off any potential safety issues (it is standard practice to try and use the smallest dose possible) and amended the trial to add a third dose. 


Moderna. The Massachusetts-based biotech said it hopes to report data on its Covid-19 vaccine for children ages two to five by March. If results are promising, the company said it will seek regulatory approval from the FDA. Moderna, which was granted full FDA approval for its shot in adults on Monday, has not yet secured authorization for teens in the U.S. after the regulator said it needed more time to examine a rare risk of heart inflammation after vaccination. This investigation is ongoing, though the European Medicines Agency greenlit the shot for use in children aged 12 to 17 in July. 


How many parents will let their young child get the shot. A Kaiser Family Foundation poll conducted in January found only 31% of parents of children under five will get them vaccinated right away, while another 29% said they’ll “wait and see.”



Novavax asked the FDA to grant it emergency authorization for its protein-based Covid-19 vaccine on Monday. The shot is already endorsed by the World Health Organization and regulators in Australia, South Korea and Europe. 


‘We are so tired’: US parents and doctors say kids under five left behind in Covid vaccine race (Guardian)


By Robert Hart, Forbes Staff

By Alison Durkee, Forbes Staff