The FDA will review a request from Pfizer and BioNTech to authorize the Pfizer vaccine for children age 6-months through 4-years-old.
Pfizer Inc and BioNTech have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age). The application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA.
Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S.,1 with children under 4 accounting for more than 1.6 million of those cases.2 Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. If authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine would be the first vaccine available to help protect children under 5 years of age from this disease, potentially including future emerging variants of concern.
“As hospitalizations of children under 5 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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”
The companies plan to provide ample supply of the 3 µg dose to meet demand should the FDA approve the EUA application. The companies previously announced planned global supply capacity of approximately four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. The companies continue to supply the vaccine under their existing supply agreement with the U.S. government, which continues through April 2022.
The FDA will convene a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb 15 to discuss authorization of the Pfizer vaccine for children 6 months through 4 years of age.
“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials,” said Acting FDA Commissioner Janet Woodcock, M.D. “In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caretakers to get vaccinated or receive a booster dose when eligible.”
The FDA authorized the Pfizer Vaccine in children 5 through 11 years of age in October 2021 and recently authorized the use of a single booster dose in individuals 12 through 15 years of age and older. As of Dec. 19, 2021, according the Centers for Disease Control and Prevention (CDC), 8.7 million COVID-19 vaccinations have been given to kids 5 through 11 years of age, which is about one-third of the approximately 24 million U.S. kids this age in the U.S. There are approximately 18 million children less than 5 years of age in the U.S.
The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube channel the meeting will also be webcast from the FDA website.