Pfizer, BioNTech Delay Seeking COVID-19 Vaccine Authorization in Children Under Five

Pfizer and BioNTech announced Friday that they will hold off pursuing an expanded FDA Emergency Use Authorization (EUA) permitting use of their COVID-19 vaccine in children under age five, in order to gather more data on whether a third booster dose is needed.

That same day, the FDA said it will postpone a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee, originally slated for Tuesday to review the expanded EUA application. Instead, the agency will reschedule the expert panel review after receiving the additional data from Pfizer and BioNTech.

“The trial in children six months through four years of age is ongoing and data on the first two 3- µg doses in this age group are being shared with the FDA on an ongoing basis,” said the companies, explaining that more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.

Meanwhile, Acting FDA Commissioner Janet Woodcock and Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said in a joint statement that being “able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.”

Earlier this month, Pfizer and BioNTech had sought an updated EUA that would allow a two-dose COVID-19 vaccine regimen in children six months to four years old, submitting data from a phase 1/2/3 trial of 8.300 children aged six months to 12 years to support their application. However, at the time, the companies noted they were still waiting on further trial data to decide whether to add a third dose to the expanded EUA request (DID, Feb. 2).

And the companies are also assessing the effectiveness of a third 10-µg booster dose in children aged five to 11 years old. The drugmakers previously won an expanded authorization allowing a two-dose vaccine regimen for this age group in late October (DID, Nov. 1, 2021).

The companies have already received full approval for the vaccine in adults and EUAs for adolescents and preteens. — Jason Scott