Pfizer and BioNTech announced plans to extend the rolling submission to the Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of their COVID-19 vaccine to include children 6 months to less than 5 years of age.
The Companies announced that they will now wait for the 3-dose protection data, which they expect to have in early April 2022. The pediatric trial (ClinicalTrials.gov Identifier: NCT04816643) includes a total of 8300 individuals under the age of 12, with the group aged 6 months to under 5 years receiving two 3µg doses of the vaccine administered 21 days apart, and a third 3µg dose administered at least 2 months after the second.
According to a press release, the independent Data Monitoring Committee for the study supports the continuation of the trial. The extension gives the FDA more time to review the 3-dose regimen.
A meeting of the Agency’s Vaccines and Related Biological Products Advisory Committee, which was scheduled to go ahead on February 15, has been postponed. According to the FDA, a new date will be scheduled once additional data on the third dose are received.
“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,” the Agency noted in a press statement.
Based on early study data and observational findings from several other age groups, Pfizer and BioNTech believe the 3-dose regimen may provide a higher level of protection in children 6 months through 4 years of age.
- Pfizer and BioNTech provide update on rolling submission for Emergency Use Authorization of their COVID-19 vaccine in children 6 months through 4 years of age. News release. February 11, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-rolling-submission
- Coronavirus (COVID-19) Update: FDA postpones advisory committee meeting to discuss request for authorization of Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years of age. News release. Accessed February 11, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-postpones-advisory-committee-meeting-discuss-request-authorization