Pfizer and BioNTech have initiated a rolling submission to the Food and Drug Administration (FDA) to revise the Emergency Use Authorization (EUA) of their COVID-19 vaccine to include children 6 months to less than 5 years of age.

The application is supported by data from a phase 2/3 trial (ClinicalTrials.gov Identifier: NCT04816643) that included approximately 8300 participants 6 months to less than 12 years of age with or without prior evidence of SARS-CoV-2 infection. Participants 6 months to less than 5 years of age received a 2-dose regimen of 3mcg administered 21 days apart.

In December 2021, Pfizer announced that the study would also include a third dose of 3mcg at least 2 months after the second dose of the 2-dose series. An immunogenicity analysis on a subset of the study population 1 month after the second dose showed noninferiority in the 6- to 24-month old population, but not the 2- to less than 5-year-old population, when compared with the 16- to 25-year-old population.

In a press release, the Companies noted that the EUA submission was made “in response to the urgent public health need in this population.” The submission is expected to be completed in the coming days. Additional data for a booster dose administered at least 8 weeks after completion of the 2-dose primary series is expected in the coming months and will also be submitted to the FDA for a potential EUA revision.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on February 15th to discuss the submission. The vaccine is currently authorized for emergency use in individuals 5 years of age and older as a 2-dose primary series and for use as a single booster dose in individuals 12 years of age and older at least 5 months after completion of the primary series.

“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the Omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “As we have done for other COVID-19 vaccine authorizations, this meeting will help ensure that the public has a clear understanding of the data and information the FDA will evaluate as it considers whether to authorize the vaccine.”

References

  1. Pfizer and BioNTech initiate rolling submission for Emergency Use Authorization of their COVID-19 vaccine in children 6 months through 4 years of age following request from US FDA. News release. Pfizer Inc. and BioNTech SE. Accessed February 2, 2022. https://www.businesswire.com/news/home/20220201006018/en/Pfizer-and-BioNTech-Initiate-Rolling-Submission-for-Emergency-Use-Authorization-of-Their-COVID-19-Vaccine-in-Children-6-Months-Through-4-Years-of-Age-Following-Request-From-U.S.-FD
  2. Coronavirus (COVID-19) update: FDA 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. US Food and Drug Administration. Accessed February 2, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-advisory-committee-meeting-to-discuss-request-for-authorization-of-pfizer-biontech-covid-19-vaccine-for-children-6-months-through-4-years-of-age-301473265.html