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# Pfizer Delays Covid Vaccine in Infants
- URL: https://www.fdaweb.com/pfizer-delays-covid-vaccine-in-infants/
- Published: 2022-02-11T12:00:00.000Z
- Updated: 2026-09-14T17:32:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151146

Pfizer and BioNTech are delaying their rolling BLA for an amended Emergency Use Authorization for the Covid-19 vaccine to include children six months through four years of age. The companies, which have already submitted data on a two-dose vaccine, want to wait for further data on a studied three-dose booster regimen after “recent observations” suggest increased “neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen.” They presumably are not comfortable with the collective data on the two-dose regimen, saying “(c)ases continue to accumulate according to the study protocol and 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.” The companies expect to have three-dose protection data available in early April. As a result, FDA has postponed a 2/15 advisory committee meeting that was going to evaluate the two-dose data.