Pfizer and BioNTech Delay FDA Request to Expand COVID-19 Vaccine in Children Under 5 Years of Age
Shots:
- The US FDA postponed the Vaccines and Related Biological Products Advisory Committee meeting to discuss the request for authorization of Pfizer-BioNTech’s COVID-19 vaccine for children 6mos. through 4yrs. of age
- The delay will provide the agency a time to evaluate the additional vaccine data and make a recommendation on the authorization of a two-dose series
- The companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. The companies expected to have three-dose protection data available in early April 2022
Ref: PR Newswire | Image: Pfizer
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