U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech’s (PFE.N), COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years.
The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.
The FDA analysis of data from Pfizer’s trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from the external advisers will determine the FDA’s decision on the vaccines.
“Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years,” FDA staff said in the review.
U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech’s (PFE.N), COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years.
The FDA reviewers said in briefing documents published on Sunday evening that their evaluation did not reveal any new safety concerns related to the use of the vaccine in young children.
The FDA analysis of data from Pfizer’s trial was published ahead of a June 15 meeting of its outside advisers. Recommendations from the external advisers will determine the FDA’s decision on the vaccines.
“Available data support the effectiveness of the Pfizer-BioNTech COVID-19 Vaccine 3-dose primary series in preventing COVID-19 in the age group of 6 months through 4 years,” FDA staff said in the review.