US Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech’s Covid-19 vaccines were effective and safe for use in children aged six months to four years.
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. An early analysis of data from Pfizer-BioNTech’s vaccine based on 10 symptomatic Covid-19 cases identified when the Omicron coronavirus variant was dominant suggested a vaccine efficacy of 80.3% in the under-5 age group.Covid-19 shots for children under the age of six are yet not approved in most parts of the world.
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