Emergency authorization was granted for the use of the Pfizer-BioNTech Covid-19 vaccines on children from six months old to under five years of age. The US Food and Drug Administration made the authorization on Friday (June 17).
All children ages 6 months and up are now eligible to receive the COVID-19 vaccine, following the US Centers for Disease Control and Prevention (CDC) accepting the recommendation of its Advisory Committee on Immunization Practices (ACIP) and the US Food and Drug Administration (FDA) authorization of the three-dose Pfizer-BioNTech vaccine and the two-dose Moderna vaccine.
CDC has recommended that all eligible children receive the vaccine to protect themselves and their families and have proven to be safe for children ages 6 months and up and help guard against the virus.
The dose of 3mg was carefully selected based on safety, tolerability and immunogenicity data.
Albert Bourla, chief executive officer at Pfizer said: “Tens of millions of older children across the globe have already been vaccinated with our COVID-19 vaccine, helping to prevent symptomatic, severe disease and hospitalization.
He said many parents in the US had been eagerly awaiting an authorized vaccine for their children under 5.
“We are proud to now offer them a vaccine option with a favorable safety profile and are grateful to all the parents and caregivers who made today’s authorization possible by choosing to enroll their children in our COVID-19 vaccine clinical trial.”
Professor Ugur Sahin, CEO and co-founder of BioNTech said: “The data from our Phase 2/3 study show that a dose level of 3mg of our vaccine, which we selected based on safety, tolerability and immunogenicity data, administered in a 3-dose series, provides young children and infants with a high level of protection, also during the recent Omicron wave.”
Pfizer said the authorization is based on data from a phase 2/3 randomized, controlled trial that included 4,526 children 6 months through to 4 years of age. In the trial, children received the third 3 mg dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo.
Pfizer and BioNTech have begun shipping 3 mg pediatric doses as directed by the US government. Eligible US residents will continue to receive the vaccine for free, consistent with the U.S. government’s commitment to free access to COVID-19 vaccines.
The Pfizer vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.
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