Pfizer and BioNTech have secured the US Food and Drug Administration (FDA) authorisation for the emergency use of their Covid-19 vaccine in children aged 5 to 11 years.
The US regulator indicated Pfizer-BioNTech Covid-19 vaccine, also called Comirnaty, in a two-dose regimen of 10µg doses for this age group, administered 21 days apart.
Pfizer and BioNTech said that the 10µg dose level was selected based on safety, tolerability and immunogenicity data.
With the FDA EUA, Comirnaty becomes the first Covid-19 vaccine to be authorised in the US for children aged 5 to 11 years.
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) has recently recommended the EUA of Covid-19 vaccine in the age group.
Pfizer chairman and chief executive officer Albert Bourla said: “This is a day so many parents, eager to protect their young children from this virus, have been waiting for.
“Over 6 million children in the U.S. have been diagnosed with Covid-19 since the start of this pandemic, and a high number of young people continue to be infected every week.
“With this FDA authorisation, we have achieved another key marker in our ongoing effort to help protect families and communities, and to get this disease under control.”
The FDA authorisation was based on data from a Phase 2/3 trial in 4,500 children aged 5 to 11 years, and review by the FDA VRBPAC.
In the study, the vaccine showed superior safety profile, immune responses with 90.7% vaccine efficacy rate in participants, one week after the second dose.
According to the study Data Monitoring Committee review, no serious safety concerns have been identified, in relation with the vaccine.
The CDC’s Advisory Committee on Immunization Practices (ACIP) is expected to recommend the rollout of the vaccine to children aged 5 to 11 years.
The Pfizer-BioNtech Covid-19 vaccine has also secured emergency use approval from the United Arab Emirates for children aged 5-11, Reuters reported, citing a statement from the country’s health ministry.
Furthermore, the two companies have filed applications with other regulators, including the European Medicines Agency, for EUA of their Covid-19 vaccine in the age group.
BioNTech CEO and co-founder Ugur Sahin said: “Today’s emergency use authorization is supported by clinical data showing a favorable safety profile and high vaccine efficacy in children, underlining its potential to address a current public health need.
“As children 5 through 11 get reacclimated to the new school year, both in and out of the classroom, our goal is to help keep them safe and protected and get them back to normalcy.”
In September this year, the FDA has authorised a booster dose of Pfizer-BioNTech Covid-19 Vaccine (Comirnaty) for emergency use in certain populations.
