Pfizer submits for under age of 5 COVID-19 vaccine EUA

Pfizer has initiated rolling submission to receive emergency use authorization (EUA) from the Food and Drug Administration (FDA) for a version of their COVID-19 vaccine to be given to children under the age of 5.

According to a news release, the submission seeks to amend the Pfizer COVID-19 vaccine EUA to include children 6 months through 4 years old and followed a request from the FDA in response to pediatric COVID-19 cases surpassing 10 million. If the EUA is extended, the vaccine will be the only one available to children in this age range.

The company is seeking authorization for the first two three microgram doses of a planned three-dose primary regimen in the age group. Information about a third dose eight weeks after the initial series is expected in the next few months and will also be submitted to regulators for a possible expansion of this EUA, the release says.

“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Albert Bourla, chairman and CEO of Pfizer, says in the release. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”

“Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old,” Ugur Sahin, MD, CEO and Co-founder of BioNTech, also says in the release. “If authorized, we are very excited about the prospect of offering parents the opportunity to help protect their children 6 months through 4 years of age from COVID-19 and the potentially severe consequences of infection.”

Pfizer intends to supply about 4 billion doses of the vaccine this year under the existing supply agreement, the release says.

The FDA has been moving to authorize and approve many COVID-19 vaccines in an effort to combat the ongoing pandemic.

Earlier this week, the agency gave approval to the COVID-19 vaccine developed by Moderna, Spikevax.