The move will delay the vaccine’s authorization for this younger group.
Pfizer has announced the company will extend its rolling submission process for an expanded emergency use authorization (EUA) of smaller doses of the company’s COVID-19 vaccine aimed at children from 6 months to 5 years.
According to a news release, the company has already submitted data based on the first two 3 µg doses to the Food and Drug Administration (FDA) and continues to submit data on an ongoing basis. The move comes as the public continues to clamor for a COVID-19 vaccine for young children.
Pfizer is evaluating a third 3 µg dose of the vaccine at least two months after the second dose of the initial series. The company plans to wait for the third-dose data as it is believed it will provide higher levels of protection than the initial two-dose regimen, the release says.
In a separate release, the FDA announced that it is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15 in order to give the agency time to consider the additional data.
“We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation,” Janet Woodcock, MD, acting commissioner of the FDA, says in the release.
Initially, Pfizer was 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, said at the time. “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.”