Pfizer delays seeking emergency use authorization for vaccine for young children

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Pfizer and BioNTech have delayed plans to seek emergency use authorization for a COVID-19 vaccine for children 6 months to 4 years old.

On Friday the companies announced plans to extend their rolling submission to the Food and Drug Administration due to the need for additional time to look at data from ongoing clinical trials.

The FDA said it was notified by Pfizer that new data has recently emerged regarding its emergency use authorization request for the use of the vaccine in children 6 months through 4 years of age. 

Pfizer and the FDA said the data was around the evaluation of a third dose of the vaccine.

"Based on the agency's preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," the FDA said. 

A Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15 has been postponed to give the FDA time to consider the additional data and allow for a transparent public discussion, the FDA said.

WHY THIS MATTERS

Children under the age of 5 are the only age group in the United States not eligible to get the COVID-19 vaccine.

The FDA had asked Pfizer to submit emergency use authorization for a COVID-19 for that age group.

The trial in children 6 months through 4 years of age is ongoing and data in this age group are being shared with the FDA on an ongoing basis, Pfizer said. 

Cases continue to accumulate, according to the study protocol, and more data is being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge, Pfizer said.

THE LARGER TREND

In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third dose at least two months after the second dose of the two-dose series in this age group. 

Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data, since Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. This is also supported by recent observations of three-dose booster data in several other age groups.

The companies expect to have three-dose protection data available in early April.

The Phase 1/2/3 trial initially enrolled 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland and Spain from more than 90 clinical-trial sites. Additional children have been enrolled in all age groups following study amendments, and the trial currently includes approximately 8,300 children, Pfizer said. 

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com