Pfizer Inc. and BioNTech SE announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days. This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA.
Since the pandemic began, more than 10.6 million children have tested positive for COVID-19 in the U.S.,1 with children under 4 accounting for more than 1.6 million of those cases. Further, reported COVID-19 cases and related hospitalization among children have spiked dramatically across the United States during the Omicron variant surge. For the week ending January 22, children under 4 accounted for 3.2% of the total hospitalizations due to COVID-19.2 If authorization is granted, the Pfizer-BioNTech COVID-19 Vaccine would be the first vaccine available to help protect children under 5 years of age from this disease, potentially including future emerging variants of concern.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “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,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “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.”
The request to amend the EUA is based on the totality of data on the safety, tolerability, immunogenicity, and available efficacy of two doses of the Pfizer-BioNTech COVID-19 Vaccine. The companies also plan to share these data with the European Medicines Agency and other regulatory agencies around the world.
The companies plan to provide ample supply of the 3 µg dose to meet demand should the FDA approve the EUA application. The companies previously announced planned global supply capacity of approximately four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022. The companies continue to supply the vaccine under their existing supply agreement with the U.S. government, which continues through April 2022.