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On Tuesday, Feb. 1, citing a host of clinical trials, the pharmaceutical company announced it is seeking emergency use authorization (EUA) to admit the vaccine to a wider range of children.
Currently, the vaccine is only approved for children 5 years old and older. Pfizer said that it plans to complete its EUA submission “in the coming days,” and has already initiated a rolling submission of data to the FDA.
Officials said that “data on a third dose given at least eight weeks after completion of the second dose is expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA.”
According to Pfizer, since the pandemic began in March 2020, more than 10.6 million children have tested positive for COVID-19 in the US.
“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,” Pfizer CEO Albert Bourla said. “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.”
Pfizer also said it expects to submit clinical trial data to the European Medicines Agency and other agencies around the world.
The FDA’s vaccine advisory committee is expected to meet on Tuesday, Feb. 15 to discuss the latest submission.
“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,” stated Dr. Ugur Sahin, CEO of BioNTech, whose headquarters is in Germany.
“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.”
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