Pfizer-BioNTech announced on Tuesday that it had officially moved forward with submitting its data that would seek emergency authorization for the use of their COVID-19 vaccine.
“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, in a statement released yesterday.
“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.”
Pfizer is now expected to ask the FDA for permission to vaccinate children as young as SIX MONTHS with their 2 shot regimen.
— Dr. David Samadi (@drdavidsamadi) February 1, 2022
Despite COVID being incredibly mild in young adults and children, the company said in their statement that more than 10.6 million children “have tested positive for COVID-19 in the U.S., 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.”
Of those 10.6 million children under the age of 5, the CDC reports that 287 have died from COVID.
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. That means that 0.00002 percent of children who have had COVID in the US have died.