The pharmaceutical companies, Pfizer and BioNTech, are seeking Emergency Use Authorization for their COVID-19 vaccine for use in children between six months and four years of age.
"Pfizer Inc and BioNTech SE today announced that following a request from the US 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," Pfizer and BioNTech said in a statement on Tuesday (local time). If authorization is granted, the Pfizer-BioNTech vaccine would be the first COVID-19 vaccine available for paediatric populations under 5 years of age.
Pfizer and BioNTech said they expect to complete the EUA submission in the coming days.
"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," Bourla added.
Ugur Sahin, MD, CEO and Co-founder of BioNTech, said that the vaccine has already demonstrated favourable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old.
"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," Sahin added.