Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have announced that following a request from the FDA, they have commenced a rolling submission to amend their EUA for the COVID-19 vaccine to include children above six months and below five years in response to the public need for this group.
Pfizer-BioBTech is finalizing EUA for their vaccine for kids below five.
The companies anticipate finalizing the EUA submission in weeks to come. The application is for approval of the initial two 3 µg doses of an expected three-dose primary series for the age group. Interestingly, data on the third dose offered at least eight weeks following the second dose is planned in months to come and will be presented to the Authorities to justify a possible EUA expansion.
Over 10.6 million kids in the United States have checked positive for COVID-19 since the start of the pandemic, with kids under the age of four accounting for over 1.6 million of such cases. Furthermore, following the Omicron variant surge, documented COVID-19 cases and accompanying hospitalizations among children have risen considerably across the US children under the age of four accounted for 3.2 percent of all COVID-19 hospitalizations in the week ended January 22. The companies’ COVID-19 Vaccination, if approved, will be the first available vaccine to protect children under the age of five from COVID-19, including any future developing variants of concern.
Pfizer-BioNTech committed to addressing variants of concern
With the hospitalization of children under five years because of COVID-19 surging, companies seek to prepare for future strains in collaboration with the agency to offer parents an alternative to protect their kids from the virus.
Pfizer and Chairman CEO Albert Bourla stated, “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.”