Pfizer, BioNTech Seek FDA Authorization of COVID-19 Vaccine for Children Under 5


The application submission paves the way for a potential decision as early as this month.

Pfizer and BioNTech have completed an FDA application for the COVID-19 vaccine in children younger than age 5, paving the way for a potential decision as early as this month, according to reporting by The Washington Post.1

Data released in May found that a third 3-µg dose elicited a strong immune response in children aged 6 months to under 5 years of age. Vaccine efficacy in this age group was 80.3%, with a descriptive analysis based on 10 symptomatic COVID-19 cases identified from 7 days after the third dose and accrued as of April 29, 2022. A formal analysis will be performed when at least 21 cases have accrued, according to a press release.2

“Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well-tolerated and produced a strong immune response,” said Albert Bourla, chairman and CEO at Pfizer, in the press release. “These topline safety, immunogenicity, and efficacy data are encouraging, and we look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible, subject to regulatory authorization.”2

In the phase 2/3 trial, 1678 children received a third dose of the 3-µg formulation at least 2 months after the second dose at a time when Omicron was the dominant variant. The immunogenicity analysis of geometric mean titer ratio and seroresponse rate was conducted on a subset of study participants 1 month following the third dose in children 6 months to under 5 years of age. These results were compared to the second dose in the 16- to 25-years-old population.2

According to the study, non-inferiority was met for both the 6- to 24-month-old population and the 2- to under 5-years-old population for both co-primary endpoints. Three 3-µg doses of the vaccine were well tolerated in this age group and no new safety signals were identified.2

The rolling submission for Emergency Use Authorization of the vaccine in children 6 months to under 5 years of age was initiated in February 2022. At that time, a 2-dose series was determined to be well-tolerated in this age group, and the companies submitted new safety, immunogenicity, and efficacy data for the 3-dose series in late May.2

“The study suggests that a low 3-µg dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” said Ugur Sahin, MD, CEO, and co-founder of BioNTech, in the press release.2

A survey from the American Pharmacists Association (APhA) found that the majority of pharmacists are prepared to administer COVID-19 vaccines to children under 5 years of age. According to the survey, 66% of responding pharmacists said they would be prepared to administer these vaccines if authorized to do so.3

Nearly half (44%) said they are currently planning to vaccinate based on community needs and the abilities of the pharmacy team following authorization and guidance from the FDA and CDC. Pharmacists’ level of engagement in this age group will be an individual practice and provider decision, and pharmacists are ready to work with other immunizers, according to the press release. CDC data have found that 70% of COVID-19 vaccinations have occurred in pharmacies, including 60% of adolescent vaccinations and 46% of vaccinations in children aged 5 to 11 years.3

“The data show that pharmacists are again poised to contribute to our nation’s health efforts and vaccinate all Americans against COVID-19,” said Scott J. Knoer, PharmD, MS, FASHP, CEO and executive vice president of APhA, in the press release. “This has been true since the first COVID-19 vaccines arrived in December 2020, and it continues to be the case today despite the enormous challenges facing pharmacists in every practice venue.”3


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