Pfizer, BioNTech Initiate Rolling EUA Submission for COVID-19 Vaccine in Children Aged 6 Months Through 4 Years

Children ages 5 to under 12 years received a 2-dose schedule of 10 µg each whereas children under age 5 received a lower 3 µg dose for each injection in the phase 2/3 study.

Pfizer and BioNTech have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include children 6 months through 4 years of age, in response to growing numbers of pediatric COVID-19 cases, according to a press release.

Since the COVID-19 pandemic began, more than 10.6 million children have tested positive for the virus in the United States, 1.6 million of whom are younger than 4 years of age. Furthermore, reported COVID-19 cases and related hospitalizations among young children have spiked dramatically during the omicron variant surge. During the week ending January 22, 2022, children under 4 years of age accounted for 3.2% of the total hospitalizations due to COVID-19.

“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 CEO of Pfizer, in the press release.

The EUA amendment request is based on the totality of data about the safety, tolerability, immunogenicity, and available efficacy of 2 doses of the Pfizer-BioNTech COVID-19 vaccine. The phase 1/2/3 trial enrolled 4500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites.

Additional children have been enrolled following study amendments and the trial currently includes approximately 8300 children, according to the press release. Children were enrolled regardless of prior evidence of SARS-CoV-2 infection.

The trial was designed to evaluate the safety, tolerability, and immunogenicity of the vaccine on a 2-dose schedule approximately 21 days apart in 3 age groups: 5 to under 12 years of age; 2 to under 5 years of age; and 6 months to under 2 years of age. Based on the phase 1 dose-escalation portion of the trial, children 5 to under 12 years of age received a 2-dose schedule of 10 µg each whereas children under 5 years of age received a lower 3 µg dose for each injection in the phase 2/3 study.

In December 2021, Pfizer and BioNTech announced they would test a third 3 µg dose given at least 2 months after the second dose in children under 5 years of age and a third dose of the 10 µg formulation in children 5 to 12 years of age.

“Ultimately, we believe that 3 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,” Bourla said in the press release. “If 2 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.”

Adverse effects reported with the vaccine include severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis; pericarditis; injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; arm pain; and fainting in association with the injection.

“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,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in the press release. “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.”

REFERENCE

Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request From US FDA. News release. Pfizer; February 1, 2022. Accessed February 2, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-emergency