Pfizer, BioNTech formally ask FDA to authorize vaccine in kids aged 5 to 11 years

Pfizer and BioNTech said Thursday that they have submitted a request to the FDA for an emergency use authorization of their COVID-19 vaccine in children aged 5 to 11 years.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” the companies said on Twitter.

Even before the official submission, the FDA had scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 to discuss allowing the use of the Pfizer-BioNTech vaccine in children aged 5 to 11 years.

“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” acting FDA Commissioner Janet Woodcock, M.D, said in the release announcing the VRBPAC meeting.

The formal submission came just over a week after Pfizer and BioNTech submitted topline data on the vaccine to the FDA, which showed that the vaccine was safe and generated “robust” neutralizing antibody titers in a phase 2/3 study, the companies said.

The vaccine, branded as Comirnaty, was fully approved by the FDA in August for people aged 16 years or older. It has been available under an EUA for children aged 12 to 15 years since May, and representatives from Pfizer have said that the vaccine could be authorized for the younger age group by Halloween.

If the VRBPAC votes to recommend the vaccine in children aged 5 to 11 years and the FDA issues an EUA, the CDC’s Advisory Committee on Immunization Practices would meet to make federal recommendations for this age group.

The proposed regimen for children aged 5 to 11 years is two shots given 21 days apart — the same as in older age groups. However, they would receive smaller doses — two 10 µg shots.

In the phase 2/3 study of 2,268 children, SARS-CoV-2-neutralizing antibody geometric mean titer was 1,197.6 (95% CI, 1,106.1-1,296.6) — a response the companies said was noninferior to that seen among people aged 16 to 25 years who received two 30 µg doses in a previous study.

Pfizer and Biotech said topline study data for two younger groups — children aged 2 to 4 years and children as young as age 6 months — “are expected as soon as the fourth quarter of this year.”

According to the AAP, in the week ending Sept. 30, children represented more than 26% of all new COVID-19 cases in the United States, and nearly 5.9 million children have been diagnosed with the disease since the pandemic began.

References:

• AAP. Children and COVID-19: State-level data report. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Accessed Oct. 7, 2021.
• FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children. https://www.fda.gov/news-events/press-announcements/fda-hold-advisory-committee-meetings-discuss-emergency-use-authorization-booster-doses-and-covid-19. Published Oct. 1, 2021. Accessed Oct. 1, 2021.
• Pfizer and BioNTech submit initial data to U.S. FDA From pivotal trial of COVID-19 vaccine in children 5 to <12 years of age. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal. Published Sept. 28, 2021. Accessed Sept. 28, 2021.
• @Pfizer. UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12. https://twitter.com/pfizer/status/1446082946335715334. Published Oct. 7, 2021. Accessed Oct. 7, 2021.