Pfizer, BioNTech begin application for COVID-19 vaccine for children under 5

Pfizer and BioNTech on Tuesday announced that they have begun submitting data to the FDA on the safety and efficacy of the first two doses of what is expected to be a three-dose COVID-19 vaccine for children younger than age 5 years.

The companies said they initiated a rolling submission, at the request of the FDA, seeking to amend the emergency use authorization (EUA) for their vaccine to include children aged 6 months to 4 years.

“With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group to address the urgent public health need,” Pfizer said in a press release.

According to the release, the companies plan to submit additional data on a third 3 µg dose “in the coming months.”

The FDA had “urged the companies to submit the application so that regulators could begin reviewing the two-shot data,” The Washington Post reported earlier. The Post and other outlets, including The New York Times, said the amended EUA for children aged 6 months to 4 years could come by the end of February.

A member of the FDA’s Vaccines and Related Biological Products Advisory Committee told Healio that the committee will meet about the matter on Feb. 15. “We’ll know more then,” the member said.

Pfizer and BioNTech said in December that they were evaluating the addition of a third 3 µg dose — one-tenth the size of an adult dose — of their vaccine for children aged 6 months to 4 years after a two-dose series failed to produce the expected level of protection among study participants aged 2 to 5 years, although protection among participants aged 6 to 24 months matched that seen in adolescents and young adults.

The AAP is “encouraged” by the news that a vaccine for children younger than age 5 years could be available soon, said its president, Moira Szilagyi, MD, PhD, FAAP.

“We look forward to seeing the data,” Szilagyi said in a statement. “Pediatricians have seen firsthand the fear, stress and hardship that so many families of young children have endured as they await a vaccine. We urge a transparent and data-driven process to evaluate this vaccine for this age group and look forward to offering its protection to our youngest children.”

The vaccine has been available under an EUA for kids aged 5 to 11 years since October and for adolescents aged 12 to 15 since last May. It is fully approved for anyone aged 16 years or older.

Reference:

McGinley L, et al. Pfizer-BioNTech coronavirus vaccine for children under 5 could be available by the end of February, people with knowledge say. Washington Post. https://www.washingtonpost.com/health/2022/01/31/coronavirus-vaccine-children-under-5/. Published Jan. 31, 2021. Accessed Feb. 1, 2022