Pfizer CEO says company 'days' away from submitting data to FDA

Pfizer CEO Albert Bourla
Posted at 11:05 AM, Sep 27, 2021

Pfizer's CEO said Sunday that the company is "days" away from submitting data to the FDA in the hopes of having its COVID-19 vaccine approved for children as young as 5.

In speaking ABC News on Sunday, Albert Bourla said that the company was "days, not weeks" away from submitting final data.

"I think we are going to submit this data pretty soon," Bourla said. "It's a question of days, not weeks. Then it is up to FDA to be able to review the data and come to better conclusions."

Once Pfizer submits data to the FDA, the agency will review the data. It's widely expected that within a matter of weeks, the agency's Vaccines and Related Biological Products Advisory Committee will hold a meeting and vote on whether to recommend the vaccine be made available for kids on an emergency use basis.

Last week, Pfizer released data from Phase 2/3 trials that it said showed the lower-dose vaccine was safe and effective for kids aged 5 to 11. The data showed that participants developed virus-fighting antibodies about as well as adults who received two typical shots of the vaccine.

The Pfizer vaccine is fully approved by the FDA and the Centers for Disease Control and Prevention for people aged 16 and up. The vaccine is also available for kids aged 12 to 15 for emergency use.

The Pfizer vaccine would be the first to receive approval from the FDA for use in children. Health officials across the country believe the approval for a vaccine for children could help keep communities across the country safe from COVID-19, especially in the middle of the school year with the delta variant spreading across the country.