Pfizer CEO: Company 'days' away from submitting data to FDA

Pfizer's CEO said Sunday that the institution is "days" distant from submitting information to the FDA successful the hopes of having its COVID-19 vaccine approved for children arsenic young arsenic 5.

In speaking ABC News connected Sunday, Albert Bourla said that the institution was "days, not weeks" distant from submitting last data.

"I deliberation we are going to taxable this information beauteous soon," Bourla said. "It's a question of days, not weeks. Then it is up to FDA to beryllium capable to reappraisal the information and travel to amended conclusions."

Once Pfizer submits information to the FDA, the bureau volition reappraisal the data. It's wide expected that wrong a substance of weeks, the agency's Vaccines and Related Biological Products Advisory Committee volition clasp a gathering and ballot connected whether to urge the vaccine beryllium made disposable for kids connected an exigency usage basis.

Last week, Pfizer released information from Phase 2/3 trials that it said showed the lower-dose vaccine was harmless and effectual for kids aged 5 to 11. The information showed that participants developed virus-fighting antibodies astir arsenic good arsenic adults who received 2 emblematic shots of the vaccine.

The Pfizer vaccine is afloat approved by the FDA and the Centers for Disease Control and Prevention for radical aged 16 and up. The vaccine is besides disposable for kids aged 12 to 15 for exigency use.

The Pfizer vaccine would beryllium the archetypal to person support from the FDA for usage successful children. Health officials crossed the state judge the support for a vaccine for children could assistance support communities crossed the state harmless from COVID-19, particularly successful the mediate of the schoolhouse twelvemonth with the delta variant spreading crossed the country.