Pfizer submits initial data for COVID-19 vaccine in children to FDA

Pfizer announced Tuesday that it has submitted initial data to the Food and Drug Administration (FDA) from the trial of its COVID-19 vaccine in children ages 5 to 11.  

The move is the latest step forward in the closely-watched process of authorizing a COVID-19 vaccine for children under 12, for whom there is no vaccine currently available.  

It is not yet a formal application for emergency authorization, which Pfizer said would follow “in the coming weeks.”

Former FDA Commissioner Scott Gottlieb said on CBS earlier this month that “if everything goes well” a vaccine for children 5-11 could be authorized by the end of October. 

Last week, Pfizer announced positive results from the trial in children, saying it had a “favorable safety profile and robust neutralizing antibody responses.” The company used doses that are a third the size of the dose used for adults. 

The FDA is under pressure to move quickly on vaccines for children. More than 100 lawmakers wrote to the agency in August asking for a timeline.  

Top FDA officials provided an update earlier in September, though they said they could not offer an exact date for an authorization. 

Janet Woodcock and Peter Marks, two top FDA officials, said then that once the full emergency use authorization application is submitted, the agency will “complete its review as quickly as possible, likely in a matter of weeks rather than months.” 

Still, they emphasized they will “follow the science” and not “cut any corners.” 

The development of vaccines for children has grown in urgency as the school year begins and the delta variant surge has caused cases among children to rise.

Pfizer said results from trials in children under 5 are expected “as soon as the fourth quarter of this year.”