FDA Staff Backs Pfizer’s Coronavirus Vaccine Data

WASHINGTON (Reuters) -
The Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md. (AP Photo/Jacquelyn Martin, File)

Pfizer Inc. cleared the next hurdle in the race to get its COVID-19 vaccine approved for emergency use on Tuesday after the Food and Drug Administration (FDA) released documents that did not raise any new issues about its safety or efficacy.

Data on the vaccine submitted to the agency was in line with its guidance on emergency use authorization, FDA staff said in documents released ahead of Thursday’s meeting of outside experts.

The experts will discuss whether the shot developed with German partner BioNTech SE should be authorized for emergency use.

A two-dose vaccination was highly effective in preventing confirmed cases of COVID-19 at least seven days after the last dose, FDA staff said.

The FDA said there was currently insufficient data to make conclusions about the safety of the vaccine in those under 16 years of age, pregnant women and those whose immune systems are compromised.

The FDA is expected to decide on whether to authorize the vaccine within days or weeks.