The Food and Drug Administration said Tuesday data from Pfizer’s coronavirus vaccine trials was “consistent” with recommendations put forth by the agency for an emergency use authorization, adding the vaccine was highly effective and did not raise any specific safety concerns.
In briefing documents published ahead of an advisory meeting Thursday to review Pfizer’s vaccine, FDA staff also said data submitted appeared to show the vaccine provided protection after the first dose. Pfizer’s vaccine requires two doses about three weeks apart. Two doses of the vaccine were “highly effective” in preventing confirmed cases of Covid-19 at least seven days following the second dose, the agency said.
“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote in documents posted on its website.
The FDA is expected to decide on whether to authorize Pfizer’s vaccine within days.
The documents posted Tuesday offer a glimpse of the FDA’s view of the vaccine. The FDA is scheduled to convene a meeting of its Vaccines and Related Biological Products Advisory Committee, known as VRBPAC, on Thursday to review Pfizer’s Covid-19 vaccine with German drugmaker BioNTech for emergency use.
Emergency use authorization means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the same as a full approval, which can typically take months. The FDA granted emergency clearance for Gilead Sciences’ remdesivir in May before giving full approval in late October.
If the meeting Thursday goes well and the advisory committee formally recommends the vaccine, the FDA could announce its authorization “within days,” Health and Human Services Secretary Alex Azar told ABC News’ “This Week” on Sunday. “But it’s going to go according to FDA’s gold-standard process, and I’m going to make sure it does,” he added.
The FDA doesn’t have to follow the advisory committee’s recommendation, but the agency often does.
An authorization for the vaccine would be a pivotal moment in the pandemic, as public health officials say the U.S. is likely to face its worst public health crisis in history this winter.
There is currently insufficient data to make conclusions about the safety of the vaccine in children less than 16 years of age, pregnant women and people with compromised immune systems, the FDA said Tuesday.
This is a breaking news story. Please check back for updates.
