"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."
"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."
Here are the docs published by the FDA today -
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."
"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."
FDA says Pfizer Covid vaccine provides some protection after first dose, meets success criteria
The FDA said data from Pfizer's coronavirus vaccine trials was "consistent" with recommendations put forth by the agency for an emergency use authorization.
www.cnbc.com
Here are the docs published by the FDA today -