The Food and Drug Administration said data from Pfizer shows its vaccine reduced the risk of COVID-19 after the first dose and was “consistent” with regulators’ recommendations for emergency approval, signaling a promising start to a review that will unfold this week and likely kickstart the U.S. immunization campaign.
Regulators also said the shots were “highly effective” at least seven days after the second dose regardless of the recipient’s age, weight or race.
The FDA released its 53-page briefing document Tuesday ahead of a Thursday meeting on the Pfizer vaccine with outside advisers.
The advisory panel will discuss Pfizer’s data and considerations for various populations before voting on whether the vaccine deserves emergency-use authorization to begin immunizing health workers and long-term care residents.
President Trump will host a vaccine summit at the White House Tuesday that will serve as a victory lap before the vaccine campaign begins.
A key FDA official, Peter Marks, will discuss the agency’s standards in vetting the vaccine and Republican governors will discuss their coordination with federal counterparts in getting doses from manufacturers to people’s arms at distribution sites across their states.
The vaccination campaign is expected to begin within 24 hours after the FDA grants emergency approval, which could be as soon as the weekend.
The U.K. began its immunization campaign on Tuesday with a 90-year-old grandmother in central England.
Margaret Keenan of Coventry became an instant celebrity by becoming the first person to receive the Pfizer vaccine outside of trials.
Donning a blue “Merry Christmas” shirt with a penguin on it, Ms. Keenan said she felt “so privileged” to be first in line and looks forward to spending time with family in the new year.
She competed for attention with the second person in line who, amazingly, was named William Shakespeare.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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