FDA’s OK Of Covid Booster Likely To Allow Shorter Gap Of 6 Months
While the Biden administration previously announced that the approved window between original doses and a third shot would be 8 months, the Wall Street Journal spoke to an official who said the timeframe would be tightened. And Pfizer and BioNTech filed an application for full approval of its booster.
The Wall Street Journal:
Biden Administration Likely To Approve Covid-19 Boosters At Six Months
Federal regulators are likely to approve a Covid-19 booster shot for vaccinated adults starting at least six months after the previous dose rather than the eight-month gap they previously announced, a person familiar with the plans said, as the Biden administration steps up preparations for delivering boosters to the public. Data from vaccine manufacturers and other countries under review by the Food and Drug Administration is based on boosters being given at six months, the person said. The person said approval for boosters for all three Covid-19 shots being administered in the U.S.—those manufactured by Pfizer Inc. and partner BioNTech SE, Moderna Inc. and Johnson & Johnson —is expected in mid-September. (Armour and Hopkins, 8/26)
Fox News:
Pfizer/BioNTech Request Full FDA Approval Of COVID-19 Booster Vaccine
Pfizer/BioNTech have initiated an application for full FDA approval of its COVID-19 vaccine booster shot for individuals aged 16 and up, the companies announced Wednesday, noting plans to complete the application later this week. The request for the so-called supplemental biologics license application draws on Phase 3 clinical trial data among 306 participants aged 18 to 55 who received a third dose between 4.8-8 months following the initial two-dose series, with some 2.6 months of follow-up. The companies said levels of neutralizing antibodies were 3.3 times higher following the third dose, versus the second dose. (Rivas, 8/25)
Planning for the rollout begins —
Reuters:
Kroger Plans For 1 Million Covid-19 Booster Shots A Week
U.S. grocery chain Kroger is gearing up to administer 1 million Covid-19 booster shots a week once they are available to the general public, and plans to offer vaccines in nursing homes for those who cannot go to its stores. (8/25)
The Detroit News:
Whitmer Set To Prioritize Nursing Homes During Vaccine Booster Rollout
Michigan Gov. Gretchen Whitmer signed an executive directive Wednesday that orders state departments to begin preparing for the Sept. 20 distribution of booster shots, with a priority placed on delivery of the shots to long-term care facilities. The state has been administering booster shots since mid-August to immunocompromised individuals but will expand the injections Sept. 20 to all residents who are at least eight months out from receiving a second dose of the Pfizer and Moderna vaccines. The initial boosters for the general public set to begin Sept. 20 will go to long-term care facilities, Whitmer said Wednesday. (LeBlanc, 8/25)
In related news —
The Washington Post:
FDA Approval Not Swaying Some Vaccine Holdouts
For five months, Chris Brummett has ignored his wife’s pleas that he get a coronavirus vaccine. He cares even less that federal regulators finally issued a long-awaited approval for one of them. “My wife is on me all the time to do it,” said Brummett, 43, from Jackson County, Ind., who followed news this week of the Food and Drug Administration’s approval of Pfizer-BioNTech’s coronavirus vaccine. But Brummett, a libertarian critical of both the Biden and Trump administrations, said he’s struggling to trust any government messages about the virus. “I guess for now it’s a no for me.” (Diamond, 8/25)
CBS News:
Some Hesitant Americans Get COVID Vaccine After Pfizer Gets Full FDA Approval: "There's Really No Running Away From It Anymore"
It was the Food and Drug Administration's Monday announcement that it has granted full approval to Pfizer and BioNTech for their COVID-19 vaccine that convinced 19-year-old Cailin Magee to line up at a vaccine clinic at the University of Louisiana at Lafayette and get the shot. "I was being ignorant. There's really no running away from it anymore," Magee told CBS News' David Begnaud. After the approval, President Biden encouraged more people who were waiting for the FDA's approval to get the vaccine—calling the FDA's approval the "gold standard." (8/24)
