Boosters For All: FDA Prepares To Give Its OK
The FDA is expected to announce that all adults 18 and older can get the Pfizer covid booster, as concerns of a winter surge mount. And the Biden administration plans to spend billions to expand vaccine production with an eye toward sending more vaccines to poor countries.
The New York Times:
F.D.A. Plans To Authorize Pfizer Boosters For All Adults This Week
The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans. The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older. (Weiland and LaFraniere, 11/16)
Roll Call:
FDA To Sidestep Advisers On Boosters-For-All Approval
The move signals that the Biden administration is willing to forge ahead without the signoff of the FDA’s scientific advisers, who twice voted to reject boosters for the young and healthy who don’t face high exposure risks, as pockets of the country show foreboding signs of a coming winter wave. After CQ Roll Call reported Tuesday that an advisory meeting was unlikely, the agency confirmed that a decision on eligibility for boosters is expected to be made without the input of the committee. (Kopp, 11/17)
The New York Times:
The U.S. Aims To Lift Covid Vaccine Manufacturing To Create A Billion Doses A Year
The White House, under pressure from activists to increase the supply of coronavirus vaccines to poor nations, is prepared to invest billions of dollars to expand U.S. manufacturing capacity, with the goal of producing at least one billion doses a year beginning in the second half of 2022, two top advisers to President Biden said in an interview on Tuesday. The investment is the first step in a new plan, to be announced on Wednesday, for the government to partner with industry to address immediate vaccine needs overseas and domestically and to prepare for future pandemics, said Dr. David Kessler, who oversees vaccine distribution for the administration, and Jeff Zients, Mr. Biden’s coronavirus response coordinator. (Gay Stolberg, 11/17)
In other news on boosters —
Reuters:
Fauci Says Boosters For All Key To U.S. Reaching COVID-19 Endemic Level
"To me, if you want to get to endemic, you have got to get the level of infection so low that it does not have an impact on society, on your life, on your economy," Fauci said. "People will still get infected. People might still get hospitalized, but the level would be so low that we don't think about it all the time and it doesn't influence what we do." To get there, he said, would take a lot more people rolling up their sleeves for initial COVID-19 shots and boosters. If the United States makes boosters available for everyone, it is possible the country can get control of the virus by spring of 2022, Fauci added. (Steenhuysen, 11/17)
Axios:
Fauci: Boosters Could See COVID Reach Endemic Level In U.S. Next Year
NIAID director Anthony Fauci believes the COVID-19 pandemic could become endemic in the U.S. next year, but increased vaccination rates and booster shots would be key to achieving this. The nation's top infectious disease expert made the comments in an interview with Reuters Tuesday on the sidelines of the STAT Summit. But he noted to CNBC that coronavirus cases need to fall "well below 10,000" a day for the U.S. "to get back to a degree of normality." (11/17)
The New York Times:
New York’s Governor Urges A Broader Group Of Adults To Get Boosters Based On Risk
Gov. Kathy Hochul urged New Yorkers on Tuesday to get a coronavirus vaccine booster if they believed they were at high risk or lived in a “high transmission area,” jumping ahead of a possible decision by federal regulators to authorize an additional shot for all adults. Ms. Hochul went further than earlier comments, but still created some confusion by offering a vague definition of high risk. That may not be an issue for too long, as the Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, according to people familiar with the agency’s plans. (Ferré-Sadurní, 11/16)
