The federal government is releasing millions of Moderna booster shots that were delayed by the Food and Drug Administration as a result of a safety inspection at an Indiana packaging plant, even as states report shortages and encourage people to get Pfizer boosters instead.
The release of the withheld doses, which has not previously been reported, represents the latest wrinkle in the Biden administration’s fall booster campaign, with officials confronting slow uptake of the redesigned shots even before President Biden’s recent comment that the “pandemic is over.” Only 34.9 percent of eligible Americans ages 5 and older have received a booster shot since the first batch was made available last year, according to federal data, and the White House has been encouraging Americans to seek out the updated Moderna and Pfizer shots that are targeting omicron and its subvariants.
The FDA’s inspection was focused on production issues at a plant in Bloomington, Ind., operated by Catalent, which is helping to bottle and package Moderna’s vaccine. Inspectors last month began raising concerns that the facility was not sufficiently sterile and started checking whether vials packaged there might have been contaminated, as part of routine safety reviews, said people with knowledge of the inspection. FDA inspectors concluded that there were no problems with Moderna’s vaccine, and the agency is set to soon release more than 10 million doses that had been held back.
“On Tuesday, FDA authorized distribution of numerous batches of the updated Moderna COVID-19 Vaccine, Bivalent booster manufactured at Catalent’s facility,” FDA spokesperson Michael Felberbaum said in a statement. “This authorization was based on FDA’s determination that the batches met all applicable specifications, following a careful review of information provided by Moderna about the manufacture of these batches. The agency has no concerns with the safety, effectiveness, or quality of these batches.”
FDA inspectors found no safety issues at a second plant, operated by Thermo Fisher Scientific, which is also working to help finish Moderna’s vaccines for U.S. distribution, officials said.
In a statement, Moderna said it was “working closely” with the government to deliver additional doses of its bivalent booster shots — which include components aimed at the latest subvariants as well as the original virus identified in China that has long since disappeared — amid “high demand” in parts of the country.
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- [health-us][4 other groups] US FDA releasing millions of...
With such “intelligent” individuals how is it that the comprehensive messaging is in such disarray? Perhaps a rhetorical question, or perhaps it is a facet of the human condition.
I am bemused and chagrinned.
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Edward D Shanshala II, MSHSA, MSEd
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Subject: [EXTERNAL] - [health-us][4 other groups] US FDA releasing millions of Moderna boosters as some states report shortages
releasing millions of Moderna boosters as states warn of shortages
Reconfigured shots are safe, but had been delayed amid inspection of an Indiana packaging plant last month.
Dan Diamond
Washington Post
The federal government is releasing millions of Moderna booster shots that were delayed by the Food and Drug Administration as a result of a safety inspection at an Indiana packaging plant, even as states report shortages and encourage
people to get Pfizer boosters instead.
The release of the withheld doses, which has not previously been reported, represents the latest wrinkle in the Biden administration’s fall booster campaign, with officials confronting slow uptake of the redesigned shots even before President
Biden’s recent comment that the “pandemic
is over.” Only 34.9 percent of eligible Americans ages 5 and older have received a booster shot since the first batch was made available last year, according to
federal data, and the White House has been encouraging Americans to seek out the updated Moderna and Pfizer shots that are targeting omicron and its subvariants.
The FDA’s inspection was focused on production issues at a plant in Bloomington, Ind., operated by Catalent, which is helping to bottle and package Moderna’s vaccine. Inspectors last month began raising concerns that the facility was not
sufficiently sterile and started checking whether vials packaged there might have been contaminated, as part of routine safety reviews, said people with knowledge of the inspection. FDA inspectors concluded that there were no problems with Moderna’s vaccine,
and the agency is set to soon release more than 10 million doses that had been held back.
“On Tuesday, FDA authorized distribution of numerous batches of the updated Moderna COVID-19 Vaccine, Bivalent booster manufactured at Catalent’s facility,” FDA spokesperson Michael Felberbaum said in a statement. “This authorization was
based on FDA’s determination that the batches met all applicable specifications, following a careful review of information provided by Moderna about the manufacture of these batches. The agency has no concerns with the safety, effectiveness, or quality of
these batches.”
FDA inspectors found no safety issues at a second plant, operated by Thermo Fisher Scientific, which is also
working to help finish Moderna’s vaccines for U.S. distribution, officials said.
In a statement, Moderna said it was “working closely” with the government to deliver additional doses of its bivalent booster shots — which include components aimed at the latest subvariants as well as the original virus identified in China
that has long since disappeared — amid “high demand” in parts of the country.
...
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