Covid booster shots that target the most common new variants of the virus should become available in the US within days, after the Centers for Disease Control and Prevention signed off on the rollout of updated vaccines Thursday.
(Bloomberg) — Covid booster shots that target the most common new variants of the virus should become available in the US within days, after the Centers for Disease Control and Prevention signed off on the rollout of updated vaccines Thursday.
CDC Director Rochelle Walensky endorsed the use of the new shots after, in two 13-1 votes, outside vaccine and health experts gave their backing to the booster shots from Moderna Inc. and from Pfizer Inc. and BioNTech SE.
“This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your Covid-19 booster and I strongly encourage you to receive it,” Walensky said in her statement.
The decision means that the boosters, which target the now-dominant BA.4 and BA.5 subtypes of the omicron variant, will be available ahead of an likely fall and winter wave of new infections. The decision was not without controversy, as several of the panelists who voted in support of the shots said they wished they had more data from human trials about their effectiveness and safety.
The original vaccine formulations are based on the strain of the coronavirus first identified in Wuhan, China almost three years ago. As new strains have arisen from mutations, they’ve evaded immunity afforded by shots and previous infections. The Biden administration has made plans to begin offering the updated boosters as soon as the Labor Day weekend, Bloomberg reported last week.
People who have received their last Covid shot at least two months prior should be eligible for the new booster, according to the Food and Drug Administration. Moderna’s shot is meant for use in people ages 18 and up, while Pfizer and BioNTech’s is for people ages 12 and older.
The CDC said in its statement Thursday that it also expects to recommend updated COVID-19 boosters for other pediatric groups in the coming weeks.
Flu Comparison
Like flu vaccines that are updated annually, the new versions of the Covid-19 shots were developed by modifying the original versions. And while flu vaccines are typically updated without extensive new human trials, the Covid shots are comparatively much newer, which created a debate on the panel about a desire for more data, but that would come with a delay in rolling out the shots.
“I really do struggle with a vaccine that has no clinical data,” said Oliver Brooks, a panel member and the chief medical officer at Watts HealthCare Corporation in Los Angeles. The data around Pfizer’s updated shot was based on a mix of information from an earlier version of the omicron-targeting booster, and non-human data, for example.
But getting more human trial data would likely push back the rollout of the shots to November or December, said Matthew Daley, a senior investigator at the Institute for Health Research at Kaiser Permanente Colorado. The CDC, in a presentation to the panel, estimated that such a delay could result in 100,000 additional hospitalizations.
“There would be a cost,” said Daley.
One of the FDA’s representatives on the panel, Doran Fink, deputy director of FDA’s Division of Vaccines and Related Products Applications, said he understood the concerns of some panelists about using the same logic for the Covid boosters as for regular flu updates.
“FDA felt very comfortable with the approach of extrapolating the safety and effectiveness or rather the known and potential benefits and risks, which underlie our emergency use authorization,” Fink said.
White House chief medical adviser Anthony Fauci said he agreed with the move to clear the shots.
“Although you can understand why some people may want more data,” he said, “I’m actually comfortable with that decision.”
There are no updated boosters available for children under 12. However, Pfizer and BioNTech are planning to file for authorization of an omicron-targeting vaccine for children ages 5 through 11 in early October. They’re also preparing an application for a similar vaccine in children 6 months through 4 years old.
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