Covid-19 boosters tailored to the latest omicron variants won support from a panel of US health advisers, a crucial step toward giving Americans additional protection as concern grows about potential new waves in the fall and winter.
(Bloomberg) — Covid-19 boosters tailored to the latest omicron variants won support from a panel of US health advisers, a crucial step toward giving Americans additional protection as concern grows about potential new waves in the fall and winter.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 to recommend Moderna Inc.’s shot in adults 18 and older and with an identical tally in support of Pfizer Inc. and BioNTech SE’s shot for people ages 12 and older. CDC Director Rochelle Walensky has the final say on making the advice official, which will allow the shots to go into arms as soon as Labor Day weekend.
The current crop of vaccines are based on the original strain of the coronavirus first identified in Wuhan, China. But as the virus has mutated and new strains arise, they can gain the ability to evade immunity afforded by shots and previous infections. The Biden administration has made plans to begin offering the new 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 booster, according to the Food and Drug Administration. The agency gave them emergency clearance Wednesday.
Flu Comparison
Like flu vaccines that are updated annually, the new versions of the 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.
More stories like this are available on bloomberg.com
©2022 Bloomberg L.P.
