The US Food and Drug Administration authorized booster doses of Covid-19 vaccines made by Moderna and Johnson & Johnson Wednesday and also said any of the three authorized vaccines could be used as a booster in a mix-and-match approach.
But it left in place a complex formula for who should get get boosters and when, with officials saying they may simplify the framework as more safety data comes in.
Now vaccine advisers to the US Centers for Disease Control and Prevention will consider the FDA’s authorization, and offer their own advice. If CDC director Dr. Rochelle Walensky signs off, people could start getting Moderna and J&J boosters within days.
The FDA gave emergency use authorization for a half dose of Moderna’s vaccine as a booster for people fully vaccinated at least six months ago who are also at least 65, or who are at least 18 and at high risk of severe Covid-19 or have frequent institutional or occupational exposure to the virus.
It also authorized booster doses of Johnson & Johnson’s vaccine for anyone who got that vaccine, so those 18 and older, at least two months ago.
And it said any of the three authorized vaccines could be used to boost. Pfizer already has authorization for booster shots for its vaccine for people vaccinated at least six months ago – with the same restrictions as those for Moderna’s vaccine: those 65 and older and those with a higher risk of severe disease.
“As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death,” FDA Acting Commissioner Dr. Janet Woodcock said in a statement.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
Dr. Peter Marks, director of the FDA’s vaccine arm, the Center for Biologics Evaluation and Research, said the ability to use any authorized vaccine as a booster will simplify matters for people.
“Being able to interchange these vaccines is a good thing. It’s like what we do with flu vaccines. Most people don’t know what brand flu vaccine they received,” Marks told reporters in a telephone briefing.
Marks said the FDA would consider lowering the age ranges for booster shots as more safety data comes in.
“We want to make sure that if we deploy the boosters in all of the age ranges, that we truly are making a benefit outweigh any risks,” Marks said. “We will not hesitate to drop this age range as we see this benefit outweigh the risk, and because of the EUA authority that we have, we can do that in a relatively quick amount of time.”
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Source: www.cnn.com