FDA nearing approval for mixing and matching covid-19 booster shots
Summary
- The agency wouldn’t recommend a specific booster but would allow people to get a different shot from their initial vaccination
The Food and Drug Administration is moving to soon allow people to receive booster shots that are different from their first Covid-19 vaccine doses, people familiar with the matter said.
The FDA won’t recommend any booster over the others but will permit people to get a booster shot that is different from the shot they first received, one of the people familiar with the matter said.
The FDA is seeking to authorize mixing and matching as soon as this week, the people familiar with the matter said. The FDA is also expected to approve Moderna Inc. and Johnson & Johnson boosters this week, according to a person familiar with the matter.
The FDA has authorized extra doses of vaccines from Pfizer Inc. and partner BioNTech SE and from Moderna for people with compromised immune systems. The FDA has also authorized Pfizer-BioNTech boosters for seniors and other people at high-risk of severe illness.
Permitting mixing and matching will require amending the labels of the different Covid-19 vaccines so that any of them can be used as boosters for any of the other authorized vaccines, which the FDA is working to do, one of the people said.
Mixing and matching vaccines has emerged as an issue, as the U.S. has begun a booster campaign to shore up the immune protection generated by vaccines, especially against the contagious Delta variant.
Some doctors and health authorities have pressed for mixing and matching to simplify logistics of the booster rollout and to ensure that people who want boosters have access to them regardless of their initial vaccine.
Preliminary data also shows that mixing and matching could provide more protection than sticking with the same vaccine, such as in the case of people who took a single dose of Johnson & Johnson’s vaccine.
The FDA’s plans to allow mixing and matching was first reported by the New York Times.
The FDA’s expert advisory committee discussed mixing and matching last week after preliminary results from a National Institutes of Health study found that doing so gives people a good immune response, especially for those who received the single dose J&J vaccine.
Several panel members said they would support mixing and matching soon, while others indicated they would want to see more data.
One key question regulators are still working on is whether people who received the Pfizer Inc. or Johnson & Johnson shots should get a 100 microgram or 50 microgram booster dose of the Moderna vaccine, if they opt to receive it, one of the people familiar with the matter said.
People who originally got two 100 microgram doses of the Moderna shot will receive a 50 microgram booster, the person said.
The NIH study informing the FDA’s decision only tested boosting with 100 microgram Moderna doses.
The NIH study found that an additional dose of the same vaccine as the primary series boosted antibody levels 4- to 20-fold, while mixing and matching primary vaccines and booster doses boosted antibody levels 6- to 76-fold.
This story has been published from a wire agency feed without modifications to the text
