FDA authorizes Moderna and Johnson & Johnson boosters

On October 20 the FDA announced that it will allow the use of booster doses for the Moderna and Johnson & Johnson vaccines. As the agency’s advisory panel had recommended days earlier, anyone 18 and older will be able to get a second dose of the Johnson & Johnson vaccine at least two months after their first dose. However, the FDA’s recommendation for the Moderna vaccine is narrower: A third dose can be administered at least six months after the second one to people age 65 and older and to those ages 18 to 64 who are at high risk of severe COVID-19 due to underlying conditions. It also includes people ages 18 to 64 who are at high risk of exposure because of where they work or live, such as health-care workers or incarcerated people. These guidelines are the same as those approved for Pfizer’s booster doses.

The FDA also authorized a “mix and match” approach to booster doses, which would, for example, allow people who received a Johnson & Johnson jab to seek a Pfizer or Moderna booster instead. The eligible populations are the same as those who were authorized for a booster dose of their primary vaccine. Although the agency’s advisory committee did not vote on the matter, they did discuss evidence from a new National Institutes of Health study suggesting that booster doses of the Moderna or Pfizer vaccines are more effective for people who originally received the Johnson & Johnson shot.

Before the U.S. can roll out the new booster doses, the CDC will weigh in on the FDA ruling to further refine its recommendations. That could come as soon as October 21, when a key CDC advisory committee is scheduled to meet to discuss the data on boosters.

The agencies are also expected to rule soon on Pfizer’s application for emergency use authorization of its COVID-19 vaccine for children ages five to 11. The FDA advisory committee will discuss the matter on October 26, with a final ruling to come in the following days or weeks. The White House has announced its plans to roll out the vaccines by working with more than 25,000 pediatricians and other primary care sites, children’s hospitals, pharmacies, school clinics, and more.

Stay up to date and read more on the latest vaccine developments here.

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