FDA advisors endorse Moderna boosters

Unanimous vote backs third shot at least six months after initial vaccination

The Food and Drug Administration panel of expert advisors voted 19-0 to endorse booster shots of the Moderna vaccine for high-risk individuals (those 65 and older, people 18-64 with underlying conditions or those working or living in high-risk situations) to be given at least six months after the second dose.

The FDA is expected to act within the next few days, followed by the CDC publishing guidelines for administering booster doses. If the typical pattern is followed, boosters could start to be given to eligible individuals by the middle of next week.

Advisors expressed concerns that the data submitted by Moderna was not overwhelmingly clear on the benefits of the booster, but the likelihood of benefit and the established safety of the vaccines was sufficient rationale to encourage high-risk individuals to get a booster dose.

The booster doses are half the strength of the initial two doses of the mRNA vaccine.

More details in the Moderna submission are available on the FDA website.