FDA authorizes Moderna and J&J booster
The Food and Drug Administration has authorized coronavirus booster shots from Moderna and Johnson & Johnson, while also announcing that boosters from all three drugmakers can be safely “mixed and matched.”
“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,” Acting FDA Commissioner Dr. Janet Woodcock said.
As with the Pfizer booster, Moderna’s third dose is authorized for people 65 and older, people with certain medical conditions and those facing workplace exposure. It can be given six months after the second dose.
Johnson & Johnson’s booster can be given two months after the first shot, and everyone 18 years and older will be eligible.
An interesting twist in the booster shot rollout: the mix and match strategy which was also authorized Wednesday night will allow patients to get a booster from Pfizer, Moderna or Johnson & Johnson, regardless of what they got for their primary series.
The eligibility and timing requirements for the mix and match booster will remain the same. For example, a J&J recipient can get a Moderna, Johnson & Johnson or Pfizer booster two months after their first shot.
Moderna or Pfizer recipients who fall into the eligibility categories can get a booster from any of the drugmakers six months after their second dose.
“We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the health care community and public with our determination in the coming weeks,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
In recent Vaccines and Related Biological Products Advisory Committee meetings, experts reviewed National Institutes of Health data that showed getting a mix and match booster yielded equal, and in some cases better, antibody responses, especially for Johnson & Johnson recipients.
Data presented during the meetings also found that both J&J and Moderna boosters increased antibody levels and offered a similar safety and side effect profile as the primary shots.
Pfizer and Johnson & Johnson boosters are the same as the original shots, and the Moderna booster is a half dose.
Further review and recommendations about boosters will come from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. Clearance from that group will become official when the CDC director signs off. Then, the boosters will become available to the public.