On Thursday, the Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of booster shots for Moderna’s vaccine for people 65 and older, younger adults with underlying medical conditions that put them at high risk of severe COVID-19 and those with occupational exposure.
Now it’s Johnson & Johnson’s turn to make its case for COVID-19 booster shots.
What You Need To Know
- A Food and Drug Administration committee of outside advisers is meeting Friday to discuss whether to grant emergency use authorization to a booster for the Johnson & Johnson vaccine
- On Thursday, the Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of booster shots for Moderna’s vaccine for people 65 and older and other high-risk adults
- In an online review posted Wednesday, FDA scientists didn’t reach a firm conclusion about whether there’s enough evidence for Johnson & Johnson boosters, citing shortcomings with the company’s data
- Adding to the complexit, preliminary results of a U.S. government study suggest that mixing and matching boosters will work at least as well — and maybe far better for J&J recipients
A Food and Drug Administration committee of outside advisers is meeting Friday to discuss whether to grant emergency use authorization to a booster for the J&J vaccine for people age 18 and older.
The panel’s vote is not binding but will play heavily into the FDA’s final decision. Last month, the agency followed the advisers’ vote in authorizing Pfizer’s booster shots for the same three groups of people.
A panel convened by the Centers for Disease Control and Prevention is set to meet next week to offer more specifics on who should get booster shots.
Pfizer and Moderna booster shots for immunocompromised people have been approved since August.
Johnson & Johnson and the FDA will both make presentations to the committee Friday before panel members hear public comments and then open debate.
In an online review posted Wednesday, FDA scientists didn’t reach a firm conclusion about whether there’s enough evidence for Johnson & Johnson boosters, citing shortcomings with the company’s data and little information on protection against the extra-contagious delta variant of the coronavirus.
Adding to the complexity is whether it’s OK to use a booster that’s a different brand than someone’s initial shots. Preliminary results of a U.S. government study suggest that mixing and matching boosters will work at least as well — and maybe far better for J&J recipients. Those people had a stronger immune response if they got either a Moderna or Pfizer shot as their booster than if they received another dose of the J&J vaccine, according to results posted online Wednesday.
Mix-and-match is also up for discussion by the FDA panel Friday.
Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19.
Aiming for uniform recommendations, Moderna asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.
FDA reviewers wrote that a study of the two-month booster plan suggests “there may be a benefit,” while pointing to only small numbers of people who got another shot at six months instead.
Overall, the J&J vaccine “still affords protection against severe COVID-19 disease and death,” the FDA’s reviewers concluded. But data about its effectiveness “are consistently less” than the protection seen with Pfizer and Moderna shots.
For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80% effective against hospitalizations in the U.S.
