The Middletown Press (Middletown, CT)
FDA panel endorses booster shot for J&J COVID-19 vaccine
WASHINGTON — U.S. health advisers endorsed a booster of Johnson & Johnson’s COVID-19 vaccine Friday, citing growing worry that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.
The company said the extra dose adds important protection as early as two months after initial vaccination — but that it might work better if people wait until six months later.
The FDA’s advisory panel voted unanimously that a booster should be offered without setting a firm time. The advisers cited evidence that J&J recipients are more vulnerable to infection than people who got vaccines from competitors Pfizer or Moderna— and that most got their single dose many months ago.
Although Friday’s meeting is part of an ongoing evaluation of vaccine boosters, many of the experts said it makes more sense to think of J&J’s vaccine as a two-dose vaccine.
“I think this frankly was always a two-dose vaccine,” said FDA adviser Dr. Paul Offit of Children’s Hospital of Philadelphia. “It would be hard to recommend this as a single-dose vaccine at this point.”
The government says all three U.S. vaccines continue to offer strong protection against hospitalization and death from COVID-19, and that the priority is getting first shots to the 66 million eligible but unvaccinated Americans who are most at risk. But J&J’s vaccine has consistently shown lower effectiveness across a series of studies, while “breakthrough” infections become a bigger concern due to the extra-contagious delta variant of the coronavirus.
“This is really — with the second dose — bringing it I think on par with those other vaccines in terms of effectiveness,” said Dr. Archana Chatterjee of Rosalind Franklin University.
The FDA isn’t bound by the vote but its ultimate decision could help expand the nation’s booster campaign.
Booster doses of Pfizer’s vaccine began last month for people at high risk of COVID-19 at least six months after their last shot, and the FDA advisory panel has recommended the same approach for Moderna recipients. In contrast, the panel Friday backed boosters for anyone who received the J&J vaccine, which is authorized for people 18 and older.
The FDA will use its advisers’ recommendations to decide whether to authorize boosters for both J&J and Moderna, after which another government agency will rule on who should roll up their sleeves.
Adding another twist, the experts also discussed preliminary data from a government “mix-and-match” study that suggested J&J recipients may have a far stronger immune response if they get either a Moderna or Pfizer booster rather than a second J&J dose.