U.S. FDA panel backs booster shot for Johnson & Johnson COVID-19 vaccine
Global News
FDA's reviewers found no new safety concerns after a second dose of J&J against COVID-19, but they cautioned about the small number of patients studied and short follow-up period.
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.
Advisers to the Food and Drug Administration weighed J&J’s proposal for a flexible booster schedule. 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 growing 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.
The decision halts an order to end broad recommendations for all children to be vaccinated against flu, rotavirus, hepatitis A, hepatitis B, some forms of meningitis and RSV.
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