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FDA panel endorses booster shot for J&J COVID-19 vaccine

FDA approves J&J booster

A panel of U.S. health advisers endorsed booster doses of Johnson & Johnson’s single-shot COVID-19 vaccine Friday, saying they should be offered at least two months after immunization.

J&J has asked the Food and Drug Administration for flexibility with its booster, arguing 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 worry that recipients of J&J’s vaccination seem to be less protected than people who got two-dose Pfizer or Moderna options — and that most got that single dose many months ago.

The FDA isn’t bound by the vote but its ultimate decision could help expand the nation’s booster campaign.

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 unvaccinated. But there’s a growing push to shore up protection against “breakthrough” infections and the extra-contagious delta variant of the coronavirus.

Booster doses of Pfizer’s vaccine began last month for people at high risk of COVID-19, and the FDA advisory panel has recommended the same approach for Moderna recipients.

The J&J vaccine was highly anticipated for its one-and-done formulation. But its rollout earlier this year was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot’s benefits outweighed those risks.

The vast majority of the 188 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while J&J recipients account for only about 15 million.



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