U.S. FDA panel backs booster shot for Johnson & Johnson COVID-19 vaccine

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US health advisors on Friday backed a booster for Johnson & Johnson’s COVID-19 vaccine, citing growing concern that Americans who got the single-dose shot are not as safe as the two-dose brand.

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Food and Drug Administration advisors weigh in on J&K’s proposal for a flexible booster schedule. The company said the additional dose provides significant protection only two months after the initial vaccination — but may work better if people wait until six months later.

The FDA’s advisory panel voted unanimously that boosters should be offered without setting a firm time. The advisors cited mounting evidence that J&J recipients are more vulnerable to infection than those who received vaccines from competitors Pfizer or Moderna_ and who received their single doses several months earlier.

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Although Friday’s meeting is part of an ongoing evaluation of a vaccine booster, several experts said it makes more sense to think of the J&K vaccine as a two-dose vaccine.

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“I think it was clearly always a two-dose vaccine,” said Dr. Paul Offitt, an FDA advisor at Children’s Hospital of Philadelphia. “It would be hard to recommend it as a single-dose vaccine at this point.”

The government says all three US vaccines offer strong protection against hospitalization and death from COVID-19, and the priority is getting the first shot to the 66 million eligible but unvaccinated Americans who are most at risk. Huh. But the J&J vaccine has consistently shown little effect in a series of studies, while “breakthrough” infections have become a major concern due to the extra-infectious delta version of the coronavirus.

Dr. Archana Chatterjee of Rosalind Franklin University said, “It’s really — bringing it up with the second dose — I think is on par with those other vaccines in terms of effectiveness.”

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The FDA isn’t bound by the vote, but its final decision could help expand the country’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 an FDA advisory panel has recommended a similar approach for Moderna recipients. In contrast, the panel on Friday endorsed a booster for anyone receiving the J&K vaccine, which is authorized for people 18 years of age and older.

The FDA will use its advisors’ recommendations to decide whether to authorize boosters for both J&J and Moderna, after which another government agency will rule on who should have one up their sleeve.

Adding another twist, experts also discussed preliminary data from a government “mix-and-match” study, which suggested that J&J recipients had far stronger benefits when they received a Moderna or Pfizer booster rather than a second J&J dose. There may be an immune response.

J&J’s single-shot vaccine is made with a technology different from the two-shot Pfizer and Moderna Vaccines.

Of the 188 million Americans who have been fully vaccinated against COVID-19, most have received Pfizer or Moderna options, while J&J recipients account for only about 15 million.

On Friday, J&J officials introduced a booster as a way to bolster a stronger vaccine, which they said has retained its protective power over eight months. But FDA scientists apparently challenged that claim.

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“There is data that suggests the effectiveness of this vaccine is actually less strong than the company’s presentation is,” said Dr. Peter Marks, the FDA’s top vaccine official. “And this is of particular concern because it has been seen potentially in minority communities and in others.”

J&J presented the results of a large study that found 70% to 94% of US recipients given a second dose two months after the first bump against symptomatic COVID-19. Instead of giving that booster six months later, there was an even bigger jump in virus-fighting antibodies.

But in their own review, FDA scientists flagged several shortcomings in J&J’s booster studies, including only a small fraction of cases involving the delta variant, a hitherto major strain among US reviewers also warned. That J&J only followed booster recipients. A little more than a month after the second dose, which makes it difficult to draw conclusions about the durability of protection. Finally, FDA employees stressed that they did not have time to independently confirm J&J’s findings, which were presented shortly before the meeting.

FDA reviewers found no new safety concerns after the second dose of J&J, but again, they cautioned about the small number of patients studied and the short follow-up period.

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

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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