Thursday, December 2, 2021

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

WASHINGTON (AP) – US health advisers on Friday backed a booster of Johnson & Johnson’s COVID-19 vaccine, citing growing concern that Americans who got the single-dose shot were more likely to get the two-dose Brands are not as safe.

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 at least two months after vaccination, but did not suggest a specific 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 those who received their single dose several months earlier.

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.

“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 low effectiveness in a series of studies, while “breakthrough” infections have become a bigger 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.”

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 the recommendations of its advisors 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.

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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 fully vaccinated against COVID-19, the majority 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.

“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.”

As its booster, J&J presented the results of a large study that found that giving a second dose two months after the first bump against symptomatic COVID-19 increased US recipients from 70% to 94%. 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 pointed out several shortcomings in J&J’s booster studies, including only a small proportion of cases involving the delta variant, a hitherto major stress among US reviewers who also warned that J&J followed only 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 emphasized that they did not have time to independently confirm J&J’s findings, which were presented shortly before the meeting.

Nation World News Desk
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