FDA panel endorses booster dose for J&J COVID-19 vaccine – Mashreq News

US health advisers Friday endorsed Johnson & Johnson’s COVID-19 vaccine boost, citing growing concern that Americans who got one dose aren’t as protected as those who got two brand-name doses.

FDA advisors have evaluated J&J’s proposal for a flexible strengthening schedule. The company said the extra dose adds important protection as early as two months after the initial vaccination – but may work better if people wait until six months later.

The FDA’s advisory committee voted unanimously that the booster drug should be introduced at least two months after vaccination, but did not suggest a specific time. The consultants cited mounting evidence that J&J recipients are more likely to get infections than people who got vaccines from rival Pfizer or Moderna — and that most got their only dose several months ago.

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

“I think this has always been a two-dose vaccine,” said FDA advisor Dr. Paul Offit of Children’s Hospital of Philadelphia. “It would be difficult to recommend this as a single-dose vaccine at this point.”

The government says all three US vaccines continue to provide strong protection against hospitalization and death from COVID-19, and that the priority is getting the first vaccines for the 66 million eligible but unvaccinated and most at-risk Americans. But the J&J vaccine has consistently shown lower efficacy across a series of studies, while “breakthrough” infection has become a greater concern due to the highly contagious delta variant of the coronavirus.

“It really – with the second dose – makes me think it’s on par with those other vaccines in terms of efficacy,” said Dr Archana Chatterjee of Rosalind Franklin University.

The Food and Drug Administration is not obligated to vote but its final decision could help broaden the country’s strengthening campaign.

Boosters of the Pfizer vaccine began last month for people at high risk of COVID-19 at least six months after the last shot, and an advisory panel to the U.S. Food and Drug Administration (FDA) has recommended the same approach for Moderna recipients. In return, the commission on Friday backed boosters for anyone who received the J&J vaccine, which is approved for people 18 and older.

The Food and Drug Administration (FDA) will use its advisors’ recommendations to decide whether to allow the use of boosters for both J&J and Moderna, and then another government agency will judge who should roll up their sleeves.

Adding to another development, experts also discussed preliminary data from a “mixed and matched” government study that indicated that J&J recipients may have a much stronger immune response if they get a booster dose of Moderna or Pfizer rather than a second dose of J&J.

The J&J single-shot vaccine is made with a different technology than the Pfizer and Moderna vaccines.

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

On Friday, J&J executives introduced a booster dose as a way to boost a potent vaccine that they said retains its protective ability over eight months. But FDA scientists have clearly challenged this assertion.

“There is data to suggest that the efficacy of this vaccine is actually less robust than the company’s presentation here,” said Dr. Peter Marks, the FDA’s senior vaccine officer. “And this is a particularly troubling finding because it has been seen in potential minority communities and others.”

As for booster, J&J presented results of a large study that found giving a second dose just two months after the first protected against COVID-19 symptoms to 94% of 70% in US recipients. Instead, giving this booster six months later led to an even bigger jump in anti-virus antibodies.

But in their own review, FDA scientists note a number of shortcomings in the J&J booster studies, including only a small portion of cases involving the delta variant, by far the dominant strain in the United States. A little more than a month after the second dose, which makes it difficult to draw conclusions about the durability of the protection. Finally, FDA employees confirmed 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 a second dose of Johnson & Johnson, but again cautioned about the small number of patients studied and the short follow-up period.

The J&J vaccine was highly anticipated for its individual formulation. But its introduction earlier this year was hit by a series of problems including manufacturing problems and some rare and serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. Either way, regulators decided that the benefits of the shot outweigh those risks.

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

 
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