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Johnson and Johnson COVID Booster Shot Approved by FDA Panel




The FDA’s committee said the J & J booster should be provided at least two months after immunization, but did not suggest a firm time.

Washington — US Health Adviser approved Johnson & Johnson’s COVID-19 vaccine booster on Friday.

J & J told the Food and Drug Administration that additional doses add important protection as early as two months after the first vaccination, but it may be better to wait up to six months later. Unanimously unable to determine the best timing, the FDA’s advisory board unanimously voted that people should provide boosters at least two months after they took their previous shots.

“Frankly, I think this was always a two-dose vaccine,” said Dr. Paul Ofit, FDA adviser to the Philadelphia Children’s Hospital. “At this point, it would be difficult to recommend this as a single-dose vaccine.”

The FDA makes the final decision and is not bound by the recommendations. In addition to the complexity of the discussion, new studies also suggest that J & J recipients may exhibit a stronger immune response if booster doses are from competing brands.

Preliminary results from ongoing studies of different methods of “mixing and matching” different shots show that boosters of all kinds increase the level of antibodies that fight the virus in people for at least a few weeks. I did. And the most dramatic jump came from giving Pfizer or Moderna shots after a single dose of J & J vaccination.

FDA advisers did not vote on whether it should be recommended, but instructed the government to allow booster flexibility. -Period protection.

“In the real world, all these types of combinations are already in place, so I think it’s an urgent matter to help the FDA organize clearly complex and challenging scenarios,” said Boston Children’s Hospital. Dr. Ofer Levy said.

The government continues to provide strong protection against hospitalization and death from COVID-19, with all three U.S. vaccines first among the 66 million eligible and unvaccinated Americans at greatest risk. It states that giving an injection of is a priority. However, the country is moving towards a broader booster campaign due to the spread of highly contagious delta mutants and signs of weakened immunity to mild infections.

Last month, Pfizer boosters began to be offered to older and younger adults at high risk for COVID-19 due to poor health, work, or living conditions at least 6 months after the first vaccination. On Thursday, the FDA Advisory Board recommended the same approach for half-dose Moderna boosters.

However, J & J vaccines have consistently shown low levels of efficacy throughout a series of studies, and the FDA panel finally separates recipients over the age of 18 at least two months after initial vaccination. I decided to inoculate.

Dr. Archana Chatterjee of Rosalind Franklin University said:

The FDA will use the advisor’s recommendations to decide whether to approve both J & J and Moderna boosters. The Centers for Disease Control and Prevention then decides who should roll up the sleeves.

The majority of the 188 million Americans who have been fully vaccinated with COVID-19 receive the Pfizer or Moderna option, but only about 15 million J & J recipients.

J & J’s vaccine was made with a different technology, and on Friday the company touted boosters as a way to fortify a powerful vaccine they said they had maintained protection for eight months. But FDA scientists disagreed with that claim.

“There are data suggesting that the effectiveness of this vaccine is actually less robust than the company’s presentation here,” said Dr. Peter Marks, FDA’s Chief Vaccine Officer. others. “

For boosters, J & J found a second dose to 70% to 94% of US recipients just two months after the first bump protection for symptomatic COVID-19. We announced the result of. Instead, giving the booster six months later, the virus-fighting antibody took a huge leap forward.

However, in their own review, FDA scientists mentioned only a small percentage of cases involving the delta mutant, the overwhelmingly predominant strain in the United States. J & J tracked booster recipients for over a month, making it difficult to draw conclusions about the sustainability of protection. FDA scientists also emphasized that they did not have time to independently review the J & J data submitted shortly before the meeting. This was extremely unusual and raised serious concerns from the advisory board.

The J & J vaccine was highly anticipated for its one-time formulation. However, developments earlier this year were hit by a series of problems, including rare but serious side effects, such as manufacturing problems and a neurological reaction called thrombosis and Guillain-Barré syndrome. In both cases, regulators have determined that the benefits of shots outweigh these risks.

The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.




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