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FDA Panel Approves Booster Shots for J & J COVID-19 Vaccine

In this March 3, 2021 file photo, a vial of Johnson & Johnson COVID-19 vaccine is on display at South Shore University Hospital in Bayshore. Johnson’s single-shot COVID-19 vaccine and when. Food and Drug Administration advisors also look at data that suggests that competing brand boosters may offer better protection.Credits: AP Photo / Mark Lennihan, File

U.S. health advisers approved Johnson & Johnson’s COVID-19 vaccine booster on Friday, raising concerns that Americans taking single-dose shots are not as protected as those given the double-dose brand. He said it was rising.

The Food and Drug Administration adviser considered J & J’s proposal for a flexible booster schedule. According to the company, additional doses add significant protection as early as 2 months after the first vaccination, but may be more effective if you wait up to 6 months.

The FDA’s advisory board unanimously voted that boost immunization should be provided at least two months after immunization, but did not indicate a firm time. Advisors say J & J recipients are more vulnerable to infection than those vaccinated from competitors Pfizer and Moderna, with increasing evidence that most people received a single dose a few months ago. It states that it is.

Although the Friday meeting is part of an ongoing assessment vaccination Many boosters and experts said it made more sense to think of the J & J vaccine as a double-dose vaccine.

“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 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, while J & J vaccines have consistently shown low efficacy throughout a series of studies, “breakthrough” infections have become a greater concern due to the highly contagious delta mutant of coronavirus. increase.

Dr. Archana Chatterjee of Rosalind Franklin University said:

The FDA is not bound by voting, but its final decision may help expand the country’s booster campaign.

A booster dose of Pfizer vaccine was started last month for people at high risk for COVID-19, at least 6 months after the last injection. Advisory Committee We recommend the same approach for Moderna recipients. In contrast, the Friday panel endorsed boosters for those who received the J & J vaccine, which is licensed for people over the age of 18.

The FDA will use the advisor’s recommendations to decide whether to approve both J & J and Moderna boosters. Another government agency then decides who rolls up the sleeves.

With a further twist, experts also discussed preliminary data from the government’s “mix and match” study.

J & J’s single-shot vaccine is made with a different technology than the two-shot Pfizer and Modana vaccines.

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.

On Friday, J & J executives said they had touted the booster as a way to fortify a powerful vaccine and maintained its defenses 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 official. “And that’s a concern, especially as it’s seen in the minority and other communities.”

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 pointed out many shortcomings in J & J’s booster study, including a small portion of cases involving delta variants. amplifier Being a recipient over a month after the second dose, it is difficult to conclude on the persistence of protection. Finally, FDA staff emphasized that they did not have time to independently review the J & J findings submitted shortly before the meeting.

FDA reviewers did not discover any new safety concerns after the second J & J dose, but again warned of the small number of patients studied and the short follow-up period. ..

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.


FDA Panel Addresses Difficult Questions About J & J COVID-19 Booster


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Quote: The FDA panel is the J & J COVID-19 vaccine (10 2021) obtained on October 15, 2021 from https://medicalxpress.com/news/2021-10-fda-panel-endorses-booster-shot.html. Approve booster shots (15th of March)

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FDA Panel Approves Booster Shots for J & J COVID-19 Vaccine

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