Johnson & Johnson Coronavirus Third Shot Approved by FDA

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

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.

While the Friday meeting is part of an ongoing assessment of vaccine boosters, many experts said it makes more sense to think of J & J’s 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.

Pfizer vaccine boosters began last month for people at high risk of COVID-19 at least 6 months after the last injection, and the FDA Advisory Board recommends the same approach to Moderna recipients. I am. 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 proposed a booster as a way to fortify a powerful vaccine and said it had 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 Officer. “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, which included a small portion of cases containing delta variants. A little over a month after the second dose, it is difficult to draw conclusions about the durability of the protection. Finally, FDA staff emphasized that they did not have time to independently review the J & J findings submitted shortly before the meeting.