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Other Questions About J & J Vaccine Booster Prior to FDA Review | Chicago News

In the file photo on Wednesday, March 3, 2021, the pharmacist has a vial of Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, NY (AP photo / Mark Renihan).

Washington (AP) —The Food and Drug Administration is working on whether and when to provide a single dose of the Johnson & Johnson COVID-19 vaccine. A new study on Wednesday increases the likelihood of using another brand as a booster. It may work.

In an online review posted Wednesday, FDA scientists did not reach a firm conclusion as to whether there was sufficient evidence of J & J boosters. This is due to the shortcomings of the company’s data and the lack of information on protection against highly contagious delta variants of the coronavirus.

The review will take place prior to the Thursday and Friday meetings and recommends whether the FDA Advisory Board will support boosted doses of both the J & J and Moderna vaccines. This is one step in the government’s vaccine review process. Next week, the FDA will make a final decision on the approval of these boosters, and the Centers for Disease Control and Prevention will discuss who actually should get them.

Adding complexity is whether it’s okay to use a different brand of booster than someone’s first shot. Preliminary results from a US government survey suggest that booster mixing and matching work at least as well — and perhaps much better for J & J recipients. According to results posted online on Wednesday, these people showed a stronger immune response when they took either Moderna or Pfizer shots as boosters than when they were vaccinated with another dose of J & J vaccine. .. Mix and match is also the subject of discussion by the FDA panel this week.

Health officials say all vaccines used in the United States continue to provide strong protection against serious illness or death from COVID-19. However, with signs that protection against mild infections may be weakened, the government has already allowed certain people to be boosted with the Pfizer vaccine six months after the last injection.

Aiming for a unified recommendation, Moderna also asked the FDA to clear the booster dose in 6 months. However, J & J complicated the decision by proposing a second shot in the range of 2 to 6 months.

FDA reviewers suggest that a two-month booster program study “may be profitable,” but instead points out only a few people who got another shot in six months. I wrote that.

Overall, the J & J vaccine “still provides protection against severe COVID-19 illness and death,” the FDA reviewers concluded. However, its effectiveness data is “consistently less” than the protection found in Pfizer and Moderna shots.

As part of that, J & J submitted data to the FDA from a real-world study that the vaccine is about 80% effective for hospitalization in the United States.

J & J’s single-dose vaccine was highly anticipated for its one-time formulation. However, its development was hampered 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.

Rival pharmaceutical companies Pfizer and Modana have provided most of the COVID-19 vaccine in the United States. Over 170 million Americans were fully vaccinated with two shots from these companies, while less than 15 million Americans received J & J shots.


Other Questions About J & J Vaccine Booster Prior to FDA Review | Chicago News

Source link Other Questions About J & J Vaccine Booster Prior to FDA Review | Chicago News

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