The FDA Advisory Board will meet later this week to discuss whether to recommend booster immunization for both the J & J and Moderna vaccines.
Washington — The Food and Drug Administration said Wednesday that single-shot Johnson & Johnson recipients are wrestling when and when they will receive it. COVID-19 (New Coronavirus Infection) vaccination Another dose required — 6 months or as early as 2 months.
In an online review, FDA scientists did not reach a firm conclusion, citing shortcomings in J & J’s data, including little 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.
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.
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.
FDA discussing when to get J & J COVID booster
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