Saturday, October 23, 2021

FDA grapples with timing of booster for J&J COVID-19 vaccine

WASHINGTON (AP) – The Food and Drug Administration said Wednesday it is battling whether recipients of the single-shot Johnson & Johnson COVID-19 vaccine need another dose — in six months or two months. at the beginning of.

In an online review, FDA scientists did not reach any firm conclusions, citing deficiencies in J&J’s data, including little information about protection against the extra-infectious delta variant of the coronavirus.

The review comes ahead of meetings on Thursday and Friday when the FDA advisory panel will recommend whether to support booster doses of both the J&J and Moderna vaccines. It’s a step in the government’s vaccine review process: Next week, the FDA will make a final decision on authorizing those boosters and then the Centers for Disease Control and Prevention will debate who should actually get them.

Health officials say all vaccines used in the US offer strong protection against serious illness or death from COVID-19. But amid signs that protection against minor infections is waning, the government has started introducing booster doses of the Pfizer vaccine for some people six months after their last shot.

Aiming for uniform recommendations, Moderna similarly asked the FDA to clean up its booster doses in six months. But J&J complicated the decision by proposing a second shot over a period of two to six months.

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FDA reviewers wrote that a study of a two-month booster plan suggests “there may be a benefit,” while only pointing to the small number of people who got another shot at six months.

Overall, the J&J vaccine “still provides protection against serious COVID-19 illness and death,” FDA reviewers concluded. But data about its effectiveness is “consistently low” compared to the safety seen with Pfizer and Moderna Shots.

For its part, J&J filed data with the FDA from a real-world study showing that its vaccine is about 80% effective against hospitalizations in the US.

J&J’s single-dose vaccine was highly anticipated for its single-dose formulation. But its rollout was hurt by manufacturing problems and a slew of troubles, including some rare but serious side effects, including a blood clotting disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of the shot outweighed those risks.

Rival drugmakers Pfizer and Moderna have provided the vast majority of US COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies’ two-dose shots, while fewer than 15 million Americans have received the J&J shot.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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