Report from federal advisory board discussions of J&J vaccine

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Wed, 2021-04-14 17:33 — mike kraft

CDC vaccine advisers review Johnson & Johnson shot after reports of rare blood clots Federal health officials had recommended Tuesday that states pause use of the vaccine while agencies review six U.S. cases of a rare and severe type of brain blood clot among the more than 7 million people who received the shot. Lena H. Sun, Carolyn Y. Johnson Washington Post

A federal vaccine advisory committee is meeting Wednesday to discuss next steps on Johnson & Johnson’s coronavirus vaccine after federal health officials recommended the day before that states pause its use while agencies review six U.S. cases of a rare and severe type of brain blood clot among the more than 7 million people who received the shot.

The CDC’s Advisory Committee on Immunization Practices focused on safety data from the company and CDC vaccine experts, including details about the cases in the six women, who were between the ages of 18 and 48. They developed symptoms, most often headaches, six to 13 days after vaccination. One vaccine recipient, a Virginia woman, died in March, and another is in critical condition, health officials have said.

Two of six patients have been discharged, and three remain in the hospital.

A CDC official and an executive from Johnson & Johnson described the six cases in the greatest detail yet. All of the women were White, and only one person was taking hormonal contraceptives that can cause blood clots, suggesting that was not the reason for the clots.

Tom Shimabukuro, of the vaccine safety team at CDC, explained that the rare, severe clots were especially alarming because they were accompanied by low levels of blood cells involved in clotting — a combination virtually unheard of among healthy, young people.

“We have a picture where we have clots forming in large [blood] vessels in the presence of low platelets, so it’s kind of a paradox here,” Shimabukuro said. “This is unusual — it usually doesn’t happen.”

The combination has also been seen, rarely, among people who received vaccine developed by AstraZeneca and University of Oxford. Four of those vaccine recipients were treated with heparin initially, an anticoagulant that is not recommended because the events closely resemble an immune-triggered reaction to the drug that could worsen the clots. ...

It’s not clear what action the advisory committee will take. It could vote to continue the overall pause for a few weeks, or pause use for certain age groups or people.

The blood clots are similar to those reported by several European countries after the use of AstraZeneca’s coronavirus vaccine, which uses a similar technology. Several experts said it is necessary to understand whether the risks of the vaccines outweigh the benefits for certain groups of people. But they also said the risk of developing a clot after receiving the vaccine appears far lower than the chance of a clotting issue caused by a severe covid-19 infection or from using hormonal birth control, such as oral contraceptives. ...

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