WASHINGTON (Reuters) -A U.S. health advisory panel on Wednesday will review six reported cases of rare blood clots in women who received Johnson & Johnson’s COVID-19 vaccine a day after federal regulators paused its use to assess the issue.
The cases, all in women under age 50, were reported out of 7.2 million U.S. doses of the J&J vaccine administered – a risk federal officials and immunology experts said was extremely low when weighed against the heavy toll of the novel coronavirus.
One of the six women died. So far, more than 562,362 people in the United States have died from COVID-19.
Top U.S. health officials, meanwhile, at a separate briefing on Wednesday urged Americans to keep their vaccination appointments as other authorized vaccines fill the void.
J&J’s single-dose shot has been far less widely used in the United States as it has faced manufacturing setbacks and received emergency authorization later than the two-dose shots from Moderna Inc and Pfizer Inc with partner BioNTech SE. About 185 million doses of those have been administered in the United States so far.
However, J&J’s vaccine has been seen as a critical option to expand protections to harder-to-reach populations.
The U.S. Centers for Disease Control and Prevention’s immunization panel will review the clotting cases and make recommendations when it convenes at 1:30 p.m. (1730 GMT). The Food and Drug Administration will then analyze the recommendations and determine the next steps.
Biden administration officials have said they do not expect the pause in use of J&J’s vaccine to hamper its fight against the pandemic, citing enough doses of the other two to stay on track. The FDA said the halt should only last a few days and was needed to help physicians understand how to recognize and treat the issue as a standard treatment for clotting could cause serious complications or death.
Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, on Wednesday told CNN the pause in administering the J&J shot would allow regulators to see if there were other possible clot events, but that he did not think there would be many more such cases.
The pause “very well may be quite temporary,” he said separately on MSNBC. Following the CDC review, the FDA could decide to resume use of J&J’s vaccine, allow its use with some changes, or decide against its continued use, he said.
Fauci said it was up to the regulatory agency but that “very likely, they’ll say we looked at it, and now we will go back, maybe make some modifications.”
J&J has said no clear causal relationship has been established between the clots and its vaccine, but that it was working closely with regulators in the United States and Europe, where it also voluntarily paused its rollout. Similar rare brain blood clots have been reported with AstraZeneca’s vaccine in Europe, where it was decided the shot’s benefits outweigh the clotting risk.
J&J shares were near flat in midday trading on Wednesday, after closing down 1.3% on Tuesday.
Some health experts worry the pause may raise public doubts about U.S. vaccination efforts, though Fauci and other top U.S. health officials have said it should give people confidence that regulators take safety seriously.
“These pauses are actually common when new vaccines and drugs are rolled out. We’re just doing the due diligence to make sure everything is safe so we can continue with our vaccination efforts,” U.S. Surgeon General Vivek Murthy said on the “CBS This Morning” program.
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