WASHINGTON-Reuters A U.S. health advisory panel will investigate six confirmed cases of unusual blood clots in women who received the COVID-19 vaccine from Johnson & Johnson one day after federal regulators stopped using the shot to assess the problem.
The six cases, in women aged between 18 and 48 years, were identified out of 7.2 million doses of the U.S.-administered J & J vaccine and were a risk U.S. officials and immunology experts said appeared extremely low considering the heavy toll of the novel coronavirus.
J & J’s single-dose shot is less commonly used around the country than the 185 million doses of Moderna and Pfizer/two-shot BioNTech’s vaccines but has been seen as a vital choice for expanding safeguards to harder-to-reach communities.
The U.S. Centers for Disease Control and Prevention will study the cases of clotting and vote on guidelines for potential shot use. The vaccine-approved Food and Drug Administration will then study the report and decide the next steps.
President Joe Biden’s administration said on Tuesday it didn’t expect the vaccine usage pause to affect its battle against the pandemic, as it has enough doses of the other two vaccines to remain on track. The FDA said the halt could last just a few days, as well as help doctors understand and fix any clot danger.
Biden’s chief medical officer, Dr. Anthony Fauci, said Wednesday the delay would allow regulators to see whether there were any potential clot cases.
Asked if there might be many more clotting cases, he told CNN: “No, I don’t.”
The FDA’s pause “might be very temporary,” he said separately on MSNBC. Following the CDC analysis, the FDA could decide to re-use J & J’s vaccine, allow it to be used with some modifications, or decide against its continued use, he said.
Fauci said it was up to the regulatory body, but “most likely, they’ll say we’ve looked at it, and now we’re going out, maybe making some changes.”
J & J said no direct causal link was identified between the clots and their vaccine but worked closely with regulators in the U.S. and Europe, where they have voluntarily halted their rollout.
Its shares in premarket trading in the U.S. fell below 1 percent on Wednesday, after closing down 1.3 percent on Tuesday.
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