WASHINGTON, April 14 (Reuters) – A U.S. health advisory panel will review six reported cases of rare blood clots in women who received the Johnson & Johnson COVID-19 vaccine a day after federal regulators on Wednesday they stopped using the shot to assess the issue.
The six cases, in women between the ages of 18 and 48, reported 7.2 million doses of the J&J vaccine given in the United States and posed a risk that U.S. officials and immunology experts said seemed extremely low, given the heavy weight of the new coronavirus. .
J&J’s single-dose shot is used less nationwide compared to the 185 million doses administered by the two Moderna and Pfizer / BioNTech vaccines, but has been seen as a critical option to extend protections to populations more difficult to access.
Immunization experts from the U.S. Centers for Disease Control and Prevention will review coagulation cases and vote on recommendations for future use of the shot. The Food and Drug Administration, which approved the vaccine, will review the analysis and determine the next steps.
President Joe Biden’s administration said Tuesday it did not expect the pause in vaccine use to affect its fight against the pandemic, as it has enough doses of the other two vaccines to stay on track. The FDA said the detention should only last a few days and would also help doctors understand and address any clot risk.
Dr. Anthony Fauci, chief physician at Biden, said Wednesday that the break would allow regulators to see if there were other possible cases of clots.
Asked if it was thought there could be many more cases of clotting, he told CNN, “No, I don’t.”
The FDA’s break “may very well be very temporary,” he told MSNBC separately. After the CDC review, the FDA could decide to resume use of the J&J vaccine, allow its use with some changes, or decide against its continued use, he said.
Fauci said it depended on the regulatory agency, but that “they will most likely say we looked at it and now we will go back, maybe we will make some modifications.”
J&J has said no clear causal relationship has been established between the clots and their vaccine, but that it was working closely with regulators in the United States and Europe, where it also voluntarily stopped its deployment.
Its shares fell less than 1% in pre-US operations on Wednesday, after closing 1.3% on Tuesday. (Report by Susan Heavey Edited by Bernadette Baum)