FDA recommends ‘pause’ on Johnson & Johnson vaccine: Speedway clinic switches to Moderna

FILE - This July 2020 photo provided by Johnson & Johnson shows a vial of the COVID-19 vaccine in Belgium. The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday, Feb. 27, 2021 cleared a Johnson & Johnson shot that works with just one dose instead of two.(Johnson & Johnson via AP, File) The Associated Press

11 a.m. update

INDIANAPOLIS (AP) — Indiana health officials are halting the use of the single-dose Johnson & Johnson COVID-19 vaccine around the state after federal officials recommended a “pause” in its use to investigate reports of potentially dangerous blood clots.

The agency said Tuesday it was switching the mass vaccination clinic being held at the Indianapolis Motor Speedway to the two-shot Moderna vaccine. The department said it was working with other clinics around the state that planned to give the Johnson & Johnson vaccine so they could provide alternative vaccines.

State health department chief medical officer Dr. Lindsay Weaver said officials weren’t immediately sure about being able to provide alternative vaccines at the Indianapolis speedway clinic after Tuesday. The clinic has been administering about 6,000 shots a day.

Weaver said she wasn’t aware of anyone from Indiana being among the six reported cases of blood clots being investigated out of more than 6.8 million doses of the J&J vaccine administered in the U.S.

8:45 a.m. update

INDIANAPOLIS — The Indiana Department of Health is proactively notifying all vaccination clinics using the single-dose Johnson & Johnson COVID-19 vaccine to pause its use following news reports that the U.S. Food and Drug Administration has called for additional review of its safety. The state has not received official notification of a directive to pause but is doing so out of an abundance of caution.

The health department will be sending the two-dose Moderna vaccine to the Indianapolis Motor Speedway, which is conducting mass vaccination clinics today, so that Hoosiers can continue to get vaccinated without interruption. The department is also working with other clinics that were scheduled to use the Johnson & Johnson vaccine in the immediate future.

NOTE: A total of 836 Bartholomew County residents had received the Johnson & Johnson vaccine as of Monday morning, according to the Indiana State Department of Health.

7:30 a.m. update

WASHINGTON (AP) — The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.

In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts. More than 6.8 million doses of the J&J vaccine have been administered in the U.S.

U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation of the cases.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a joint statement.

 

ORIGINAL STORY

WASHINGTON (AP) — US recommends ‘pause’ for single-dose Johnson & Johnson COVID-19 vaccine to investigate clotting reports.

For more on this story, see Wednesday’s Republic.