CDC, FDA cite blood clots in COVID vaccine

The Food and Drug Administration and the Centers for Disease Control and Prevention recommend the US break in using Johnson & Johnson COVID-19 vaccine after reports of blood clots in people who received the vaccine.

Health officials released a statement Tuesday morning recommending the break “out of caution” and saying blood clots are still “extremely rare”. So far, the CDC and FDA are reviewing six reported cases in the United States

All six recipients were women between the ages of 18 and 48, with symptoms reportedly occurring 6 to 13 days after vaccination. One woman died and one was hospitalized in critical condition. The New York Times reported.

The CDC Advisory Committee on Immunization Practices (ACIP) will hold a meeting on Wednesday to analyze the cases. The FDA said it will review the committee’s analysis as it is also investigating the cases.

“Until this process is complete, we recommend taking this break,” said Dr. Anne Schuchat, Deputy Chief Executive Officer of the CDC, and Dr. Peter Marks, director of the FDA Center for Evaluation and Research of Biologics, in a joint statement. “This is important to ensure that the healthcare provider community is aware of the potential of these adverse events and can plan based on the unique treatment that is required for this type of blood clot.”

The type of blood clot that has been reported in people who received the J&J vaccine is called cerebral venous sinus thrombosis (CVST). In most clinical situations, an anticoagulant called Herapin is usually given to treat blood clots. However, health officials say the use of this drug could be dangerous and recommend alternative treatments.

A press conference is scheduled for 10 a.m. As of April 12, more than 6.8 million doses of the Johnson & Johnson vaccine had been administered in the United States and about 9 million more had been shipped to states, according to the CDC.

“The safety of COVID-19 vaccines is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” said Schuchat and Marks.

People who have received the J&J vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks of vaccination should see their doctor as recommended by health authorities.

The hiatus could complicate the country’s vaccination plans, especially after the Biden government postponed the deadline to qualify all adults for a COVID-19 vaccine from May 1 to April 19.

The J&J vaccine was approved by the FDA for emergency use in late February. The company had promised 100 million single doses to the US government by the end of May.

Follow Adrianna Rodriguez: @AdriannaUSAT.

U.S. TODAY health and patient safety coverage is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide any editorial contributions.


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