U.S. Lifts Pause on Johnson & Johnson COVID Vaccine Despite Blood Clot Risk

U.S. health officials on Friday lifted the pause on the use of the Johnson & Johnson's COVID vaccine following a recommendation by an expert panel. This gives the state and local officials the green signal to distribute the COVID vaccine doses.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration's (FDA) announcement came after the CDC's Advisory Committee on Immunization Practices (ACIP) recommended the continued use of the Johnson & Johnson vaccine early Friday.

ACIP said the benefits of the vaccine outweighed the risks, CNBC reported. Members of the panel proposed that the FDA consider adding a warning label for women under 50 years old.

Other than that, they did not recommend U.S. health regulators to restrict the Johnson & Johnson vaccine based on age or gender.

FDA and CDC both consider the Johnson & Johnson vaccine to be safe and effective in preventing COVID. Officials noted that the risk of blood clots was "very low."

"Our vaccine safety systems are working. We identified exceptionally rare events - out of millions of doses" of the J&J shot and will continue to monitor them," CDC Director Dr. Rochelle Walensky said as reported by Associated Press.

Acting FDA Commissioner Dr. Janet Woodcock said that safety is their top priority. Woodcock added that the pause was an example of their extensive safety monitoring.

Johnson & Johnson COVID Vaccine

The U.S. has placed an immediate pause on distributing the Johnson & Johnson COVID vaccine after reports of blood clots in six people who had received the shot.

The women involved in the blood clot cases were all women between 18 and 48 years old. They all experienced adverse reactions six to 13 days after receiving the shot, according to Business Insider.

Woodcock earlier said that she expected the pause on the said vaccine to be temporary, adding that it would be just a matter of days.

In a statement, Johnson & Johnson said it is working with regulators and medical experts to look into the blood clot reports. The company added that it has delayed its rollout in Europe and has stopped vaccinating new volunteers in trials.

Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said that one of the blood clot cases was fatal, and one patient was in critical condition.

Dr. Anne Schuchat, the CDC's principal deputy director, noted that people who received the vaccine during the past week should observe if they have symptoms of blood clots. These symptoms include severe headache, abdominal pain, leg pain, and shortness of breath.

Meanwhile, the blood clot incidents are not the only thing that J&J faced during the distribution. A Baltimore factory contracted to manufacture J&J doses was found to commit some manufacturing violations.

An FDA inspection report stated that the factory was dirty, had poorly trained staff, and did not follow proper manufacturing procedures to prevent contamination.

According to CBS News, the report cited peeling paint, black and brown residue on the factory's walls and floors, and employees not following procedures to prevent contamination.

But the FDA assured that nothing made at the said factory for Johnson & Johnson had been distributed. Nearly eight million people in the U.S. had already received the J&J shot.

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