CDC, FDA lift pause on J&J COVID-19 vaccine

Photo by Kevin Dietsch/UPI

April 23 (UPI) — The Centers for Disease Control and Prevention and Food and Drug Administration on Friday lifted the pause on administering the Johnson & Johnson COVID-19 vaccine, which has been suspended for more than a week.

The agencies recommended last week that the shots be paused nationwide after a small number of reported cases of blood clotting complications in recipients. More than 7 million doses of the vaccine have already been administered in the United States.

“The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older,” the FDA said in a statement.

The CDC’s Advisory Committee on Immunization Practices earlier Friday voted 10-4 with one abstention to recommend resuming administering the vaccinations with a warning about the risk of blood clots.

“I think the pause gave us a chance to know the right pathway of workup and treatment and to know the patients who need the workup started,” said Dr. Antoinette Pragalos, a member of the panel.

CDC Director Rochelle Walensky said she’s “encouraged” by the growing body of real-world evidence that the COVID-19 vaccines currently in use are “safe and effective.”

“Above all else, health and safety are at the forefront of our decisions,” she said. “Our vaccine safety systems are working. We identified exceptionally rare events — out of millions of doses of the Janssen COVID-19 administered — and we paused to examine them more carefully.

“I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.”

The clotting cases were seen in six women who’d received the Johnson & Johnson vaccine. They were between the ages of 18 and 48 and began to see symptoms between six and 13 days after they got the shot.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and President Joe Biden’s chief medical adviser, said last week that the blood clots are a rare event, “less than one in a million.”

On Thursday, Oregon health officials said the CDC was investigating the death of another woman there who developed clots after receiving the vaccine, which is produced by Johnson & Johnson subsidiary Janssen. She was in her 50s and died this week.

“Until the investigation is complete, it cannot be concluded whether her death is related to the vaccine,” the Oregon Health Authority said.


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