CDC, FDA Lift Pause On Johnson & Johnson's COVID-19 Vaccine
PITTSBURGH (KDKA) -- The nation's only single-dose Coronavirus vaccine will soon be back in rotation.
The CDC and FDA have lifted the pause that had been placed on Johnson & Johnson's COVID-19 vaccine.
While the CDC advisory committee did not recommend new restrictions based on age or gender, the vaccine will be updated with a new label indicating that women under the age of 50 years old should be aware of the risk of blood clots.
The committee concluded the benefits of getting the vaccine outweigh the possible risks, pointing out that as many as 45 adults could suffer a clot, but up to 1,400 lives might be saved.
Use of the vaccine was paused after six cases of blood clots were reported in pre-menopausal women.
Since then, CBS News learned of nine more potential cases, all in women. Three have died, while seven remain hospitalized.
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Those 15 cases are out of more than 7 million people who received the Johnson & Johnson vaccine in the United States.
"I think it's important to point out that this is a treatable condition if you recognize it right away," said Dr. Francis Collins, Director of the National Institute of Health.
"It's been good to have this pause to get everybody apprised of that, so that all physicians know this is something to watch out for," Dr. Collins said.
FDA officials say the agency will continue working with the CDC to monitor the vaccine for more cases and to update guidance as more information comes to light.
This decision puts more than 9 million doses of the vaccine back into the pipeline. The Pennsylvania Department of Health has told vaccine administrators to resume using the Johnson & Johnson vaccine immediately.
Health officials say there are four main symptoms of clots that people can be aware of and look out for, including:
- Shortness of breath
- Abdominal pain
- Severe headaches
- Leg pain
These symptoms could be a sign of a more serious problem.
