PHILADELPHIA (KYW Newsradio) - The FDA and CDC have lifted the pause on Johnson & Johnson's single-dose COVID-19 vaccine.
On Friday, US health officials concluded the benefits of the single-dose shot outweigh a rare risk of blood clots.
“Above all else, health and safety are at the forefront of our decisions,” said CDC Director Dr. Rochelle P. Walensky.
“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. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.”
Earlier in the day, the CDC’s vaccine advisory board recommended the resumption of the Johnson and Johnson vaccine.
However, they did it with a warning that would address the rare blood clots combined with a low platelet count.
Johnson and Johnson Dr. Joanne Waldstreicher said anyone getting the shot would get an explanation of the symptoms.
“It talks about bloodclots involving vessels in the brain," she said. "It talks about how it’s occurred in some people who have received the vaccine.”
CDC officials said there have been three deaths and 15 known cases, all women, among the nearly 8 million people who have received the Johnson and Johnson vaccine.
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Health officials in the meeting say it is still unclear exactly what causes the issue.
While the committee wrestled with the best way to get the blood clot concerns across, many members also discussed the challenge of overcoming vaccine hesitancy.
Dr. Beth Bell, a committee member from the University of Washington, noted the system worked as it was supposed to, triggering a pause when a rare event raised red flags.
“It’s a paradox that by recognizing and detecting and acting on a very rare risk, which should in fact inspire vaccine confidence, perhaps it has the opposite effect," Bell admitted.
Pfizer and Moderna are a different kind of vaccine and have not had any similar issue.
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