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J&J pause in US shows how seriously FDA and CDC are taking vaccine safety, says doctor


FILE — In this March 31, 2021 file photo, a nurse fills a syringe with a dose of the Johnson & Johnson's one-dose COVID-19 vaccine at the Vaxmobile, at the Uniondale Hempstead Senior Center, in Uniondale, N.Y. The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots. In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts. (AP Photo/Mary Altaffer, File)
FILE — In this March 31, 2021 file photo, a nurse fills a syringe with a dose of the Johnson & Johnson's one-dose COVID-19 vaccine at the Vaxmobile, at the Uniondale Hempstead Senior Center, in Uniondale, N.Y. The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots. In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said it was investigating clots in six women in the days after vaccination, in combination with reduced platelet counts. (AP Photo/Mary Altaffer, File)
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WASHINGTON (SBG) - The U.S. Food and Drug Administration and Centers for Disease Control and Prevention have recommended that the United States pause use of Johnson & Johnson’s COVID-19 vaccine over six reported cases of a rare and severe type of blood clot.

“I want to emphasize how rare this adverse event is. So the pause is actually coming after six reported cases out of 6.8 million vaccinations,” said Dr. Tara Kirk Sell to The National Desk’s Jan Jeffcoat. “I think it really shows how seriously CDC and FDA take vaccine safety signals.”

Dr. Sell says we’ll learn more about the six cases of blood clots as they are further reviewed.

“I do think at the end of the day the risk-benefit balance will still come out in favor of getting the vaccine,” said Dr. Sell.

The AstraZeneca vaccine, which has not been approved for use in the U.S., has been suspended in a number of European countries, also due to a potential for blood clots.

“This is a different type of blood clot I do think that the treatment of this is slightly different from the normal treatment for blood clots,” said Dr. Sell. “If someone has received the Johnson & Johnson vaccine and develops a severe headache or abdominal pain or leg pain or shortness of breath within three weeks after the vaccination they should contact their doctor.”

All six cases occurred among women aged 18 to 48, but Dr. Sell says more information is still needed.

“We're going to have to look into it and see if it's happening in other groups and the women are just reporting it more, or if it's just something to do with younger women,” said Dr. Sell.

The other two approved vaccines in the U.S., Pfizer and Moderna, have not had any reports of blood clots, according to Dr. Sell.

“I don't think that right now we're seeing any long-term signals about these vaccines. We have over 100 million people vaccinated so far, very few safety signals,” said Dr. Sell. “I’m pretty happy with the vaccine, it’s very effective.”

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