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Coronavirus

US approves restart of Johnson & Johnson COVID vaccinations: Regulators

Published: Updated:

Johnson & Johnson COVID vaccinations can restart, US health regulators said Friday, after the shots’ rollout was paused due to worries over blood clotting.

“We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older,” said a statement from the Centers for Disease Control and Prevention.

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Health authorities in the United States on April 14 proposed a halt on the vaccine following instances of severe blood clots out of millions of Americans who received the vaccine.

The panel 10 to 4 in favor of recommending the lifting of the pause, but the head of the Centers for Disease Control and Prevention (CDC) Rochelle Walensky will make the final decision.

"The Janssen Covid-19 vaccine is recommended for persons 18 years of age and older in the US population under the FDA, emergency use authorization," the experts convened by the CDC said.

According to data presented Friday, of 3.9 million women who got the Johnson & Johnson shot, 15 developed serious blood clots and three died.

The majority of the confirmed cases, 13 of the 15, was less than 50 years old. There were no reported cases among men.
Europe's medicines regulator said Tuesday that blood clots should be listed as a "very rare" side effect of Johnson & Johnson's coronavirus vaccine.

The regulator said its safety committee "concluded that a warning about unusual blood clots with low blood platelets should be added to the product information" for the J&J shot.