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US health regulators lift pause on J&J vaccine

April 23, 2021

The director of the FDA has said use of the Johnson & Johnson vaccine can resume immediately, as the "benefits outweigh the risks." The vaccine's rollout had been paused after 15 recipients developed rare blood clots.

Johnson & Johnson COVID vaccine
The J&J vaccine had been linked to rare cases of blood clotting.Image: Dado Ruvic/REUTERS

US health officials on Friday lifted an 11-day pause on using the Johnson & Johnson coronavirus vaccine, following the recommendation by a panel of experts from the Centers for Disease Control and Prevention (CDC).

"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 Janet Woodcock, head of Food and Drug Administration (FDA) in a joint statement with the CDC.

"We are no longer recommending a pause in the use of this vaccine," CDC Director Rochelle Walensky told a news conference, adding that resumption of the J&J rollout would begin immediately.

Walensky said "exceptionally rare" blood clots were identified, adding that regulators will continue to monitor the vaccine's use.

US health authorities halted the use of the J&J shot on April 14 after officials uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot. Some 8 million people have so far been given the one-dose J&J vaccine.

What are the possible risks?

All the instances of blood clotting after receiving the J&J vaccine occurred in women, most of whom were under the age of 50. Three subsequently died, and seven remain hospitalized.

CDC advisers said while J&J's vaccine is important for fighting the pandemic, it's also important that younger women are made aware of the risks in clear, understandable terms.

The panel of experts voted 10-4 in favor of lifting the 11-day pause, while adding warnings that women and health workers would see in leaflets at vaccination centers.

The panel had debated the use of outright age restrictions before electing not to implement such advice.

It would appear younger people are more vulnerable and one member of the panel believed the advice does not go far enough.

"This is an age group that is most at risk (of the clotting) that is getting the vaccine predominately to save other peoples' lives, not their own. And I think we have a responsibility to be certain that they know this," said Dr. Sarah Long of Drexel University College of Medicine, who voted against the proposal.

J&J has agreed with the FDA to work on a warning label for the vaccine. 

jsi/wmr (AP, Reuters, dpa, AFP)