US health agencies lift pause on use of Johnson & Johnson Covid-19 vaccine

Health systems and vaccine recipients to be warned of risk of syndrome involving blood clots, say FDA and CDC

Bottles of the single-dose Johnson & Johnson Janssen Covid-19 vaccine. Photograph: Jorge Guerrero/AFP

Bottles of the single-dose Johnson & Johnson Janssen Covid-19 vaccine. Photograph: Jorge Guerrero/AFP


The United States will resume use of Johnson & Johnson's Covid-19 vaccine, top health regulators said on Friday, ending a 10-day pause to investigate the vaccine's link to extremely rare but potentially deadly blood clots.

Scientific advisers decided its benefits outweigh the rare risk of adverse side effects.

The agencies made the decision following a meeting by outside advisers to the CDC that recommended the vaccine pause be ended. The decision followed investigations by the agencies into the risks of the vaccine.The US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) said in a joint statement that health systems and vaccine recipients would be warned of the risk of a potentially fatal syndrome involving severe blood clots and low platelets.

"We are no longer recommending a pause in the use of this vaccine," CDC director Rochelle Walensky told a news briefing, adding that the vaccine could be used starting immediately.

Earlier on Friday, the CDC panel voted 10-4 that the Johnson & Johnson's Covid-19 vaccine is recommended for use in people 18 years of age and older, the parameters of its current FDA authorisation.

"The benefits do clearly outweigh the risk from a population and individual perspective," said Dr. Beth Bell, a member of the advisory panel and a clinical professor at the University of Washington in Seattle.

"The committee's recommendation is an essential step toward continuing urgently needed vaccinations in a safe way for millions of people in the U.S," Johnson & Johnson chief scientific officer Paul Stoffels said in a statement.

The FDA will update the emergency use authorisation for the vaccine to include information about the risk and how to recognise and treat the condition, Johnson & Johnson executives told the panel. - Reuters