U.S. to resume J&J COVID-19 vaccinations despite rare clot risk

The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot

Updated - April 24, 2021 06:50 am IST

Published - April 24, 2021 06:49 am IST - Washington

Rochelle Walensky, director of the Centers for Disease Control and Prevention testifies during a U.S. Senate Health, Education, Labor and Pensions Committee hearing to examine the COVID-19 response in Washington. File photo

Rochelle Walensky, director of the Centers for Disease Control and Prevention testifies during a U.S. Senate Health, Education, Labor and Pensions Committee hearing to examine the COVID-19 response in Washington. File photo

U.S. health officials lifted an 11-day pause on COVID-19 vaccinations using Johnson & Johnson's single-dose shot, after scientific advisers decided its benefits outweigh a rare risk of blood clot.

The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot , out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized.

 

But ultimately Friday, the Food and Drug Administration and Centers for Disease Control and Prevention decided that J&J's one-and-done vaccine is critical to fight the pandemic — and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.

“Above all else, health and safety are at the forefront of our decisions,” CDC Director Dr. Rochelle Walensky said in a statement. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses" of the J&J shot and will continue to monitor them.

The US decision — similar to how European regulators are rolling out J&J's shot — comes after CDC advisers earlier Friday voted 10-4 to resume vaccinations but panelists made clear that they must come with warnings about the risk. The group debated but ultimately steered clear of outright age restrictions.

“This is an age group that is most at risk (of the clotting) that is getting vaccine predominately to save other peoples' lives and morbidity, 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 because she felt it did not go far enough in warning women.

The committee members all agreed the J&J vaccine "should be put back into circulation,” panel chairman Dr. Jose Romero, Arkansas' health secretary, said in an interview after the vote. “The difference was how you convey the risk ... It does not absolve us from making sure that people who receive this vaccine, if they are in the risk group, that we inform them of that.” European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J's shot. But how Americans ultimately handle J&J's vaccine will influence other countries that don't have as much access to other vaccination options.

Dr. Paul Stoffels, J&J's chief scientific officer, pledged that the company would work with US and global authorities “to ensure this very rare event can be identified early and treated effectively.” J&J already was working with the FDA on a warning label for the shot.

0 / 0
Sign in to unlock member-only benefits!
  • Access 10 free stories every month
  • Save stories to read later
  • Access to comment on every story
  • Sign-up/manage your newsletter subscriptions with a single click
  • Get notified by email for early access to discounts & offers on our products
Sign in

Comments

Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.