/FDA authorizes COVID booster shot for immunocompromised ahead of CDC meeting – WPVI-TV

FDA authorizes COVID booster shot for immunocompromised ahead of CDC meeting – WPVI-TV


WASHINGTON — U.S. regulators have okayed an extra dose of COVID-19 vaccine for transplant recipients and others with weakened immune systems as the delta variant continues to surge.

In the decision, announced late Thursday night, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine.

It comes as the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals.

The announcement by the FDA applies to millions of Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders.

Several other countries, including France and Israel, have similar recommendations.

It’s harder for vaccines to rev up an immune system suppressed by certain medications or diseases, so those patients don’t always get the same protection as otherwise healthy people – and small studies suggest for at least some, an extra dose may be the solution.

“This action is about ensuring our most vulnerable … are better protected against COVID-19,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said ahead of the FDA’s announcement.

Importantly, the decision only applies to this high-risk group, about 3% of U.S. adults. It’s not an opening for booster doses for the general population.

Instead, health authorities consider the extra dose part of the initial COVID-19 vaccine prescription for the immune-compromised. For example, France since April has encouraged that such patients get a third dose four weeks after their regular second shot.

Separately, U.S. health officials are continuing to closely monitor if and when average people’s immunity wanes enough to require boosters for everyone – but for now, the vaccines continue to offer robust protection for the general population.

Copyright © 2021 by The Associated Press. All Rights Reserved.

Original Source