CDC and FDA Recommend Resumed Use of J&J COVID-19 Vaccine

By: Courtney Caprara

Early this evening, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended lifting the pause on the use of the Johnson & Johnson/Janssen (J&J) COVID-19 vaccine, saying the benefits outweigh the risks.

Dr. Graham Snyder

The organizations examined 15 cases of a rare, but serious, blood-clotting complication that occurred in women ages 18 to 59, with symptoms beginning six to 15 days after vaccination. After a thorough safety review, regulators believe the United States should resume use of the vaccine.

“This vaccine remains safe and effective, and the surveillance system in place to understand and identify rare side effects of the vaccine is working well,” said Dr. Graham Snyder, UPMC’s medical director of infection prevention and hospital epidemiology. “Fifteen incidents out of millions of doses administered means this complication is a very rare event.”

Additional public health guidance on resuming the use of the single-dose J&J vaccine is expected next week, and the CDC and FDA will continue monitoring for adverse events nationwide. UPMC will review this information to determine how it will reintroduce the vaccine across the communities it serves.

Dr. Lee Harrison

Dr. Lee Harrison, professor of medicine and epidemiology at the University of Pittsburgh, urged those who are concerned about the potential side effects of the J&J vaccine to consult with their health care providers about obtaining one of the two other vaccines currently available in the U.S.

“We are still in the midst of a pandemic, and the risks of COVID-19 remain high while the risks associated with vaccination are low,” said Harrison. “This third vaccine is a key tool for protecting our communities from COVID-19, and I urge everyone who has not received a vaccine already to get one.”

Providers, patients and their loved ones should report any suspected adverse events following COVID-19 vaccination through VAERS, the federal vaccine monitoring system.

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