• By Deb Balzer

FDA limits use of J&J COVID-19 vaccine

May 6, 2022
2 vials of the Johnson and Johnson COVID-19 vaccine

The Food and Drug Administration (FDA) has limited use of the Johnson & Johnson (J&J) COVID-19 vaccine for adults due to risks associated with blood clots.

"The FDA's decision to limit the use of the Johnson & Johnson vaccine for SARS-CoV2 (the virus that causes COVID-19) was due to an FDA analysis that indicated an elevated but low risk for blood clots in some patients who received the vaccine," says Dr. Andrew Badley, an infectious diseases specialist at Mayo Clinic. "According to the FDA, 15 cases have been reported out of about 8 million doses of vaccine given, which means that the risk of this complication is very low."

The J&J COVID-19 vaccine was authorized for emergency use on Feb. 27, 2021, and administered in a single dose. It's a viral vector vaccine, unlike the Moderna and Pfizer COVID-19 vaccines, which are messenger RNA vaccines.

For those who have concerns about possible health risks, Dr. Badley says it depends on what vaccines you have already received and when.

"If you received a Johnson & Johnson vaccine recently, then if you experience any unusual symptoms, such as shortness of breath, slurring speech, etc., you should seek a medical evaluation," says Dr. Badley. "If you received a Johnson & Johnson vaccine more than two weeks ago and are due for a booster vaccination, you should proceed to get a booster with a different vaccine."

Vaccination against COVID-19 infection remains an important tool against severe illness and death. Mayo Clinic has been performing, and continues to perform, research on the safety and efficacy of COVID-19 vaccines.

Patients can get vaccinated at any Mayo Clinic location. More than 577 million doses of COVID-19 vaccines have been administered, according to the Centers for Disease Control and Prevention.