CDC, FDA Say Johnson & Johnson Vaccine Safe to Use Despite Recent Blood Clots

The Johnson & Johnson single-dose COVID-19 vaccine that was paused last week by the federal government has been given the green light again, despite 15 blood clots and one death that caused the pause in the first place.

The Centers for Disease Control (CDC) and the U.S. Food and Drug Administration (FDA) approved the drug's reentry into the vaccine market for emergency use authorization (EUA).

"Following a thorough safety review, including two meetings of the CDC's Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume," the FDA stated in a release Friday evening.

Johnson & Johnson COVID-19 Vaccine
Brian Taylor, 59, of Point Pleasant, West Virginia receives the Covid-19 Johnson & Johnson Janssen vaccine as part of a collaborative effort from the West Virginia National Guard on March 26, 2021 on the grounds of the Toyota plant in Buffalo, West Virginia. Photo by Stephen Zenner/Getty Images

The pause was implemented after reports of six rare cases of a rare, and severe, type of blood clot in individuals following administration of the Johnson & Johnson Janssen COVID-19 Vaccine.

"During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts," the FDA stated.

The CDC and FDA both determined the following:

  • Use of the Janssen COVID-19 vaccine should be resumed in the United States.
  • The FDA and CDC deem this vaccine is safe and effective in preventing COVID-19
  • The FDA determined that available data show the vaccine's known and potential benefits outweigh its known and potential risks for those 18 and older
  • For now, data suggests that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing their investigations
  • Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheets for healthcare providers, recipients and caregivers

"Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases," said Janet Woodcock, M.D., Acting FDA Commissioner. "We've lifted the pause based on the FDA and CDC's review of all available data and in consultation with medical experts and based on recommendations from the CDC's Advisory Committee on Immunization Practices.

"We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider."