The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration on Friday lifted their recommended pause on the use of Johnson & Johnson’s COVID-19 vaccine.
Following a thorough safety review, the agencies said use of the vaccine should resume because the benefits outweigh its known and potential risks.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine.
According to the FDA, medical and scientific teams at FDA & CDC examined available data during the pause in usage.
“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,” acting FDA Commissioner Janet Woodcock said in a statement. “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.”
According to a joint release issued Friday, the two agencies have determined the following:
- Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
- The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
- The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
- At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
- Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
“Our vaccine safety systems are working,” CDC Director Dr. Rochelle P. Walensky said in a statement. “We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death.”
The FDA and Johnson & Johnson are updating the label for the vaccine to include a warning about the risk of a blood clotting syndrome. The fact sheets accompanying the vaccine are also being updated electronically, as noted in a statement from Johnson & Johnson.
