ATLANTA — Following a safety review, the Centers for Disease Control and Prevention and the Food and Drug Administration announced April 23 the pause related to the use of the Johnson and Johnson COVID-19 vaccine be lifted and use of the vaccine should resume.
The CDC and FDA recommended use of the Johnson and Johnson vaccine be paused following six cases of a rare and severe type of blood clot in individuals following administration of the Johnson and Johnson COVID-19 Vaccine.
“Above all else, health and safety are at the forefront of our decisions,” stated CDC Director Rochelle Walensky. “Our vaccine safety systems are working. 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.”
During the pause, the CDC stated that 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 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 health care providers administering vaccines at www.fda.gov/media/146304/download, and the fact sheet for recipients and caregivers at
- www.fda.gov/media/146305/download, 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.
The CDC also confirmed that nine additional cases of TTS were reported for 15 total out of nearly seven million doses administered.
All of these cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptom onset between six and 15 days after vaccination.
AppHealthCare Health Director Jennifer Greene said the agency understands that people are cautious of the Johnson and Johnson vaccine due to the recent pause.
“We want to provide reassurance that this vaccine is safe and effective and blood clots are extremely rare,” Greene said. “It is always important to bring your questions about any health treatment to your trusted health care provider who can discuss the risks and benefits with you. We want people to make informed decisions about their health, and we remain confident vaccines will be the way we can get back to our normal lives.”
Melissa Bracey, spokesperson for AppHealthCare, said the pause was out of an abundance of caution and shows the vaccine safety system is working.
If people have questions, Greene said AppHealthCare is available to help answer them and also encourages people out to reach out to their health care provider.
“A CDC expert panel reviewed all the data during the pause to better understand the degree of risk associated with the Johnson and Johnson vaccine and reported blood clots,” Bracey said. “The CDC and FDA determined the level of risk for blood clots with the J&J vaccine is very low, and they have confidence that this vaccine is safe and effective in preventing COVID-19.”
App State spokesperson Megan Hayes said the university will use the Moderna vaccine at its April 29 COVID-19 vaccine clinic. Before the pause, the university had used Johnson and Johnson vaccines for its clinics.
According to the North Carolina Department of Health and Human Services, there are approximately 132,000 doses of the Johnson and Johnson vaccine available in North Carolina.