ATLANTA — The Centers for Disease Control and Prevention and the Food and Drug Administration are recommending a pause in the use of the Johnson and Johnson vaccine out of an abundance of caution after six women — out of 6.8 million doses administered — had cases of a rare and severe type of blood clot.
The announcement came on April 13.
The type of blood clot is called a cerebral venous sinus thrombosis (CVST) and was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination, according to the CDC and FDA.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to further review the cases and assess their potential significance. FDA will review that analysis as it also investigates the cases.
Mandy Cohen, secretary of the North Carolina Department of Health and Human Services, said at a April 13 press conference if someone got the Johnson and Johnson vaccine and is feeling well, they do not need to do anything right now and they should not be concerned.
"What we are talking about today is an incredibly rare event — literally one in a million," Cohen said. "If you are someone who has had Johnson and Johnson in the last three weeks and after day three of your vaccine you develop a severe headache, severe abdominal pain, difficulty breathing and leg pain, then you should be calling your doctor or other health care provider to let them know you are having those symptoms and that you had the Johnson and Johnson vaccine."
The CDC and FDA said the pause is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.
In a joint statement, Principal Deputy Director of the CDC Anne Schuchat and Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said the adverse events appear to be extremely rare.
"COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously," stated the joint statement. "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at vaers.hhs.gov/reportevent.htmlexternal icon."
After the CDC and FDA announcement, the NCDHHS released a statement.
"Our primary concern is the health and safety of all North Carolinians," NCDHHS said in the statement. "Out of an abundance of caution, we are following the recommendations of the FDA and CDC and have paused the administration of the Johnson & Johnson COVID-19 vaccine until we learn more. The safety system in place is working as it should. If you have an appointment for Pfizer or Moderna, please go to your appointment as planned. If you have an appointment for Johnson & Johnson, your appointment will be re-scheduled."
AppHealthcare spokesperson Melissa Bracey said just as the agency normally would, it is encouraging individuals to monitor for any concerning symptoms they may have like shortness of breath, difficulty breathing, abdominal pain or severe headache, to contact their health care provider.
"If someone has received a Johnson & Johnson vaccine and is concerned, they are welcome to reach out to us at (828) 795-1970 or contact their healthcare provider directly," Bracey said.
Appalachian State, which has given out over 3,800 Johnson and Johnson vaccines, is pausing use of the Johnson and Johnson vaccine. App State was originally scheduled to give more Johnson and Johnson vaccines at a community clinic on April 15, but will instead use the Moderna vaccine.
"Our clinic was originally scheduled to administer J&J but we are working with local public health to keep the clinic on schedule," said App State spokesperson Megan Hayes. "We are pleased to assist with North Carolina’s COVID-19 vaccination distribution plan for rural areas by administering COVID-19 vaccines, and continue to remind our students, faculty, staff and community members of the importance of vaccination as a means to returning to more normal operations, and the full return to campus for the fall 2021 semester."
AppHealthCare and Appalachian Regional Healthcare System are both pausing use of the Johnson and Johnson vaccine, as of April 13.
ARHS Senior Vice President Rob Hudspeth said the pause won't effect ARHS that much as the agency has administered more Moderna vaccines. Hudspeth said only three people were scheduled to get a Johnson and Johnson vaccine this week and that they are now being rescheduled to take the Moderna vaccine.
AppHealthCare had not planned to administer the Johnson and Johnson vaccine on April 13.
"However, we will pause administering Johnson and Johnson vaccine while we await additional guidance from CDC and NCDHHS," Bracey said. "We take this very seriously and will be watching carefully for additional guidance as CDC reviews the data."