Johnson & Johnson Vaccine Administration Paused

April 13, 2021

Dear Yale community,

We are writing to provide you with information about today’s joint statement by the Centers for Disease Control and Federal Drug Administration, which called for a pause in administration of Janssen (Johnson & Johnson or J&J) COVID-19 vaccine. The CDC and FDA took this action out of an abundance of caution because of the possible association of J&J vaccination with a rare blood clotting disorder.

More specifically, the CDC and FDA cited six cases of central nervous system blood clots associated with a low platelet count that have been reported in women between the ages of 18 and 48 who had received the J&J vaccine. These patients were diagnosed between 6 and 13 days after vaccination. To date, 6.8 million doses of the J&J vaccine have been administered in the US, so the frequency of this clotting disorder has been less than one case per million individuals vaccinated. No such cases have been reported in Connecticut.

The CDC and FDA are investigating these cases to determine whether there is a significant relationship between vaccination and the occurrence of this rare condition and whether vaccination with the J&J vaccine may resume. We will monitor for updates and keep you apprised. In the meantime, the key takeaway points are:

  1. All upcoming J&J vaccinations have been paused. If you are currently scheduled to receive a J&J vaccine, we encourage you to check with your vaccination site to see if it is possible for the site to provide you with either the Moderna or Pfizer vaccine. Alternatively, you may choose to look for an appointment at another site. Do not hesitate to call the Campus COVID Resource Line (203-432-6604) or the state’s Vaccine Appointment Assist Line (877-918-2224).
  2. If you’ve already received the J&J vaccine:
    1. Within the past three weeks, contact your health care provider or seek emergency medical assistance if you develop any of the following symptoms starting a week after vaccination:
      1. Severe headache
      2. Confusion, dizziness, trouble speaking or difficulty understanding speech, numbness or weakness in the face/arm/leg, trouble seeing, trouble walking, loss of balance or coordination
      3. Shortness of breath
      4. Abdominal pain
      5. Leg swelling

      Be sure to mention that you received the J&J vaccine.

    2. Four or more weeks out from receiving a J&J vaccination, you can be reassured getting this clotting condition is exceedingly unlikely.
    3. It is important to note that the symptoms of central venous sinus thrombosis (CVST) in the cases that have thus far been reported did not occur immediately after vaccination, and therefore should not be confused with the mild flu-like symptoms that commonly occur in the first day or two after vaccination. 
  3. This pause in the J&J vaccine rollout is evidence that our national safety monitoring program for vaccines is working as it should. Even extremely rare conditions warrant further investigation to ensure patient safety. 
  4. Vaccination, along with social distancing and frequent testing, remains key to overcoming this pandemic. The mRNA vaccines from Pfizer and Moderna have not been linked to clotting disorders, and you should not hesitate to get your scheduled vaccination with either of these products as more information is gathered regarding the J&J vaccine. 

If you have any questions or concerns, please get in touch with your primary care provider. Other resources include:

Thank you for your ongoing commitment to the safety of our community.

Kind regards,
Dr. Paul Genecin
CEO, Yale Health

Dr. Christine Chen
Chief, Student Health