The Johnson and Johnson Vaccine Pause

During the week of April 12th, The Center for Disease Control and Prevention (CDC) release a recommendation to pause use of the Johnson and Johnson vaccine to investigate a specific adverse event to the vaccine. Later in the month of April, the CDC recommended to resume using the vaccine, effective on April 23rd. 

Why was there a pause in the use of the vaccine?

  • There were 6 reported US cases of a rare adverse event after receiving the vaccine.
  • 6.8 million doses of the vaccine had already been given at this point.
  • The rare adverse event was a serious type of blood clot called cerebral venous sinus thrombosis (CVST) found in combination with low levels of blood platelets (thrombocytopenia).
    • This event is dangerous as the treatment is different than traditional blood clots.
  • All 6 cases occurred among women between the ages of 18 and 48.
    • Symptoms occurred 6 to 13 days after vaccination
What did the CDC and the FDA aim to do?
  • Recommend a pause in the vaccine until the events could be investigated.
  • Schedule a meeting of the Advisory Committee on Immunization Practices (ACIP) that week to review the cases and provide an analysis.
  • Review the analysis as well as investigate the cases. 
What did they conclude after the investigation?
  • The events suggest an increased risk of a rare adverse event, however, nearly all reports have been in adult women younger than 50 years old.
  • The CDC's statement says:
    • "The review of all available data at this time shows that the J&J/Janssen COVID-19 Vaccine's known and potential benefits outweigh its known and potential risks"
  • The CDC and the FDA recommended to resume use of the vaccine, effective on April 23, 2021. 
  • The CDC attached to their statement a suggestion that women younger than 50 years old should be aware of the event and any symptoms they experience after receiving the Johnson & Johnson vaccine.
    • They also suggest talking to your doctor if you have significant concerns for this, and that the other vaccines are also an option. 
So what are the signs and symptoms of this rare event?
  • The following signs and symptoms are on the list that was released by the CDC of what to look for for three weeks after receiving the vaccine:
    • Severe or persistent headaches or blurred vision
    • Shortness of breath
    • Chest pain
    • Leg swelling
    • Persistent abdominal pain
    • Easy bruising or tiny blood spots under the skin beyond the injection site 

As of April 23, 2021, more than 8 million doses of the Johnson and Johnson vaccine had been given in the United States. Of these more than 8 million doses, experts reviewing safety reports have only found 15 women who developed this adverse event, so the event is a rare occurrence.