Johnson & Johnson COVID-19 Vaccine Pause: What You Need to Know

Out of the highest degree of caution, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended a pause in the use of the Johnson & Johnson (J&J) COVID-19 vaccine. What does the pause mean and what does it tell us about the vaccine monitoring system? Let’s review the facts:


Fast Facts:


  • Of the nearly 7 million people who have received the J&J vaccine in the U.S., 6 women between the ages of 18 and 48 experienced a very rare type of blood clot called cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia).

  • These women experienced symptoms between 6 and 13 days following immunization with the J&J vaccine.

  • One woman has died and one woman is in critical condition. 

  • The FDA, CDC, and CDC's independent expert committee (Advisory Committee on Immunization Practices) are all reviewing these cases and determining next steps.

  • There are no concerns about blood clots for people who received the Pfizer or Moderna COVID-19 vaccines.

Q&A:

Are CVST blood clots associated with the J&J vaccine common?

No. Less than 1 in 1,000,000 people have experienced CVST in combination with low after administration of the J&J vaccine.

Is the J&J vaccine more dangerous than COVID-19 infection?

No. Blood clots associated with COVID-19 infection are much higher than those associated with the J&J vaccine.  In 1,000,000 COVID-19 cases, 165,000 cases of blood clots have been documented (representing 16.5% of infections, compared to 0.00000015% of J&J vaccines).  Blood clots are serious health concerns, but it’s important to keep the cases associated with the J&J vaccine in perspective as compared to the harms of COVID-19 infection.

I already received the J&J COVID-19 vaccine. What now?

If you did get the J&J vaccine, your risk of developing a blood clot is extremely low, regardless of how long ago you received it. However, if you got the J&J vaccine within the last three weeks, take caution and monitor the symptoms of a possible blood clot:

  • Severe headache

  • Blurred vision

  • Fainting

  • Seizures

  • Pain in your abdomen (chest or stomach)

  • Leg pain or swelling

  • Shortness of breath


Has anyone who received Pfizer or Moderna COVID-19 vaccines had problems with blood clots?

No. As of April 16, 2021, no cases of this blood clot have been reported among the more than 180 million people who received the Pfizer or Moderna vaccines.

If the risk of blood clots is so small, why the pause in distributing the J&J vaccine?

Because of thorough vaccine monitoring, a rare and serious adverse event occurring in less than one in 1,000,000 people was identified. Immediate steps were taken to review cases and halt recommendation of the J&J vaccine until more information is known. The pause allows scientists and doctors to determine if the clots are caused by the vaccine and/or if the vaccine should not be administered to certain groups (e.g. women of a particular age with low blood platelets).  Concerns about CVST are only associated with J&J COVID-19 vaccines, not the Pfizer or Moderna vaccines, which are both monitored just as closely. The pause shows us that vaccine surveillance and monitoring continues to function just as it should.  


Sources:


https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html?fbclid=IwAR24_6l0G2rr5rG5BfroGAfG-RYFchH8BhkSgjYo1o90bl6-YweVSotn5Xw

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html



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Update: Johnson & Johnson COVID-19 Vaccine Resumes

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The Johnson & Johnson COVID-19 Vaccine: A Closer Look