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Q & A: Why Has The Johnson & Johnson Vaccine Been Paused?

Associated Press file photo
Use of the Johnson & Johnson coronavirus vaccine has been paused.

The Mayo Clinic has put together a Q&A about the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) joint recommendation to pause distribution of the Johnson & Johnson vaccine after reported cases of rare blood clotting events in recipients.

Why is the FDA and CDC recommending a pause on distributing the Johnson & Johnson vaccine?

Out of an abundance of caution, the FDA and CDC recommends a pause on the Johnson & Johnson vaccine based on six rare blood clotting events in recipients. While a review is underway to address next steps, the FDA and CDC are asking health care providers to watch for, evaluate and report cases.

How long will this pause last?

The Advisory Committee on Immunization Practices (ACIP) is meeting Wednesday, April 14, to evaluate and review the data from the rare adverse event cases reported so far. ACIP is an independent immunization advisory group for the federal government agencies. Based on that evaluation and recommendation the FDA and CDC may communicate their findings and next steps regarding this pause. Mayo Clinic is committed to patient safety and will take the time required to understand more about the evolving situation.

What should patients who have received Johnson & Johnson do at this time?

This rare blood clotting reaction has occurred in 6 people out of nearly 7 million people who have received the Johnson & Johnson vaccine. The six cases involved women between ages 18 and 48 and occurred 6 to 13 days after vaccination.

If you have received the Johnson & Johnson COVID-19 vaccine in the last three weeks and are experiencing unexplained new severe symptoms after 72 hours and up to three weeks after vaccination, such as new severe headaches, leg pain, abdominal pain or shortness of breath, you should seek emergency care.

Does this affect the Pfizer and Moderna vaccines?

Evidence of these blood clots have not been reported in either the Pfizer or Moderna vaccines.