COVID-19 update: Johnson & Johnson Vaccine Paused

The FDA and CDC have recommended a pause on administration of the Johnson & Johnson (Janssen) COVID-19 vaccine.

We want to take a moment to address the announcement that on Tuesday, April 13, the FDA and CDC recommended a pause on administration of the Johnson & Johnson (Janssen) COVID-19 vaccine.

First and foremost, safety is at the core of this pause. It has been done out of an abundance of caution.

As you may know from media reports, this pause is to allow the FDA and CDC to further review six cases of blood clots (thrombosis) and low platelets (thrombocytopenia) in women ages 18-48 that occurred approximately 1-2 weeks after vaccination. About 6.8 million doses of the J&J vaccine have been administered in the United States, so these have been extremely rare events and may or may not be related to the vaccine.

How this affects you

If you had the J&J vaccine more than three weeks ago, you are not at risk for this rare complication as a result of your vaccination.

If you had the J&J vaccine in the last three weeks, you may experience common side effects including mild headache, fever, chills and arm pain. These commonly occur in the first 1-2 days after vaccination and usually resolve within one day. These are not symptoms of this rare event.

If you had the J&J vaccine in the last three weeks and experience any of the following symptoms, you should seek medical care right away. The few reported cases occurred more than three days after vaccination.

• Severe headache
• Severe abdominal pain
• Unexplained bruising
• Shortness of breath

Please note that St. Mary's has not administered any doses of the J&J vaccine. If you received your vaccine through St. Mary's, you received either the Pfizer (BioNtech) vaccine or Moderna vaccine. Neither of these vaccines is involved in this pause.

If you have a vaccination appointment with St. Mary's, please keep your appointment as scheduled. We are not administering the J&J vaccine and will go forward with your Moderna vaccination as planned.

If you have a vaccination appointment scheduled with another provider, be on the lookout for messages confirming, postponing or canceling your appointment.

What else do I need to know?

1. This pause is an example of the Vaccine Adverse Events Reporting System (VAERS) working as intended. Reporting of these rare events allowed for escalation to a further review to determine if additional guidelines are needed around who should receive the J&J vaccine, or if it should be studied further.
2. VAERS is a safety net that serves as a "national early warning system to detect possible safety problems in U.S. licensed vaccines."
3. CDC Advisory Committee on Immunization Practices (ACIP) will meet and review all of the safety information on Wednesday, April 14.
4. We feel confident in the safety of the Pfizer and Moderna vaccines, with over 180 million doses administered in the U.S. alone. They are a different type of vaccine from the J&J vaccine.
5. Vaccination is the world's best hope for ending the pandemic. If you have not received a COVID-19 shot, we urge you to get vaccinated.
6. To request a vaccine appointment at St. Mary's, please complete our vaccine registration form.
7. Because of high levels of community exposure and transmission, variants continue to spread that threaten to prolong the pandemic.
8. It is vital that we all continue to wear masks, maintain social distance, and avoid large gatherings until the CDC advises that community transmission is low enough to relax these precautions.
9. People who are fully vaccinated (2 weeks since their J&J vaccine or their second dose of the Pfizer or Moderna vaccine) can follow CDC guidance for relaxing precautions in certain circumstances.