APRIL 23, 2021, UPDATE: Following a thorough safety review, the CDC and FDA lifted a temporary pause on the Johnson & Johnson COVID-19 vaccine’s use on April 23. The Johnson & Johnson vaccine is not being offered at any of OHSU’s currently scheduled public vaccination events; information on which vaccines OHSU will offer in the near future is available on the OHSU COVID-19 Vaccines website. OHSU will await further guidance from the Oregon Health Authority before determining its next steps regarding this vaccine. More information on the new federal recommendation is available in a CDC news release.
Following federal and state recommendations on April 13, OHSU paused its use of the Johnson & Johnson (also known as Janssen) COVID-19 vaccine while the CDC reviews the vaccine’s safety data out of an abundance of caution.
This pause follows reports that six of the approximately 6.8 million Americans who have received the Johnson & Johnson vaccine to date experienced a rare blood-clotting disorder after receiving the vaccine. The CDC’s Advisory Committee on Immunization Practices is meeting to discuss the vaccine on April 14.
Per the U.S. Centers for Disease Control and Prevent and Food and Drug Administration, the six individuals who have experienced this condition were women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Symptoms to watch for are a severe headache or backache, new neurologic symptoms, severe abdominal pain, leg pain, shortness of breath, and new or easy bruising. COVID-19 and blood-clotting disorders from COVID-19 are much more common than this extremely rare blood-clotting condition.
To our knowledge, none of the approximately 4,000 people who have received the Johnson & Johnson vaccine from OHSU’s public vaccination efforts have experienced blood clotting issues. In addition, no blood clotting issues were experienced by the 16 Oregonians who enrolled in the Johnson & Johnson vaccine trial through OHSU.
OHSU is in the process of adjusting its vaccination plans in light of this pause. We had planned to administer about 500 Johnson & Johnson vaccines this weekend at invite-only community events, but will now offer other FDA-approved vaccines at those events instead. OHSU will maintain its existing vaccination commitments during this pause. We will await further guidance from federal and state officials before determining our next steps regarding the Johnson & Johnson vaccine.
Anyone who receives a COVID-19 vaccine from OHSU and experiences any health issues afterward is encouraged to contact their healthcare provider.
OHSU will also continue to monitor and follow up with its participants in the Johnson & Johnson vaccine trial throughout the trial’s two-year duration. If someone experiences any health issues while participating in a clinical trial with OHSU, we provide state-of-the-art care and thoroughly investigate whether the health issue is related to the trial.
As with any new vaccine, it’s appropriate to ensure all COVID-19 vaccines receive a high level of regulatory scrutiny and oversight to ensure they are safe and effective, including undergoing review and approval by the CDC, FDA and independent review committees such as the Western States Scientific Safety Review Workgroup. The fact that six cases have triggered a federal safety review indicates the vaccination regulatory system is working well and will continue to ensure the safety and health of all Americans who receive COVID-19 vaccinations.
OHSU encourages all Oregonians to get a COVID-19 vaccination as soon as they are able, as widespread vaccination will be key in stopping the pandemic from causing further devastation in our community.