April 23, 2021, Johnson & Johnson COVID-19 Vaccine Updates, FDA and CDC Announcement: Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.
Read more from CDC on this matter here: CDC News Release
Read more about the three COVID-19 vaccines authorized for use in the U.S. here: Authorized COVID-19 Vaccines
On April 13, 2021, the Centers for Disease Control and Prevention and the United States Food & Drug Administration recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine out of an abundance of caution after six people in the U.S. developed a rare blood-clotting disorder (of nearly 7 million doses administered). During this pause, the CDC is convening a meeting of the Advisory Committee on Immunization Practices to evaluate these cases, and the FDA will review this analysis.
In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). These cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the vaccination.
While blood clotting events in connection with the Johnson & Johnson vaccine appear to be extremely rare, people who receive the vaccine should discuss any concerns they have with their healthcare provider. If they develop new, severe, and constant headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination, they should contact their health care provider right away, or go to the nearest hospital or emergency room.
The Medical & Scientific Advisory Board of the National Blood Clot Alliance stresses the importance of vaccination among members of the clotting and clotting disorders community. The reported combination of the vaccine and blood clots incidents seen are exceedingly rare, and the benefits of the COVID-19 vaccine far outweigh the risk of blood clotting. Having a prior blood clot is not a known risk factor for developing this rare post-COVID-19 vaccine clotting problem. Notably, this complication has not been observed with the other two vaccines for COVID-19 that have received emergency use authorization in the US (Pfizer and Moderna). People should speak with their healthcare providers about any questions they have.
More Information and Updates:
April 13, 2021, Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
Read more about COVID-19 and blood clotting, and vaccines for COVID-19, here.
