Johnson & Johnson/Janssen Vaccine Recall

Sara Harley

May 19, 2021

On April 13, 2021, Federal officials recommended a pause in the use of the Johnson & Johnson/Janssen (“J and J”) COVID-19 vaccine due to serious concerns about side effects. Between six and thirteen days after receiving the shot, six women between the ages of 18 and 48 reported severe blood clots, and one had died. The rare blood clot type is called “cerebral venous sinus thrombosis,” or CVST, and prevents blood from draining from the brain. According to the FDA and CDC, the women also experienced “low levels of blood platelets or thrombocytopenia.” 

The J and J vaccine received Emergency Use Authorization by the Federal Food and Drug Administration (FDA) in February, 2021. In clinical trials, it was  around 77% effective in protecting fully-vaccinated individuals from a severe case of SARS-COVID-19 (according to the CDC, an individual is “fully-vaccinated” two weeks after receiving their shot or shots). Like the two other Emergency Use-authorized COVID-19 vaccine options, Moderna and Pfizer, side effects from the J and J vaccine are exceedingly common after vaccination. Individuals, particularly between the ages of 18 to 59, may experience fevers, nausea, headaches, and/or various other flu-like symptoms. 

When the J and J vaccine pause became public, over six million Americans had already received the shot. Consequently, around one in one million vaccine recipients have developed CVST. On April 18, 2021, Dr. Anthony Fauci, chief medical advisor to President Biden and director of the National Institute of Allergy and Infectious Diseases, stated, “my estimate is that we will continue to use [the J and J vaccine] in some form. I doubt very seriously if they just cancel it. I don’t think that’s going to happen. I do think that there will likely be some sort of warning or restriction or risk assessment.” Other international government publications have already reported reviewing complications with the vaccine and resumed administering it to patients. 

As Dr. Fauci predicted, as of late April, states have begun to again distribute the J and J vaccine, as the rare blood clots were not widespread enough to halt its administration. The FDA and CDC reported, “ [we] have confidence that this vaccine is safe and effective in preventing COVID-19. The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.” There will now be a warning regarding CVST given to J and J vaccine recipients.

The CDC cautions women between ages 18 and 50 to think carefully before receiving this vaccine. Those who have received the J and J shot and who are experiencing any symptoms, including migraines, leg pain, shortness of breath, or abdominal pain, should contact a doctor or emergency services immediately.