The CDC and the FDA Lift the Restriction on the Johnson & Johnson Vaccine

A photo of the Johnson & Johnson vaccine from Maj. Michael O’Hagan of the U.S. Air National Guard.

The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration lifted their moratorium on the usage of the Johnson & Johnson vaccine on April 23. 

The announcement comes a week after the vaccine was initially pulled from distribution centers across the United States due to a heightened risk of blood clots in women under the age of 50. After receiving the vaccine, six women developed blood clots, and one died. At the time of the initial restriction, the Johnson & Johnson vaccine had been administered to nearly 8 million individuals.

Due to the possible negative side effects of the vaccine, the Advisory Committee on Immunization Practices (ACIP) and the CDC met to discuss the efficacy of the vaccine; however, in a decision that was not unanimous, the committee ultimately recommended the distribution of the vaccine to people 18 and older, and they recommended the addition of a warning label about the risks associated with the Johnson & Johnson vaccine. 

Janet Woodcock, the current administrator of the Food and Drug Administration, lauded her support for the Johnson & Johnson vaccine, saying that regulators had “full confidence that this vaccine’s known and potential benefits outweigh its known and potential risks.” 

Rochelle Walensky of the CDC said, “This vaccine was shown to be safe and effective for the vast majority of people.” 

Similarly, European regulators from the European Medicines Agency resumed the distribution of the Johnson & Johnson vaccine on April 20, citing that there are “very rare side effects of the vaccine.” 

The readoption of the Johnson & Johnson vaccine represents a pivotal point in the fight against COVID-19. Given the shot’s convenience—one dose as opposed to two—it has the potential to be distributed quickly and at a lower cost than the alternatives. 

The chief scientific officer at Johnson & Johnson, Paul Stoffels, claimed that Johnson & Johnson “will collaborate with health authorities around the world to educate health care professionals and the public to ensure this very rare [blood clotting] event can be identified early and treated effectively.”