The US Food and Drug Administration (FDA) has withdrawn the emergency authorization for Johnson & Johnson’s Covid-19 vaccine, following a request from Janssen, Johnson and Johnson’s pharmaceutical arm and the vaccine’s manufacturer. This decision came after the vaccine’s availability was restricted in 2022 due to its potential to cause thrombosis with thrombocytopenia syndrome (TTS), a dangerous condition involving blood clotting and low platelet counts. Janssen did not modify the vaccine’s strain composition to combat emerging variants, leading to its eventual withdrawal from the U.S. market in May 2023.
Janssen’s CFO Joseph Wolk anticipates no future sales of their vaccine, which uses an adenovirus base instead of the messenger RNA mechanism employed by Pfizer and Moderna. As of May 10, 19 million doses of the Johnson & Johnson vaccine were administered in the United States, while an additional 12 million doses were distributed but remained unused.
The U.S. government had initially agreed to purchase 100 million doses of the Johnson & Johnson vaccine for over $1 billion in 2020. However, production delays and the risk of TTS resulted in fewer doses being delivered.
The Moderna, Pfizer, and Novavax vaccines remain available in the U.S. under emergency authorization, as per the Public Readiness and Emergency Preparedness Act. This legislation, updated by Health and Human Services Secretary Xavier Becerra on May 11, extends liability protections to manufacturers, distributors, and administrators of emergency-authorized vaccines.
