The Food and Drug Administration (FDA) has revoked the authorization of Johnson & Johnson’s Covid vaccine following concerns over rare blood clots, which lead to a significant decline in demand.
J&J’s parent company, Janssen, had anticipated this action and requested that the FDA withdraw authorization for the vaccine after discovering that the last batch of doses, approximately 12.5 million, had expired.
To date, nearly 231 million Americans have received either one dose of the J&J vaccine or two doses of the mRNA vaccines from Pfizer or Moderna. Vaccine fatigue has set in across the country, with many Americans frustrated by the realization that vaccination does not guarantee immunity.
Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, stated, “Because FDA understands that Janssen Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19 Vaccine, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.”
Compared to the other vaccines approved for use in the U.S., J&J’s vaccine has been administered to a smaller percentage of the population. Over 367 million Americans have received the Pfizer vaccine, while more than 232 million have received a dose of Moderna’s vaccine. J&J’s shots have accounted for only slightly over 19 million of the total doses administered in the US since early 2021.
Since its introduction in February 2021, Johnson & Johnson’s vaccine has been marked by controversy. By that time, over 2.1 million mRNA shots from Pfizer and Moderna had already been administered, establishing them as the preferred options. Shortly after receiving emergency use authorization from the FDA, J&J’s vaccine faced scrutiny due to a small but increasing number of severe blood clotting disorders known as thrombosis with thrombocytopenia syndrome (TTS) in individuals who received the vaccine.
TTS is characterized by the formation of blood clots along with significantly low platelet counts, impairing the body’s ability to prevent bleeding from wounds. Symptoms typically manifest between four and 42 days after vaccination.