The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern.
On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the U.S., six recipients experienced cases of a rare and severe type of blood clot. Of those blood clot cases, one death was recorded.
Following a safety review that included two meetings of the CDC’s Advisory Committee on Immunization Practices, the pause was lifted on Friday, April 23, according to a news release Medical and scientific teams at the FDA and CDC examined available data to evaluate the risk of the form of blood clot known as cerebral venous sinus thrombosis (CVST) that was seen in combination with low levels of blood platelets (thrombocytopenia).
The two agencies concluded that the use of the vaccine could resume, as they are confident that it is safe and effective in its main job of preventing COVID-19. Simultaneously, the data shows that the known and potential benefits of the vaccine outweigh the known and potential risks. Available data suggest that the chance of the blood clots occurring is very low, but the agencies will continue investigating the risk.
“This pause was an example of our extensive safety monitoring working as they were designed to work — identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” acting FDA Commissioner Dr. Janet Woodcock said in the release. “We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider.”
CDC Director Dr. Rochelle P. Walensky: “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered — and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated.”