FDA, CDC lift pause on J&J COVID-19 vaccine
The FDA and CDC have lifted the pause placed on the Johnson & Johnson 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.
The J&J Vaccine is back, after the FDA review confirmed that the benefits of the vaccine far outweighed the risks.
As more Americans continually skip out on their second dosage, the one and done dose may prove particularly useful. pic.twitter.com/cBU6Jr8sMS
— Affinity Magazine (@TheAffinityMag) April 25, 2021
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.
— Face The Nation (@FaceTheNation) April 25, 2021
Former FDA Commissioner Scott Gottlieb says he agrees with stopping the pause on the J&J COVID vaccine, adding “the risk-benefit of this vaccine looks favorable.”