The CDC and FDA have issued a joint statement calling on states to pause the rollout of J&J’s COVID-19 vaccine due to concerns over blood clots.
The discovered cases of blood clots that may be linked to the vaccine have been rare — so far, just six cases have been reported out of about 6.8 million doses administered. But one of the patients died due to the blood clot and another is currently hospitalized in critical condition. All of the patients were women under 50.
The FDA now plans to review the analysis of the vaccine while a CDC advisory panel is scheduled to meet to discuss the issue on Wednesday.
Similar concerns have been raised about the AstraZeneca vaccine in the EU where the vaccine has been widely distributed. After slowing distribution of the AZ vaccine, regulators in the bloc have sought to resume its widespread use, saying that the benefits outweigh the rare risk of blood clots.
This pause by regulators is the latest setback for J&J, which has already struggled with fulfilling orders for doses in the U.S. due to manufacturing hiccups. Earlier this month, it was reported that Emergent BioSolutions, the CDMO producing J&J’s shot, had to scrap 15 million doses after employees accidentally mixed up ingredients.
