US health agencies have recommended that states pause the administration of the Johnson & Johnson (J&J) coronavirus vaccine, after reports of rare and severe blood clots emerged in six women as more than 6.8 million doses of the vaccine have been administered nationally, The Guardian reports on Tuesday.
The concerns, the paper reports, mirror those of medical and health regulatory agencies in Europe and Australia over the AstraZeneca vaccine.
“People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider,” the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said in a joint statement on Tuesday, stating: “Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.”
All six women were between the ages of 18 and 48. One woman died, and a woman in Nebraska is hospitalized in critical care, according to the New York Times. Johnson & Johnson’s vaccine is also under scrutiny by the European Medicines Agency, which is investigating four cases of clotting.
Because US states control their own health response, the health agencies framed their statement as a recommendation, even as federal sites will immediately pause administration of the vaccine.
The pause in administration of the Johnson & Johnson vaccine is certain to be a blow to the American immunization campaign, which was set to administer hundreds of thousands of easy-to-administer doses provided by the company.
Unlike vaccines developed by Pfizer and Moderna, Johnson & Johnson’s vaccine requires only one dose to provoke immunity, and can be stored in a common refrigerator. Both Pfizer and Moderna’s vaccine require ultra-cold storage and a two-dose regiment.
Health agencies said the blood clotting concern is “extremely rare”. That rarity may in fact be part of the concern, as it may make it more difficult to recognize and treat.
The pause is a blow to Johnson & Johnson, which only recently was forced to throw away between 13 and 15 million doses of vaccine after a federal contractor botched doses.
feature Photo credit: Dado Ruvić/Reuters
