FDA Pausing Johnson & Johnson Vaccine After 6 Clotting Cases

The Food and Drug Administration and the Centers for Disease Control and Prevention called for an immediate pause in the federal use of the Johnson & Johnson vaccine after six recipients in the U.S. developed a rare blood clotting disorder within two weeks of inoculation.

All six cases were women between the ages of 18 and 48. One woman died and another is hospitalized in critical condition. Nearly 7 million people have already received the shot.

In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to C.D.C. data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous sinus thrombosis, is extremely rare. All of the women developed the condition between six and 16 days of vaccination, and government experts are concerned that an immune system response triggered by the vaccine was the cause.

The federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same. While shipments and usage of the Johnson & Johnson vaccine have been more limited than the mRNA vaccines from Pfizer and Moderna, the Biden administration has been counting on using hundreds of thousands of the single-shot doses every week.

The concerns are similar to the problem in Europe with the Astra-Zeneca vaccine after some of the recipients developed blood clots.

Out of 34 million people who received the vaccine in Britain, the European Union and three other countries, 222 experienced blood clots that were linked with a low level of platelets. The majority of these cases occurred within the first 14 days following vaccination, mostly in women under 60 years of age.

An emergency meeting of the CDC advisory committee is scheduled for Wednesday.

From the New York Times.

Alternate source at CNBC.