Skip to Main Content
April 16, 2021

Health Law Weekly

FDA, CDC Recommend Pause of J&J Vaccine

  • April 16, 2021

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended April 13 a pause the use of the Johnson & Johnson (J&J) COVID-19 vaccine after six reported cases of a rare and severe type of blood clot in women who received the one-dose shot.  

All six cases were in women between the ages of 18 and 48, with symptoms presenting six to 13 days after vaccination.

In a statement, the agencies said the recommendation to suspend use of the J&J vaccine is “out of an abundance of caution,” noting more than 6.8 million doses of the J&J vaccine have been administered in the United States so far.

“This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” Most blood clots are treated with the anticoagulant drug heparin, but the agencies noted that administering heparin in these types of cases may be dangerous.

The CDC Advisory Committee on Immunization Practices held an emergency meeting on April 15 but adjourned after determining they needed more information before making specific recommendations.

Meanwhile, Pfizer CEO Albert Bourla said in a tweet this week that the company was ramping up production and could deliver 10% more doses to the United States by the end of May than the 200 million initially agreed to, with the full 300 million doses available by the end of July, two weeks early.