FDA, CDC lift pause on Johnson and Johnson COVID-19 vaccine

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United States health officials lifted their recommended pause on the Johnson and Johnson (J&J) vaccine April 23, after 11 days of the hold. After conducting a review of available data and reaching out to healthcare providers across the U.S., the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) agreed to end the pause and continue recommending the J&J vaccine for COVID-19 prevention. 

The agencies initially recommended the pause after six reported cases of blood clots attributable to the vaccine. During the pause, the two agencies worked to determine if the J&J vaccine was safe for continued use in the U.S.

In so doing, they conducted an outreach program to U.S. hospitals and healthcare providers across the nation. They found evidence of nine more cases of blood clots linked to the J&J vaccine, bringing the overall total to 15. This total is out of almost eight million administered doses of the vaccine since it was first authorized. Looking at available data, the agencies found that the occurrence of blot clots and other related issues is exceedingly rare. 

While vowing to maintain vigilance, the agencies lifted the pause. Information on the risks of blood clots will now appear in a fact sheet and will be handed out with the vaccine. 

The end of the pause comes as a welcome sign to the U.S. vaccination effort. Prior to the pause, J&J was featured in U.S. vaccination plans because, unlike the Moderna and Pfizer vaccines, J&J is a single-dose vaccine and does not have to be stored at subzero temperatures. 

Those qualities made the J&J vaccine particularly useful in plans to vaccinate vulnerable populations of the U.S. – including those that are homebound and the homeless. Before the pause, when given the option, the J&J vaccine was preferred in many instances by the homeless population. 

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