J&J VACCINE IS CLEARED BY CDC

With blood clot risk low, panel says vaccinations can resume.

A federal advisory panel recommended Friday that immunizations with Johnson & Johnson’s COVID-19 vaccine be resumed despite a tiny risk of blood clots.

On a 10-4 vote, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices reaffirmed its earlier guidance that the vaccine be used for people ages 18 and up.

The vote effectively ends a “pause” recommended April 12 by experts at the CDC and the U.S. Food and Drug Administration. Their concern arose from six cases of a rare and perplexing clotting disorder seen among recipients of the single-shot vaccine. All six of those cases involved women between the ages of 18 and 48.

The blood clots were unusual because they were accompanied by a dangerously low level of platelets, the building blocks of blood clots.

The initial six cases rose to 15 when safety experts went back and reviewed records of adverse reactions to the J&J vaccine. All of those cases were in women, and all but one of them was under 50.

Even so, the advisory panel said the risk was still tiny — effectively 1.9 cases per million people in the general population, or 7 cases per million women under 50.

The panel rejected a plan that would have explicitly called on women between the ages of 18 and 50 to “be aware” of the risk of the clotting disorder and make clear that they “may choose” another COVID-19 vaccine.

Panel members cautioned that such language might be seen as requiring these women to give explicit consent to taking the Johnson & Johnson shot, or that it might oblige vaccine clinics to carry alternative vaccines, thereby imposing logistical and other constraints that could hamper vaccination.

The FDA granted emergency use authorization for the J&J vaccine in February.