Vaccine experts say J&J's COVID-19 vaccine is safe despite blood clot risk

Melissa Healy
·2 min read
FILE - In this Wednesday, March 3, 2021 file photo, a pharmacist holds a vial of the Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, N.Y. Janssen Pharmaceuticals is a division of Johnson & Johnson. On Wednesday, April 21, 2021, the Food and Drug Administration released a report saying the now-idle Emergent Biosciences factory where a key contractor hired to help make Johnson & Johnson's COVID-19 vaccine was dirty, didn't follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of a batch of the vaccine. (AP Photo/Mark Lennihan)
A hospital pharmacist holds a vial of the Johnson & Johnson COVID-19 vaccine. (Mark Lennihan / Associated Press)

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 April12 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 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 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.

This story originally appeared in Los Angeles Times.

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Unless ACIP votes against lifting the pause, this means this vaccine will be coming back into use. pic.twitter.com/Bq3kbFoyuW— Helen Branswell (@HelenBranswell) April 23, 2021 Put another way, if 1 million people were vaccinated using the Johnson & Johnson vaccine, 2,000 fewer people would be expected to die of Covid-19, 6,000 fewer hospitalized, and seven people would be expected to develop the serious blood clots associated with the vaccine. However, the individual risk for women younger than 50 is higher. Among 1 million people, 12 Covid-19 deaths and 657 hospitalizations expected to be prevented, with 13 cases of the blood clotting disorder expected, according to the CDC. A description of the risks and symptoms of blood clots would appear in a patient fact sheet distributed with the vaccine. In the general population, between 0.7 and 1.6 people per million develop the specific type of blood clot with low platelet count associated with the vaccine. 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