Use of the one-shot vaccine can resume, feds say after study

Federal health officials lifted a temporary pause Friday night on the use of the one-dose Johnson & Johnson coronavirus vaccine after an extensive safety review by the Centers for Disease Control and Prevention and the Food and Drug Administration.

The officials said the benefits of the vaccine far outweigh the risks from a rare and severe type of blood clot.

The decision to lift the pause allows state and local officials to resume giving the vaccine they have available on shelves, CDC officials said. The CDC and FDA will publish education and communication materials and updated patient fact sheets by early next week.

The agencies had paused use of the Johnson & Johnson vaccine last week because of reports of six cases of blood clots among the millions of people who had received the vaccine. The announcement Friday evening followed an all-day meeting of an independent advisory panel to the CDC that recommended the inoculations with the Johnson & Johnson vaccine resume. The panel said the benefits outweigh the risks even as it heard about an additional small group of recipients who developed blood clots.

The FDA and Johnson & Johnson are updating the vaccine's label to carry a warning about a rare risk of blood clots paired with low counts of platelets, blood cells involved in clotting.

The CDC's independent expert panel, the Advisory Committee on Immunization Practices, voted 10-4, with one member abstaining. CDC Director Rochelle Walensky approved its recommendation.

Janet Woodcock, acting FDA commissioner, said the agencies lifted the pause based on FDA and CDC reviews of all available data and in consultation with medical experts and based on recommendations from the advisers.

"We have concluded that the known and potential benefits of the (Johnson & Johnson) COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older," she said in a statement. "We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality."

Walensky, in a statement, said the agencies "identified exceptionally rare events … and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization and death."

The advisory committee heard data about 15 cases of the rare and severe blood clots that prompted federal officials to recommend that states pause using the vaccine.

All of the committee members said the benefits far outstrip the risks, but several members expressed concern that people receiving the vaccine will not be sufficiently informed of the rare but potential danger or that they have options for other vaccine brands.

All the blood clot cases were in women, including three who died and seven who remain in the hospital. The 15 cases mostly involved clots in the brain in women between the ages of 18 and 59. The 15 cases were identified among nearly 8 million doses administered as of April 21.

CDC officials who presented the data said it was too early to conclude that the incidents affected only women and said a few unconfirmed cases in men were being reviewed.

By lifting the pause and adding the FDA warning, the U.S. position would be similar to one taken by Europe's drug regulator. The European Medicines Agency said this week the Johnson & Johnson vaccine should carry a warning but placed no restrictions on its use. The European agency also said the shot's benefits continue to outweigh the risks.

The rarity of the cases had persuaded many federal officials that the complication can be addressed by adding a warning that describes the groups at higher risk for the adverse outcome, and by working to ensure that doctors know how to identify and treat the problem.

People who have received the Johnson & Johnson vaccine and develop severe headaches, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their medical provider. Most notably, physicians were advised to avoid using heparin, a common treatment for blood clots, because it can exacerbate the vaccine-related condition.

Experts have said the risk of developing a clot after receiving the vaccine appears far lower than the chance of a clotting issue caused by a severe COVID-19 infection or from using hormonal birth control, such as oral contraceptives.

The Johnson & Johnson vaccine, which was authorized for adults 18 and older, was a large part of the U.S. and global vaccination strategy. It has clear practical and logistical advantages over the other two authorized vaccines in the United States: It does not have to be kept frozen, and requires just one dose. That makes it particularly useful for rural areas and other hard-to-reach communities.

Most of the more than 210 million shots administered in the United States have been made by Pfizer-BioNTech and Moderna using a different technology.