FDA Lifts Restriction of Johnson & Johnson Vaccine

After pausing its use, the FDA has lifted restrictions on the Johnson & Johnson vaccine for use Friday:

Federal health officials lifted a pause on the use of the Johnson & Johnson coronavirus vaccine Friday night 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 single-shot 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 immediately giving the vaccine they have available on shelves, CDC officials said. The FDA has updated patient and health-care provider fact sheets for use as early as Saturday, and both agencies will publish additional education and communication materials by early next week.

The agencies had halted the 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 in the United States.

The announcement Friday evening followed an all-day meeting of an independent advisory panel to the CDC that recommended inoculations with the Johnson & Johnson vaccine should restart. The panel said the benefits outstrip the risks even as it heard about an additional small group of recipients who developed blood clots.

The Johnson & Johnson vaccine “can be reinstituted and should be reinstituted. I acknowledge, as does everyone else, that these events are rare, but serious,” Jose Romero, chair of the committee, said. “It is our responsibility as clinicians to make sure that women understand this risk and, when possible, that they have an alternative at the same site that you’re administering the vaccine.”

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.