Federals lift the COVID J&J vaccine break, add a new warning


This story was updated at 8:35 p.m.

April 23, 2021 – Use of the Johnson & Johnson COVID-19 vaccine should be resumed in the United States for all adults, the FDA and CDC said Friday, although care providers patients should warn patients of the risk of developing rare and severe blood clots that caused agencies to stop distributing the vaccine earlier this month.

“What we are seeing is that the overall rate of events was 1.9 cases per million people. In women aged 18 to 49 there were approximately 7 cases per million. The risk is even lower in women over 50, with 0.9 cases per million, “CDC director Rochelle Walensky, MD, said in a briefing Friday evening.

In the end, the potential benefits of the vaccine far outweighed its risks.

“In terms of benefits, we found that for every million doses of this vaccine, the J&J vaccine could prevent more than 650 hospitalizations and 12 deaths among women ages 18 to 49,” Walensky said. The potential benefits for women over 50 were even greater: it could prevent 4,700 hospitalizations and 650 deaths.

“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Walensky said at a news conference Friday night.

The recommendation to continue vaccine implementation came just two hours after a CDC advisory committee on immunization practices voted to recommend the withdrawal of the pause. The vote was 10 to 4 with one abstention.

The decision also includes instructions for the warning aimed at women under the age of 50 who are at increased risk for a rare but severe blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).

As of April 21, 15 cases of TTS have been confirmed, all in women and 13 of them in women under the age of 50, between 7.98 million doses of the J&J vaccine administered in the US Three women have died.

The FDA and CDC recommended the break on April 13 after reporting that 6 women developed a blood clotting disorder 6 to 13 days after receiving the J&J vaccine.

William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview that the group made the right recommendation.

He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, especially women, who get vaccinated ”.

As for women in the risk group who need to opt for vaccines, Schaffner said it will be addressed differently across the country.

“Not all providers will have alternative vaccines at their location, so there will be many different ways to do this. You may need to get this information and select where you go based on the vaccine available if this issue is important. for you, ”he said.

ACIP has made the decision today after a 6-hour emergency meeting to hear evidence on the benefit of Johnson & Johnson’s protective benefits against COVID-19 against the risk of TTS.

At the CDC-FDA press conference, Walensky noted that in recent days, as regulators have reviewed rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not the case. advises for the treatment of TTS.

As a result, regulators felt that their messages had reached doctors who now knew how to take special precautions when treating patients with this disorder.

He said the Johnson & Johnson shot was still an important option because it was convenient to administer and was easier to store than other vaccines currently authorized in the U.S.

Peter Marks, MD, director of the FDA’s Center for Biological Product Evaluation and Research, said the agency had already added to its patient and physician fact sheets information describing the risk of this clotting disorder. .

Janet Woodcock, the FDA’s acting commissioner, said vaccination centers could resume vaccines “one and done” as early as tomorrow morning.

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