The Feds lifted the pause of the J&J COVID vaccine, adding a new warning


This story was updated at 8:35 PM

April 23, 2021 – Use of the Johnson & Johnson COVID-19 vaccine in the United States should be resumed for all adults, according to the Food and Drug Administration and the Center for Disease Control Friday, although health care providers must warn patients of the risk of rare and dangerous blood infections . The clots caused the agencies to stop distributing the vaccine earlier this month.

“What we’re seeing is that the overall rate of events was 1.9 cases per million people. In women from 18 to 29 years old, there were nearly 7 cases per million. CDC director Rochelle Wallinski said in a press release Friday evening,” The risk is lower in women over the age of 50 at 0.9 cases per million.

In the end, the potential benefits of the vaccine far outweigh the 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 in women between the ages of 18 and 49,” said Walinsky. The potential benefits for women over 50 were greater: it prevented 4,700 hospitalizations and 650 deaths.

“Ultimately, this vaccine has been shown to be safe and effective for the vast majority of people,” Walinsky said at a Friday evening news conference.

The recommendation to continue rolling out the vaccine came just two hours after the CDC’s advisory committee voted on immunization practices to recommend lifting the temporary suspension. The votes were 10 to 4, with one abstention.

The decision also includes instructions for warning directed at women under 50 who are at increased risk of a rare but serious 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. Of the 7.98 million doses of J&J vaccine given in the United States, three women have died.

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended a temporary halt on April 13 after reports 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 committee made the correct recommendation.

He commended both the decision to restart the vaccine and the updated warning information that “will be interpreted.” [TTS] Entirely for people, especially women, who come to receive the vaccination. “

Regarding women in the risk group who need to choose vaccines, Schaffner said that will be treated differently across the country.

“Not every provider will have alternative vaccines on their sites, so there will be many different ways to do this. You may have to obtain this information and decide which location to move to depending on the available vaccine if this is important to you.”

ACIP made its decision today after a 6-hour emergency meeting to hear evidence about Johnson & Johnson’s preventive benefits against COVID-19 versus TTS risks.

At the CDC-FDA press conference, Walinsky noted that over the past few days, as organizers have reviewed rare events, newly identified patients have been treated appropriately, without the use of heparin, which is not recommended for the treatment of TTS.

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

She said the Johnson & Johnson injection remained an important option because it was convenient to serve and easier to store than other vaccines currently authorized in the United States.

Peter Marks, director of the Food and Drug Administration’s Center for Biology Research and Assessment, said the agency has already added information describing the risk of a rare clotting disorder to its fact sheets for patients and clinicians.

Janet Woodcock, Commissioner for the Food and Drug Administration, said vaccination centers could resume administering vaccinations and “finished” as early as tomorrow morning.

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