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Feds Lift Pause of J&J COVID Vaccine, Add New Warning

Johnson & Johnson’s use of the COVID-19 vaccine is expected to resume in the United States for all adults, the FDA and CDC said on Friday, although healthcare professionals should warn patients of the risk of developing the rare and severe blood clots that caused the agencies to pause the distribution of the vaccine earlier this month.

“What we are seeing is that the overall event rate was 1.9 cases per million people. In women aged 18 to 29, there were approximately 7 cases per million. The risk is even lower in women over 50, with 0.9 cases per million, ”said CDC director Rochelle Walensky, MD, at a news conference on Friday night.

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

“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine can prevent more than 650 hospitalizations and 12 deaths among women aged 18-49,” said Walensky. The potential benefits for women over 50 were even greater: it could prevent 4,700 hospitalizations and 650 deaths.

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

The recommendation to continue launching the vaccine came just 2 hours after a CDC Immunization Practices Advisory Committee voted to recommend that the break be lifted. The vote was 10-4 with one abstention.

The decision also includes instructions for alerting women under 50 who are at an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).

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

The FDA and CDC recommended a break 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 specialist at Vanderbilt University in Nashville, and a non-voting member of ACIP, said in an interview that the panel 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 are coming to be vaccinated”.

As for women in the high-risk group who need to have a choice of vaccines, Schaffner said this will be treated differently across the country.

“Each provider will not have alternative vaccines at its location, so there will be many different ways to do this. You may have to obtain this information and select the website you are going to, depending on which vaccine is available if this subject is important to you, ”he noted.

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

In the CDC-FDA press release, Walensky noted that in recent days, as regulators have reviewed rare events, newly identified patients have been treated appropriately, without the use of heparin, which is not recommended for the treatment of STT.

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

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

Peter Marks, MD, director of the FDA’s Center for Biological Research and Evaluation, said the agency had already added information describing the risk of the rare clotting disorder to its technical sheets for patients and doctors.

Janet Woodcock, interim FDA commissioner, said vaccination centers could resume the application of “ready” injections as early as tomorrow morning.

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