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Friday, June 18, 2021

Johnson & Johnson COVID-19 Vaccine CDC in US, FDA Non-Stop as Updated Guidance

Federal health agencies say they are ending their recommended stay on Johnson & Johnson’s use of Jensen Coronavirus vaccineFollowing a vote of a panel of advisors from the Centers for Disease Control and Prevention on the resumption of the single-pill vaccine.

The Food and Drug Administration said they have revised their Emergency Use Authority for the vaccine to include a new warning about the “possible” risk of a rare but serious blood clot in adult women under 50.

A panel of advisors from the Centers for Disease Control and Prevention voted Friday to recommend the Johnson & Johnson vaccine resume. Shots are expected for adult women under 50 with rare but new warnings about the risk of severe blood clots.

A federal health official told the panel on Friday that vaccination could resume after the CDC director approved its recommendations, and the Food and Drug Administration publishes updates to its emergency use authority for the vaccine.

A total of three women have died of clotting disorder after receiving the Janssen vaccine, out of a total of 16 cases among women in the US, the CDC told its panel of advisors on Friday. Seven are hospitalized and five have been released. Most were under 50 years old.

In Johnson & Johnson’s clinical trials, a person was diagnosed with similar symptoms after receiving the shot.

According to CDC data released on Friday, there is a small portion of the more than 8 million doses. During the recommended pause, at least 170,338 Johnson & Johnson shots were given and another 9.6 million doses that were distributed in the jurisdiction have gone unused.

By resuming Janssen’s vaccine for all adults, COVID-19 can prevent 600 to 1,400 deaths, the CDC estimates, but blood clotting can range from 26 to 45. The agency predicted that vaccinating all interested Americans could be delayed by up to two weeks if shots were not resumed for all adults.

“The benefits clearly outweigh the risks from a population point of view and from a personal point of view, and I think it’s reassuring to me anyway, while we don’t have all the information, I think we have a way forward. There is enough information for that. ” . Beth Bell, a member of the panel and a former CDC official.

Panel vote comes after one week The delivery of the vaccine was stopped After initial reports of blood clots in eight people under 50 years of age.

A CDC official told the panel that the agency planned an “public education” effort to raise awareness of the risks. Johnson & Johnson said it agreed with the Food and Drug Administration On specific language For warnings with shots for health professionals.

The agency said it has seen a handful of fatiguing incidents between modern and those receiving Pfizer shots, but unusual and dangerous combinations of low blood platelets were not found in 16 people following Janssen’s vaccine.

“At the same time I think there is a real risk. It’s actually a very small risk, and smaller than many other risks that we want to take every day. But still, the least option for us in the United States is Huh.” “Dr. Bell commented.

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