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UPDATED: Regulators recommend suspension of Johnson & Johnson vaccines in U.S.

The U.S. Centers for Disease Control and Prevention and the US Food and Drug Administration have recommended that the United States pause the use of Johnson & Johnson’s Covid-19 vaccine over six reported U.S. cases of a “rare and severe” type of blood clot.

This six cases occurred among women aged 18 and 48, and symptoms occurred six to 13 days after vaccination, according to a joint statement on Tuesday from Anne Schuchat, principal deputy director of the CDC and Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.

In a statement, the CDC said, it will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance.

“FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” the statement said.

According to the FDA, “treatment of this specific type of blood clot is different from the treatment that might typically be administered.”

This development follows the suspension of usage of the Oxford AstraZeneca vaccine n various countries following similar issue.

In a joint media call Tuesday, the CDC, FDA speaking through Anne Schuchat, Principal Deputy Director, CDC, said people who took the shots months ago have no reason to panic as they are at little or no risk.

However, those who received the vaccine in the past weeks should pay attention to symptoms (severe abdominal pain, severe leg pain, severe headache or shortness of breadth) and seek medical attention if such occurs adding that these symptomps are different from the mild symptoms people experience after taking the vaccine.

Schuchat added that arrangements will be made to reschedule people to take other vaccines available in the US, as they wait to gain clarity on the issues of blood clotting in the coming days.

Speaking to the possible increase in vaccine hesitancy, Janet Woodcock, Acting FDA Commissioner encouraged people to take other vaccines available to them as vaccines are an impoetant tools to bringing the pandemic under control and “the risk from the pandemic are very significant.”

The agencies noted that they have not recorded any of the issues related to the Janssen vaccine and the Oxford Astrazeneca in the other two vaccines -Moderna and Pfizer.

Hopefully, the pause will not affect President Biden’s target for vaccination said Peter Marks Director FDA Centre for Biologics Evaluation and Research. Schuchat added that it will be too early to tell the number of Janssen vaccine supplies that will be affected by this recommendation.

According to a statement by Jeff Zients, White House COVID-19 Response Coordinator, “this announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date.”

“Earlier this year, based on the actions of the president, the United States had secured enough Pfizer and Moderna doses for 300 million American,” he said.

“Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines.

“This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the President’s goal of 200 million shots by his 100th day in office—and continue on to reach every adult who wants to be vaccinated.

“We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine."

ovu: Tuesday, 13 April 2021 at 4/13/2021 06:57:00 pm


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