FDA, CDC urge suspension of J&J COVID vaccine

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This story is updated at 1:25pm

April 13, 2021-The FDA and CDC announced on Tuesday that after reports of blood clots in patients receiving injections, the FDA and CDC recommended on Tuesday to suspend the use of Johnson & Johnson’s COVID-19.

The FDA said in a statement that 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of rare and severe blood clots in patients receiving the vaccine.

Experts said at the CDC-FDA media briefing on Tuesday that the purpose of the pause is to give people time to be alert to this “very rare” situation.

FDA Acting Commissioner Dr. Janet Woodcock said: “It is clear that we need to remind the public.” This move will also give “the medical community time to learn what they need to know about how to diagnose, treat and report. “.

The CDC will hold an immunization practice advisory committee meeting on Wednesday to review these cases.

Of the six reported cases related to Johnson & Johnson vaccine, all cases were between the ages of 18 and 48. One of the women died and the other was ultimately in critical condition.

“I know that today’s information will be very important to Americans who have been vaccinated against Johnson & Johnson,” said Anne Shukat, chief deputy director of the CDC.

She said: “For people who were vaccinated more than a month ago, the risk at this time is very low.” “For those who have been vaccinated recently, in the last few weeks, look for symptoms.”

Headache, leg pain, abdominal pain, and shortness of breath are reported symptoms. Within 6 to 13 days after receiving the Johnson & Johnson vaccine, all 6 cases appeared.

Traditional treatment is dangerous

It is important that traditional blood clots (such as the drug heparin) should not be used for these blood clots. Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation, said: “The problem with this type of blood clot is that if we implement our standard treatment for blood clots, it may cause huge harm and may even be fatal.” and research.

Marks added that if health care providers see people with these symptoms and low platelet counts or blood clots, they should ask about their recent vaccination.

Mark added that headache is a common side effect of COVID-19 vaccination, but it usually occurs within a day or two. On the contrary, the headaches associated with these blood clots will appear after 1 to 2 weeks and are very severe.

Schuchat said that not all of the six women who participated in the event already had medical conditions or risk factors.

Severe but “extremely rare”

To better illustrate these numbers, the six incidents reported so far have occurred among millions of people vaccinated by Johnson & Johnson.

Shuchart said: “So far there have been six reports of severe stroke-like diseases caused by low platelet counts, and six million doses of Johnson & Johnson vaccine have been vaccinated so far.”

Woodcock said: “I want to emphasize that these incidents rarely happen, but we take all reports of adverse events after vaccination very seriously.”

Company response

Johnson & Johnson said in a statement: “We know that among the few people who received the COVID-19 vaccine, there is a very rare disease involving blood clot patients with low platelets. The Centers for Disease Control (CDC and Food and Drugs) The Supervision Administration (FDA) is reviewing six reported cases in the United States involving more than 6.8 million doses. Out of caution, the CDC and FDA recommend that our vaccine be suspended.”

The company said that they are also reviewing these cases with European regulators, “We have decided to proactively postpone the launch of our vaccine in Europe.”

Overall vaccination continues to accelerate

Jeff Zients, White House COVID-19 Response Coordinator, said: “This announcement will not have a significant impact on our vaccination program. Johnson & Johnson Vaccines has so far recorded less than 5% of weapon shots in the United States. “In a statement.

“According to actions taken by the President earlier this year, the United States has received enough Pfizer and Moderna doses for 300 million Americans to receive.” We are currently working with our state and federal partners to make any J&J vaccine scheduled People quickly reschedule Pfizer or Moderna vaccines,” he added.

The possible duration of the suspension remains unclear.

Shuchart said: “I know this is a long and difficult pandemic, and people are tired of the steps that must be taken.” “The steps taken today ensure that the healthcare system is ready for diagnosis, treatment and reporting. [any additional cases] The public has the necessary information to ensure safety. “

WebMD Health News

source

Twitter.com: @US_FDA, April 13, 2021

White House Press Conference, April 13, 2021

Johnson & Johnson, press release, April 13, 2021


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