FDA advises states to pause the use of the J&J Covid vaccine after blood-clotting issue 

By Rek Hanibal Published on April 14, 2021
FDA advises states to pause the use of the J&J Covid vaccine after blood-clotting issue 

The FDA asks states to temporarily halt using J&J's Covid-19 vaccine after six people in the U.S. developed a rare blood-clotting disorder. The FDA said the recommendation is "out of an abundance of caution.” The cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after receiving the shot. The Food and Drug Administration asked states on Tuesday to temporarily halt using Johnson & Johnson's Covid-19 vaccine "out of an abundance of caution" after six women in the U.S. developed a rare blood-clotting disorder that left one woman dead and another in critical condition.

"Right now, these adverse events appear to be extremely rare," the FDA said in a joint statement with the Centers for Disease Control and Prevention. "COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after receiving the shot. Doctors typically treat that type of blood clot with heparin, but health regulators noted that it could be dangerous in this case and recommended a different treatment.

J&J said in a statement that "no clear causal relationship" has been identified between the blood clots and the vaccine, adding it is working closely with regulators to assess the data.More than a month ago, people who got the J&J vaccine were at shallow risk of developing the blood clots, Dr. Anne Schuchat, the CDC's principal deputy director, told reporters on a conference call Tuesday. For people who recently got the vaccine within the last couple of weeks, they should be aware of looking for any symptoms, blood clotting generally occurs about a week after vaccination, but not more than three weeks after, with a median timeframe of 9 days, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said on the call.

Johnson & Johnson COVID-19 vial and box saw at a vaccination site. Doses of the Johnson & Johnson vaccine are being administered throughout Florida despite a small number of patients who have experienced adverse reactions, including blood clots. Shares of J&J fell by almost 3% in intraday trading. Not received authorization for use in the U.S.J&J submitted its Covid vaccine data to the FDA in February, and no specific concerns were identified at the time when analyzed by age, race, and comorbidities, according to the agency. The FDA said at the time, the most common side effects reported were headache and fatigue, followed by muscle aches, nausea, and fever.

It's unclear how the pause will impact J&J's goal to deliver 100 million doses to the U.S. by the end of May. The company has already been plagued by manufacturing issues after a plant run by Emergent BioSolutions ruined 15 million doses of the vaccine. Jeffrey Zients, President Joe Biden's Covid czar, said the pause would not have a "significant impact" on the administration's goal to administer 200 million Covid shots within Biden's first 100 days in office. He said J&J's vaccine makes up less than 5% of the recorded shots in arms in the U.S. to date.

"Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans," he said in a statement. "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."

 

Rek Hanibal

Rek Hanibal

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