FDA calls for ‘pause’ on Johnson & Johnson Covid vaccine after six women get blood clot disorder resulting in one death
The US Food and Drug Administration (FDA) and the CDC have called for a pause of Johnson & Johnson’s Covid-19 vaccine after it reportedly caused at least one death and gave others serious blood clotting.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” declared the FDA on Tuesday, pointing toward six “extremely rare” cases of people suffering a “severe type of blood clot” after being vaccinated. Over 6.8 million Americans have received the Johnson & Johnson vaccine, with even more internationally.
— U.S. FDA (@US_FDA) April 13, 2021
Revealing that the Centers for Disease Control and Prevention (CDC) “will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance,” the FDA added in its statement that until the investigation is complete, it is “recommending this pause” of Johnson & Johnson’s vaccine.
This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.
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The six affected people were all women between the ages of 18 and 48 who developed the condition between six and 13 days of vaccination, the statement says.
Professor Sabra Klein, the co-Director of the Johns Hopkins Center for Women’s Health, Sex, and Gender Research, responded to the news by questioning when the FDA and the CDC would “start requiring partitioning and analyzing clinical trials by biological sex” to determine vaccine effects on women.
Last week, the European Medicines Agency announced an investigation into Johnson & Johnson’s vaccine and its potential links to blood clotting.
The AstraZeneca Covid-19 vaccine is also being investigated over blood clot cases, and several countries have advised against using the vaccine on young recipients.
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