The CDC and FDA called for a temporary but immediate halt to the use of J&J’s COVID vaccine while they investigate at least six cases of potentially dangerous blood clots in people who received the vaccine.
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Federal agencies today said they will stop using the single-shot Johnson & Johnson (J&J) COVID vaccine at mass vaccination sites while they investigate the vaccine’s possible link to potentially dangerous blood clots. States and other providers also are expected to pause vaccinations.
In a joint statement from the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA), the agencies said they are investigating six cases of blood clots in the U.S. All six occurred in women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.
One woman died and a second woman in Nebraska was hospitalized and is in critical condition, The New York Times reported.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices Wednesday to further review the cases and assess their potential significance. The FDA will review that analysis, according to the joint statement.
The agencies said that until “that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.”
In addition to advising healthcare workers to report any adverse reactions to the Vaccine Adverse Event Reporting System, the agencies recommended people who have received the J&J vaccine and develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their healthcare provider.
Blood clots have also been linked to AstraZeneca’s COVID vaccine, which has not yet been approved in the U.S.
EU regulators on April 7 said they identified a “possible link” between AstraZeneca’s vaccine and blood clots, but said the benefits of the vaccine outweighed the risks. At the time, the European Medicines Agency said it was also investigating several reports of blood clots in recipients of the J&J vaccine.
On Monday, the FDA confirmed it is investigating blood clots in people who received the J&J vaccine.
Read full story here: Source: Breaking: U.S. Pauses Johnson & Johnson Vaccine, Citing ‘Rare’ Blood Clots • Children’s Health Defense
Report according the New York Times: https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html