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Johnson & Johnson vaccine blocked in the US by the FDA

In a shocking report that could have dramatic implications for the implementation of vaccinations in the United States, federal public health authorities in the United States have decided to stop administering the COVID vaccines developed by Johnson & Johnson and are asking states to follow their guidance . The reason? Authorities have identified six cases of rare and life-threatening blood clots, at least one of which resulted in death. According to the NYT, which broke the news, all six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska was hospitalized in critical condition, officials said. The FDA released its notice shortly after the NYT broke the news.

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the US CDC and the FDA is reviewing data from six reported US cases of a rare and severe type. of blood clots in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) has been observed in combination with low platelet levels (thrombocytopenia). All six cases occurred among women aged 18 to 48, and symptoms occurred 6 to 13 days after vaccination.

Treatment of this specific type of blood clot is different from the treatment that might typically be given. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this context, the administration of heparin can be dangerous and alternative treatments must be given. CDC will convene an Immunization Practices Advisory Committee (ACIP) meeting on Wednesday to further examine these cases and assess their potential significance. The FDA will look into that analysis as it also investigates these cases. Until this process is complete, we recommend a pause in the use of this vaccine for an abundance of caution. This is important, in part, to ensure that the healthcare community is aware of the potential of these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot. At this time, these adverse events appear to be extremely rare.
The vaccine in question was received in Italy in minimal quantities and not yet inoculated, even if it was heavily relied upon also because it was the only vaccine currently inoculable with a single dose.

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The article The Johnson & Johnson vaccine blocked in the US by the FDA comes from ScenariEconomici.it .


This is a machine translation of a post published on Scenari Economici at the URL https://scenarieconomici.it/il-vaccino-johnson-johnson-bloccato-negli-usa-dalla-fda/ on Tue, 13 Apr 2021 12:45:28 +0000.