The Amsterdam-based company, which acts as the EU’s pharmaceutical monitoring authority, has so far reported four thromboembolic events, namely blood clots at risk of vascular obstruction, among those vaccinated with Johnson.
Of the four cases of abnormal blood clotting, one occurred at an unnamed location during the clinical trial phase and three occurred in the United States after vaccine administration. A case is dangerous, they added.
This was the highlight: Johnson is awaiting an investigation into whether there is a causal link between the vaccine and the low number of blood clotting cases. The Agency’s Efficient Risk Assessment Team (PRAC) began reviewing cases to determine if product information for the vaccine should be updated.
Johnson’s corona virus vaccine is currently used only in the United States, and the vaccine received provisional marketing approval in the European Union on March 11. The vaccine has not yet been introduced in any of the EU member states and is expected to be used in Europe in the coming weeks. On October 8, the European Commission signed an agreement with Johnson & Johnson to purchase an additional 200 million doses of the vaccine, with an option to purchase an additional 200 million doses.
The vaccine developed by Johnson creates a technology base that is already used to develop and manufacture vaccines against the pharmaceutical company Ebola and Zika, RSV and HIV. The crown protein characteristic of the corona virus is removed by vaccination with an adenovirus in the body. The immune system then treats this protein as a foreign substance and a natural defense against which antibodies and T cells belonging to the group of white blood cells are formed. The adenovirus in the vaccine cannot reproduce and does not cause disease.
The European Pharmaceuticals Institute on Wednesday released partial results of an investigation into British-Swedish pharmaceutical company AstraZeneca and a vaccine called Oxford University VaxJevria. The company concluded that there is a potential link between previously reported thrombosis and the astrogenic corona virus vaccine, but the benefits of the vaccine outweigh the risks of side effects. As reported, the risk of developing blood clots should be reported as a “very rare side effect” of the vaccine.
The assessment confirms that the estrogen vaccine is safe and can effectively prevent coronavirus infection and reduce the risk of hospitalization and death. It was also stressed that the risk of dying from the corona virus was much higher than possible and a very rare occurrence by blood clots. The company does not recommend any restrictions on the use of the vaccine in people over 18 years of age. Further testing of the vaccine is reported to be ongoing.
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