Friday, April 16, 2021

Anvisa asks for change of package insert for Oxford vaccine after connection with cases of thrombosis – Prime Time Zone

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In more than 4 million doses of the vaccine applied, 47 suspected cases of thromboembolic adverse events were recorded

Luis Lima Jr./Estadão ContentsAnvisa maintained the recommendation to continue applying the immunizer, claiming that the benefits outweigh the risks of using the vaccine

A National Health Surveillance Agency (Anvisa) asked that the vaccine package insert Covid-19 developed by AstraZeneca in partnership with Oxford University be changed after linking with cases of thrombosis. The information was released by the agency on Wednesday night, 7. According to Anvisa, “These are very rare cases of blood clots forming associated with thrombocytopenia and, in some cases, bleeding that may be associated with the use of vaccine”. However, according to the statement, cases have been reported in some countries. In the request, Anvisa maintains the recommendation to continue applying the immunizer, claiming that the benefits outweigh the risks of using the vaccine.

According to Anvisa data, in more than 4 million doses of vaccine applied, were recorded 47 suspected cases of thromboembolic adverse events, with only one being associated with thrombocytopenia. All cases were registered in the VigiMed, which is a system used to notify adverse events in the use of medicines and vaccines in Brazil. However, the agency stated that it was not possible to establish a direct relationship between the 47 suspected cases and the use of the vaccine, as well as no risk factors for the occurrence of the event were identified.

In the note, Anvisa explains that it understands that there may be a relationship between the vaccine and the cases, but points out that the risk for “the occurrence of blood clots is very low”, but asks the population to seek immediate medical attention if they experience any symptoms. The agency also pointed out that most of the side effects that occur after applying the vaccine are transient and do not last “more than a few days”. Finally, the regulatory body states that events must be notified by VigiMed and that the data entered is essential for product analysis and identification to inform the material manufacturer.

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