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Folhapress

European agency says Oxford vaccine can be used by all adults

BRUSSELS, BELGIUM (FOLHAPRESS) – In a second round of studies on the side effects of the Oxford / AstraZeneca vaccine against Covid-19, the European regulatory agency said it remains recommended for all age groups and genders. According to Emer Cooke, director of the agency, hematologists, neurologists and independent epidemiologists who worked together with the EMA pharmacological risk group (Prac), did not identify specific risks in the use of the immunizer. “We maintain our assessment that the vaccine should continue to be used, because it is safe and effective and its benefits outweigh the risks,” said Cooke. Investigations into the product developed by AstraZeneca began after reports of a rare venous disease that caused deaths in Europe. So far, however, there is no evidence that the vaccine is the cause of the problems, although the hypothesis has also not been ruled out. By the beginning of this week, 62 cases of the rare disease had been evaluated, of which 44 occurred in the 30 countries of the European Economic Area (the 27 in the EU plus Norway, Iceland and Liechtenstein). In the same period in that territory, 9.2 million people received the AstraZeneca vaccine. Of the European cases, 14 ended in death. The new EMA analysis comes a day after the German government announced that it would stop administering the immunizer to people under the age of 60. The decision, also made by France for children under 55, is based on the fact that the majority of reported strokes happened to young women. According to Cooke, it is not yet possible to determine why there were more reports among vaccinated women, but in the general population the incidence of this type of rare clot also occurs more frequently among women. A survey carried out in parallel by Denmark’s Aarhus University Hospital, published on Wednesday (31) in the scientific journal Lancet, indicated that clots in people who received the Oxford / AstraZeneca vaccine were as rare as in the general population. Denmark and Norway are the only countries that have not yet resumed application of the product, among the 21 that had stopped administering it while the EMA was investigating side effects. According to the European regulator, immunization still prevents many more serious health problems than the possible serious side effects, considered rare – 1 per 100,000 inhabitants under 60, according to Cooke. The director stated, however, that the decision to limit the use of a particular product to a range of the population depends on the specific conditions of each country, including the number of infections and the vaccines available. In Brazil, where the AstraZeneca vaccine is the main immunizer of the federal government, there are no reports of similar strokes in vaccinated people so far. The adverse events considered serious registered in Brazil in the first month of the vaccination campaign against the coronavirus represent 0.007% of the doses applied in the period, shows a report released by the Ministry of Health. So far there is no confirmation that they are related to the immunizers. The vast majority of the suspected adverse effects reported so far are not serious. The most frequent cases are headache, pain in general and muscle pain (myalgia), in addition to fever, nausea and diarrhea. UNDERSTAND THE EVALUATION Why has the European regulator made further inquiries about the Oxford / AstraZeneca vaccine? Because countries have reported blood clots in people to whom the immunizer has been applied. What problems have been reported? The most worrisome were blood clots associated with low levels of blood platelets (elements in the blood that help clot), with or without bleeding, and rare cases of clots in the vessels that drain blood from the brain. How often did these problems happen? In about 9.2 million people vaccinated in 30 European countries, 44 cases of clots in the brain vessels (CVST) have been reported, 14 of them resulting in death. What are the conclusions of the analysis? The safety committee concluded that: the benefits of the vaccine in combating Covid-19 (which alone results in clotting problems and can be fatal) outweigh the risk of side effects; the immunizer is not associated with an increased overall risk of blood clots (thromboembolic events) in vaccinated people; there is no evidence of a problem related to specific vaccine batches or to specific manufacturing sites; it was not possible to prove that the vaccine caused the cases of DIC and CVST, but this hypothesis was also not ruled out and deserves further analysis. How do the conclusions affect vaccination? The EMA recommends that vaccination proceed normally, as the risks are rare and the benefits are proven. But you will be making care alerts for patients and healthcare staff What alerts have been given to patients? They should seek immediate medical attention and mention their recent immunization if they experience any of these symptoms after receiving the vaccine: shortness of breath, chest or stomach pain, swelling or cold in an arm or leg, severe or worsening headache or blurred vision after vaccination persistent bleeding, several small bruises, reddish or purplish spots or blood bubbles under the skin

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