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[Frankfurt / Paris / Amsterdam, 18 de Reuters]-European drug regulators report a small number of reports of bleeding, blood clots, and low platelet counts in people vaccinated with AstraZeneca’s new coronavirus vaccine.
The European Medicines Agency (EMA), the European Union’s drug regulator, said yesterday that it had reached a “clear” conclusion that the benefits would continue to outweigh the risks after conducting a survey of reported cases of the vaccine. Emer Cooke, EMA chief executive, said he could not completely eliminate the causal link between vaccination and blood clots and said he would continue the investigation.
In response, Germany, France, Italy and others have decided to resume vaccination.
I summarized what I knew from the 17th.
Since the start of vaccination with the new crown about three months ago, the EU and the European Economic Area have been vaccinated more than 45 million times in total for all manufacturers.
The EMA is investigating 30 cases of rare blood disorders among the 5 million people vaccinated with AstraZeneca in the EU.
The main concern of EMA is the case of blood clots in the brain. It is a rare and difficult to treat symptom called cerebral venous thrombosis (CVT).
In Germany, as of the 16th day, seven people between the ages of 20 and 50 had been diagnosed with CVT within 16 days of vaccination. The Paul Erich Institute (PEI), a national vaccine research institute, has revealed. According to PEI, the incidence of normal CVT in the entire population is 1 in 1.6 million.
<¿Cuáles son las opiniones de otros países y AstraZeneca?>
The UK has been vaccinated with the AstraZeneca vaccine more than 11 million times and reports that the incidence of blood clots is not higher than normal. UK drug regulators are asking the public to continue vaccinations, including those by AstraZeneca.
Canada says medical experts are confident that all new corona vaccines inoculated domestically, including those made by AstraZeneca, are safe.
AstraZeneca announced Wednesday that it has verified the safety data of more than 17 million people vaccinated with the company’s vaccine in the United Kingdom and the European Union, but found no evidence of an increased risk of blood clots.
As of day 17, the EMA researchers are checking whether the cases are more frequent than normal in the vaccinated group.
The usual frequency of occurrence is obtained from public health statistics and insurance records. This will be combined with the findings obtained from the medical analysis and the scientific literature of each case.
Peter Arlet, who leads security monitoring operations at EMA, explains that CVTs are a rare symptom and that EMAs will have to rely on case-by-case analysis rather than poor statistical data.
A spokeswoman for the German vaccine authorities involved in the investigation said the EMA would not make a causal decision.
Rather than elucidate the causal relationship, the EMA will assess the possible increased risk of CVT due to vaccination and compare it with the benefits of preventing new corona infections and providing space for medical care.
The vaccines developed by Pfizer and Moderna, for example, have been associated with an increased risk of anaphylactic symptoms, but are still recommended because they outweigh the risks of treatable side effects.
The EMA says it is “confident” that the benefits of the vaccine outweigh any risks at this time.
AstraZeneca and European regulators said there were no concerns about coagulopathy in human trials.
According to PEI, post-approval security monitoring is key. Very rare side effects, that is, side reactions that affect a small part of the population, are almost impossible to identify in clinical trials.
In Japan, the government recommended vaccination against the human papillomavirus (HPV), which causes cervical cancer, but since the pain syndrome complaint was reported in the media, the active recommendation was suspended after 2013. ing. This answer has been criticized by the WHO.
A study published last year in the Lancet Public Health concludes that if HPV vaccination continues to be discontinued, cancer deaths will rise by the thousands in the coming decades.
In Ukraine, there is deep mistrust of vaccines and the situation allows measles epidemics. Vaccine evasion is rooted in anger over corruption and mistrust of authorities, but the government died temporarily in 2008 after a 17-year-old boy who had been vaccinated with the combined measles and measles vaccine died. rubella. One of the reasons is that vaccination was stopped.
(Translation: Acrelen)
