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The list of countries that have suspended the administration of the vaccine by the pharmaceutical company AstraZeneca and the University of Oxford due to serious (but rare) reactions continues to grow. As of Tuesday, a total of 21 countries had suspended the injection, indefinitely or for a few weeks.
Austria, for example, has only suspended inoculation with a specific batch of vaccines. And Venezuela, which has not yet begun to inoculate the population, has totally banned the administration. The AUDIENCE gathered some questions (and answers) about what is at stake.
Who stopped or did not proceed with the administration of this vaccine?
So far, Portugal, Spain, Italy, Germany, France, Norway, Austria, Romania, Estonia, the Netherlands, Iceland, Lithuania, Latvia, Bulgaria, Luxembourg, Cyprus, Ireland, Denmark, Sweden, Indonesia and Venezuela have already taken measures to caution. .
What is at risk?
The decision of several countries comes after some cases of blood clots and the death of some people inoculated with this vaccine are known. On March 7, Austria stopped using the vaccine after one person died and another became seriously ill. This specific batch of vaccines was sent to 17 countries of the European Union (list that Portugal does not include). Days later, one of the three hospitalized healthcare professionals in Norway died after receiving the AstraZeneca injection.
How many cases of reactions have been detected?
According to Reuters, until March 10, 30 cases Thromboembolic events (when a blood clot blocks a vein). The president of Infarmed, Rui Santos Ivo, confirmed that Portugal registered two cases of thromboembolism, but guarantees that these situations are “of a different clinical profile” and that they are recovering.
Is it known if the reactions are related to the vaccine?
No. As the director general of the WHO, Tedros Adhanom Ghebreyesus, warned at a press conference, the fact that the reactions occurred after vaccination “does not necessarily mean that these events are related.”
How many doses were administered in Portugal? And in Europe?
Approximately 400 thousand doses of the drug AstraZeneca have already been administered in Portugal and around 200 thousand doses will now be in storage. According to the General Director of Health, Graça Freitas, on Monday, 17 million doses of this vaccine have already been administered in Europe.
What are the consequences of the suspension for Portugal?
The vaccination process against covid-19 will be delayed for two weeks. Henrique Gouveia e Melo, coordinator of workgroup For vaccination, he said that teachers were one of the groups expected to receive this vaccine in the coming weeks. The same happened with users older than 50 years with comorbidities, but Gouveia e Melo guaranteed that they will be vaccinated with the available doses of the other authorized vaccines.
What should the person who took the first dose do?
Graça Freitas said this Monday, at a press conference, that Portuguese citizens who took this vaccine should “wait in peace.” The Director General of Health said that reactions to the vaccine are “extremely serious, but extremely rare”, and asked that they be attentive to any prolonged discomfort, “especially if it is accompanied by bruises or skin bleeding”, if it persists consult a doctor .
Health professionals who suspect adverse reactions in patients should also be alert and notify the National Pharmacovigilance System.
Will the second dose be administered?
Still, according to Graça Freitas, the second dose is expected to occur “in a long time”, now waiting for the European Medicines Agency (EMA) and all other entities to reach a conclusion.
What is being done at the global and European level?
The World Health Organization (WHO) expert committee on vaccine safety will meet Tuesday to discuss the vaccine.
The EMA has also announced that it will hold a special meeting on Thursday to analyze this situation, but again stressed, on Tuesday morning, that the benefits of using the vaccine continue to outweigh the risks. The agency’s executive director, Emer Cooke, said the vaccine-related problems “are not unexpected,” given millions of people are vaccinated, and affect “a small number” of those vaccinated.
The official also stressed that “there is no evidence that the vaccination [com o fármaco da AstraZeneca] that caused these situations ”, in addition to the side effects that only occurred“ in a small number of people who received the vaccine ”. Cooke assured, however, that the EMA will continue to investigate this situation, “taking into account the fears of the citizens”, adding that the regulator’s priority is “to guarantee the safety of the vaccine”. The EMA is expected to issue a final opinion on the matter after Thursday’s meeting.
If the risk is low, why was the administration suspended?
First, because, as the WHO director general explained, it is common practice to investigate cases such as those that have been reported to find out the origin of the effects. Furthermore, in many countries, such as Germany, France and Portugal, this is just a “precautionary measure”, as the German Health Minister said, Jens spahn.
“Given the many millions of doses administered so far, I suspect that these episodes should not be caused by the vaccine and are simply random associated events. If it was a real phenomenon, I expected to have many more cases now. Even so, these cases have to be properly investigated, ”Paul Hunter, professor of medicine at the University of East Anglia (United Kingdom), explained to the PUBLIC on Monday.
Miguel Castanho, from the Institute of Molecular Medicine at the University of Lisbon, says that “there may be a problem with a certain batch of the product”. “There, it is no longer the intrinsic rarity of the phenomenon that will appear on a large scale. Then something happened in a certain batch, ”he says.
Professor Andrew Pollard, coordinator of the Oxford University group that developed the vaccine, told the BBC that there was “very reassuring evidence that there is no increase in the phenomenon of blood clots in the UK, where most of doses in Europe [foram] given so far ”.
What does the pharmaceutical company say?
The company has already said that there is no reason to worry about the vaccine and that fewer cases of thrombosis have been reported in people who received the injection than in the general population. “The numbers were much lower than would be expected in a sample this size and are similar to other licensed vaccines,” AstraZeneca said in a statement.
Developed in conjunction with the University of Oxford, the AstraZeneca vaccine was one of the first covid-19 vaccine to be developed and launched in large volume since the novel coronavirus was first identified in China. Because it is cheaper (and not only), it is a crucial part of vaccination programs in many developing countries.
Are there reports of similar reactions with other vaccines?
The UK Medicines and Health Products Regulatory Agency (MHRA), a country that has already vaccinated 11 million people with this vaccine, tells the The Guardian that as of February 28, more cases of blood clots were detected in people who received the Pfizer / BioNTech vaccine (38 cases) than in AstraZeneca / Oxford (30 such reactions). “These cases are not proven side effects of the vaccine. Blood clots can occur naturally, ”a spokesperson told the newspaper.