EMA’s opinion on AstraZeneca’s vaccine stirs up European immunization | Society

A health worker shows a vial of AstraZeneca, on March 24 in Rome (Italy).
A health worker shows a vial of AstraZeneca, on March 24 in Rome (Italy).ANDREAS SOLARO / AFP

The pharmaceutical AstraZeneca should finally warn that among the “very rare side effects” of its vaccine against covid-19 is the “unusual” possibility that it generates blood clots. Using the utmost caution, the European Medicines Agency (EMA) concluded on Wednesday that there is a relationship between the drug and cases of blood clots detected in European Union citizens who had been administered the vaccine. The opinion, which emphasizes the “high effectiveness” of the vaccine to save lives, has caused a new shift in the criteria used by EU countries for their vaccination campaigns. Spain, Italy and Belgium decided to impose new restrictions after a meeting by videoconference of the 27 health ministers.

The EMA report is the result of an in-depth investigation of 86 cases of thrombi reported by national authorities up to March 22, of which 18 resulted in death. 62 thrombi were cerebral and 24 abdominal. After that date, countries continued to bring cases to the EMA, so that as of April 4, 222 cases had been registered across the EU. Until that day, 34 million people had been vaccinated in the countries of the European Economic Area and the United Kingdom.

Much of the vaccination strategy of the 27 EU partners depended on the conclusions of the Pharmacovigilance Risk Assessment Committee, since the agency left the application of the opinion in the hands of the States. The Netherlands, Germany or Finland had decided to restrict the use of the AstraZeneca vaccine to citizens aged 60 years and over, since most of the cases had occurred in women under that age. The EMA, however, has not yet been able to confirm that the factors of age, sex or medical history are determining factors for suffering clots. Moreover, the experts of the agency have reasoned that given the different use that is being given to this vaccine in each country – with greater administration to women of that age – it cannot be concluded that this group has a higher risk than the rest. .

Despite the fact that the EMA has insisted that it could not establish a more vulnerable population layer, several countries (including Belgium, Spain and Italy) have chosen to be more cautious with the use of AstraZeneca serum. Anticipating the effects that the EMA’s opinion could have on the vaccination campaign, the rotating presidency of the EU, in the hands of Portugal, called a ministerial meeting to try to agree on a position that would give “confidence” in European citizenship, that until now has seen how the capitals have made the vaccination criteria a strange gibberish.

The European Commission has also tried to encourage a coordinated response. At the meeting in which the 27 partners shared the decisions they suspected, the European Health Commissioner, Stella Kyriakides, warned the ministers that while the decisions they adopt were to be political, they should be based on “ a scientific evaluation of the risks and benefits ”. “It is essential that we follow a coordinated European approach. An approach that does not confuse our citizens, and that does not ignite the suspicions of vaccines, that is based on science, “he said.

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However, Belgium has not waited even for the end of that meeting to announce that it was going to restrict the administration of the vaccine to people over 55 years of age, as France is currently doing. After the meeting, Spain and Italy have reported that they would dispense the drug from the Anglo-Swedish company to those over 60, following in the footsteps of Germany, the Netherlands and Finland.

These changes of criteria that countries may adopt will mean new adjustments in a European vaccination campaign that, after a first quarter at idle due to non-compliance by AstraZeneca, was beginning to pick up pace. Despite the fact that on Wednesday only 6.4% of the European population had received the complete immunization schedule, the Commission considers mid-July as the date on which 70% of the adult population could be vaccinated if they strictly comply with deliveries.

A man receives the AstraZeneca vaccine on Tuesday in Ronquieres (Belgium).
A man receives the AstraZeneca vaccine on Tuesday in Ronquieres (Belgium).YVES HERMAN / Reuters

EMA experts maintain that they will continue to investigate the side effects of this vaccine, for which there is currently no treatment. However, they support the use of a drug that has been shown to be “highly effective”, in the words of the executive director of the EMA, Emer Cooke, and that practically prevents the covid-19 from evolving into a serious phase. “The risk of mortality from covid-19 is much higher than mortality from these very rare side effects,” Cooke said at a press conference from Amsterdam.

The EMA’s message was clear: there is a link between the thrombi detected and the administration of the vaccine by the Anglo-Swedish pharmaceutical company, but these are very rare cases and the benefits of the vaccine continue to prevail. “Covid-19 is a very serious disease, and the vaccine is effective in preventing illness, hospitalization, and mortality. As a whole, the benefit outweighs the risk ”, explained Sabine Straus, head of the EMA Security Committee. The decision was made after having also studied reports from independent experts.

More cautious than the EMA was the World Health Organization, which has considered that the link between the vaccine and registered thromboembolisms is “plausible, but not confirmed”. The pharmaceutical company highlighted in a statement that the tests by the British and European agencies “reaffirmed that the vaccine offers high-level protection against all serious forms of COVID-19 and that those benefits continue to far outweigh the risks.” AstraZeneca’s drug was the third to be cleared by the EMA and the European Commission to go on the market. Before, the Pfizer-BioNTech and Moderna vaccines had done it, and then Janssen’s.

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