“Our work on the AstraZeneca vaccine is aimed at determining the balance between benefits and risks of adverse side effects (ie deaths – ed) in administration and we remain convinced that the former outweigh the latter.” The Executive Director of the Medicines Agency (EMA) Emer Cooke, from Ireland, repeated this concept several times like a litany, postponing until Thursday for the final conclusion of the analysis and the publication of the response.
In a hasty press conference to react to the wave of decisions by governments of half of Europe including Italy, France and Germany, to suspend vaccinations with the newly discovered AstraZeneca, Cooke staggered by claiming, however, with extreme conviction that “the decisions of Ema are based on available scientific evidence “and this evidence does not indicate the emergence of a vaccine safety problem for those who take it. It is the same position claimed in the statement issued last night by the EMA, while one government after another decided to stop the AstraZeneca vaccine.
The EMA will issue on Thursday a recommendation that States can in principle also not apply because they exercise full sovereignty over vaccinations (strategies, implementation, choice of vaccines). The EMA is based on data from the EU Member States themselves. States base their decisions on the data of their territory as a starting point. The first, if today’s words make sense, seems to lean towards the “green light” for the AstraZeneca vaccine; you are already wondering what the second answer will be.
While over ten governments have placed the AstraZeneca vaccine in quarantine pending clarification from the European Medicines Agency, this appears to confirm what it has been repeating for days: there is no scientific evidence that proves the causality between taking that vaccine and thrombotic events leading to death. Too few cases of deaths, moreover – it seems – lower than the incidence detected beyond the anti Covid vaccinations.
Of course executive director Cooke added that EMA experts continue to work with the help of thrombosis experts; that the Agency is not operating in a pneumatic vacuum but the member states are also represented in the committee that decides. “We’ll have a clear conclusion on Thursday,” he promised. The moment is very complicated: governments must manage a public opinion seriously tested by confinements and by the persistent danger of contagion, as if seriously alarmed by the news on the deaths obviously amplified in the collective perception of what is happening. Legitimate and serious concerns. The EMA does not have the breath on the neck of public opinion, but it does have that of the governments that too often forget that the powers of the Agency are exactly those that they have granted it. The picture is completed by AstraZeneca’s failure to comply with the vaccine delivery commitments: however, this is not mentioned at the moment because confidence in the vaccine of the Anglo-Swedish pharmaceutical company is at a minimum. In fact, the cases in which the citizens themselves refuse to have it inoculated have multiplied.
It is therefore a question of rebuilding confidence in the entire process starting, obviously, with the AstraZeneca vaccine if it passes the exam on Thursday. Emer Cooke indicated that the Elma experts know by sifting through all aspects of the problem and all the data available to evaluate any “rare side effects related to taking the vaccine” AstraZeneca. It proceeds on a case-by-case basis on the basis of information provided by the States. So far, the head of the EMA insisted, “there are no indications that the AstraZeneca vaccine has caused thrombosis: thousands of people die in the EU every day, we have authorized four vaccines and we find ourselves with very rare thrombosis events”. On the numbers, Cooke was not unbalanced: «They evolve, in the rest of the world there are numbers similar to those that are evident in Europe; when a vaccine is injected into millions of people it is not uncommon to experience adverse reactions: we are evaluating any case to see if we are facing side effects or coincidences “and added:” A situation like this is not unexpected: when vaccinating millions of people it is inevitable that rare serious episodes of disease will occur after vaccination ‘.
In last night’s statement, the EMA indicated that “blood clot events, some with unusual characteristics such as low platelet counts, have occurred in a very limited number of people who have received the vaccine. Many thousands of people develop blood clots every year in the EU for various reasons. The number of overall thromboembolic events in vaccinated people does not appear to be higher than that observed in the general population ». This is the preliminary conclusion: “The EMA currently remains of the opinion that the benefits of the AstraZeneca vaccine in the prevention of Covid-19, with the associated risk of hospitalization and death, outweigh the risks of side effects”.
What was written yesterday was reiterated today in the press conference. The suspension by half of Europe of the AstraZeneca vaccine highlights the absence of a common line shared between governments and a common instrument with clear powers in which this sharing is reflected in a coherent way. Healthcare is a “territory” in which the Commission has only one possibility of coordination. Basically it does not move a step without the green light of the States. On the response to the economic crisis, the EU has responded quickly and with considerable ammunition with a European fiscal operation with a common issue of bonds, in dimensions never seen before (Next Generation EU is worth 750 billion euros). On the other hand, coordination in the management of the health crisis was difficult from the beginning (confinements, opening / closing of internal borders). Then there was the preventive joint purchase of vaccines: a winning operation only to find themselves grappling with AstraZeneca which did not respect the agreements by exploiting the links of the contracts obviously too loose on the one hand, on the other hand vaccine nationalism on a global scale with the interruption of the production chains of the vaccine (for example by the US which does not allow its export). In fact, the EU is experiencing problems not unlike those that occurred in the ten-year financial crisis, when there was no common line to protect all economies from the crisis with common tools. Ten years later he learned his lesson for economics, not yet for a terrible health crisis.