EU chaos on vaccines, AstraZeneca “burned”: the specter of a political decision and the first credibility test for Draghi
It is difficult to imagine a worse management of the European (and Italian) vaccination campaign. But reality is exceeding our already very low expectations. The bomb was dropped yesterday afternoon: with a coordinated decision at least in time, Germany, France, Italy and Spain suspended the administration of the AstraZeneca vaccine in their respective countries pending a final word from the EMA on recent cases of thrombosis and other reactions adverse. Too bad that the EMA will take until Thursday to pronounce (again because we are in an emergency …). Within 24 hours, AIFA went from reassuring citizens, speaking in an official statement of "unjustified alarm" and "no proven causality" between the deaths and the administration of doses, to the prohibition of using AstraZeneca "on everything the national territory "," as a precaution and temporary, pending the pronouncements of the EMA ". In the meantime, Ema assures that it will continue to investigate but reiterates that it considers the suspension unjustified.
Not even 24 hours earlier, the new extraordinary commissioner, General Figliuolo, had been sent on television to outline the new amazing vaccine plan (500,000 doses per day and 80 percent of the population vaccinated by September: a dream). A plan that, as we shall see, risks being crippled by the decision to suspend AstraZeneca . Not even 12 hours earlier, at SkyTg24 , Professor Franco Locatelli, president of the Higher Health Council, had reassured us as follows: “I would let my loved ones do it, without any hesitation, reserve or reluctance. It is a safe vaccine, which has an excellent efficacy profile, and it is important that it is used ”.
The question we have all asked ourselves is: why ? Why a decision that seems to be self-defeating, which once again exposes the vaccination campaign of the European Union and the individual states that are part of it to ridicule?
What we know from sources cited by all the agencies is that it was a decision taken at a political level between the major EU countries – Germany, France, Italy and Spain (and communicated in that order) – following a comparison between the respective ministers of health. As for Italy, sources of the Ministry of Health have specified to the agencies that the decision was taken after an interview between Prime Minister Draghi and Minister Speranza, after the latter had spoken with his colleagues in Berlin. Paris and Madrid.
The circumstance is confirmed by the director general of Aifa, Nicola Magrini, who last night at 8 and a half , on La7 , reiterated that "the vaccine is safe", that it is a question of "verifying the onset of very rare cases of thrombosis which caused a stir ”, and spoke of a“ political will of Germany, France, Italy and Spain to move together ”.
First short circuit: Aifa, a theoretically independent agency, which should make its decisions on a scientific basis, has aligned itself with a coordinated decision at a political level between several European governments. Where has the science-based EU approach gone, without influencing independent agencies?
It is also the first real credibility test for the Draghi government and the Prime Minister himself: a crisis that requires very convincing explanations to be given as soon as possible to the hundreds of thousands of citizens already vaccinated, or waiting to be vaccinated, with AstraZeneca . If the premier wanted to distinguish himself from his predecessor for a more measured and sober use of words, well he succeeded. But now his silence on such a far-reaching decision, precisely because of the vaccine plan announced a few hours earlier with great fanfare, raises concern.
We will probably have some indication as to the reason for this suspension in the light of the EMA's pronouncement on Thursday.
One of the hypotheses is that the governments of these four countries, pending the decision of the EMA, wanted to block the vaccine as a precaution to show their public opinions that they care about transparency and safety. A communication strategy, therefore, and not a scientific evaluation, would be at the basis of the precautionary principle adopted, especially since both the EMA and the WHO reaffirmed the validity of the AstraZeneca vaccine even after the news of the suspension decided by the governments. .
Second short circuit: the EU approach with anti- Covid vaccines was to centralize their purchase (European Commission) and authorization (Ema), but then the governments went in no particular order to block AstraZeneca .
Taking the other countries with it, as too often happens in Europe, is Berlin, which announces its decision to its partners after 7 cases of thrombosis out of 1.6 million doses administered – but perhaps above all after the electoral blow suffered last Sunday by the party by Angela Merkel in Baden-Württemberg and Rhineland-Palatinate. The governments of other countries obviously found themselves in the position of not being able to show less caution than the German one. The French government was "taken by surprise" by the German decision, Paris government sources admitted to Radio France last night. The two countries had agreed to await an opinion from the EMA, but faced with the decision of Germany, "our main European partner", France could not remain isolated and continue the vaccination, explained the same sources.
So, all together, but pushed by Berlin, they were afraid to take responsibility and decided to wait for the full "coverage" of the EMA.
In a note, the Director General of the Prevention Department of the Ministry of Health, Gianni Rezza, explained that "the EMA will meet shortly to clarify any doubts in order to be able to start again as soon as possible and in complete safety with the AstraZeneca vaccine".
But the most serious mistake is precisely that of thinking that after such a drastic decision we can restart with the administrations as if nothing had happened, indeed with greater confidence of citizens in vaccines and in the "validation" process. On the contrary, the risk we see is that of a terrible backlash on the vaccination campaign. Even if the EMA confirms its green light , AstraZeneca is "burned". Already presented, erroneously, to the public as a "series B" vaccine – when instead it provides 100 percent coverage from the most severe forms of the disease and is already very effective within hours of the first dose (while with Pfizer and Moderna after a week from the second, which occurs after 3/4 weeks from the first) – even if readmitted, many citizens will refuse it, canceling their reservations or worse by not showing up. And how to blame him?
After fueling terrorism on the virus, they are now irresponsibly fueling terrorism on one of the most effective (not the only) strategies to get back to normal: vaccines. A “comma 22” , as Marco Faraci observes. With a tragic paradox: by blocking the administration of a vaccine in the presence of adverse reactions as we will see very rare, without a greater statistical incidence compared to the general population, and above all without demonstrated correlation, the European governments to protect themselves from the controversy of the no-vax in fact the line.
But there is a second hypothesis: that we wanted to “burn” AstraZeneca itself . A passage of Magrini's intervention at 8 and a half should sound an alarm bell: “There are three more mature vaccines on the way, safe even against variants”. It is alarming to talk about vaccines "coming" a week from the beginning of spring, with a vaccination campaign already terribly late, as if we could lightly give up AstraZeneca because so many others are about to arrive.
Suffice it to say that without AstraZeneca we would have 37 million fewer doses than planned (25 percent less) at the peak of the campaign, from April to September. And 2.9 million fewer doses by March (38 percent less).
It would mean crippling the plan just announced by General Figliuolo. But we repeat: even if AstraZeneca were to be readmitted, many citizens could refuse it based on the suspicions raised in recent days. Which would open up another very thorny question: what to do with these citizens? If excluding them from the plan would be counterproductive, and forcing them unacceptable, it would open the way for everyone to choose their "preferred" vaccine, with the risk of leaving millions of doses unopened.
One of the "incoming" vaccines, coincidentally, is that of the German company Curevac , already under review by the EMA. And it is news a few days ago that the Swiss Novartis has concluded a preliminary agreement for the production of Curevac in a newly built plant in Austria. Without forgetting that there is always the Russian Sputnik V vaccine at the window.
Considering the alarm now raised in public opinion, and the delays in deliveries, Berlin and Paris may have decided to "sacrifice" AstraZeneca for the benefit of other Big Pharmas , which would offer them an alibi for the failure of the EU vaccination campaign (one of the vaccines we had bet on proved unreliable) and an opportunity for revenge on the English rebels.
But Ema's no is not necessary for the perfect crime. To "burn" AstraZeneca , and justify the use of other brands now "on the way", it is enough to have insinuated in the population the suspicion that it is more risky than other vaccines.
In both of our hypotheses, behind the decision to suspend AstraZeneca there would be a purely political motivation. And if we try to enter into the merits, this suspicion is strengthened.
Considering production errors highly unlikely, only in batches destined for the EU, such as to cause such fatal outcomes, we look at the country where AstraZeneca's vaccine was administered en masse. Transparency is a tangible reality in the UK and all data on reported adverse reactions is public, online and easily searchable . Recall that these are not proven correlations, but only suspected on the basis of the coincidence in time. Well, AstraZeneca shows no substantial differences with Pfizer after approximately 10 million administered doses of each vaccine.
As reported by the newspaper Domani , an initial examination by the EMA revealed that the number of thrombosis cases among those vaccinated with AstraZeneca (30 out of 5 million doses) is in line with the cases of thrombosis that occurred in the same period of time in the unvaccinated population. Out of 11 million AstraZeneca doses administered in the UK, 45 cases of thrombosis have been detected, slightly fewer than those detected with Pfizer (48).
As David Spiegelhalter pointed out in the Guardian , about one in a thousand people get thrombosis every year, and probably more in the older population, who are vaccinated first. Thus, there could be 5,000 for every 5 million vaccinated in a year, about 100 every week. Up to February 28, about 54,000 "yellow cards" have been reported for AstraZeneca out of about 10 million doses administered ( Pfizer slightly less). Thus, for both vaccines, the reporting rate is around 3-6 per 1,000, much less than the side effects reported in trials .
According to data collected by Alex Berenson , far more fatal adverse reactions were reported in Europe after Pfizer doses than after AstraZeneca .
A substantial equivalence in adverse reactions should also result from the health authorities of EU countries. Why then only the AstraZeneca vaccine ended up on trial? If, on the other hand, the EU authorities were in possession of different data, they would have to produce them.
The post EU chaos on vaccines, AstraZeneca "burned": the specter of a political decision and the first credibility test for Draghi appeared first on Atlantico Quotidiano .
This is a machine translation from Italian language of a post published on Atlantico Quotidiano at the URL http://www.atlanticoquotidiano.it/quotidiano/caos-ue-sui-vaccini-bruciato-astrazeneca-lo-spettro-di-una-decisione-politica-e-primo-test-di-credibilita-per-draghi/ on Tue, 16 Mar 2021 05:00:00 +0000.