Emer Cooke, director of the European Medicines Agency (EMA), reiterated on Tuesday his confidence in the questioned punctures of AstraZeneca. “We remain convinced that the benefits of this vaccine outweigh the risks,” Cooke said at an extraordinary press conference in which he appeared by videoconference to explain the steps to be followed by the EU regulator, after at least 16 countries have suspended or limited vaccination with the Anglo-Swedish company drug.
Spain ended the campaign yesterday with the punctures of AstraZeneca in a movement in step with the great states of the continent – Germany, France and Italy – waiting for the experts of the agency based in Amsterdam to speak. The decision of the different national authorities comes after suspicions that the drug could be related to cases of thrombosis and embolisms, some of which have ended in death.
The EMA is in full investigation to determine if there is “a causal relationship” between the company’s vaccines and the incidents detected. To date, he has discarded this evidence. But he intends to provide more detailed conclusions this Thursday. The new facts “require a detailed evaluation,” said the agency’s director. “And only later will we be in a position to answer this question”
Cooke has highlighted that the episodes have been detected “in a small number of people”, when it is known that “many thousands” develop thrombi and embolisms annually “for many reasons”. These cases, at the moment, “do not seem superior to those of the general population,” he assured.
Given the medical emergency, the EMA’s Pharmacovigilance Risk Assessment Committee met this Tuesday in an “ad hoc” meeting, as explained by the director, with the intention of continuing with the analysis of the data that are arriving from the different countries “as we speak” and whose recommendations will be made public, in principle, in two days.
Cooke explained that the investigation does not rule out any hypothesis: some specific items are being tracked, the manufacturing process in European plants is also being analyzed, and at the same time the general and individual clinical information of the cases is being analyzed. reported by the different countries, in case the drug could affect certain subpopulations.
The director did not want to give figures for the number of cases that would be under investigation. In a statement last week, the EMA claimed that 30 thromboembolic episodes had been reported after administering nearly five million doses in the EU. The figure would be somewhat higher at this time. And it has encouraged the population and medical authorities to report any suspicious cases.
Cooke did not want to assess the decisions of member states to discontinue vaccination with AstraZeneca. “I understand that they are clearly awaiting our opinion,” he said. “It is a responsibility that we take very seriously.” The EMA is aware that the battle between skepticism and the credibility of citizens towards vaccines is at stake. “Our job is to maintain trust based on proper scientific evaluation.”
“With these vaccines we had very extensive clinical trials, which gave very good evidence that they were safe,” explained Peter Arlett, head of the Department of Pharmacovigilance and Epidemiology at the EMA, who also joined the press conference to explain that the safety committee is now examining “all the available evidence”, from the aforementioned clinical trials, to the doses sent to the countries, as well as epidemiological information and other health data that arrive in real time, as vaccination progresses. Among these reports we will “specifically” study those related to blood clots and “very rare side effects”.
Doubts about the AstraZeneca vaccine come amid growing tension between Brussels and the Anglo-Swedish company, over repeated breaches of its delivery schedule. The company acknowledged last week that it would not reach the target set for the first quarter, despite having already revised it downward. Of the nearly 100 million doses that had been agreed until March, it will finally provide about 30 million. Looking ahead to the second quarter, it will only deliver 70 million doses of the 180 planned.
In any case, to date, more than half of the AstraZeneca vaccines distributed in the countries remain uninjected. The company has shipped 14.8 million doses to member states of which 7.3 million have so far been used, according to ECDC data. The proportion is 49% (in Spain 48%), well below the average for the four authorized vaccines, which is 77%. And the difference is abysmal with that of the Pfizer-BioNtech preparation, of which 37 million doses of the 42 million sent have been injected, 88% (92% in Spain).
The Pfizer-BioNTech company, in fact, is taking advantage of the gap and seems destined to become the true European vaccine. The Commission has also announced this Tuesday that it will receive 10 million punctures of this drug ahead of schedule, which were scheduled for later, raising the laboratory’s deliveries to 200 million for the second quarter. “This is very good news,” said the president of the Community Executive, Ursula von der Leyen. “It gives member states room to maneuver and possibly fill the gaps in deliveries.” Pfizer’s is the vaccine of choice in the European portfolio: the EU has negotiated the advance purchase of up to 600 million doses, more than with any other laboratory.
Vaccination in the EU is still not progressing at the expected rate. Only 9% of the population has received a dose and only 3.9% have received a complete vaccination, according to ECDC data, still far from the target of 70% of the population set by Brussels for the end of the summer. So far, 61 million doses have been delivered to the 27 EU countries, of which 47 million (77%) have been administered. The United States, at the pace of a locomotive, more than doubles these figures, with 135 million doses distributed and 109 million administered (80%).
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