Economy

AstraZeneca, vaccine approval goal is already on Wednesday 27. Ema sprints

The Vaccinations In Italy today they are approaching one million and three hundred thousand. This means that if the daily rate reached last week – around 80,000 administrations every 24 hours – had been maintained, it would have been possible to reach the target set by Emergency Commissioner Domenico Arcuri of 6 million vaccinated by March. However, the delays announced by Pfizer-BioNTech for the next three weeks, and the consequent 28,000 vaccinations recorded on average in recent days, risk delaying everything.

For this, it becomes necessary to have the expected 8 million doses available from Italy as soon as possible by March AstraZeneca Oxford. For this to happen, however – as Arcuri himself also made clear yesterday at the press conference – so whoIlliterateEuropean Regulatory Authority. Final approval is expected on January 29 which, as we have learned from Italian sources close to the EU structure, “It can be expected a day or two in advance.” This was also confirmed by Austrian Prime Minister Sebastian Kurz, who announced yesterday that he “is working with other European Union countries to obtain approval faster and with less bureaucracy than AstraZeneca And other vaccines. The goal, in practice, is to be able to repeat what has already happened to validate Pfizer and Moderna, and to recover at least 48 hours.

However, roughly half of these will be used by the Italian Medicines Agency Aifa to give the green light to the English serum by determining the percentage of equivalence in relation to the vaccines already in use. “AstraZeneca This is the vaccine in the most advanced stage in terms of licensing review by Ema – explains Giorgio Palo, microbiologist and president of Aifa – but in Phase 3, there are now also CureVac and Johnson & Johnson. The first was developed by a German company, in collaboration with Bayer, and it uses messenger RNA just like Pfizer and Moderna. On the other hand, J&J, who has just published the stage 2 work but is already in stage 3, is using the adenovirus as a vector. But for these people, we will still need time. ”

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It is therefore not possible at the present time to determine exactly when and afterwards AstraZenecaOther “reinforcements” will arrive but we are considering, based on current assessments, in perspective a few months. So the time horizon for approval is spring. However, keep in mind that these are single-dose vaccines, and in the case of J&J, they have declared 80% effectiveness.

Meanwhile, the countdown to the Russian and Chinese vaccines has begun, too. In fact, EMA is working on the results so far produced by both Sputnik V and SinoVac. In the first case, the scientific review ended on January 19 and is now preparing to start the delegation process which will take a few months. Second, on the other hand, evaluations may take longer – perhaps not before summer – because it will first be necessary to understand whether the rigor used in conducting analyzes and experiments is suitable for European standards.

On top of that, Sputnik V actually had two significant openings yesterday. The first is that Hungary approved it under the licensing procedure for use in emergencies, and was the first country in the European Union to do so (the vaccine is already in use in Argentina, Bolivia, Serbia, Algeria, Palestine and Belarus). The second, and most important, from German Chancellor Angela Merkel: “If the vaccine is approved by the EMA, we will be able to talk about production and even use agreements.” Not only that, Merkel stressed that she had offered that through the Paul Ehrlich Institute, Russia would have “support in developing” the vaccine. “In addition to the wide political differences, we can certainly work together in the event of a pandemic, in the humanitarian sector,” the chancellor said.

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However, doubts remain greater on the Chinese front. What is cause for concern – other than the fact that the vaccine is already widely used in many countries around the world – are the various results obtained from tests conducted by experts. The proven effectiveness in Turkey, for example, is 91%, while in Brazil it is between 50 and 60%. A vast field on which the hopes of millions of people rest.

Last updated: 00:36


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