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The “accumulated” delays in the roadmap of some vaccine candidates: Oxford Astrazeneca and Sanogi Gsk in particular – the number one and founder of Biontech, the German company that developed the vaccine with Pfizer, seem to be of great concern. Ugur Sahin, in an interview with Der Spiegel, explained that they will be there gaps in dose supply in Europe until more vaccines are approved, even though the company is working at full speed to increase production of the drug.
“At the moment the situation does not seem good – Sahin said – a gap is being created because there are no other approved vaccines and we must fill the gap with ours.” However, the company aims to make a new production plant in the german city of Marburg in February, “much earlier than expected”, which should be able to produce more 250 million doses in the first half of 2021. Biontech so far has entered into agreements with five pharmaceutical companies in Europe to increase production and negotiations are under way with other specialized companies. “By the end of January, we should be clear about what and how much we can still produce,” Sahin added. The two companies initially planned to supply 1.3 billion doses worldwide this year, enough to immunize 650 million. people.
The German Health Minister, Jens Spahn, for his part urged the EMA to quickly approve the vaccine developed by the British university that was authorized just two days ago in the United Kingdom, although with the full double-dose modality that had proven its worth . less effective. The problem is that the vaccine – for a case that the researchers call fortuitous – has shown greater efficacy with doses and a half. But for the moment – despite the fact that new tests have been started to validate these results – for the EMA it is “unlikely” that it will give the green light to the vaccine in January for the European Union because precisely “we need more data on the quality of the drug “. The UK authorization for AstraZeneca had also been widely announced in recent days: London aims to start distribution from January 4.
In an interview with the Sunday Times, AstraZeneca CEO Pascal Soriot spoke of a “winning formula” against Covid. That is why the words pronounced by the Deputy Executive Director of the EMA were also surprising Noel wathion. However, due to the delay in the approval of the EMA, methodological errors would be made in the first experimentation of the candidate vaccine. AstraZeneca and Oxford: precisely the administration for a fortuitous event of doses and a half. Unlike the Sanofi case, which instead announced a postponement because, sadly, the candidate vaccine has proven ineffective in the elderly and will therefore have to be remodeled to elicit the necessary immune response. India, the second country in the world by number of infections after the United States, approved today the use of the vaccine, as reported by the Reuters website. The country wants to start administering the vaccine on a tight basis, probably by Wednesday, and thus joins the UK and Argentina.
On the home straight, except for surprises, it should be there‘Modern vaccine approval – developed with the messenger RNA technique like Biontech Pfizer but can be stored at much higher temperatures – on January 6 by Ema. The American company – which has already obtained approval in the United States by the FDA – has communicated official efficacy data that slightly exceed 94% in general and the 100% in the prevention of severe forms of Covid 19. Also, a few days ago, just to try to maximize production, Moderna and the Recipharm company announced an agreement for aseptic production and filling of drugs for supply to countries outside the United States. The activity will take place in the production plant of France. Subject to regulatory approval of the vaccine in countries outside the United States, supply is expected to begin shortly.
Ema’s approval on January 6 is particularly important for Italy – which between Oxford Astrazeneca and Sanofi Gsk had opted for some 80 million doses – because as the president of the Higher Health Council, Franco Locatelli, explained yesterday, with Que luz Green will be available another 10 million and 600 thousand doses of vaccine and by adding doses from Pfizer and Moderna, “basically we reached almost 62 million doses. Italy, Locatelli explained, “has at its disposal For the first vaccine that has been approved 27 million and 370 thousand doses. Negotiations at the European level then led to the availability for Italy of 13 million and 285 thousand additional doses. So only with Pfizer, in our country we basically exceed 40 thousand doses ”.
Meanwhile, the Pfizer / Biontech vaccine became the first vaccine to receive WHO validation for emergency use since the outbreak began. “Equal global access to vaccines is key to fighting the pandemic.”
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