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L ‘European Medicines Agency gave conditional green light to the anti-Covid vaccine Pfizer-BioNTech. This means that the drug, registered under the name ‘Comirnaty‘- everything happened security reviews envisaged by European scientific protocols and is safe to combat coronavirus. “We have reached this milestone thanks to the dedication of scientists, doctors and trial volunteers, as well as many experts from all EU member states ”, said the executive director of the EMA, Emer Cooke. “We can guarantee to EU citizens the safety and efficacy of this vaccine that satisfies them Quality standards necessary. “Then he clarified that it will be used” to prevent Covid-19 in people 16 years old and up“While for the pregnant women “more data” is needed. For them, a “case-by-case approach” is recommended. At night, the go-ahead for the marketing of the drug by the European Comission: the president Ursula von der Leyen announced that the vaccine “will be available to all Member States at the same time and under the same conditions” and vaccination will begin “on December 27, 28 and 29. This – he added – is a great way to end this difficult year and finally start moving forward. The Minister of Health also commented on the green light Roberto Speranza: “Having a vaccine effective and safe, it opens a new stage and gives us more strength and confidence ”, he said, recalling, however, that the battle continues to be a challenge and that we must not lower our guard.
Cash against the English variant – Regarding the fears that have arisen in recent hours about its possible resistance to mutation unearthed in UKInstead, Cooke explained that “at this time no directions that the vaccine will not work against the English variant ”. “It would be worrying if we had multiple mutations, especially in protein spike“he added Marco Cavalry, responsible for vaccination strategies of the EU Agency. “However, I think that to force us to update the vaccine with the new strains, the virus must change substantially. At the time we are not worried“.
What does approval mean? “Conditioned” – The authorization to Pfizer-Biontech comes just over a week after the counterpart’s similar decision. U.S Ema and took place in the form “conditioning“. What does that mean? It’s a formula of urgency used multiple times in the past and allowing you to reduce approval times without sacrificing security. The initial roadmap provided for the green light for December 29 and the start of the vaccination campaign in mid-January, but last week the EMA announced that it could further anticipate the procedures. Therefore, the first doses of the vaccine can be administered in Europe as soon as December 27, the date of V-day.
First doses from December 27 – That day, as the president of the Commission Ursula announced a few days ago Von der leyen under pressure from EU leaders (including Italy), the vaccination campaign will start at the same time in the 27 countries of the Union symbolically seal the result of the common fight against the pandemic. Although the director of EMA Cooke warns: “The vaccine by itself will not be the ‘silver bullet’ that will allow us to return to normal life. But the authorization of this first vaccine is definitely an important step in the right direction. Meanwhile – he warned – we must do everything possible to prevent “Covid-19” following the indications of the health authorities: wear masks, wash your hands and keep your distance“.
Von der Leyen: “Turning point, now act fast” – As soon as the news of the green light arrived, all the European chancelleries expressed their satisfaction. And late in the afternoon the second green light came, the EU Commission. “Today we add an important chapter to our battle against Covid-19. We have decided to make the first vaccine against Covid-19 available to European citizens: we have granted a conditional marketing authorization to the vaccine produced by BionTech me Pfizer“Announced the president Ursula von der Leyen. L ‘Mother, Points von der Leyen, “They examined the vaccine thoroughly and concluded that it is safe and effective against Covid-19. Based on this scientific evaluation, we proceeded to authorize it for the EU market. As promised, it will be available to EU countries at the same time and under the same conditions. The first packages will be shipped from the Pfizer factory here in Belgium in the next few days. “
Vaccines, continued von der Leyen, “They can start at the same time, during the EU vaccination days, on December 27, 28 and 29. It’s a very positive way to end this difficult year and start turning the page on Covid-19. It is our first vaccine: others will be approved soon, if they are safe and effective ”. Then he recalled that “the EMA will give its opinion on the vaccine Modern the January 6 and while we deliver vaccines to Europeans, we also ensure them for the rest of the world ”. Von der leyen says she is “proud” that the first Covid-19 vaccine “available in Europe it is a true product of European innovation. BionTech – remember – received more than 9 million euros from EU funds to develop this technology and a loan of 100 million euros from TO, guaranteed by the Commission, in June. This helped expand its production capacity and distribute the vaccine quickly around the world. It is a true European success story ”, he concluded.
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