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There is fibrillation in the scientific community and among researchers and scientists who have been fighting for months to counteract Sars on 2 which triggers Covid 19, more than 50 million infected in the world to date and more than 1.2 million deaths. A Covid vaccine candidate jointly developed by Pfizer me BioNTech it was effective in preventing 90 percent of infections during phase 3 of the trial, which is still ongoing. The first data from the last phase of the experimentation are analyzed by an independent committee that met yesterday. “The results show that our mRna-based vaccine can help prevent Covid-19 in the majority of people who receive it. This means that we are potentially one step away from supplying people around the world. a much-needed breakthrough to help end this global pandemicAlbert Bourla, Pfizer’s number one, says in a letter posted on the website of the US pharmaceutical company. News that has also excited the markets. The two companies are working to increase production, with the ambitious goal of having 50 million doses, enough for 25 million people since the administration includes 2 doses, by the end of the year and 1.3 billion doses in 2021. “Encouraging news” for WHO Director General Tedros Adhanom Ghebreyesus.
How BNT162 works – The vaccine candidate BNT162 uses messenger RNA, similar to that of modern American society, also in phase 3. The vaccine uses a innovative technology. Each injection contains lipid nanoparticles (fat bubbles) that surround a strip of genetic material, theRNA messenger indeed. After the serum is injected, the fat capsule carries its cargo to the cells and the messenger RNA signals them to build the protein spike, effectively teaching the immune system how to recognize and block the coronavirus thanks to T cells and antibodies. When one comes into contact with the virus, all are already activated to fight Sars Cov 2. The effectiveness of the Pfizer vaccine is “extraordinary”, says the American immunologist Anthony Fauci: will have a major impact on the response to Covid-19. The scientist also said that the vaccine being tested by the American biotechnology company Moderna, in conjunction with the National Institutes of Health, “could have similar results to the Pfizer vaccine because it is also based about messenger RNA technology“.
Pfizer: “A historic moment” – The company developed the vaccine in collaboration with Pfizer in the United Statesand with Shanghai Fosun Pharmaceutical Group in China. The companies selected one of their four initial candidates for the human trial, which generated the most promising antibody responses, to now move on to a phase 3 study of more than 40,000 people. Bourla had stated that this vaccine would likely become a seasonal administration like the flu. “I would say it is a historic moment – he says Kathrin Jansen, Head of Vaccine Research and Development at Pfizer – Nothing like this has ever happened before. The world has had to face such a terrible situation, the pandemic, and being able in such a short time to do what usually takes many years. But above all, Jansen says in an interview, “to feel that in the intermediate analysis we have achieved an effectiveness of more than 90%, it was almost amazing“.
At the trial it involved 44 thousand volunteers, there have been 94 cases of Covid-19 so farAbout 9 of these cases occurred in people who had received two doses of the vaccine, “a strong sign of efficacy.” The data has not yet been published. According to the independent committee, no particular safety concerns arose: Side effects are injection site pain, fatigue and fever, which are more common among younger people. Pfizer and the German company Biontech aim to submit the emergency authorization request to the FDA, the US pharmaceutical agency, after the third week of November. when they will have the safety data available, after 2 months of follow-up, in half of the trial participants, in addition to data from the production process. The trial will continue until reaching 164 cases of Covid-19, which should take place in a few weeks.
To understand the importance of the news, if this is confirmed by the final data on experimentation, it is enough to remember that a few weeks ago the American Journal of Preventive Medicine published a work in which it was explained that in the absence of other interventions to prevent an epidemic, the vaccine must be effective (i.e. likely to prevent infection) at least 70% when vaccination covers at least 75% of the population. While to extinguish an ongoing epidemic and avoid the need for other measures (for example, social distancing), the vaccine must be at least 80% effective with 75% vaccination coverage. Obviously, achieving 75% coverage is not easy, since you need to have the number of doses and the personnel necessary to administer it.
And the president thanks the volunteers – “The results show that our mRNA-based vaccine can help prevent Covid-19 in the majority of people who receive it. This means that we are potentially one step away from supplying people around the world. a much-needed breakthrough to help end this global pandemic – says Albert Bourla, president of Pfizer, in a letter posted on the website of the US pharmaceutical company -. Currently, we are unable to request FDA clearance for the use of emergency vaccines based solely on these efficacy results. In fact, more safety data is needed, which we estimate will arrive in the third week of November, as part of our clinical trial which is still ongoing“Bourla also points out that the company, which is working on the vaccine in collaboration with BionTech,” is working to demonstrate that the vaccine can be produced consistently meeting quality standards, “recalled the president of Pfizer” lefficiency, safety and constant production are the three necessary requirements before applying for authorization“” I want to thank the thousands of people who have volunteered to participate in the clinical trial – he concludes – our collaborators and researchers, colleagues from all over the world who are dedicating their time to this crucial task. We could not have reached this point without the great commitment of all., his dedication and courage are the reasons why we continue to believe that science will win. ” Pfizer had submitted the application for authorization to the EMA (European Medicines Agency) on October 6.
Virologist Uk Jones: “Awesome” – “At present, it is likely that a vaccine against a new virus can be achieved rapidly as never before in human history,” said the German foreign minister. Jens spahn – We can be optimistic ”. The announced results are “really impressive” for the level of “protection”, comments the virologist Ian Jones, from the British University of Reading, hypothesizing a potentially better result even than that, hitherto considered in the first position in the front of anti-Covid hopes, recently leaked in the context of the same phase 3 for the prototype developed byOxford University together with the pharmaceutical manufacturer AstraZeneca and with the collaboration of the Italian company Irbm de Pomezia. Jones outlines the all-new procedure used for the Pfizer prototype, the only one in the world that Moderna Inc (USA) is testing. “Of all the vaccine candidates in development, BioNtech seems to have the best shot in the barrel.” continues the British scientist. “The data from the trial shows really impressive, excellent results and no adverse side effects were reported. The only thing we do not yet know is the duration of response in all “patient groups”.
Von der Leyen: “300 million doses for Europe” – “Excellent news from Pfizer and BioNTech on the positive results of their clinical trial for a Covid-19 vaccine. European science works! The Commission will soon sign a contract with them for up to 300 million doses. In the meantime, we continue to protect each other ”, writes the President of the European Commission, Ursula von der Leyen, on Twitter. Meanwhile, the European Commission has “signed pre-purchase contracts with three pharmaceutical companies that are developing a vaccine against Covid-19”, AstraZeneca, Sanofi-Gsk and Johnson & Johnson. “We are negotiating contracts with three other companies, including Biontech-Pfizer,” recalls the spokesman for the Health Commission, Stefan de Keersmaecker, during the press conference in Brussels. “As soon as we have reached an agreement on the contract with Biontech-Pfizer or another company, we will inform you. What we care about is developing a portfolio of vaccines that is as diverse as possible“.
Oxford AstraZeneca vaccine trials to begin in Italy – With Pfizer and Moderna in the final phase, there are at least nine other candidate vaccines. Including that of Oxford AstraZeneca which will also be tested in Italy. The tests will begin in December at the Aou in Modena, one of the seven Italian centers selected for this delicate and complex phase of the vaccine study. 300 volunteers will sign up in Modena alone. The first results will be achieved in six months, while the hope is that the vaccine will be available to the population in April 2021. “We are part of a worldwide study of 30 thousand patients – explained in videoconference Cristina Mussini, director of the complex structure of Infectious Diseases Aou de Modena and professor at UniMoRe, and this will require a huge effort. Our room for maneuver for longer bureaucratic times is nil ”, he stresses, on pain of excluding the center of experimentation. “We look forward to participation.” And judging by the location, which is the Polyclinic switchboard jammed “as if we were at war” with orders, it won’t cost you to find candidates.
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