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It won’t be long. Completion of the Oxford vaccine trial is scheduled for late October. Italian Prime Minister Giuseppe Conte announced today: “If the last stages of preparation, the so-called ‘continuous review’, of the Oxford-Irbm Pomezia-Astrazeneca vaccine are completed in the coming weeks, the first doses will be available early in December”. Another trustworthy candidate (from the modern American company) will publish the test results in November. A handful of plants in the world, even before the end of the trials, have already started the production of the first doses, including the huge Indian center of the Serum Institute, capable of producing one billion doses of the Oxford vaccine in the coming months . Meanwhile, the agency that regulates medicines in Europe (Ema) has begun with the review of the data, both of the Oxford candidate, produced by the Anglo-Swedish company Astra Zeneca with the collaboration of Pomezia Irbm biotechnology, and of the BioNTech vaccine. and Pfizer, who announced the first doses by the end of the year. In Italy, Anagni’s company Catalent, which will be in charge of filling the Oxford vaccine for the whole of Europe, is working to guarantee the first packages soon.
At the beginning of December we will have the first two or three million doses ”, Conte explained. “Millions more will arrive shortly thereafter. The European Commission has commissioned Astra Zeneca and other companies a few hundred million doses. I think that to fully contain the pandemic we will have to wait until next spring anyway.” The Minister of Health, Roberto Speranza, had indicated the categories to vaccinate first in health workers, policemen and the elderly in RSA, because they are more exposed to contagion. Getting to cover the entire population, then, will be a job that will take months or years. Also, because vaccine immunity begins about a month after inoculation and most study vaccines (including Oxford) require a booster one to two months after the first dose. According to Andrea Crisanti, director of the microbiology laboratory at the University of Padua, “I don’t think we’ll talk about it before 2022. Only then will everyone have access to a vaccine that works.” One of the biggest questions about the vaccine is how long your protection will last. The fear is that it will not exceed one or two years. In this case, once the entire population has been immunized, it will be time to start over.
Meanwhile, Britain has authorized a so-called “Human Challenge”. Yesterday he announced that he will first test the vaccine on some volunteers, then subject them to an intentional infection, injecting small doses of the virus into the nose. In this way it will be possible to check the effectiveness of the immunization very quickly. This is a controversial decision, because it admits the possibility of making healthy people sick with a virus that can also put young organisms in difficulty. The advantage is that it will allow us to evaluate the effectiveness of a vaccine in a few weeks.
In normal trials, it is first necessary to administer the candidate vaccine to a certain number of volunteers, then to verify the proportion of infected people in normal life conditions, and finally to compare these data with those of the non-immunized population. If the statistical difference is significant (but it will take months for this to emerge), it will be possible to measure the effectiveness of a vaccine. The British Human Challenge, coordinated by Imperial College London, will involve up to 90 volunteers between the ages of 18 and 30 starting in January, who will receive an injection of coronavirus, in minute quantities, into their nostrils, then will be isolated in a structure ad hoc, subjected to strict isolation. On the American site 1DaySooner, independent and disconnected from official initiatives, almost 40 thousand people have left their names and expressed their willingness to submit to the Human Challenge.
Meanwhile, the American company Moderna – which has developed a vaccine against Covid with a pioneering method, never before used, called messenger RNA, also used by Pfizer and BioNTech – announced that it could distribute the first doses in December. “We will apply to the FDA for emergency clearance,” Chief Executive Officer Stéphane Bancel announced in the Wall Street Journal. The FDA is the US regulatory body charged with evaluating the efficacy and safety of new pharmaceutical products. There are around three hundred candidate vaccines for study worldwide, 35 in phase one of the human trials, 19 in phase two and 11 in phase three, the last. “The first analysis of the FDA – explained Bancel – will probably take place in November, but it is difficult to say exactly in which week, because it depends on the number of cases. If, on the contrary, it will take longer to obtain the results, the green light it could come next year. “
By November, Russia also promised to publish the results of the first 5-10 thousand volunteers immunized with its Sputnik vaccine. China, which said it was able to begin immunizing the general population within a year, is moving ahead with trials of its five candidates that have reached final tests in humans. Sinovac vaccine is offered to all residents of Jiaxing City these days. The China National Biotechnology Group, on the other hand, is offered free of charge to Chinese students who want to study abroad. The Serum Institute in Pune, India, which normally produces 60% of the world’s vaccines, said it was ready to launch the first doses of its plants in December. But this race to curb the pandemic has a price: the Indian pharmaceutical giant has had to stop the production of vaccines against measles, rubella, mumps and hepatitis B. Since the priority of the low doses produced goes to the countries developing, suffer Rich countries should be more than hardships.
