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1 – Why is the Pfizer-Biontech vaccine innovative?
It is an RNA vaccine, very different from the traditional ones. It would be the first in the world based on this technology that uses the information contained in the nucleus of Sars-CoV-2 related to the Spike protein that the virus uses to bind human cells and penetrate them. Once inoculated, the vaccine stimulates the production of antibodies against this protein. According to the announcement by the company Pfizer, a consortium with the German biotechnology company Biontech,BNT162b2 has been shown to protect 90% from coronavirus.
2 – How many are the “candidates” to become Covid vaccines?
According to three major international organizations (WHO, London School of Hygiene and Tropical Medicine, American National Institute of Health) vaccine candidates arein total 261, based on different technologies, and 55 are in the clinical phase. While we wait for a specific vaccine to be arrived at, we also test decades-old vaccines, assuming they can influence the immune system beyond the response against a specific pathogen for which they were created and provide broad-spectrum protection. against infectious diseases. An example is the tuberculosis vaccine: 20 centers are testing it, it could reduce the risk of contracting Covid-19. In the United States, a research group led by Robert gallo, one of the discoverers of the AIDS virus, studies the polio vaccine developed by Sabin in 1957.
3 – What other vaccines are close to the goal?
Very close seems to be that of the modern American, always based on RNA. The president of the multinational, Stephen hoge, told CNN last month: “We are on our way to apply to the FDA, the Food and Drug Administration, for authorization to place our candidate on the market in early December.” All the companies in pole position expect to be ready with the doses by the end of December and to begin distribution in the first months of 2021.
4 – Is there any Italian?
Among the most promising candidates is the vaccine developed by the Jenner Institute in Oxford, also developed at Advent-IRBM in Pomezia and produced by AstraZeneca. On October 6, the European agency EMA began examining the first laboratory (non-clinical) data. The procedure called continuous review “It does not imply that a conclusion can already be reached on the safety or efficacy of the vaccine, since most of the data has not yet been presented to the committee. The vaccine uses technology based on a adenovirus It acts as a ship to transport the Spike protein throughout the body and produce the immune response.
5 – What are the stages of the vaccine test?
To a preclinical phase (preparation of the preparation, in vitro studies, in vivo studies) follows a clinical stage which, in turn, requires three stages of human testing on a growing number of volunteers. It begins with the evaluation of safety, then efficacy and the presence of adverse reactions, before large-scale administration.
6 – Has Italy ensured the purchase of the doses, regardless of the approved vaccine?
Italy, as an EU country, is part of the agreements concluded by the EU with manufacturing companies. The president of the commission, von der Leyen, announced a contract with Pfizer / BioNtech to purchase 200 million doses, with an option for another 100 million. It is the sixth contact with so many companies in the race. The commissioner had previously met Sanofi-GSK (July) and in august Janssen (one of Johnson & Johnson’s industries), Cure Vac and Modern. The first real contract was signed with AstraZeneca in June and see Italy as a promoter together with Holland, Germany and France. The agreement provides for an acquisition of approx. 400 million doses.
7 – What happens once there is one or more vaccines available?
Each country must organize a dose distribution plan identify the population groups to be subjected to prophylaxis as a priority and the network of administration centers. The German ethics committee has indicated as priority categories elderly and chronically ill people, medical and health personnel, employees of law enforcement and firefighters, school teachers.
8 – The Pfizer / Biontech vaccine should be stored at 80 degrees below zero. Is there a cold chain for drugs that require these temperatures?
Is one of big problems, all over the world. In Italy, the only two airports certified to receive medicines are Fiumicino and Malpensa, but they are not equipped with refrigerators at such low temperatures. All vaccines for other diseases, like the flu, actually come stored at -2 / -8 degrees. The cold chain it must be ensured from the time the drug leaves the production site until the dose is administered.
(Collaborated by Gennaro Ciliberto, Scientific Director Ifo / Regina Elena).
November 10, 2020 (change November 10, 2020 | 07:37)
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