(by Francesco Matera) Great Britain started the first licensed vaccine Pfizer BioNTech, while in Europe scientific data and evaluations of the Ema regulatory body are expected. The British regulatory body MHRA has stated, however, that the vaccine is effective and safe, already ordering 40 million doses.
The Minister of Health, Roberto Speranza spoke in the House about our plan, anticipating some numbers, Italy will therefore have 28,2 million doses in the first quarter, 57,2 in the second, 74 in the third, 39,4 in the fourth and 8 in the first quarter of 2022. In total we are talking about 202.573.000 doses. The desired goal is that in July 2021 we can have at least 20 million Italians immunized.
Speranza also specified that there will be an information campaign "and following the best practices"And that the vaccine will be free and given on a voluntary basis. The distribution will take place by the personnel of the Ministry of Defense. For the organizational machine, therefore, at least 20 thousand doctors, nurses, social health assistants and administrative staff will be called, also thousands of young people enrolled in the first years of specialization schools will be called. The first categories that will be vaccinated they will be: health workers (1.404.037) residents and RSA personnel (570.287) people over 80 (4.442.048). To these are added 13.432.005 people between 65 and 79 years, and 7.403.578 people with at least one chronic disease.
Vaccines for Italy, according to the data on the Ministry of Health website, will be AstraZeneca for 16,1 million doses in the first quarter of 2021, 24,2 in the second, of Pfizer 8,7 in the first, 8 in the second and 10 in the third, of Johnson and Johnson for 14,8 in the second, 32,3 in the third, 6,7 in the fourth, of Sanofi for 20.1 in the third and 20,1 in the fourth, of curevac 2 million in the first, 5,4 in the second, 8,7 in the third, 8, in the fourth and 8 in the first quarter of 2022 and Modern 1,3 in the first, 4,7 in the second and 4,7 in the third.
All pharmaceutical companies beyond the scientific results on the effects of individual vaccines will receive procurement orders for the various European countries. In addition to vaccines there is the syringe node, it is not easy to acquire such a large number in a short time. Then there is the question of the announcement issued by Commissioner Arcuri which provides for special syringes whose cost is ten times higher than the normal syringes used for traditional vaccines. The characteristics of the syringes, however, were indicated by the Italian health experts.
Some unresolved doubts about vaccines
Another element of reflection is that we always talk about vaccines that have undergone a very fast testing phase compared to the standards, for example it is not yet known whether it can be given to pregnant women. The immunologist Antonella Viola, professor of General Pathology at the Department of Biomedical Sciences of the University of Padua and Scientific Director of the Institute of Pediatric Research (IRP-Città della Speranza wrote on her fb profile on the Moderna vaccine: "Moderna presented a phase 2/3 study evaluating the Covid19 vaccine in adolescents (12-18 years). The recruitment of the required 3000 volunteers will begin shortly, half of whom will receive 2 doses of the vaccine, 28 days apart. The study is expected to be completed by the end of June 2021. We know that children will need to be vaccinated, we have said that. We therefore proceed with caution but towards a solution that protects us all with standardized protocols that provide for administration first in adults and then in adolescents and children".
Each vaccine then has different ways of storage and administration. The American-German vaccine (Pfizer-BioNTech) should be administered twice and only in a hospital setting and the vials should be stored at a temperature below minus 70-80 degrees. Some ultra-refrigerators are needed, partly existing, partly being found, for a total of 300 structures scattered throughout the regions. The Pfizer-BioNTech vaccine takes 4 weeks to develop protection, i.e. after the first injection, 12 days pass and immunity begins to build, the second injection must take place 21 days after the first, finally, complete protection is there. on the twenty-eighth day. It is not yet known how long the immunity will last, or rather if after a year all the effort made will be in vain.
Not all vaccines are the same
On La Stampa, Professor Viola also illustrated the work on vaccines that will be used in the world as early as the first months of 2021: “Some companies have focused on classical methods, based on viral proteins or on the attenuated or inactivated virus. These systems are more laborious, require the production of large quantities of viruses or proteins, but they are also the ones that have always been used to produce the vaccines we use. This is, for example, the strategy chosen by Sinopharm, the Chinese state company that distributed the vaccine without waiting for the end of the phase III studies, without therefore being sure of its safety and efficacy. Other companies, such as AstraZeneca, Johnson & Johnson and the Chinese CanSinoBio, have instead focused on viral vectors. It involves using viruses that cause colds, adenoviruses, rendered harmless and capable of transporting the genetic material necessary to produce SARS-CoV-2 proteins within our cells. This approach, recently used to generate an Ebola vaccine, has pros and cons. Among the problems, there is the existence of pre-immunity against adenoviruses which limits the effectiveness of vaccination, just as large-scale production is not trivial. Among the various participants in the race, there are also those who have risked a lot, focusing on a new, fast, simple and flexible strategy: vaccines based only on information transfer. These vaccines carry a message into our cells - theMessenger RNA, in fact - which allows the production of Spike protein of SARS-CoV-2 and the subsequent activation of the immune system. The message, as in the best action films, will be destroyed as soon as it is sent and there will therefore be no danger of seeing ourselves transformed into GMOs. Despite the high degree of innovation, it was the companies that focused on this approach, Moderna and Pfizer / Biontech, the first to cross the finish line. On November 20 and 30, respectively, Pfizer and Moderna submitted their request for emergency authorization for the use of the vaccine to the FDA, the body that in the USA will have to decide whether the vaccines meet the necessary safety and efficacy requirements. And on December 10 and 17, respectively, the FDA sessions are scheduled to discuss the data. The announced, but not yet published results are very encouraging for both vaccines. Moderna, with its announcement, said that of the 15.000 vaccinated volunteers, 11 developed COVID-19, compared to 185 of the 15.000 unvaccinated. Furthermore, among the 11 who showed symptoms despite the vaccine, none became seriously ill, while as many as 35 subjects in the control group were affected by a severe disease and one of them died. All information that, given in hand, will have to be verified, but that bodes well. Certainly there is still a lot to understand: why did those 11 subjects get sick? Were they older? Did they have other pathologies? And what do we know about the infection? To answer these questions, we must await the evaluations of the regulatory agencies. What will happen now? By the end of December, Moderna plans to immediately begin distributing 20 million doses of its vaccine in the US and to produce 500 million to 1 billion doses during 2021. For the time being, this vaccine will not arrive in Italy. Pfizer instead has planned the distribution of 200 million doses in Europe as soon as the approval of the European equivalent of the FDA, the EMA, arrives. Of these, 3,4 million doses are for our country. "