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After the green light of the EMA comes the Aifa for the Pfizer Biontech vaccine. The leaders of the Italian pharmaceutical agency ensure a safe and effective compound that will supervise and control the vaccination campaign in the coming months. Important information and facts about the vaccine were presented at a lengthy press conference with the president Giorgio Palù, and the CEO, Nicola Magrini. “There are no absolute contraindications, just precautions.”
The vaccine can also be given to immunosuppressed people or pregnant or lactating women and has been approved for people 16 years of age and older. “No special precautions are required for specific subpopulations or for the elderly or immunosuppressed, including those who have problems with blood clotting or bleeding. Even for pregnancy and lactation, which were said to be absolute contraindications, they are not, because even in this case the benefits outweigh the risks, ”Magrini explained. “Today there is a vaccine with a very high safety margin, around 95%,” said Palù. A certain percentage found only in measles and rubella vaccines. “We had vaccines with this efficiency. 100% in nature does not exist“.
About the efficacy Palù, virologist and Former president of the European Society of Virology and Emeritus Professor of the University of Padua, answering a question about the so-called English variant, explained that “the mRna platform (the one used to develop the Pfizer and Moderna vaccines, ed) easily modulates And, if the virus evolves in such a way as to overcome immune defenses, it has an advantage over traditional platforms with live or killed viruses or based on recombinant proteins. In fact, it is a platform that allows modular and It will form the basis for future vaccines, not only in the infectious field, but also against cancer.“.
When asked if he can get sick between one administration and the other (21 days will pass between the first and the second dose), Magrini replied: “From the first evidence, the antibodies develop after 6-7 days– This is a rare test that you may get sick in the first few days after the first dose. This is a long shot. ” And in any case, the infection would not be serious. Aifa has created a technical scientific committee on vaccines. Therefore, active pharmacovigilance programs with patient reminders and text messages are planned in the course of 2021 with analysis capabilities at 3, 6 and 9 months to understand the immune response in the Italian population. “Italy will see specific studies next year in different populations to know the general response and will be evaluated both efficacy and adverse reactions defined as such“. Magrini then explained that” there will be studies in dialysis patients, nursing homes and pregnant womenAnd of patients with ALS he said: “They can and should be vaccinated.
“Aifa has just approved the Pfizer Biontech vaccine after Ema’s approval at the European level. On December 27, in all Italian regions, the first vaccinations of health personnel and the elderly of the RSA will begin. It’s still difficult, but now we have an extra weapon. Let’s go ”, writes the Minister of Health. Roberto Speranza in a post on Facebook. For the next 2-3 month phases, the administration of the vaccine will be coordinated and administered by Commissioner and Regional structure for RSA health workers and guests on specific regional lists. Then, with family doctors, we will see how to do it, but in the coming months there will not be a reserve mechanism but a call mechanism ”, explained Magrini. Vaccination against Covid-19 in Italy “will begin on Sunday with a limited group of health workers. Then it will be all health workers, about a million, in January, to be vaccinated. So the folks at RSA, for a similar volume of population. Subsequently, populations at risk, the elderly or people with specific pathologies – explains Magrin – The 27th is V-day at the European level: this is also a great step forward, in symbolic terms, to feel part of a large community, in the context of a global pandemic “.
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