[ad_1]
The Sars-CoV-2 coronavirus vaccine is not recommended for people with allergies or hypersensitivity to its active ingredients and its excipients, its effectiveness will last at least one year and even those who have become ill with Covid-19 should do so. These are the advice of Marco Cavaleri, 51, a pharmacologist who leads Ema’s vaccine working group, who talks about it today in an interview with Alberto D’Argenio to Republic.
Community vaccine: who should not do it and how long it will be effective
Cavaleri explains that after the authorization for the Pfizer-BioNTech vaccine arrived yesterday, the agency is ready to verify the adverse events and side effects of the preparation. In fact, we know that the vaccine is 95% effective but not how long its coverage lasts and if a booster is needed: “There are data that we will have only with the vaccination of a large number of individuals, but these are complementary aspects,” he says. , recalling that the third phase of experimentation has in any case shown an effectiveness of at least 100 days: “I don’t think it is less than that of the influenza vaccine”, which lasts about a year.
Cavaleri is not overly exposed to the issue of blocking the transmission of infection, but he is optimistic on this point. The effectiveness is the same even in those with other diseases but there are some categories that should not do so: “We do not recommend the vaccine if there are allergies or hypersensitivity to its active ingredients and its excipients. Who has asthma or is allergic to cats or grasses does not they will have no problem, although we always recommend that you talk to your doctor. Serious food allergies, which in themselves are not a contraindication, should be discussed with the doctor because they can be a sign of hypersensitivity to the vaccine. ”
As for those who have already been ill, the EMA executive is open to the possibility: “The trial provided limited data that did not show additional protection in the short term, while the safety data is reassuring. vaccination does not require tests before administration, we do not see any safety problems in administering the vaccine to people who have already contracted the virus. We cannot exclude that the vaccine may act as a booster and, therefore, may contribute to a long-term sustained protection “. Professor Massimo Galli, director of the department of infectious diseases of the Sacco hospital in Milan, invited in ‘Carta Bianca’, said yesterday that between the first and the second dose there is still the risk of contagion.
Self-certification starting tomorrow: how to complete it and ways to circumvent the rules
The Pfizer-BioNTech vaccine in Italy starting tomorrow and Aifa’s frequently asked questions
In contrast, the president of Aifa, Giorgio Palù, maintains that the vaccine blocks contagion in an interview with the Ansa news agency: “Vaccines induce sterilizing immunity” or, in addition to protecting against Covid disease, they prevent infection. asymptomatic and make the subject not contagious, even if they are still preliminary observations, will be confirmed by the evidence “and will also be one of the objectives of pharmacovigilance. In addition, Aifa will activate surveillance with analytical skills at 3, 6 and 9 months to understand the immune response in the Italian population. On how to administer the vaccine “in this first phase – stressed the general director of Aifa Magrini – and during the first 2 or 3 months, the vaccine will be coordinated and administered through the commissioner and regions The agency yesterday published a series of questions and answers (FAQ) about the vaccine:
– What is it and what is it for?
The COVID-19 mRNA BNT162b2 vaccine (Comirnaty) is a vaccine intended to prevent coronavirus disease 2019 (COVID-19) in people 16 years of age and older. It contains a molecule called messenger RNA (mRNA) with instructions for making a protein found in SARSCoV-2, the virus responsible for COVID-19. The vaccine does not contain the virus and cannot cause disease.
– Has the trial been shortened to have the product soon?
Studies on COVID-19 vaccines, including the COVID-19 mRNA vaccine BNT162b2 (Comirnaty), began in the spring of 2020, so they lasted a few months compared to the usual times, but had the participation of a large number of people – ten times higher than the standards of similar vaccine development studies. Therefore, a large study could be conducted, sufficient to demonstrate efficacy and safety. None of the usual phases of verification of the efficacy and safety of the vaccine have been skipped: the short times that led to rapid registration have been made possible thanks to the research carried out over many years on RNA vaccines, to the great human resources and made available in a very short time and for the evaluation of the regulatory bodies of the results obtained as they were produced and not, as usual, only when all the studies are completed. These simple steps have saved years of approval times.
– Is the protection effective immediately after the injection?
No, the efficacy was demonstrated one week after the second dose.
– What adverse reactions were observed?
The most commonly observed adverse reactions (more than 1 in 10 people) in the COVID-19 mRNA BNT162b2 vaccine study (Comirnaty) were generally mild or moderate in severity and resolved within a few days of vaccination. These included pain and swelling at the injection site, fatigue, headache, muscle and joint pain, chills, and fever. Fewer than 1 in 10 people experienced redness and nausea at the injection site. Itching at the injection site, pain in the extremities, swollen lymph nodes, difficulty falling asleep and nausea were rare and affected less than 1 in 100 people. one side of the face (acute peripheral facial paralysis) occurs rarely, in less than 1 in 1000 people.
– What serious adverse reactions were observed during the trial?
The only serious adverse reaction more frequent in those vaccinated than in the placebo group was enlargement of the lymph nodes. However, it is a benign disease that heals on its own. In general, systemic reactions were more frequent and pronounced after the second dose. In countries where mass administration of the vaccine has already begun, reports of adverse reactions have also begun, from the least serious to the most significant, including allergic reactions. All countries that start the administration of the vaccine extended to the entire population will collect and evaluate all the reports received by the pharmacological surveillance system of adverse reactions to the vaccine, in order to be able to define with increasing precision the type of risk profile associated with it. to vaccination.
