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The van with the doses of the Comirnaty Pfizer-Biontech vaccine addressed to the Spallanzani infectious diseases institute in Rome will shortly depart from the Salvo D’Aquisto carabinieri headquarters in Tor di Quinto. The doses will be divided by region and vaccination will begin tomorrow, day V.
V-Day, tomorrow December 27 the Pfizer-BioNTech vaccine
The vaccination campaign will begin tomorrow, December 27: at 8 a.m. at the Spallanzani hospital in Rome, the first to be vaccinated will be the nurse Claudia Alivernini, the symbolic face of the health personnel on the front line for months in the battle against the coronavirus. Among the first to be subjected to the vaccine will be them, doctors, nurses, health personnel including RSA, the elderly over 80 years of age and the frail. In a first phase, military vehicles and aircraft will help distribute the first 9,750 doses, delivering them to their destination. The Carabinieri will provide escort service to ground movements.
Meanwhile, the consent form was published explaining what will be given to those who will receive it and what the possible adverse reactions are. Those who are vaccinated must state that they have been “correctly informed in clear words, I understand the benefits and risks of vaccination, the therapeutic methods and alternatives, as well as the consequences of any refusal or refusal to complete the vaccination with the second dose.”
They must also state that they are “aware that if any side effects occur, it will be my responsibility to immediately inform my doctor and follow the instructions” and to remain in the waiting room for at least 15 minutes from the administration of the vaccine to ensure that no happen. immediate adverse reactions occur. “The product is identified as” “Pfizer-BioNTech COVID-19” and in the consent form it is explicitly written that “can be administered from the age of 16” and “cannot be administered to women pregnant and meal time “. It requires 2 doses, 21 days apart and its effectiveness is estimated at 95% and “may be less in people with immune problems.” The possible adverse reactions are listed below, starting with the most common, affecting one in ten patients:
- pain, redness, swelling at the injection site, tiredness, headache, body aches, chills, joint pain, fever
Then move on to the rare ones, or the swollen lymph nodes. There are also some rare allergic reactions, namely:
- hives (bumps on the skin that are often very itchy);
- swelling of the face, tongue, or throat;
- labored breathing
Comirnaty Pfizer-BioNTech Vaccine, Consent Form
Community vaccine, who shouldn’t
Finally, we warn that in case of presenting serious symptoms or symptoms that could be related to an allergic reaction it is necessary to “immediately consult your doctor or go to emergency services”. It is added that in clinical trials “no vaccine-related deaths were observed” and that “the overexposed list of adverse reactions is not exhaustive of all possible side effects that could occur while taking the Pfizer-BioNTech COVID-19 vaccine. If you experience any adverse effects not mentioned, inform your doctor immediately. Finally, point 10 concludes: “Currently it is not possible to predict long-term damage.” Aifa has published in recent days 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, it was possible to conduct a large study, 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 by the research carried out over many years on RNA vaccines, to the large 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 protection effective immediately after injection?
No, 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) has occurred 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, ranging 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.
