Towards V-Day, Aifa’s Pfizer Vaccine Leaflet and Consent Form: Information You Need to Know Before Injecting



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The vaccination campaign in Italy is about to start: the date of the V-day is approaching, made in coordination with Europe on December 27. And the first 9,750 doses of the vaccine called Comirnaty, produced by Pfizer and Biontech, arrived at the Brenner border on Christmas morning. The truck, which left Belgium, will be escorted by the carabinieri to the Spallanzani hospital in Rome. Meanwhile, the National Order of Biologists has posted the consent form for the Cominarty vaccine on its website.

Anyone who undergoes the administration of the biological drug against Coronavirus will have to sign a document in which he admits that he has been “correctly informed in clear words, I have understood the benefits and risks of vaccination.” Among the informative notes attached to the form, we read then that «it may take up to 7 days after the second dose to develop protection against Covid-19 ». So considering me twenty-one days that must elapse between the first and second administration, the patient’s immune response will occur approximately one month after the first dose.

In the form, in addition to the list of ingredients contained in the vaccine, a long list of adverse reactions appears, divided into three categories: very common, infrequent and rare. Among the most frequent are fever, joint and muscle pain, headache. These reactions can affect all patients. 10 vaccinated. The so-called unusual reactions, that is, those that concern everyone. 100, include swollen lymph nodes. Among the rare adverse reactions, “some serious allergic reactions have been reported,” the information note reads.

The document explains what are the symptoms induced by an allergic reaction of this type: hives, swelling of the face, tongue or throat and difficulty in breathing. Then at the end of the note, a point about the long-term effects of the drug: “It is not possible at this time to predict long-range damage.” Meanwhile, the Italian Medicines Agency has published a structured guide on its website 35 Related questions and answers about the Comirnaty vaccine.

From the method of administration, “two injections, usually into the muscle of the upper arm, at least separated twenty-one days apart “, to the estimates on the protection induced by the vaccine,” the duration of protection is not yet defined with certainty because the observation period was necessarily a few months, but knowledge about the other types of coronavirus indicates that protection must be at least 912 months. “Even the AIFA, when it does not have certain information on subjects related to the vaccine, prefers to suspend the answers to the questions that it still reports in its Faq.

It does not appear in the consent to be signed before the vaccine, but the AIFA considers that it is an important piece of information to communicate, an undesirable effect of the drug observed in one out of every thousand people: “Weakness in the muscles on one side of the face, Acute peripheral facial paralysis “. The Agency, after a list of explanations about the specific conditions of individuals, from maternity to predisposition to allergies, reports that 286 hospitals will administer the doses. In the Aifa guide, the spring of the architect Stefano Boeri to be installed in Italian squares are not even mentioned.

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