benefits, doubts and side effects – Libero Quotidiano



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Stefano Re

There is good news and some gray areas in the 34-page document that says what is officially known about Comirnaty, the vaccine from the US-German consortium Pfizer / BionTech whose first doses, distributed in symbolic quantities, begin to be administered today in Italy. L ‘Mother, the European Medicines Agency, has just authorized the Italian translation of the “Summary of Product Characteristics”, the “Package Leaflet” (also known as Package Leaflet) and the rest of the documentation relating to serum. These certifications are always “prudential”. Even the ones for regular over-the-counter drugs seem to be purposely made to scare people, and in a sense they do: it’s the same drug company law firms that recommend this approach, so no one can say that has not been warned. . This time, however, we are faced with a new product, not yet tested in a large population and for a long period of time. And just the uncertainty about some important aspects is what stands out the most when reading those pages.

Starting with one of the main characteristics, namely the immunization period. ‘The duration of protection offered by the vaccine is unknown; The clinical trials destined to establish it are still in progress, ”the document warns. We will know more in some time. In any case, “as with all vaccines, vaccination with Comirnaty it may not protect everyone who receives it. Subjects may not be fully protected until 7 days after the second dose of the vaccine. On paper, however, it is the best vaccine among the six treated byEuropean Union. One week after the administration of the second dose, which must take place “at least 21 days” after the first injection, the efficacy of the serum “was 94.6%”. So far, a similar level of protection is found only in serum from Modern, another American company, which is expected to be cleared by the EMA on January 6.

Another unexplored terrain is that of the effects on the so-called “pediatric population”. ‘The safety and efficacy of Comirnaty in children and adolescents under 16 years of age have not yet been established. The available data are limited. ‘ Which is why, the package insert warns, “Comirnaty is not recommended for children under 16 years of age.” With regard to pregnant women and those who have recently given birth, the discussion is even more delicate. In fact, we learned from the document that, due to the few cases studied so far, “there are no data available in Comirnaty related to placental transfer or excretion in the Cow milk“And only to a certain extent it reassures to read that in the studies carried out in rats” there were no effects related to the vaccine in terms of fertility in females, pregnancy, development embryonic / fetal or development of offspring. “Therefore, women are advised:” If you are pregnant, if you suspect or plan to be pregnant, or if you are breastfeeding, consult your doctor or pharmacist before receiving this vaccine. “A separate chapter dedicated to “Adverse reactions.” Among the consequences classified as “very common”, that is, found in more than ten percent of the subjects who received the vaccine, are normal headache, fatigue, chills, pain in muscles or joints Nausea is less frequent (in percentages between 1 and 10%) and, with an incidence of less than 1%, insomnia.

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There have also been cases of “Anaphylaxis”, a term for a severe allergic reaction. Its frequency is defined as “not known”, since it is impossible to estimate “on the basis of available data”. Also for this reason, the document states that “appropriate treatment and medical assistance must always be immediately available in the event of an anaphylactic reaction after administration of the vaccine.” After vaccination it is recommended “Careful monitoring” of the patient “for at least 15 minutes”, and it is obviously forbidden to administer the second dose of Comirnaty to subjects who have experienced a similar reaction after the first injection. Four subjects out of a total of 21,744 who participated in clinical trials of this vaccine experienced ‘acute peripheral facial paralysis’, even with a considerable delay compared to injection. This occurred 37 days after the first dose (the participant did not receive the second dose) and 3, 9 and 48 days after the second dose. The reaction is classified as “weird”, it affects less than one person in a thousand, and has always been “temporary.” On the subject, however, there is still to write and understand. In fact, the Comirnaty is subject to “additional monitoring”, a kind of special surveillance, and health workers are “obliged to report any suspected adverse reaction»Through a specific national system.



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