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Coronavirus vaccine, instructions for use. Following the approval of the vaccine developed by Pfizer and BioNTech, the European Medicines Agency (EMA) also gave the green light to publication the basic information and the leaflet in all EU languages, including Italian. The document sheds light on the many questions related to dosing specific categories of patients, but also sheds light on the actual immunizing efficacy of the vaccine.
Age of those vaccinated
Comirnaty, this is the trade name chosen by the pharmaceutical company that first found an effective and safe vaccine, is administered intramuscularly and in two doses at least 21 days apart. Safety and efficacy in children and adolescents under 16 years of age have not yet been established because the available data are limited, while immunization in the elderly has been confirmed. No dosage adjustment is necessary in subjects over 65 years of age.
Pregnancy status
Data on the use of the vaccine in pregnant women are limited. For this reason, the administration of Comirnaty during pregnancy should only be considered if the potential benefits outweigh the potential risks to the mother and fetus.
Effectiveness and duration
The duration of protection provided by the only vaccine approved in the EU is currently unknown. People vaccinated in the clinical trial will continue to be monitored for two years to gather more information on the duration of protection. A very large clinical trial showed that Comirnaty was effective in preventing Covid-19 in people 16 years of age and older. The trial involved about 44,000 people in total, half of whom received the vaccine and the other half received a sham injection, without either group knowing. Efficacy was estimated in more than 36,000 people (including patients older than 75 years) who had not had a previous infection. The study showed a 95% reduction in the number of symptomatic cases of Covid-19 in people who received the vaccine. Only 8 of 18,198 people have had symptoms of Covid-19. A much lower number than people who received a sham injection, of whom 162 of 18,325 people had symptoms. This means that the vaccine has been shown to be 95% effective in the trial. The trial also showed approximately 95% efficacy in participants at risk for more severe viral forms, including those with asthma, chronic lung disease, diabetes, high blood pressure, or a body mass index greater than 30 kg. / m2.
Side effects
The most common side effects found in the trial were generally mild or moderate and disappear within a few days of vaccination. Among the most common are pain and swelling at the injection site, fatigue, muscle and joint pain, chills, and fever. These side effects affected more than 1 in 10 people. In fewer than 1 in 10 people there was redness at the injection site and nausea. Itching at the injection site, pain in the limbs, swollen lymph nodes, trouble sleeping, and feeling sick were rarer side effects, affecting fewer than one in 100 people. Allergic reactions have occurred with Comirnaty, including a very small number of cases of severe allergic reactions (anaphylaxis) when the vaccine was used in vaccination campaigns. As with all vaccines, Comirnaty must be administered under close medical supervision and appropriate medical treatment must be available.
