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Today, December 27, the Pfizer-Biontech vaccine will be administered in Italy. The vaccine was called Comirnaty, but what are the indications and recommendations? Does it have side effects? Here are the answers contained in the ‘brochure’ posted on the Aifa website and containing the information published by the EMA.
Pfizer vaccine, what is it for?
Comirnaty is indicated for active immunization for the prevention of COVID-19, a disease caused by the SARS-CoV-2 virus, in people 16 years of age or older. The vaccine is administered intramuscularly after dilution as a cycle of 2 doses (0.3 ml each) at least 21 days apart. The preferred site is the deltoid region of the arm.
No data are available on the interchangeability of Comirnaty with other COVID-19 vaccines to complete the vaccination cycle. This means that subjects who received 1 dose of Comirnaty should receive a second dose of the same product.
Anti-covid vaccine, general recommendations
Among the general recommendations, “Cases of anaphylaxis have been reported. Appropriate treatment and medical assistance should always be immediately available in the event of an anaphylactic reaction after administration of the vaccine.”
With vaccination, “anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress-related reactions, may occur as a psychogenic response to needle injection. It is important that precautions are taken to avoid injury from fainting.” .
“Vaccination should be postponed in subjects suffering from a severe acute febrile state or an acute infection. The presence of a mild infection and / or mild fever should not lead to postponement of the vaccine,” it reads again.
Undesirable effects of the vaccine
Adverse Reactions Chapter, based on clinical studies: “The most common adverse reactions in subjects 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%). %), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and swelling at the injection site (> 10%) These reactions were generally mild to moderate in intensity and resolved within a few days . of vaccination. A slightly lower frequency of reactogenicity reactions was associated with older age. “
The ‘Package Leaflet: Information for the User’ explains that “like all vaccines, Comirnaty can cause side effects, although not everyone gets them.
They are “very common side effects” that “may affect more than 1 in 10 people: at the injection site: pain, swelling; tiredness; headache; muscle pain; joint pain; chills, fever.” They are “common side effects: may affect up to 1 in 10 people: redness at the injection site; nausea.” Instead, they are “rare side effects: may affect up to 1 in 100 people: swollen lymph nodes; malaise; pain in limbs; insomnia; itching at the injection site.” Finally, as a rare side effect that can “affect up to 1 in 1,000 people” is “temporary asymmetry on one side of the face.”
Anti-covid vaccine, the duration of protection.
The duration of protection offered by the vaccine is unknown; Clinical trials aimed at establishing it are still ongoing, the document highlights. As with all vaccines, vaccination with Comirnaty may not protect everyone who receives it. People may not be fully protected for up to 7 days after the second dose of the vaccine.
In reaction to pregnant women, “there is limited data on the use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development.. Administration of Comirnaty. during pregnancy should only be considered if the potential benefits outweigh the potential risks to the mother and fetus. It is not known whether Comirnaty is excreted in human milk. ” Fertility chapter: “Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.”
