Community doses and effects

Published on: 12/26/2020 6:30 PM

Sunday December 27 is ‘Vaccine Day’ The first doses of the Pfizer-Biontech vaccine are administered in Italy. Here are the answers to the main questions about Comirnaty, the name with which the vaccine was baptized, according to the drug leaflet published on the Aifa website and which contains the information published by the EMA.

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 in a cycle of 2 doses (0.3 ml each) with an interval of at least 21 days (see sections 4.4 and 5.1). 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.

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.

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 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.”