![]() ![]() The importance of a booster vaccine dose was strongly recommended after the emergence of the B.1.1.529 (Omicron) SARS-CoV-2 variant in late November 2021, and the rapid surge of cases of infection with this variant globally. 1, COVID-19 vaccination (primary course or booster) vaccination was made mandatory by the Italian Minister of Health for all subjects who have reached the age of 50 years. In Italy, through the decree law 07 January 2022, n. Food and Drug Administration (FDA) amended the emergency use authorizations for mRNA COVID-19 vaccines (BNT162b2, Comirnaty/Pfizer-BioNTech and Spikevax/Moderna) with the use of a single booster dose after the completion of primary vaccination course. The transient, mild to moderate, and common to very common side reactions reported should be used to reassure potential recipients of the lack of safety concerns. The study findings revealed no serious or unexpected adverse events, and are in agreement with data available on booster dose for both mRNA vaccines. Compared to the primary vaccination, lymphadenopathy was more common after the booster (pā<ā0.001), especially after Comirnaty vaccine. The most frequent adverse reactions were pain, redness, or swelling at the injection site and fatigue, while malaise and fever significantly occurred after the Comirnaty, and vomiting after the Spikevax booster. 87.7% and 68.2% of all recipients described at least one local or systemic reaction, respectively: 97.3, 38.6 and 4.7% reported mild, moderate, or severe events, respectively. Of a total of 622 participants interviewed, 554 (89.1%) reported at least one adverse event (88.2% and 92.9% after the Comirnaty or Spikevax vaccine, respectively): 63.4% were female, and 78.5% aged 17 to 64 years, regardless of vaccine. Primary outcomes related to the occurrence of adverse events post-booster were stratified by vaccine, and frequency of local/systemic, mild/moderate/severe events. Eligible participants were enrolled and interviewed via phone using a structured questionnaire. Active surveillance was used to investigate reporting of adverse events post-booster dose of either of the licensed mRNA Comirnaty (Pfizer/BioNTech) or Spikevax (Moderna) vaccines in adult (17 years and older) recipients in central Italy. A booster dose after primary COVID-19 vaccination series was considered crucial after the emergence of the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants. ![]()
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