Cargando…
ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance
BACKGROUND: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up...
Autores principales: | , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9122344/ https://www.ncbi.nlm.nih.gov/pubmed/35614901 http://dx.doi.org/10.1016/j.eclinm.2022.101468 |
_version_ | 1784711324507308032 |
---|---|
author | Di Valerio, Zeno La Fauci, Giusy Soldà, Giorgia Montalti, Marco Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia Salussolia, Aurelia Gori, Davide |
author_facet | Di Valerio, Zeno La Fauci, Giusy Soldà, Giorgia Montalti, Marco Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia Salussolia, Aurelia Gori, Davide |
author_sort | Di Valerio, Zeno |
collection | PubMed |
description | BACKGROUND: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context. METHODS: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021. FINDINGS: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs. INTERPRETATION: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac. FUNDING: None. |
format | Online Article Text |
id | pubmed-9122344 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-91223442022-05-21 ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance Di Valerio, Zeno La Fauci, Giusy Soldà, Giorgia Montalti, Marco Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia Salussolia, Aurelia Gori, Davide eClinicalMedicine Articles BACKGROUND: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context. METHODS: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021. FINDINGS: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs. INTERPRETATION: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac. FUNDING: None. Elsevier 2022-05-20 /pmc/articles/PMC9122344/ /pubmed/35614901 http://dx.doi.org/10.1016/j.eclinm.2022.101468 Text en © 2022 The Author(s) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Articles Di Valerio, Zeno La Fauci, Giusy Soldà, Giorgia Montalti, Marco Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia Salussolia, Aurelia Gori, Davide ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance |
title | ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance |
title_full | ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance |
title_fullStr | ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance |
title_full_unstemmed | ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance |
title_short | ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance |
title_sort | rocca cohort study: nationwide results on safety of gam-covid-vac vaccine (sputnik v) in the republic of san marino using active surveillance |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9122344/ https://www.ncbi.nlm.nih.gov/pubmed/35614901 http://dx.doi.org/10.1016/j.eclinm.2022.101468 |
work_keys_str_mv | AT divaleriozeno roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT lafaucigiusy roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT soldagiorgia roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT montaltimarco roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT lenzijacopo roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT forcellinimarcello roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT barvasedoardo roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT guttmannsusanna roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT poluzzielisabetta roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT raschiemanuel roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT riccardirossano roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT fantinimariapia roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT salussoliaaurelia roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance AT goridavide roccacohortstudynationwideresultsonsafetyofgamcovidvacvaccinesputnikvintherepublicofsanmarinousingactivesurveillance |