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ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance
BACKGROUND: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8413252/ https://www.ncbi.nlm.nih.gov/pubmed/34505029 http://dx.doi.org/10.1016/j.eclinm.2021.101027 |
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author | Montalti, Marco Soldà, Giorgia Di Valerio, Zeno Salussolia, Aurelia Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Messina, Rossella Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia La Fauci, Giusy Gori, Davide |
author_facet | Montalti, Marco Soldà, Giorgia Di Valerio, Zeno Salussolia, Aurelia Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Messina, Rossella Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia La Fauci, Giusy Gori, Davide |
author_sort | Montalti, Marco |
collection | PubMed |
description | BACKGROUND: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was to describe the adverse events following immunization (AEFIs) with this vaccine through participant-based active surveillance in the country. METHODS: Beginning from 4 March to 8 April 2021, a nationwide study was conducted on San Marino's population aged 18–89 years who received one or two doses of Sputnik V. E-questionnaire dissemination occurred through e-mails, QR-codes or live/phone interviews ~7 days after the first and second vaccine dose. A descriptive analysis was conducted to quantify AEFI incidence on both occasions, stratifying results by type and severity of symptoms. FINDINGS: Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache and joint pain. INTERPRETATION: Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs. FUNDING: None. |
format | Online Article Text |
id | pubmed-8413252 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-84132522021-09-08 ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance Montalti, Marco Soldà, Giorgia Di Valerio, Zeno Salussolia, Aurelia Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Messina, Rossella Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia La Fauci, Giusy Gori, Davide EClinicalMedicine Research Paper BACKGROUND: In August 2020, Sputnik V was registered as Gam-COVID-Vac by the Russian Ministry of Health, and since December 2020 it has been distributed in 61 countries worldwide. On 25 February 2021, the Republic of San Marino started its vaccination campaign, which includes Sputnik V. Our aim was to describe the adverse events following immunization (AEFIs) with this vaccine through participant-based active surveillance in the country. METHODS: Beginning from 4 March to 8 April 2021, a nationwide study was conducted on San Marino's population aged 18–89 years who received one or two doses of Sputnik V. E-questionnaire dissemination occurred through e-mails, QR-codes or live/phone interviews ~7 days after the first and second vaccine dose. A descriptive analysis was conducted to quantify AEFI incidence on both occasions, stratifying results by type and severity of symptoms. FINDINGS: Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache and joint pain. INTERPRETATION: Our results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs. FUNDING: None. Elsevier 2021-07-08 /pmc/articles/PMC8413252/ /pubmed/34505029 http://dx.doi.org/10.1016/j.eclinm.2021.101027 Text en © 2021 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 | Research Paper Montalti, Marco Soldà, Giorgia Di Valerio, Zeno Salussolia, Aurelia Lenzi, Jacopo Forcellini, Marcello Barvas, Edoardo Guttmann, Susanna Messina, Rossella Poluzzi, Elisabetta Raschi, Emanuel Riccardi, Rossano Fantini, Maria Pia La Fauci, Giusy Gori, Davide ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance |
title | ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance |
title_full | ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance |
title_fullStr | ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance |
title_full_unstemmed | ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance |
title_short | ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance |
title_sort | rocca observational study: early results on safety of sputnik v vaccine (gam-covid-vac) in the republic of san marino using active surveillance |
topic | Research Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8413252/ https://www.ncbi.nlm.nih.gov/pubmed/34505029 http://dx.doi.org/10.1016/j.eclinm.2021.101027 |
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