Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
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
_version_ 1783747622007209984
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
work_keys_str_mv AT montaltimarco roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT soldagiorgia roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT divaleriozeno roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT salussoliaaurelia roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT lenzijacopo roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT forcellinimarcello roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT barvasedoardo roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT guttmannsusanna roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT messinarossella roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT poluzzielisabetta roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT raschiemanuel roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT riccardirossano roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT fantinimariapia roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT lafaucigiusy roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT goridavide roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance
AT roccaobservationalstudyearlyresultsonsafetyofsputnikvvaccinegamcovidvacintherepublicofsanmarinousingactivesurveillance