ArticleEClinicalMedicine2021
ROCCA observational study: Early results on safety of Sputnik V vaccine (Gam-COVID-Vac) in the Republic of San Marino using active surveillance.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A landscape on disorders following different COVID-19 vaccination: a systematic review of Iranian case reports.European journal of medical research · 2023Pooled it
- Vaccines for COVID-19: A Systematic Review of Immunogenicity, Current Development, and Future Prospects.Frontiers in immunology · 2022Pooled it
- Sputnik V update: safety and neutralizing antibodies in healthy adults and adolescents.Frontiers in immunology · 2026Trial
- Identifying adverse reactions following COVID-19 vaccination in Korea using data from active surveillance: a text mining approach.Epidemiology and health · 2025Article
- Active Surveillance for Safety Monitoring of XBB.1.5-Containing COVID-19 mRNA Vaccines in Korea.Journal of Korean medical science · 2024Article
- Side Effects of COVID-19 Vaccination Following First and Second Doses: A Cross-Sectional Survey Based on Vaccine-associated Factors.Tanaffos · 2024Article
- Article
- Review
- Adverse events following immunisation with the first dose of sputnik V among Iranian health care providers.Clinical and experimental vaccine research · 2023Article
- The impact of COVID-19 vaccination programme in the Republic of San Marino: Focus on effectiveness of Gam-Covid-Vac.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022Observational
- Article
- Article
- Article
- Knowledge, Attitudes and Practices towards SARS-CoV-2 vaccination among morbid obese individuals: a pilot study.Acta bio-medica : Atenei Parmensis · 2022Article
- ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance.EClinicalMedicine · 2022Article
- Effectiveness of Coronavirus Disease 2019 Vaccines in Preventing Infection, Hospital Admission, and Death: A Historical Cohort Study Using Iranian Registration Data During Vaccination Program.Open forum infectious diseases · 2022Article
- An overview of current drugs and prophylactic vaccines for coronavirus disease 2019 (COVID-19).Cellular & molecular biology letters · 2022Review
- COVID-19 vaccination policies and the new challenges of international travel.Clinical and experimental vaccine research · 2022Article
- Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 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.
methodsBeginning 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.
findingsMean 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%) (
interpretationOur results, albeit preliminary, suggest that Sputnik V has a high tolerability profile in the population aged ≥60 years in terms of short-term AEFIs.
fundingNone.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.