New vaccines that are initially approved in clinical trials are not completely free of risks. Systematic vaccine safety surveillance is required for ensuring safety of vaccines. This study aimed to ...provide a protocol for safety monitoring of COVID-19 vaccines, including Sputnik V, Sinopharm (BBIBP-CorV), COVIran Barekat, and AZD1222.
This is a prospective cohort study in accordance with a template provided by the World Health Organization. The target population includes citizens of seven cities in Iran who have received one of the available COVID-19 vaccines according to the national instruction on vaccination. The participants are followed for three months after they receive the second dose of the vaccine. For each type of vaccine, 30,000 people will be enrolled in the study of whom the first 1,000 participants are in the reactogenicity subgroup. The reactogenicity outcomes will be followed seven days after vaccination. Any hospitalization, COVID-19 disease, or other minor outcomes will be investigated in weekly follow-ups. The data are gathered through self-reporting of participants in a mobile application or phone calls to them. The study outcomes may be investigated for the third and fourth doses of vaccines. Other long-term outcomes may also be investigated after the expansion of the follow-up period. We have planned to complete data collection for the current objectives by the end 2022.
The results of this study will be published in different articles. A live dashboard is also available for managers and policymakers. All data will be available on reasonable requests from the corresponding author.The use of the good and comprehensive guidelines provided by WHO, along with the accurate implementation of the protocol and continuous monitoring of the staff performance are the main strengths of this study which may be very useful for policymaking about COVID-19 vaccination.
This study aimed to evaluate the reactogenicity effects of COVID-19 vaccines, used in Iran.
At least 1000 people were followed up with phone calls or self-report in a mobile application within 7 days ...after vaccination. Local and systemic reactogenicities were reported overall and by subgroups.
The presence of one or more local and systemic adverse effects after the first dose of vaccines was 58.9% (95% Confidence Intervals): 57.5-60.3) and 60.5% (59.1-61.9), respectively. These rates were reduced to 53.8% (51.2-55.0) and 50.8% (48.8-52.7) for the second dose. The most common local adverse effect reported for all vaccines was pain in the injection site. During the first week after the first dose of vaccines, the frequency of the pain for Sinopharm, AZD1222, Sputnik V, and Barekat was 35.5%, 86.0%, 77.6%, and 30.9%, respectively. The same rates after the second dose were 27.3%, 66.5%, 63.9%, and 49.0%. The most common systemic adverse effect was fatigue. In the first dose, it was 30.3% for Sinopharm, 67.4% for AZD1222, 47.6% for Sputnik V, and 17.1% for Barekat. These rates were reduced to 24.6%, 37.1%, 36.5%, and 19.5%, in the second dose of vaccines. AZD1222 had the highest local and systemic adverse effects rates. The odds ratio of local adverse effects of the AZD1222 vaccine compared to the Sinopharm vaccine were 8.73 (95% CI 6.93-10.99) in the first dose and 4.14 (95% CI 3.32-5.17) in the second dose. Barekat and Sinopharm had the lowest frequency of local and systemic adverse effects. Compared to Sinopharm, systemic adverse effects were lower after the first dose of Barekat (OR = 0.56; 95% CI 0.46-0.67). Reactogenicity events were higher in women and younger people. Prior COVID-19 infection increased the odds of adverse effects only after the first dose of vaccines.
Pain and fatigue were the most common reactogenicities of COVID-19 vaccination. Reactogenicities were less common after the second dose of the vaccines. The adverse effects of AZD1222 were greater than those of other vaccines.
Regarding the paucity of evidence on the side effects of the booster dose of Oxford AstraZeneca vaccine in vaccinated people with Sinopharm or Sputnik V, we aimed to set up a cohort event monitoring ...(CEM) study to capture adverse events occurring in individuals who will receive the booster doses of AstraZeneca (either the first or second booster dose) following being vaccinated with Sinopharm or sputnik V vaccines in Iran.
The present study is an active COVID-19 vaccine safety surveillance through an observational prospective cohort study that will be conducted in vaccination centers in Iran. The study will be conducted in twelve provinces of Iran. Study sites are vaccination centers where the AstraZeneca vaccine is administered to the cohort population. The study population includes all individuals who have received two doses of Sinopharm or Sputnik V vaccines and either the first or second booster dose of AstraZeneca according to the national guidelines for immunization in Iran in 2023. We are planning to include 30,000 eligible people in this study. Each individual will be followed up for 13 weeks after either the first or second booster dose of the AstraZeneca vaccine. Furthermore, convenience sampling is used to include participants in the present study. Participation in the study will be strictly voluntary.
With the planned study we will provide a valid epidemiological evidence to improve the understanding of the safety of the booster dose of the AstraZeneca and to better evaluate the effectiveness of public health interventions. This could help policy makers in managing the COVID-19 pandemic according to scientific evidence.
ObjectiveTo investigate the incidence of coronavirus disease 2019 (COVID-19) cases, hospitalizations and deaths in Iranians vaccinated with either AZD1222 Vaxzevria, CovIran® vaccine, SARS-CoV-2 ...Vaccine (Vero Cell), Inactivated (lnCoV) or Sputnik V. MethodsWe enrolled individuals 18 years or older receiving their first COVID-19 vaccine dose between April 2021 and January 2022 in seven Iranian cities. Participants completed weekly follow-up surveys for 17 weeks (25 weeks for AZD1222) to report their COVID-19 status and hospitalization. We used Cox regression models to assess risk factors for contracting COVID-19, hospitalization and death. FindingsOf 89 783 participants enrolled, incidence rates per 1 000 000 person-days were: 528.2 (95% confidence interval, CI: 514.0-542.7) for contracting COVID-19; 55.8 (95% CI: 51.4-60.5) for hospitalization; and 4.1 (95% CI: 3.0-5.5) for death. Compared with SARS-CoV-2 Vaccine (Vero Cell), hazard ratios (HR) for contracting COVID-19 were: 0.70 (95% CI: 0.61-0.80) with AZD1222; 0.73 (95% CI: 0.62-0.86) with Sputnik V; and 0.73 (95% CI: 0.63-0.86) with CovIran®. For hospitalization and death, all vaccines provided similar protection 14 days after the second dose. History of COVID-19 protected against contracting COVID-19 again (HR: 0.76; 95% CI: 0.69-0.84). Diabetes and respiratory, cardiac and renal disease were associated with higher risks of contracting COVID-19 after vaccination. ConclusionThe rates of contracting COVID-19 after vaccination were relatively high. SARS-CoV-2 Vaccine (Vero Cell) provided lower protection against COVID-19 than other vaccines. People with comorbidities had higher risks of contracting COVID-19 and hospitalization and should be prioritized for preventive interventions.
phrase omitted phrase omitted Metodos Se inscribieron personas de 18 anos o mas que recibieron su primera dosis de la vacuna contra la COVID-19 entre abril de 2021 y enero de 2022 en siete ciudades ...iranies. Los participantes completaron encuestas de seguimiento semanales durante 17 semanas (25 semanas para AZD1222) para informar sobre su estado de la COVID-19 y la hospitalizacion. Se utilizaron modelos de regresion de Cox para valorar los factores de riesgo de contraer la COVID-19, de ser hospitalizado y de morir.
ObjectivesCardiovascular mortality in Western Asia is high and still rising. However, most data documented on risk prediction has been derived from Western countries and few population-based cohort ...studies have been conducted in this region. The current study aimed to present the process of pooling data and cardiovascular disease (CVD) mortality incidences for four Iranian cohorts.MethodsFrom the Iran Cohort Consortium, the Golestan Cohort Study (GCS), Tehran Lipid and Glucose Study, Isfahan Cohort Study (ICS) and the Shahroud Eye Cohort Study (ShECS) were eligible for the current study since they had appropriate data and follow-up visits. Age-standardised CVD mortality rates were estimated for ages 40–80 and 40–65 years. Cox regression was used to compare mortalities among cohorts. Adjusted marginal rates were calculated using Poisson regression.ResultsOverall, 61 291 participants (34 880 women) aged 40–80 years, free of CVD at baseline, were included. During 504 606 person-years of follow-up, 1981 CVD deaths (885 women) occurred. Age-standardised/sex-standardised premature CVD mortality rates were estimated from 133 per 100 000 person-years (95% CI 81 to 184) in ShECS to 366 (95% CI 342 to 389) in the GCS. Compared with urban women, rural women had higher CVD mortality in the GCS but not in the ICS. The GCS population had a higher risk of CVD mortality, compared with the others, adjusted for conventional CVD risk factors.ConclusionsThe incidence of CVD mortality is high with some differences between urban and rural cohorts in Iran as a Western Asian country. Pooling data facilitates the opportunity to globally evaluate risk prediction models.
Prediction models for cardiovascular disease (CVD) mortality come from high-income countries, comprising laboratory measurements, not suitable for resource-limited countries. This study aims to ...develop and validate a non-laboratory model to predict CVD mortality in a middle-income setting.
We used data of population aged 40-80 years from three cohort studies: Tehran Lipid and Glucose Study (n = 5160), Isfahan Cohort Study (n = 4350), and Golestan Cohort Study (n = 45,500). Using Cox proportional hazard models, we developed prediction models for men and women, separately. Cross-validation and bootstrapping procedures were applied. The models’ discrimination and calibration were assessed by concordance statistic (C-index) and calibration plot, respectively. We calculated the models' sensitivity, specificity and net benefit fraction in a threshold probability of 5%.
The 10-year CVD mortality risks were 5.1% (95%CI: 4.8-5.5) in men and 3.1% (95%CI: 2.9%-3.3%) in women. The optimism-corrected performance of the model was c = 0.774 in men and c = 0.798 in women. The models showed good calibration in both sexes, with a predicted-to-observed ratio of 1.07 in men and 1.09 in women. The sensitivity was 0.76 in men and 0.66 in women. The net benefit fraction was higher in men compared to women (0.46 vs. 0.35).
A low-cost model can discriminate well between low- and high-risk individuals, and can be used for screening in low-middle income countries.
Considering the importance of cardiovascular disease (CVD) risk prediction for healthcare systems and the limited information available in the Middle East, we evaluated the SCORE and Globorisk models ...to predict CVD death in a country of this region.
We included 24 427 participants (11 187 men) aged 40-80 years from four population-based cohorts in Iran. Updating approaches were used to recalibrate the baseline survival and the overall effect of the predictors of the models. We assessed the models' discrimination using C-index and then compared the observed with the predicted risk of death using calibration plots. The sensitivity and specificity of the models were estimated at the risk thresholds of 3%, 5%, 7%, and 10%. An agreement between models was assessed using the intra-class correlation coefficient (ICC). We applied decision analysis to provide perception into the consequences of using the models in general practice; for this reason, the clinical usefulness of the models was assessed using the net benefit (NB) and decision curve analysis. The NB is a sensitivity penalized by a weighted false positive (FP) rate in population level.
After 154 522 person-years of follow-up, 437 cardiovascular deaths (280 men) occurred. The 10-year observed risks were 4.2% (95% CI: 3.7%-4.8%) in men and 2.1% (1.8-2%.5%) in women. The c-index for SCORE function was 0.784 (0.756-0.812) in men and 0.780 (0.744-0.815) in women. Corresponding values for Globorisk were 0.793 (0.766- 0.820) and 0.793 (0.757-0.829). The deviation of the calibration slopes from one reflected a need for recalibration; after which, the predicted-to-observed ratio for both models was 1.02 in men and 0.95 in women. Models showed good agreement (ICC 0.93 in men, and 0.89 in women). Decision curve showed that using both models results in the same clinical usefulness at the risk threshold of 5%, in both men and women; however, at the risk threshold of 10%, Globorisk had better clinical usefulness in women (Difference: 8%, 95% CI: 4%-13%).
Original Globorisk and SCORE models overestimate the CVD risk in Iranian populations resulting in a high number of people who need intervention. Recalibration could adopt these models to precisely predict CVD mortality. Globorisk showed better performance clinically, only among high-risk women.
Objectif Analyser l'incidence des cas, hospitalisations et déces liés a la maladie a coronavirus 2019 (COVID-19) chez les Iraniens vaccinés avec Vaxzevria AZD1222, CovIran®, le vaccin contre le ...SARS-CoV-2 (cellule Vero), le vaccin inactivé (lnCoV) ou Spoutnik V. Méthodes Nous avons recruté des individus de minimum 18 ans ayant reçu leur premiere dose de vaccin contre la COVID-19 entre avril 2021 et janvier 2022 dans sept villes iraniennes. Les participants ont rempli des enquetes de suivi hebdomadaires pendant 17 semaines (25 semaines pour AZD1222) afin de communiquer sur leur statut COVID-19 et leur hospitalisation. Nous avons utilisé des modeles de régression de Cox pour évaluer les facteurs augmentant les risques de contracter la COVID-19, d'etre hospitalisé et de mourir. Résultats Sur 89 783 participants recrutés, le taux d'incidence pour 1 000 000 jours-personnes était de 528,2 (intervalle de confiance de 95%, IC: 514,0-542,7) en termes d'infection a la COVID-19; de 55,8 (IC de 95%: 51,4-60,5) en termes d'hospitalisation; et de 4,1 (IC de 95%: 3,0-5,5) en termes de déces. Comparé au vaccin contre le SARS-CoV-2 (cellule Vero), le rapport de risque (RR) de contracter la COVID-19 s'élevait a 0,70 (IC de 95%: 0,61-0,80) avec AZD1222; a 0,73 (IC de 95%: 0,62-0,86) avec Spoutnik V; et a 0,73 (IC de 95%: 0,63-0,86) avec CovIran®. Concernant l'hospitalisation et le déces, tous les vaccins offraient un niveau de protection similaire 14 jours apres la seconde dose. Avoir contracté la COVID-19 par le passé prémunissait contre une réinfection (RR: 0,76; IC de 95%: 0,69-0,84). Le diabete et les maladies respiratoires, cardiaques et rénales entraînaient un risque accru de contracter la COVID-19 apres la vaccination. Conclusion Le taux d'infection a la COVID-19 apres la vaccination était relativement élevé. D'autre part, le vaccin contre le SARS-CoV-2 (cellule Vero) s'est révélé moins efficace que les autres vaccins. Enfin, les personnes souffrant de comorbidités avaient plus de risques de contracter la COVID-19 et d'etre hospitalisées; elles devraient donc étre prioritaires lors des interventions préventives.
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