Reactogenicity within the first week after Sinopharm, Sputnik V, AZD1222, and COVIran Barekat vaccines: findings from the Iranian active vaccine surveillance system.

BACKGROUND: This study aimed to evaluate the reactogenicity effects of COVID-19 vaccines, used in Iran. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

COVID-19 cases, hospitalizations and deaths after vaccination: a cohort event monitoring study, Islamic Republic of Iran.

Objective: To 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. Methods: We 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. Findings: Of 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. Conclusion: The 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.

Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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.

Cancer in Iran 2008 to 2025: Recent incidence trends and short-term predictions of the future burden.

Policymakers require estimates of the future number of cancer patients in order to allocate finite resources to cancer prevention, treatment and palliative care. We examine recent cancer incidence trends in Iran and present predicted incidence rates and new cases for the entire country for the year 2025. We developed a method for approximating population-based incidence from the pathology-based data series available nationally for the years 2008 to 2013, and augmented this with data from the Iranian National Population-based Cancer Registry (INPCR) for the years 2014 to 2016. We fitted time-linear age-period models to the recent incidence trends to quantify the future cancer incidence burden to the year 2025, delineating the contribution of changes due to risk and those due to demographic change. The number of new cancer cases is predicted to increase in Iran from 112 000 recorded cases in 2016 to an estimated 160 000 in 2025, a 42.6% increase, of which 13.9% and 28.7% were attributed to changes in risk and population structure, respectively. In terms of specific cancers, the greatest increases in cases are predicted for thyroid (113.8%), prostate (66.7%), female breast (63.0%) and colorectal cancer (54.1%). Breast, colorectal and stomach cancers were the most common cancers in Iran in 2016 and are predicted to remain the leading cancers nationally in 2025. The increasing trends in incidence of most common cancers in Iran reinforce the need for the tailored design and implementation of effective national cancer control programs across the country.

The Effect of Hajj Trip on Mental Health: A Longitudinal Study.

Hajj is a spiritual journey and religious ritual which is performed every year. Here, we evaluate the psychological effect of the Hajj. Using General Health Questionnaire (GHQ) questionnaire with 28 questions, the mental health of the pilgrims was assessed before and after the journey. A total of 154 people were questioned, 72 pilgrims (47%) were male. The mean GHQ score of participants before the journey was 50.1 and after the journey was 49.5 (P = 0.248). The results of analysis of variance and generalized estimating equation indicated that the GHQ scores had no significant difference before and after the journey.

Mother's education is the most important factor in socio-economic inequality of child stunting in Iran.

OBJECTIVE: Malnutrition is one of the most important health problems, especially in developing countries. The present study aimed to describe the socio-economic inequality in stunting and its determinants in Iran for the first time. DESIGN: Cross-sectional, population-based survey, carried out in 2009. Using randomized cluster sampling, weight and height of children were measured and anthropometric indices were calculated based on child growth standards given by the WHO. Socio-economic status of families was determined using principal component analysis on household assets and social specifications of families. The concentration index was used to calculate socio-economic inequality in stunting and its determinants were measured by decomposition of this index. Factors affecting the gap between socio-economic groups were recognized by using the Oaxaca-Blinder decomposition method. SETTING: Shahroud District in north-eastern Iran. SUBJECTS: Children (n 1395) aged <6 years. RESULTS: The concentration index for socio-economic inequality in stunting was -0·1913. Mother's education contributed 70 % in decomposition of this index. Mean height-for-age Z-score was -0·544 and -0·335 for low and high socio-economic groups, respectively. Mother's education was the factor contributing most to the gap between these two groups. CONCLUSIONS: There was a significant socio-economic inequality in the studied children. If mother's education is distributed equally in all the different groups of Iranian society, one can expect to eliminate 70 % of the socio-economic inequalities. Even in high socio-economic groups, the mean height-for-age Z-score was lower than the international standards. These issues emphasize the necessity of applying new interventions especially for the improvement of maternal education.

Socioeconomic inequality in smoking and its determinants in the Islamic Republic of Iran.

BACKGROUND: The role of socioeconomic inequality and related factors has not been well reported in tobacco consumption. AIMS: To investigate the socioeconomic inequality in smoking and its associated factors in the Islamic Republic of Iran. METHODS: Data were collected from surveillance for noncommunicable diseases in 2005, which included 89 404 people aged 15-65 years. Economic status was defined by principal component analysis on variables related to socioeconomic status. Concentration index and slope index of inequality were used to determine the inequality value. The gap between the high and low economic status groups was decomposed using the Oaxaca-Blinder decomposition method for explained and unexplained components. RESULTS: The total prevalence of smoking was 17.0%; 28.0% in males, and 5.8% in females, 15.8% in urban and 19.1% in rural areas. The concentration index was -0.032 in the whole of country; -0.098, in males, -0.246 in females, 0.014 in urban and -0.059 in rural areas and varied in different provinces of country. The smoking rate was 18.0% for the first quintile and 13.5% for the fifth quintile, a gap of 4.5%. The major part of this gap was related to differences in education level, sex, marital status and age in economic groups. CONCLUSION: There was a pro-rich socioeconomic inequality in smoking, especially in females and in the southern provinces. Increase in education level and empowering females of low socioeconomic status are sound interventions for alleviating inequality and for tobacco control.

Cancer incidence in Iran in 2014: Results of the Iranian National Population-based Cancer Registry.

BACKGROUND: We aimed to report, for the first time, the results of the Iranian National Population-based Cancer Registry (INPCR) for the year 2014. METHODS: Total population of Iran in 2014 was 76,639,000. The INPCR covered 30 out of 31 provinces (98% of total population). It registered only cases diagnosed with malignant new primary tumors. The main sources for data collection included pathology center, hospitals as well as death registries. Quality assessment and analysis of data were performed by CanReg-5 software. Age standardized incidence rates (ASR) (per 100,000) were reported at national and subnational levels. RESULTS: Overall, 112,131 new cancer cases were registered in INPCR in 2014, of which 60,469 (53.9%) were male. The diagnosis of cancer was made by microscopic confirmation in 76,568 cases (68.28%). The ASRs of all cancers were 177.44 and 141.18 in male and female, respectively. Cancers of the stomach (ASR = 21.24), prostate (18.41) and colorectum (16.57) were the most common cancers in men and the top three cancers in women were malignancies of breast (34.53), colorectum (11.86) and stomach (9.44). The ASR of cervix uteri cancer in women was 1.78. Our findings suggested high incidence of cancers of the esophagus, stomach and lung in North/ North West of Iran. CONCLUSION: Our results showed that Iran is a medium-risk area for incidence of cancers. We found differences in the most common cancers in Iran comparing to those reported for the World. Our results also suggested geographical diversities in incidence rates of cancers in different subdivisions of Iran.

Obesity and its socioeconomic determinants in Iran.

OBJECTIVE: To investigate the socioeconomic inequality of obesity and its determinants in Iran. METHODS: Data was from Iran's surveillance system for risk factors of non-communicable diseases which was conducted on 89,400 individuals aged 15-64 years in 2005. Principal component analysis was used to create a new variable for defining socioeconomic status of participants. We assessed inequality by calculating a slop index of inequality and concentration index for obesity. Oaxaca-Blinder decomposition analysis was used to determine the determinants of inequality. RESULTS: The slop index of inequality and concentration index for obesity was -13.1 (95% Confidence Intervals [CI]: -16.3 to -9.8) percentage points and -0.123, respectively. The level of inequality varied widely between different provinces in Iran and was more severe in women and urban population. Obesity persisted in 20.2% (95% CI: 19.4-20.9) of the low-socioeconomic group and 11.0% (95% CI: 10.5-11.6) of the high-socioeconomic group. More than 90% of this gap was due to differences of independent variables (mainly age, gender and marital status) in two socioeconomic status groups. CONCLUSIONS: A pro-rich inequality existed in the obesity in Iran. Older age, female gender and rural residency contributed most to the economic inequality of obesity.

Syringe-type and needle gauge have no role in adverse events following DTwP immunization: a randomized multicenter trial.

BACKGROUND: Auto-Disable syringes are recommended for immunization because of their greater safety and preventing reuse. In this study, the role of the syringe and needle gauge on the adverse events following Diphtheria, Tetanus toxoids and whole-cell Pertussis immunization was studied. METHODS: In this study, 1000 children from 2 months to 6 years of age, eligible for Diphtheria, Tetanus toxoids and whole-cell Pertussis immunization and who referred to 4 health centers, were randomized into 2 groups of regular syringe users (the Auto-Disable syringe with a 23 gauge and 25 mm needle) and new syringe users (the disposable syringe with a 24 gauge and 25 mm needle). Adverse events following immunization were evaluated on days 2, 4 and 6 after immunization by visiting the children at their home and examining them. RESULTS: The occurrence of the primary endpoint (severe local reaction) was found to be 2.1% in all the children, 2.0% in the children vaccinated with the Auto-Disable syringe and 2.2% in the children vaccinated with the new syringe. This difference is not significant (P = 0.818). The evaluation of other milder adverse events (secondary endpoints) showed that the syringe type has no effect on the occurrence of these adverse events. CONCLUSIONS: Syringe types and needle diameter played no role in precipitating the adverse events following immunization of the Diphtheria, Tetanus toxoids and whole-cell Pertussis vaccine.

Socioeconomic inequality in hypertension in Iran.

OBJECTIVE: Hypertension covers a large portion of burden of diseases, especially in the developing countries. The unequal distribution of hypertension in the population may affect 'health for all' goal. This study aimed to investigate the socioeconomic inequality of hypertension in Iran and to identify its influencing factors. METHODS: We used data from Iran's surveillance system for risk factors of noncommunicable diseases which was conducted on 89 400 individuals aged 15-64 years in 2005. To determine the socioeconomic status of participants, a new variable was created using a principal component analysis. We examined hypertension at different levels of this new variable and calculated slop index of inequality (SII) and concentration index (C) for hypertension. We then applied Oaxaca-Blinder decomposition analysis to determine the causes of inequality. RESULTS: The SII and C for hypertension were -32.3 and -0.170, respectively. The concentration indices varied widely between different provinces in Iran and was lower (more unequal) in women than in men. There was significant socioeconomic inequality in hypertension. The results of decomposition indicated that 40.5% of the low-socioeconomic group (n = 18190) and 16.4% of the high-socioeconomic group (n = 16335) had hypertension. Age, education level, sex and residency location were the main associated factors of the difference among groups. CONCLUSION: According to our results, there was an inequality in hypertension in Iran, so that individuals with low socioeconomic status had a higher prevalence of hypertension. Age was the most contributed factor in this inequality and women in low-socioeconomic group were the most vulnerable people for hypertension.

Cancer incidence and trend analysis in shahroud, iran, 2000 - 2010.

BACKGROUND: Cancer is the third leading cause of death in Iran, and its trend isincreasing in recent years. National reports state that cancer registries in Shahroud district had 204% coverage in 2008. This study investigated cancer situation in Shahroud with complete details between 2000-2010. METHODS: Data was obtained from national cancer registry software and analyzed after removing the repeated records. World standard population and direct standardization method was used to calculate Age Standardized incidence Rates (ASRs). Annual percentage changes calculated using Jointpoint software and Poisson regression model was performed to calculate cancer incidence trends. RESULTS: A total of 2240 cancer cases were identified, 1234 (55.1%) in man and 1006 (44.9%) in woman. The mean age was 61.6 years (Confidence Interval, CI 95%: 60.9- 62.3). ASRs of total cancers was 95.4 (CI 95%: 89.2-101.6) per 100,000; this rate was 114.8 (CI 95%: 107.9-121.6) for men and 105.2 (CI 95%: 100.6 -109.8) for women. The average annual increase in ASR was 12.4%, which could not be attributed only to improve reporting. Gastric cancer is the most common cancer in men, and breast cancer is most common in women. CONCLUSION: Cancer incidence rate has increased significantly in Shahroud in recent years. A portion of this increase can be attributed to increased incidence of cancers, especially cancers of colorectal, gastric, breast, and skin.

Respiratory Tract Infections and its Preventive Measures among Hajj Pilgrims, 2010: A Nested Case Control Study.

BACKGROUND: Respiratory tract infections are very common among the Hajj pilgrims. Some preventive measures including Influenza vaccination, using face mask and salt water gargling have been considered to control these infections and the reports show conflicting results about the effects of each one of these measures. This study is trying to assess the effects of these recommendations on respiratory tract infections. METHODS: According to nested case-control design, in a cohort consisting of 338 Iranian pilgrims, the outcome examined, was all types of respiratory tract infections other than common colds. With occurrence of any patient in convoy, data collection form was completed for that person. On the same day, two people were randomly selected as control group from among pilgrims who have not affected so far. RESULTS: During Hajj, 32 pilgrims (9.5%) were affected by respiratory tract infections other than common colds. In univariable logistic regression analysis, salt water gargling (OR = 2.4, P = 0.08), existence of other patient in the room (OR = 2.14, P = 0.19), age over 60 years (OR = 1.84, P = 0.15) and the education more than or equal to 3 years (OR = 1.93, P = 0.16) were effective in the respiratory tract infections (P < 0.2). However, multivariable logistic regression analysis showed that none of the above mentioned factors are significantly associated with these infections. CONCLUSIONS: This study showed that measures such as seasonal influenza vaccination, use of face masks and personal prayer carpet have no effect on the incidence of respiratory tract infections. However, washing throat and mouth with salt water can be considered the most effective preventive measures.