The Psychometric Properties of Intention to Receive the COVID-19 Vaccine Scale Based on the Health Belief Model.

Acceptance of the SARS-CoV-2) COVID-19( vaccine is a very important factor to keep health workers safe. The study aimed to evaluate the psychometric properties of intention to receive the COVID-19 vaccine using a health belief model among health workers in Iran The study was a tools design study that was conducted in the period from February to March 2020, Iran Questionnaire items were designed using text review. The sampling method was multi-stage. Data were analyzed using descriptive statistics, confirmatory and exploratory factor analysis at a 95% confidence level using SPSS software version 16. The designed questionnaire had an appropriate content validity and internal consistency. Also, the exploratory factor analysis showed that a 5-factor structure was extracted and confirmatory factor analyses revealed that the conceptual five-factor structure of the measure had good fit indices. Reliability was evaluated using internal consistency. Cronbach Alpha coefficient was .82 and the intra-class correlation coefficient (ICC) was .9. It can be concluded that the instrument designed in the preliminary stage of psychometrics properties had good validity and reliability indicators. Also, the constructs of the health belief model well explain the determinants of the intention to receive the COVID-19 vaccine at the individual level.

Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial.

Importance: The protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown. Objective: To evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults. Design, Setting, and Participants: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021. Interventions: In cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection. Main Outcomes and Measures: The primary outcome was polymerase chain reaction-confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed. Results: In cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths. Conclusions and Relevance: In this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19-related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price. Trial Registration: isrctn.org Identifier: IRCT20210303050558N1.

An overview of Iran's actions in response to the COVID-19 pandemic and in building health system resilience.

This article is part of the Research Topic 'Health Systems Recovery in the Context of COVID-19 and Protracted Conflict'. The considerable human, social, and economic impacts of COVID-19 have demonstrated a global lack of health system resilience, highlighting gaps in health system capacities due to fragmented approaches to health system financing, planning, and implementation. One of the key actions for ensuring equitable essential health services in all countries in normal situations as well as emergencies is through strengthening the primary healthcare (PHC) system. In the context of the unfolding pandemic, the Iranian Ministry of Health and Medical Education (MoHME) undertook a variety of strategic actions to ensure the sustainability of health services during the current health emergency and to promote health system resilience against future shocks. Right after the Alma-Ata declaration in 1978, MoHME pursued the PHC philosophy incorporating the principles within the WHO health system framework and its six building blocks. In response to the evolving pandemic, MoHME put in place several interventions to ensure the maintenance of essential health services in addition to the provision of response. Some interventions were new, informed by global experience with COVID-19, while others leveraged existing strengths within the existing health system. Those were taking a whole-of-government approach; leveraging the PHC capacity; supporting the workforce; strengthening preparedness and response; improving access to medicines, vaccines, and health products; and leveraging the health information system into the pandemic response. Health system strengthening that promotes resilience is imperative for governments as health systems are fundamental to sustainable socioeconomic development. In recognition of this, the WHO Eastern Mediterranean Regional Office (EMRO) has recently outlined regional priorities for advancing universal health coverage (UHC) and ensuring health security. Iran's approach both prior to and during the pandemic is strongly aligned with those regional priorities, which are "primary health care-oriented models; enhancing health workforce; promoting equity; enabling environment for research; improving access to countermeasures; and fostering health system resilience."

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial.

Background: SOBERANA-02 is a COVID-19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phases 1/2 clinical trials demonstrated high immunogenicity, promoting neutralising IgG and specific T-cell response. A third heterologous dose of SOBERANA-Plus (RBD-dimer) further increased neutralising antibodies. The aim of this study is to evaluate the safety and efficacy of two immunisation regimes: two doses of SOBERANA-02 and a heterologous three-dose combination with SOBERANA-Plus added to it. Methods: From March 8th to June 24th, 2021 we conducted in Havana, Cuba a multicentre randomised, double-blind, placebo-controlled, phase-3 trial evaluating a two doses SOBERANA-02 scheme and a heterologous scheme with one dose SOBERANA-Plus added to it (RPCEC00000354). Participants 19-80 years were randomly assigned to receiving 28 days apart either the two or three dose scheme or placebo. The main endpoint was vaccine efficacy in preventing the occurrence of RT-PCR confirmed symptomatic COVID-19 at least 14 days after the second or third dose in the per-protocol population. We also assessed efficacy against severe disease and, in all participants receiving at least one vaccine/placebo dose, safety for 28 days after each dose. Findings: We included 44,031 participants (52.0% female, 48.0% male; median age 50 years, range 19-80 years; 7.0% black, 24.0% mixed-race, 59.0% white) in a context of initial Beta VOC predominance, with this variant being partially replaced by Delta near the trial's end. Vaccine efficacy in the heterologous combination was 92.0% (95%CI 80.4-96.7) against symptomatic disease. There were no severe COVID-19 cases in the vaccine group against 6 in the placebo group. Two doses of SOBERANA-02 was 69.7% (95%CI 56.5-78.9) and 74.9% (95%CI 33.7-90.5) efficacious against symptomatic and severe COVID-19, respectively. The occurrence of serious and severe adverse events (AE) was very rare and equally distributed between placebo and vaccine groups. Solicited AEs were slightly more frequent in the vaccine group but predominantly local and mostly mild and transient. Interpretation: Our results indicate that the straightforward to manufacture SOBERANA vaccines are efficacious in a context of Beta and Delta VOC circulation, have a favourable safety profile, and may represent an attractive option for use in COVID-19 vaccination programmes. Funding: This study received funds from the National Fund for Science and Technology (FONCI-CITMA-Cuba, contract 2020-20) of the Ministry of Science, Technology and Environment of Cuba.

Determinants of COVID-19 vaccine acceptance in healthcare workers in Iran: National Survey.

BACKGROUND AND AIM: It seems that acceptance of COVID-19 vaccination is the most effective way to tackle the COVID-19 pandemic now. Health care workers (HCWs) are one of the most important groups who are at risk for COVID-19 infection. This study aimed to assess the COVID-19 vaccine acceptance among HCWs in Iran and its determinants. METHODS: A cross-sectional survey was carried out among 3600 HCWs in Iran. Data were collected through a self-administered questionnaire by a trained team from February to March 2021. Multi-stage cluster sampling method was used for selecting respondents of the study. Multivariate logistic regression analysis was used to determine the key factors of COVID-19 vaccine acceptance among participants. P-value < 0.05 was considered statistically significant. RESULTS: Out of the 3536 respondents, 2191 (62.1%) intended to uptake the COVID-19 vaccine. Only about 10 percent of respondents said they did not trust any vaccine (domestic or foreign). Willing to accept a COVID-19 vaccine was relatively high among males, doctors, and those who had a history of hospitalization due to COVID-19 infection. The multivariate regression analysis showed respondents who were 40-50 years (aOR: 1.56; 95% CI: 1.47-1.66), had a history of COVID-19 infection (aOR: 0.85; 95% CI: 0.83-0.88), and hospitalized due to COVID-19 infection (aOR: 2.18; 95% CI: 1.97-2.39), were significantly associated with vaccine acceptance (p < 0.05). CONCLUSION: Our study showed moderate acceptance of COVID-19 vaccination in the HCWs in the Islamic Republic of Iran. The most important factor in the acceptance of the COVID-19 vaccine by the health staff is having a history of hospitalization. Further training and justification of health personnel is needed to increase the acceptance of COVID 19 vaccine.

Whole genome sequencing of SARS-CoV2 strains circulating in Iran during five waves of pandemic.

PURPOSE: Whole genome sequencing of SARS-CoV2 is important to find useful information about the viral lineages, variants of interests and variants of concern. As there are not enough data about the circulating SARS-CoV2 variants in Iran, we sequenced 54 SARS-CoV2 genomes during the 5 waves of pandemic in Iran. METHODS: After viral RNA extraction from clinical samples collected during the COVID-19 pandemic, next generation sequencing was performed using the Nextseq platform. The sequencing data were analyzed and compared with reference sequences. RESULTS: During the 1st wave, V and L clades were detected. The second wave was recognized by G, GH and GR clades. Circulating clades during the 3rd wave were GH and GR. In the fourth wave GRY (alpha variant), GK (delta variant) and one GH clade (beta variant) were detected. All viruses in the fifth wave were in clade GK (delta variant). There were different mutations in all parts of the genomes but Spike-D614G, NSP12-P323L, N-R203K and N-G204R were the most frequent mutants in these studied viruses. CONCLUSIONS: These findings display the significance of SARS-CoV2 monitoring to help on time detection of possible variants for pandemic control and vaccination plans.

SARS-CoV-2 in domestic cats (Felis catus) in the northwest of Iran: Evidence for SARS-CoV-2 circulating between human and cats.

This study aimed to investigate the prevalence of COVID-19 in domestic cats, focusing on the disease in the northwest of Iran and then showing the natural transmission of SARS-COV-2 circulating between domestic cats and humans. After receiving ethic codes from Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1399.303) and confirmed by the Center of Communicable Diseases Control (CDC) of Iran, 124 domestic cats were collected from the homes and only one hospital of Meshkin -Shahr district from northwestern Iran where SARS-CoV-2 patients were hospitalized and quarantined during 2020. Samples were prepared from fluid materials of oropharynx and nasopharynx. All samples were tested by real-time PCR (RT-PCR) using specific genes N and ORF1ab in Pasteur Institute of Iran, and then partial sequence analyses of S gene were performed. All collected cats were kept in separated cages until SARS-COV-2 infection was confirmed with the RT-PCR. RT- PCR Ct values of 123 collected cats were ≥40; thus, all of them showed negative results, but one of the collected cats with close contact with its owner, whom confirmed SARS-CoV-2 showed positive results with gene N(Ct=30) and gene ORF1ab (Ct=32). Furthermore, the positive pet cat showed respiratory and gastro-intestinal clinical manifestations, and its owner was infected with SARS-CoV-2 two weeks ago. Cats are susceptible animals to SARS-CoV-2 infection. Epidemiological evidence showed that SARS-COV-2 is able to transmit to healthy cats due to having close contact with its owner as a reverse zoonosis.

COVID-19 in patients with diabetes: factors associated with worse outcomes.

Purpose: Diabetes is one of the major comorbidities associated with COVID-19. We aimed to determine the clinical and epidemiological factors associated with the mortality of COVID-19 in diabetic patients in Iran, and also the impact of prescribed antiviral and antibiotics on patients' status. Methods: In this study, we used the national registry of hospitalized patients with Severe Acute Respiratory Syndrome (SARS) Symptoms with diabetes from February 18, 2020, to December 22, 2020. Demographic, clinical features, treatments, concurrent comorbidities, and their associations with mortality and severity outcomes were assessed using logistic regression. Results: 78,554 diabetic in-patients with SARS symptoms were included from 31 provinces of whom 37,338 were PCR positive for COVID-19. Older age and male gender are associated with COVID-19 mortality in diabetic patients. CVD is the most frequent comorbidity (42%). CVD, kidney disease, liver disease, and COPD are associated comorbidities which increased the risk of mortality. The mortality rate is higher in diabetic patients comparing to patients with no comorbidities, particularly in younger age groups. The frequency of antiviral, and antibiotics in COVID-19 positive patients was 34%, and 31%, respectively. Antibiotic treatment has no association with mortality in COVID-19 patients. Conclusions: Diabetic patients indicate higher mortality comparing to patients without any underlying comorbidities. Restrict strategies on increasing effective health care utilization must be considered in diabetic patients, especially in those with parallel underlying comorbidities. Regarding the antibiotic resistance issue and the noticeable use of antibiotics in diabetic patients, it is recommended to prioritize an antibiotic guideline prescription in COVID-19 patients for better stewardship by countries.

Severity and mortality of COVID-19 infection in HIV-infected individuals: Preliminary findings from Iran.

Background: Higher mortality due to coronavirus disease 2019 (COVID-19) is reported among some immunocompromised patients; however, the relation between immunosuppression due to HIV infection and severity of COVID-19 infection remains unclear. We aimed to investigate the severity and mortality of COVID-19 infection in HIV-infected patients. Methods: This was a retrospective cohort study on all COVID-19 suspected and confirmed cases hospitlized in Iran between Febuary 19 (epidemic onset date) and April 8, 2020, whose data were recorded in the national database for Medical Care Monitoring Center. Hospitalized patients were followed from admittion to death/discharge. Patients' HIV status was recorded based on their self report. Logistic and Cox regression models were used to evaluate the association between HIV infection and the severity (according to the Glascow-Coma Scale situation, need for intubation and hypoxemia) and mortality of COVID-19 infection, respectively. Analyses were performed separately for COVID-19 suspected and confirmed cases. Results: Out of 122 206 severe acute respiratory infection (SARI) cases, 90 were HIV-positive (0.07%), with a similar mean age (Pt-test= 0.750) and distrubtion of gender (PChi-square= 0.887) and nationality (PChi-square= 0.202) as HIV-negative patients. A comparable proportion of HIV-positive and HIV-negative cases were tested for COVID-19 (p= 0.170); however, the frequency of positive results was lower among HIV-positives (p= 0.038). The frequency of COVID-19 and HIV coinfection was lower than expected among confirmed cases (adjusted OR= 0.54; 95% CI: 0.29-1.02) and suspected cases (adjusted OR= 0.68; 95% CI: 0.45- 1.02), which means that the frequency of COVID-19 infection was lower among HIV-positive cases. HIV infection decreased the risk of death among confirmed (adjusted HR= 0.33; 95% CI: 0.05-2.32), suspected cases (adjusted HR= 0.81; 95% CI: 0.33-1.94), and among SARI cases (adjusted HR= 0.73; 95% CI: 0.35-1.54). Conclusion: Our findings support the concept that HIV infection was not a risk factor to increase the severity and risk of death among COVID-19 infected patients.

Clinical outcomes of patients with mild COVID-19 following treatment with hydroxychloroquine in an outpatient setting.

The role of hydroxychloroquine (HCQ) in early outpatient management of mild coronavirus disease 2019 (COVID-19) needs further investigation. This study was a multicenter, population-based national retrospective-cohort investigation of 28,759 adults with mild COVID-19 seen at the network of Comprehensive Healthcare Centers (CHC) between March and September 2020 throughout Iran. The baseline characteristics and outcome variables were extracted from the national integrated health system database. A total of 7295 (25.37%) patients who presented with mild COVID-19 within 3-7 days of symptoms onset received HCQ (400 mg twice daily on day 1 followed by 200 mg twice daily for the next four days and were then followed for 14 days). The main outcome measures were hospitalization or death for six months follow-up. COVID-19-related hospitalizations or deaths occurred in 523 (7.17%) and 27 (0.37%) respectively, in HCQ recipients and 2382 (11.10%) and 287 (1.34%) respectively, in non-recipients. The odds of hospitalization or death was reduced by 38% (odds ratio [OR] = 0.62; 95% confidence interval [CI]: 0.56-0.68, p = < 0.001) and 73% (OR = 0.27; 95% CI: 0.18-0.41, p = < 0.001) in HCQ recipients and non-recipients. These effects were maintained after adjusting for age, comorbidities, and diagnostic modality. No serious HCQ-related adverse drug reactions were reported. In our large outpatient national cohort of adults with mild COVID-19 disease who were given HCQ early in the course of the disease, the odds of hospitalization or death was reduced significantly regardless of age or comorbidities.

Iran COVID-19 Epidemiology Committee: A Review of Missions, Structures, Achievements, and Challenges.

BACKGROUND: Since the beginning of the coronavirus disease 2019 (COVID-19) epidemic in Iran, the control and management of the epidemic were headed by the National Headquarter for the Control of COVID-19 Epidemic through setting up different scientific committees, including the COVID-19 National Epidemiology Committee. The present study reviews the missions, structures, achievements, and challenges of the Epidemiology Committee. STUDY DESIGN: A rapid review . METHODS: All relevant reports, documents, guidelines, published literature, and surveillance data related to the establishment, visions, missions, roles, activities, and outputs of the COVID-19 Epidemiology Committee were critically reviewed in this study. RESULTS: The efforts of the committee's working groups may have impacted improvements in data registration/usage, provincial data quality at provincial levels, and perception of the epidemic situation in the provinces. The committees have also played role in informing the policies in different stages of the epidemic through routine or problem-based data/evidence analyses, epidemic investigations, and mathematical modeling. CONCLUSION: The structure and experience gained by the committee can be used in similar situations within and outside the country. To further improve the impacts of our activities, it is essential to have effective interaction, collaboration, and data flow between the committee and a broad range of organizations within and outside the Ministry of Health and Medical Education.

A Report on Statistics of an Online Self-screening Platform for COVID-19 and Its Effectiveness in Iran.

BACKGROUND: The most recent emerging infectious disease, coronavirus disease 2019 (COVID-19), is pandemic now. Iran is a country with community transmission of the disease. Telehealth tools have been proved to be useful in controlling public health disasters. We developed an online self-screening platform to offer a population-wide strategy to control the massive influx to medical centers. METHODS: We developed a platform operating based on given history by participants, including sex, age, weight, height, location, primary symptoms and signs, and high risk past medical histories. Based on a decision-making algorithm, participants were categorized into four levels of suspected cases, requiring diagnostic tests, supportive care, not suspected cases. We made comparisons with Iran STEPs (STEPwise approach to Surveillance) 2016 study and data from the Statistical Centre of Iran to assess population representativeness of data. Also, we made a comparison with officially confirmed cases to investigate the effectiveness of the platform. A multilevel mixed-effects Poisson regression was used to check the association of visiting platform and deaths caused by COVID-19. RESULTS: About 310 000 individuals participated in the online self-screening platform in 33 days. The majority of participants were in younger age groups, and males involved more. A significant number of participants were screened not to be suspected or needing supportive care, and only 10.4% of males and 12.0% of females had suspected results of COVID-19. The penetration of the platform was assessed to be acceptable. A correlation coefficient of 0.51 was calculated between suspected results and confirmed cases of the disease, expressing the platform's effectiveness. CONCLUSION: Implementation of a proper online self-screening tool can mitigate population panic during wide-spread epidemics and relieve massive influx to medical centers. Also, an evidence-based education platform can help fighting infodemic. Noticeable utilization and verified effectiveness of such platform validate the potency of telehealth tools in controlling epidemics and pandemics.

First Cases of SARS-CoV-2 in Iran, 2020: Case Series Report

In Jan 2020, the outbreak of the 2019 novel coronavirus (SARS-CoV-2) in Wuhan, Hubei Province of China spread increasingly to other countries worldwide which WHO declared it as a public health emergency of international concern. Iran was included in the affected countries. Throat swab specimens were collected and tested by using real-time reverse transcription PCR (RT-PCR) kit targeting the E region for screening and RNA dependent RNA polymerase for confirmation. Conventional RT-PCR was conducted for the N region and the PCR products were sequenced by Sanger sequencing. The first seven cases of SARS-CoV-2 infections were identified in Qom, Iran. This report describes the clinical and epidemiological features of the first cases of SARS-CoV-2 confirmed in Iran. Future research should focus on finding the routes of transmission for this virus, including the possibility of transmission from foreign tourists to identify the possible origin of SARS-CoV-2 outbreak in Iran.