ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance

Background: Gam-COVID-Vac is the world's first registered vector vaccine against COVID-19 based on a combination of two heterologous adenoviruses. It was chosen by the Republic of San Marino as the main tool in its vaccination campaign, which started on 25 February 2021. Our aim was to build up on the ROCCA study, focused on the older population, by describing adverse effects following immunisation (AEFIs) rates and characteristics in all age groups for the first time in a real-world context. Methods: An active surveillance study on recipients of at least one dose of the Gam-COVID-Vac vaccine was conducted. Participants were administered online questionnaires through live/phone interviews with physicians, by e-mail or by scanning a QR code at different points in time after the first dose: one week (Q1) one month (Q2), and three months (Q3) between March and August 2021. Findings: Overall, 6190 vaccine recipients were recruited. Mean age was 52·4 ± 18·2 years. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at injection site and myalgia. Grade 3 or 4 AEFIs were reported by 2·7% and 1·1% of the participants, respectively. Multivariate analysis showed younger age, being a woman and food allergies are risk factors for more severe AEFIs. Interpretation: Our results confirm a good tolerability profile for the population aged 18 and over providing useful data for vaccination campaigns ongoing in countries planning to use Gam-COVID-Vac. Funding: None

Long-term analysis of antibodies elicited by SPUTNIK V: A prospective cohort study in Tucumán, Argentina

Background: Gam-COVID-Vac (SPUTNIK V) has been granted emergency use authorization in 70 nations and has been administered to millions worldwide. However, there are very few peer-reviewed studies describing its effects. Independent reports regarding safety and effectiveness could accelerate the final approval by the WHO. We aimed to study the long-term humoral immune response in nay¨ve and previously infected volunteers who received SPUTNIK V. Methods: Humoral immune responses, assayed by anti-SARS-CoV-2-spike-RBD IgG ELISA and neutralization assays, were measured in 602 healthcare workers at 0, 14, 28, 60 and 180 days after receiving SPUTNIK V between December 2020 and July 2021 in Tucuman, Argentina. Findings: Seroconversion was detected in 97% of individuals after 28 days post-vaccination (dpv) (N = 405). Anti-RBD titers began to decrease after 60 dpv (N = 328), but remained detectable in 94% at 90 dpv (N = 224). At 180 dpv, anti-RDB titers persisted in 31% (N = 146). Previous infection triggered an increased immune response to the first dose and increased neutralization activity against variants of concern (VOC). Second doses in previously infected individuals further increased titers, even 90 dpv (N = 75). Basal antibody titers had more influence on postvaccination anti-RBD responses than the time elapsed between diagnosis and vaccination (N = 274). Interpretation: Data presented herein provides essential knowledge regarding the kinetics of antibodies induced by SPUTNIK V up to six months after immunization, and suggests that when considering one-dose vaccination policies for individuals with previous SARS-CoV-2 infection, serological studies to determine basal titers may be important, independent of when diagnosis occurred.Fil: Chahla, Rossana Elena. Ministerio de Salud Pública de Tucumán; ArgentinaFil: Tomas Grau, Rodrigo Hernán. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; ArgentinaFil: Cazorla, Silvia Ines. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; ArgentinaFil: Ploper, Diego. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; ArgentinaFil: Vera Pingitore, Esteban. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; ArgentinaFil: Aguilar López, Mónica. Gobierno de la Provincia de Tucuman. Ministerio de Salud. Departamento Bioquimico. Laboratorio de Salud Publica.; ArgentinaFil: Aznar, Patricia. Gobierno de la Provincia de Tucuman. Ministerio de Salud. Departamento Bioquimico. Laboratorio de Salud Publica.; ArgentinaFil: Alcorta, María Elena. Gobierno de la Provincia de Tucuman. Ministerio de Salud. Departamento Bioquimico. Laboratorio de Salud Publica.; ArgentinaFil: Velez, Eva Maria del Mar. Gobierno de la Provincia de Tucuman. Ministerio de Salud. Departamento Bioquimico. Laboratorio de Salud Publica.; ArgentinaFil: Stagnetto, Agustín. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; ArgentinaFil: Avila, Cesar Luis. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; ArgentinaFil: Maldonado Galdeano, María Carolina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; ArgentinaFil: Socias, Sergio Benjamin. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; ArgentinaFil: Heinze, Dar. University Of Boston. School Of Medicine. Center For Regenerative Medicine.; Estados UnidosFil: Navarro, Silvia Adriana. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; ArgentinaFil: Llapur, Conrado Juan. Ministerio de Salud Pública de Tucumán; ArgentinaFil: Costas, Dardo. Gobierno de la Provincia de Tucuman. Ministerio de Salud. Departamento Bioquimico. Laboratorio de Salud Publica.; ArgentinaFil: Flores, Isolina. Gobierno de la Provincia de Tucuman. Ministerio de Salud. Departamento Bioquimico. Laboratorio de Salud Publica.; ArgentinaFil: Edelstein, Alexis. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud "Dr. C. G. Malbrán"; ArgentinaFil: Kowdle, Shreyas. Icahn School of Medicine at Mount Sinai; Estados UnidosFil: Perandones, Claudia. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud "Dr. C. G. Malbrán"; ArgentinaFil: Lee, Benhur. Icahn School of Medicine at Mount Sinai; Estados UnidosFil: Apfelbaum, Gabriela. Universidad Nacional de Tucumán; ArgentinaFil: Mostoslavsky, Raul. Harvard Medical School; Estados UnidosFil: Mostoslavsky, Gustavo. University Of Boston. School Of Medicine. Center For Regenerative Medicine.; Estados UnidosFil: Perdigon, Gabriela del Valle. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Centro de Referencia para Lactobacilos; ArgentinaFil: Chehin, Rosana Nieves. Universidad Nacional de Tucuman. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Gobierno de la Provincia de Tucuman. Ministerio de Salud. Sistema Provincial de Salud. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario. - Consejo Nacional de Investigaciones Cientificas y Tecnicas. Centro Cientifico Tecnologico Conicet Noa Sur. Instituto de Investigaciones En Medicina Molecular y Celular Aplicada del Bicentenario.; Argentin

Self-reported side effects after vaccination against COVID-19 in Honduras

Background: In December 2019, in the community of Wuhan, in Hubei, China, a series of atypical pneumonia cases with severe course was identified and the new disease was called COVID-19. By March 2020, the World Health Organization declared a pandemic. Understanding SARS-CoV2 genomic allowed the scientific community to develop vaccine candidates against COVID-19. Over 41 scientific groups conducted clinical trials to prove vaccines efficiency, efficacy, and safety.Method: A cross sectional retrospective study performed in Honduras since July 21st, 2021, to December 1st, 2021. This study included the population who received at least one dose of any COVID-19 vaccine. The data were collected using an online survey using Google Forms and a QR code to make it easier for the participants to access the survey and to avoid collecting any personal data from the participants. The symptoms were self-reported. A total of 2108 participants were included in the study through the online survey.Results: The average age of the participants was 34.61±11.129 years with higher frequency of people between 20-29 years old. In 60.7% of the cases, side effects were reported after the first dose of COVID-19 vaccine or in cases when only one dose was required. Only 1916 received a second dose of COVID-19 vaccine and 38.9% of them presented side effects after that second dose. The most common side effect is pain in the injection site (49.7% and 30.7%). The most common systemic side effects are fever (34.8% and 17.5%), headache (33.5% and 19.1%) and myalgia (32.8% and 17.6%). Conclusions: The side effects reported by the population after any vaccination against COVID-19 are mainly systemic effects like fever, myalgia and headache, while the most common local side effect is pain in the injection site. The rates of side effects are higher in females, and younger participants after both doses, the differences are statistically significant

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects.

Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.This study protocol preparation was funded by Masaryk University, grant numbers MUNI/IGA/1543/2020 and MUNI/A/1608/2020.S

COVID-19 Immunisation Strategy: Priority Populations

Additional support from ISGlobal’s Antoni Plasència and Josep M. AntóWith a limited initial supply of COVID-19 vaccines doses and an expected delay for the universal vaccination of those eligible to receive it, it is relevant to analyse how best to prioritise the first available doses to achieve the greatest impact, both in terms of protecting individuals and minimising community transmission. Ethical issues are key in guiding a fair distribution. Different scenarios on vaccine implementation are summarised in this report. After a critical review of the documents and considering that these criteria are applied to Spanish citizens, the members of theGCMSC establish a priority vaccination list based on ethical principles and adapted to our count

Implementing national COVID-19 vaccination programmes in sub-Saharan Africa- early lessons from Zimbabwe: a descriptive cross-sectional study

Introduction: Zimbabwe was one of the first countries to run a national COVID-19 vaccination programme in Africa. Lessons learnt could inform the rollout of similar programmes in sub-Saharan Africa. To describe the trends of uptake of the COVID-19 vaccines in the first three months (February - May 2021) of the Zimbabwe vaccination programme and the lessons learnt. Methods: a secondary descriptive analysis of routinely available COVID-19 vaccination data extracted from the daily situation reports published by the Ministry of Health and Child Care. Results: in the first three months of the programme, 1 020 078 doses were administered, with 675 678 being first doses and 344 400 were second doses. Using population estimates, at three months, 5.2% of the population had received at least one dose and 2.6% had received the full two doses. Uptake was initially slow, followed by a gradual, and subsequently an exponential increase. Conclusion: by the end of May 2021, Zimbabwe had rolled out one of the largest COVID-19 vaccination programme in sub-Saharan Africa. The uptake followed a pattern and trend that is consistent with vaccine hesitancy reported in the literature, driven by a combination of confidence, complacency and convenience factors. The gradual increase in uptake followed a series of national and local community engagement programmes. The roll-out of similar programmes must recognise likely patterns of uptake across the population and ensure plans are in place to address vaccine hesitancy. The available data did not allow granular analysis to understand the demographics of people who participated in the programme, which is important for surveillance, targeted action, preventing inequalities and ensuring adequate and proportionate protection of residents prioritising the most vulnerable. Further analysis of the process, outcomes and impact of the programme will be helpful in informing the rollout of similar programmes across Africa

COVID-19 VACCINES: EVIDENCE, CHALLENGES AND THE FUTURE

Through an unprecedented research and development process, in early 2021, just one year after the COVID-19 pandemic started devastating the world, there are several vaccines commercially available or in advanced phase of testing, each with its own characteristics and challenges. For the first time in the history of vaccination, a global immunization programme has started at a time of intense pandemic activity characterized by high virus transmission, facilitating selection of variants potentially able to escape the vaccine-induced antibody response. The reality is that one cannot rely on a single vaccine when dealing with a pandemic emergency: the urgent need of billions of doses clashes with the production capacity of the pharmaceutical industry. There is therefore no ideal vaccine, but there are many good vaccines to be used immediately. Today,  the international debate about COVID-19 vaccines is the hottest topic in global health whether it relates to technical and scientific issues or to the ethical aspects of access to vaccinations for all. This article aims at reviewing the status of vaccines that are used, or about to be used, in immunization campaigns worldwide

COVID 19 Vaccination strategies in India- A Public Health perspective

COVID-19 has emerged as one of the most challenging pandemics of the recent times.  Although physical-distancing and other transmission-mitigation strategies have helped battling this virus in the most effective way, but this will also paradoxically leave the population without immunity to COVID-19 and thus susceptible to additional waves of infection. Thus, to return to pre-pandemic normalcy, safe and effective vaccination programme is required globally with robust vaccination strategies. This article pens down the important strategies being implemented globally for successful vaccination programme and critically reviewing them from public health perspective

COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)-A Systematic Review of Study Designs and Methods

BACKGROUND: Post-marketing vaccine safety surveillance aims to monitor and quantify adverse events following immunization in a population, but little is known about their implementation in low- and middle-income countries (LMICs). We aimed to synthesize methodological approaches used to assess adverse events following COVID-19 vaccination in LMICs. METHODS: For this systematic review, we searched articles published from 1 December 2019 to 18 February 2022 in main databases, including MEDLINE and Embase. We included all peer-reviewed observational COVID-19 vaccine safety monitoring studies. We excluded randomized controlled trials and case reports. We extracted data using a standardized extraction form. Two authors assessed study quality using the modified Newcastle-Ottawa Quality Assessment Scale. All findings were summarized narratively using frequency tables and figures. RESULTS: Our search found 4254 studies, of which 58 were eligible for analysis. Many of the studies included in this review were conducted in middle-income countries, with 26 studies (45%) in lower-middle-income and 28 (48%) in upper-middle-income countries. More specifically, 14 studies were conducted in the Middle East region, 16 in South Asia, 8 in Latin America, 8 in Europe and Central Asia, and 4 in Africa. Only 3% scored 7-8 points (good quality) on the Newcastle-Ottawa Scale methodological quality assessment, while 10% got 5-6 points (medium). About 15 studies (25.9%) used a cohort study design and the rest were cross-sectional. In half of them (50%), vaccination data were gathered from the participants' self-reporting methods. Seventeen studies (29.3%) used multivariable binary logistic regression and three (5.2%) used survival analyses. Only 12 studies (20.7%) performed model diagnostics and validity checks (e.g., the goodness of fit, identification of outliers, and co-linearity). CONCLUSIONS: Published studies on COVID-19 vaccine safety surveillance in LMICs are limited in number and the methods used do not often address potential confounders. Active surveillance of vaccines in LMICs are needed to advocate vaccination programs. Implementing training programs in pharmacoepidemiology in LMICs is essential

BRICS in the production and distribution of COVID-19 vaccines to countries of the south

Este artigo aborda a participação do BRICS na produção e distribuição de vacinas contra covid-19 durante 2020 e 2021, e o compromisso com a priorização do acesso aos países do Sul Global. Faz, ainda, uma reflexão sobre como o grupo lidou com os desafios do compartilhamento de tecnologias e do empoderamento econômico dos países periféricos, sinalizando a disputa de espaço entre a diplomacia da vacina e os interesses econômicos das nações. A análise se deu com base em relatórios institucionais, dados documentais jornalísticos e científicos, e no diálogo destes com os conhecimentos da Diplomacia da Saúde e da Cooperação Internacional em Saúde, demonstrando a complexidade e os desafios do mundo após o surgimento do vírus SARS-CoV-2 e suas variantes.This study describes the participation of the BRICS in the production and distribution of COVID-19 vaccines in 2020 and 2021 and its commitment to prioritizing access by the countries of the Global South. It also reflects on how the Group dealt with the challenges of technology sharing and the economic empowerment of peripheral countries, signaling the space dispute between vaccine diplomacy and the economic interests of nations. This analysis was based on institutional reports, journalistic and scientific documentary data, and their dialogue with the knowledge of Health Diplomacy and International Health Cooperation, showing the complexity and challenges of the world after the emergence of the SARSCoV-2 virus and its variables