ABSTRACT
Background: NVX-CoV2373, a Covid-19 vaccine was developed in the USA with â¼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study. Methods: This was an observer-blind, randomised, phase 2/3 study in 1600 adults. In phase 2, 200 participants were randomized 3:1 to SII-NVX-CoV2373 or placebo. In phase 3, 1400 participants were randomized 3:1 to SII-NVX-CoV2373 or NVX-CoV2373 (940 safety cohort and 460 immunogenicity cohort). Two doses of study products (SII-NVX-CoV2373, NVX-CoV2373 or placebo) were given 3 weeks apart. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 to NVX-CoV2373 in terms of geometric mean ELISA units (GMEU) ratio of anti-S IgG antibodies 14 days after the second dose (day 36) and to determine the incidence of causally related serious adverse events (SAEs) through 180 days after the first dose. Anti-S IgG response was assessed using an Enzyme-Linked Immunosorbent Assay (ELISA) and neutralizing antibodies (nAb) were assessed by a microneutralization assay using wild type SARS CoV-2 in participants from the immunogenicity cohort at baseline, day 22, day 36 and day 180. Cell mediated immune (CMI) response was assessed in a subset of 28 participants from immunogenicity cohort by ELISpot assay at baseline, day 36 and day 180. The total follow-up was for 6 months. Trial registration: CTRI/2021/02/031554. Findings: Total 1596 participants (200 in Phase 2 and 1396 in Phase 3) received the first dose. SII-NVX-CoV2373 was found non-inferior to NVX-CoV2373 (anti-S IgG antibodies GMEU ratio 0.91; 95% CI: 0.79, 1.06). At day 36, there was more than 58-fold rise in anti-S IgG and nAb titers compared to baseline in both the groups. On day 180 visit, these antibody titers declined to levels slightly lower than those after the first dose (13-22 fold-rise above baseline). Incidence of unsolicited and solicited AEs was similar between the SII-NVX-CoV2373 and NVX-CoV2373 groups. No adverse event of special interest (AESI) was reported. No causally related SAE was reported. Interpretation: SII-NVX-CoV2373 induced a non-inferior immune response compared to NVX-CoV2373 and has acceptable safety profile. Funding: SIIPL, Indian Council of Medical Research, Novavax.
ABSTRACT
Mental wellness is a crucial component of happiness. A person is happy with better relationships, financial stability, good mental health, and longevity. Disinformation, stigma, ongoing isolation, and disruption of daily activities are all quite prevalent. Any of these elements may impact one's mental health. The Ministry of Health and Family Welfare has taken several steps to address COVID's mental health concerns. In addition to frontline healthcare personnel, who engage in dealing with COVID-19, the general population's mental health was also at stake due to the unprecedented and catastrophic emergency of COVID. Various keywords, including MeSH terms, were used in PubMed and Google Scholar searches. This paper was based on previously available data and article searches on how COVID-19 affected the mental health of the general population and the elements that may influence it. Quarantine and self-isolation have been found to have affected people's daily livelihoods and behaviors, leading to increased feelings of loneliness, anxiety, dejection, insomnia, risky alcohol and drug use, self-harm, and suicidal thoughts. Many of the victims of COVID-19 who were critical survivors exhibited lasting psychological harm a year after being discharged, including high anxiety levels, melancholy, and post-traumatic stress disorder. Healthcare employees too experienced significant psychological consequences due to factors such as an excessive workload or the number of hours worked, inadequate personal safety equipment, overly enthusiastic media coverage, and a sense of being under-supported. As a result of this major disaster, mental health concerns have surfaced, perhaps leading to long-term health problems, loneliness, and guilt. To reduce this deportment, global health solutions should be used, particularly while executing the isolation/quarantine and dealing with the people with fear and vulnerability. The mental health of the general population should be at the forefront of any worldwide response.
ABSTRACT
Background COVID-19 has restricted the education of students on a global scale. With the nationwide stay-at-home directives, schools, colleges and universities have been shut down. Online education is a measure for continuing the learning of the students in times of pandemic. However, the school-going children of urban slum areas face challenges in attending online classes. Through this study, we have tried to highlight the problems and challenges faced by the students and their parents from an urban slum area of Mangalwarpeth, Pune for attending online education in times of COVID. The urban slum area mainly consists of people from low socioeconomic backgrounds lacking the necessary resources and supportive environment for an online mode of education. We have observed and recorded the response of the participants in the context of online education in times of COVID and challenges faced by the lower socio-economic strata due to reasons like non-availability of resources, poor internet connectivity, poor understanding, and distractions while classes leading to low attendance. Methods A cross-sectional qualitative study was conducted in an urban slum area of Mangalwarpeth, Pune. Data was collected over four months after receiving consent from the parents of the children from the metropolitan slum area of Mangalwarpeth. A structured questionnaire was used. Data was coded on an excel sheet and was transferred to SPSS software version 21 (IBM Corp., Armonk, NY) and was represented in frequency and percentage. Result After the data collection and analysis, we found that (according to the modified Kuppuswamy scale for socioeconomic status) around 53% of the study population were from the lower middle class followed by the upper lower class (27.16%), upper middle class (9.87%), lower class (8.64%) and upper class (1.23%). Sixteen percent of participants do not have smartphones available, and 95.5% do not have a laptop required for online classes. A total of 19.5% of the students do not have access to internet services. Eighty-four percent of parents agreed on increased expenses of the internet. Conclusion Students from urban slum areas belong to lower socioeconomic classes and face problems while attending online classes like the nonavailability of resources and lack of a supportive environment. There are increased expenses of the internet as a result of the online mode of education, with increased distractions from the surroundings, concentration problems, and less understanding of the subjects. The students cannot interact with their teachers and friends and as a result, their social interaction is reduced. A supportive environment and proper resources are essential for the learning of students to continue education in times of emergencies like pandemics.
ABSTRACT
Background: Preventive public health has been suggested as methods for reducing the transmission of COVID-19. Safety and efficacy of one such public health measure: WASH intervention for COVID-19 has not been systematically reviewed. We undertook a rapid review to assess the effect of WASH intervention in reducing the incidence of COVID-19. Methods: We conducted searches in PubMed, MEDLINE, and EMBASE. We undertook screening of studies in two stages and extracted data and assessed the quality of evidence for the primary outcome using GRADE recommendations. Main results: We included a total of 13 studies with three studies on COVID-19 and 10 on SARS. The study found that hand washing, sterilization of hands, gargling, cleaning/shower after attending patients of COVID-19, or SARS was protective. Evidence also found that frequent washes can prevent SARS transmission among HCWs. However; one study reported that due to enhanced infection-prevention measures, front-line HCWs are more prone to hand-skin damage. The certainty of the evidence for our primary outcome as per GRADE was very low. We did not find any studies that assessed the effect of WASH on hospitalizations, and mortality due to COVID-19. Also; we did not find any study that compared WASH interventions with any other public health measures. Conclusions: Current evidence of WASH interventions for COVID-19 is limited as it is largely based on indirect evidence from SARS. Findings from the included studies consistently show that WASH is important in reducing the number of cases during a pandemic. Timely implementation of WASH along with other public health interventions can be vital to ensure the desired success. Further good-quality studies providing direct evidence of the efficacy of WASH on COVID-19 are needed.