A Phase 2/3 observer-blind, randomized, controlled study to determine the safety and immunogenicity of SARS-CoV-2 recombinant spike protein vaccine in Indian children and adolescents aged 2 to 17 years (preprint)

Background: A recombinant, adjuvanted COVID-19 vaccine, SII-NVX-CoV2373 was manufactured in India and evaluated in Indian children and adolescents to assess safety and immunogenicity. Methods: This was a Phase 2/3 observer-blind, randomized, controlled study in children and adolescents aged 2 to 17 years. Participants were randomly assigned in 3:1 ratio to receive two doses of SII-NVX-CoV2373 or placebo on day 1 and day 22. Solicited adverse events (AEs) were collected for 7 days after each vaccination. Unsolicited AEs were collected for 35 days following first dose and serious AEs (SAEs) and adverse events of special interest (AESI) were collected throughout the study. Anti S IgG and neutralizing antibodies against the SARS-CoV-2 were measured at baseline, day 22, day 36 and day 180. Variant immune responses were assessed in a subset of participants at baseline, day 36 and day 180. Primary objectives were to demonstrate non-inferiority of SII-NVX-CoV2373 in each pediatric age group (12 to 17 years and 2 to 11 years, separately) to that in adults in terms of ratio of titers of both anti-S IgG and neutralizing antibodies 14 days after the second dose (day 36). Non-inferiority was to be concluded if the lower bound of 95% CI of the ratio was >0.67. Results: A total of 920 children and adolescents (460 in each age cohort; 12 to 17 years and 2 to 11 years) were randomized and vaccinated. The demographic and baseline characteristics between the two groups were comparable in both age groups. After the second dose, there were more than 100-fold rise in anti-S IgG GMEUs and more than 84-fold rise in neutralizing antibodies GMTs from baseline in the participants who received SII-NVX-CoV2373. The GMTs in both age groups were non-inferior to those observed in Indian adults. The seroconversion rate was [≥] 98% (anti-S IgG) and [≥] 97.9% (neutralizing antibodies) in both age groups, respectively. Similar findings were seen in the baseline seronegative participants. SII-NVX-CoV2373 also showed robust responses against various variants of concern. Injection site pain, tenderness, swelling, erythema and fever, headache, malaise, fatigue, myalgia, arthralgia, nausea and vomiting were the common solicited adverse events which were transient and resolved without any sequelae. Throughout the study, only two causally unrelated SAEs and no AESI were reported. Conclusion: SII-NVX-CoV2373 has been found safe and well tolerated in children and adolescents of 2 to 17 years. The vaccine was highly immunogenic and the immune response was non-inferior to that in adults.

Parents perceptions and intention to vaccinate their children against COVID-19: Results from a cross-sectional national survey in India (preprint)

Background Despite the success of adult vaccination against COVID-19, providing vaccines to children remains a challenge for policymakers globally. As parents are primary decision-makers for their children, we aimed to assess parents perceptions and intentions regarding COVID-19 vaccination in India. Methods A cross-sectional web-based study was designed, parents or caregivers (N=770) were recruited through snowball sampling using Google form. Cross-tabulation was performed by parents intention to vaccinate their children against COVID-19 virus with sociodemographic characteristics and their risk perception towards COVID-19, trust in the healthcare system, and their history of vaccine hesitancy behavior. Multivariable logistic regression analysis was performed to compute the predictors of child vaccination intention among Indian parents. Results Seven hundred seventy parents across the country have completed the survey. Of the 770 participants, 258 (33.5%) have shown intent to vaccinate their children. The stated likelihood of child vaccination was greater among parents who had a bachelors degree or higher education (aOR: 1.98, 95% CI: 1.15-3.51); as well as among parents who intended to vaccinate themselves (aOR: 2.35, 95% CI: 1.30-4.67). Parental concerns centered around vaccine safety and side effects. Conclusion Indian parents reported high knowledge of the COVID-19 virus and were aware of the development of a novel vaccine. However, about one-third of parents intended to vaccinate their children, and about half of them were not sure whether to vaccinate their children or not against the COVID-19 virus. The study highlighted the need for health promotion strategies that promote vaccine uptake among parents.

COVID-19 vaccine acceptance among healthcare workers in India: Results from a cross-sectional survey (preprint)

BackgroundRemarkable scientific progress has enabled expeditious development of effective vaccines against COVID-19. While healthcare workers (HCWs) have been at the frontlines for the pandemic response, vaccine acceptance amongst them needs further study. MethodsA web-based survey to assess vaccine acceptance and preparedness in India was disseminated to HCWs working in various settings between January and February 2021, shortly after the launch of Indias vaccination campaign. Descriptive statistics were used to examine respondent demographics and Likert scale responses. Binomial logistic regression analyses were used to identify factors associated with vaccine acceptance. ResultsThe survey yielded 624 respondents from 25 states and five union territories in India; 53.5% were male, and median age was 37 years (IQR 32-46). Amongst all respondents, 84.1% (525/624) supported COVID-19 vaccines, and 63.2% (141/223) of those unvaccinated at the time of survey administration were willing to accept a vaccine. Reliability on government sources, healthcare providers or scientific journal articles for COVID-19 related information was reported by 66.8%, while confidence in social media for this information was reported by only 4.5%. Factors independently associated with vaccine acceptance included advancing age (aOR 3.50 [95% CI, 1.04-11.76] for those above 45 years), evidence of vaccine effectiveness and safety (aOR 3.78 [95% CI 1.15-12.38]), and provision of free/no-cost vaccine (aOR 2.63 [95% CI, 1.06-6.50]). Most respondents (80%) were confident about their hospital being equipped to efficiently rollout COVID-19 vaccines to the general population. ConclusionsOverall attitudes towards COVID-19 vaccination and preparedness were positive among HCWs in India, although acceptance was lower among healthier and younger HCWs. Data availability on vaccine safety and effectiveness, and cost considerations were important for acceptance. Targeted interventions are needed to improve vaccine acceptance amongst HCWs, since they are critical in promoting vaccine acceptance amongst the general population.

Assessment of COVID-19 Vaccination Intention Among Community Health Workers: a Web-based Cross-sectional Survey During the First Wave of the Pandemic in India (preprint)

Background: Vaccine hesitancy is of considerable concern as it threatens the great potential of a vaccine against COVID-19. Community health workers (CHWs) bridge the gap between the community and the health care system. Their intention to get vaccinated will not only affect them but will also affect the community’s perception of the vaccine.  This study aims to understand the intention to get vaccinated against COVID-19 among community health care workers in India and its determinants.Methods: A web-based, cross-sectional study was conducted among 357 community health workers using snowball sampling. A self-administered anonymous questionnaire was shared with study participants across major geographical regions in India through social media during the first wave (November-December 2020).Results: Among 357 community health workers, 208 (58%) responded positively regarding their intention to get a COVID-19 vaccine. Graduate [aOR 2.26 (95% CI: 1.27-4.01), p=0.006] and post-graduate participants [aOR 2.85 (95% CI: 1.43-5.68), p=0.003], those with lower risk perception [aOR 1.86 (95% CI: 1.03-3.35), p=0.038] and respondents who trusted the healthcare system [aOR 2.60 (95% CI:1.59-4.26), p<0.001] were more likely to get vaccinated. Respondents who were exposed to COVID-19 cases were less likely to uptake the hypothetical vaccine [aOR 0.57 (95% CI: 0.34-0.96), p=0.034].Conclusions: Increasing knowledge regarding the COVID-19 vaccine might not be enough to improve vaccine acceptance rates. Enhancing trust among community health workers in the healthcare system and regarding the available vaccines seem necessary. In addition, targeted interventions addressing socio-demographic determinants related to COVID-19 vaccination should help improve acceptance of the vaccine.

Shifting research priorities in maternal and child health in the COVID-19 pandemic era in India: a renewed focus on systems strengthening (preprint)

Background: The remarkable progress seen in maternal and child health (MCH) in India over the past two decades has been impacted by setbacks from the COVID-19 pandemic. We aimed to undertake a rapid assessment to identify key priorities for public health research in MCH in India within the context and aftermath of the COVID-19 pandemic. Methods: A web-based survey was developed to identify top research priorities in MCH. It consisted of 26 questions on six broad domains: vaccine preventable diseases, outbreak preparedness, primary healthcare integration, maternal health, neonatal health, and infectious diseases. Key stakeholders were invited to participate between September and November 2020. Participants assigned importance on a 5-point Likert scale, and assigned overall ranks to each sub-domain research priority. Descriptive statistics were used to examine Likert scale responses, and a ranking analysis was done to obtain an average ranking score and identify the top research priority under each domain. Results: Amongst the 84 respondents, 37% were public-health researchers, 25% healthcare providers, 20% academic faculty and 13% were policy makers. Across the six domains, most respondents considered conducting research on systems strengthening as extremely important. The highest ranked research priorities were strengthening the public sector workforce (vaccine preventable diseases), enhancing public-health surveillance networks (outbreak preparedness), nutrition support through community workers (primary care integration), encouraging at least 4-8 antenatal visits (maternal health), neonatal resuscitation to reduce birth asphyxia (neonatal health) and pediatric and maternal screening and treatment of tuberculosis (infectious diseases). Common themes identified through open-ended questions were also systems strengthening priorities across domains. Conclusions: The overall focus for research priorities in MCH in India during the COVID-19 pandemic is on strengthening existing services and service delivery, rather than novel research. Our results highlight pivotal steps within the roadmap for advancing and sustaining maternal and child health gains during the ongoing COVID-19 pandemic and beyond.

Consideration for the asymptomatic transmission of COVID-19: Systematic Review and Meta-Analysis (preprint)

Objective: Worldwide countries are experiencing viral load in their population, leading to potential infectivity of asymptomatic COVID-19. Current systematic review and meta-analysis aimed to investigate the role of asymptomatic infection worldwide reported in family-cluster, adults, children, health care workers, and travelers. Design: Online literature search (PubMed, Google Scholar, medRixv, and BioRixv) was accomplished using standard Boolean operators, studies published till 07th June 2020. Setting: Studies were included from case reports, short communication, and retrospective to cover sufficient asymptomatic COVID-19 transmission reported. Participants: Familial-clusters, adults, children, health care workers, and travelers. Results: We observed asymptomatic transmission among familial-cluster, adults, children, health care workers, and travelers with a proportion of 32% 37%, 26%, 6%, and 32%, respectively. This study observed an overall proportion of 31% (95%CI: 0.19-0.44) with heterogeneity of I2 (97.28%, p=<0.001) among all asymptomatic populations mentioned in this study. Among children and healthcare workers, this study showed no heterogeneity; to overcome the interpretation from a fixed model, the random effect model was also applied to estimate the average distribution across studies included in the meta-analysis. Conclusion: We found and suggest the rigorous epidemiological history, early isolation, social distancing, and increased quarantine period (at least 28 days) after screening asymptomatic cases as well as their close contacts for chest CT scan even after their negative nucleic acid testing to minimize the spread among the community. This systematic review and meta-analysis support asymptomatic COVID-19 transmission between person to person depending on the variation of virus incubation period among individuals. Children especially, school-going aged <18 years, need to be monitored and prevention strategy, e.g., chest CT and social distancing required to prevent the community transmission of COVID-19 in asymptomatic mode.

The use of facemasks by the general population to prevent transmission of Covid 19 infection: A systematic review. (preprint)

Background The pandemic of COVID-19, caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2), has become a serious worldwide public health emergency. This systematic review aims to summarize the available evidence regarding the role of face mask in community settings in slowing the spread of respiratory viruses such as SARS- CoV-2. Methods The preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines were used for this review. A literature search using PUBMED, Google Scholar, and Cochrane database were performed using Medical subject heading (MeSH) words from the year 2000-2020. The articles focused on the use of masks and N95 respirators in healthcare workers were excluded. Results A total of 305 records were identified, out of which 14 articles were included in the review based upon quality and eligibility criteria. All the articles mentioned about the role of face masks in preventing the spread of respiratory viruses like influenza, SARS, and SARS-CoV-2, in the community or experimental setting. Studies also suggested that early initiation of face mask usage was more effective. Masks were also reported to be more effective in viruses that transmit easily from asymptomatic individuals, as is now known in SARS-CoV-2. Conclusion Theoretical, experimental, and clinical evidence suggested that usage of face masks in a general population offered significant benefit in preventing the spread of respiratory viruses especially in the pandemic situation, but its utility is limited by inconsistent adherence to mask usage.