Search

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products--a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products. [ABSTRACT FROM AUTHOR]

Many children do not receive a full schedule of childhood vaccines, yet there is limited evidence on the cost-effectiveness of strategies for improving vaccination coverage. Evidence is even scarcer on the cost-effectiveness of strategies for reaching 'zero-dose children', who have not received any routine vaccines. We evaluated the cost-effectiveness of periodic intensification of routine immunization (PIRI), a widely applied strategy for increasing vaccination coverage. We focused on Intensified Mission Indradhanush (IMI), a large-scale PIRI intervention implemented in India in 2017–2018. In 40 sampled districts, we measured the incremental economic cost of IMI using primary data, and used controlled interrupted time-series regression to estimate the incremental vaccination doses delivered. We estimated deaths and disability-adjusted life years (DALYs) averted using the Lives Saved Tool and reported cost-effectiveness from immunization programme and societal perspectives. We found that, in sampled districts, IMI had an estimated incremental cost of 2021US$13.7 (95% uncertainty interval: 10.6 to 17.4) million from an immunization programme perspective and increased vaccine delivery by an estimated 2.2 (−0.5 to 4.8) million doses over a 12-month period, averting an estimated 1413 (−350 to 3129) deaths. The incremental cost from a programme perspective was $6.21 per dose ($2.80 to dominated), $82.99 per zero-dose child reached ($39.85 to dominated), $327.63 ($147.65 to dominated) per DALY averted, $360.72 ($162.56 to dominated) per life-year saved and $9701.35 ($4372.01 to dominated) per under-5 death averted. At a cost-effectiveness threshold of 1× per-capita GDP per DALY averted, IMI was estimated to be cost-effective with 90% probability. This evidence suggests IMI was both impactful and cost-effective for improving vaccination coverage, though there is a high degree of uncertainty in the results. As vaccination programmes expand coverage, unit costs may increase due to the higher costs of reaching currently unvaccinated children. [ABSTRACT FROM AUTHOR]

According to the 2018 WHO R&D Blueprint, Nipah virus (NiV) is a priority disease, and the development of a vaccine against NiV is strongly encouraged. According to criteria used to categorize zoonotic diseases, NiV is a stage III disease that can spread to people and cause unpredictable outbreaks. Since 2001, the NiV virus has caused annual outbreaks in Bangladesh, while in India it has caused occasional outbreaks. According to estimates, the mortality rate for infected individuals ranges from 70 to 91%. Using immunoinformatic approaches to anticipate the epitopes of the MHC-I, MHC-II, and B-cells, they were predicted using the NiV glycoprotein and nucleocapsid protein. The selected epitopes were used to develop a multi-epitope vaccine construct connected with linkers and adjuvants in order to improve immune responses to the vaccine construct. The 3D structure of the engineered vaccine was anticipated, optimized, and confirmed using a variety of computer simulation techniques so that its stability could be assessed. According to the immunological simulation tests, it was found that the vaccination elicits a targeted immune response against the NiV. Docking with TLR-3, 7, and 8 revealed that vaccine candidates had high binding affinities and low binding energies. Finally, molecular dynamic analysis confirms the stability of the new vaccine. Codon optimization and in silico cloning showed that the proposed vaccine was expressed to a high degree in Escherichia coli. The study will help in identifying a potential epitope for a vaccine candidate against NiV. The developed multi-epitope vaccine construct has a lot of potential, but they still need to be verified by in vitro & in vivo studies. [ABSTRACT FROM AUTHOR]

As dengue expands globally and many vaccines are under trials, there is a growing recognition of the need for assessing T cell immunity in addition to assessing the functions of neutralizing antibodies during these endeavors. While several dengue-specific experimentally validated T cell epitopes are known, less is understood about which of these epitopes are conserved among circulating dengue viruses and also shared by potential vaccine candidates. As India emerges as the epicenter of the dengue disease burden and vaccine trials commence in this region, we have here aligned known dengue specific T cell epitopes, reported from other parts of the world with published polyprotein sequences of 107 dengue virus isolates available from India. Of the 1305 CD4 and 584 CD8 epitopes, we found that 24% and 41%, respectively, were conserved universally, whereas 27% and 13% were absent in any viral isolates. With these data, we catalogued epitopes conserved in circulating dengue viruses from India and matched them with each of the six vaccine candidates under consideration (TV003, TDEN, DPIV, CYD-TDV, DENVax and TVDV). Similar analyses with viruses from Thailand, Brazil and Mexico revealed regional overlaps and variations in these patterns. Thus, our study provides detailed and nuanced insights into regional variation that should be considered for itemization of T cell responses during dengue natural infection and vaccine design, testing and evaluation. [ABSTRACT FROM AUTHOR]

Background: The need of developing a vaccine on emergency basis to COVID-19 has captured the attention of the regulator during the recent pandemic. There is no comprehensive regulatory pathway for the development of a novel candidate provided in India. Materials and Methods: The COVID-19 vaccines were developed and approved in a short duration when compared to the historical timelines. A questionnaire was sent to the manufacturers of COVID-19 vaccine and collected the information of various regulatory approvals obtained for the development of the vaccine, clinical trials conducted along with the details on their design, conduct and assessment. Results and Discussion: Based on the data collected the time to approval and the innovative measures such as application of adaptive clinical trial design, comparator, rolling review by the regulator, end point, functional antibody, animal challenge study etc were tabulated. The details of the expert review were collected from the NRA website. The approval was based on the totality of evidence from all the parameters. Conclusion: Based on the data obtained from the questionnaire and the gaps and best practices collected from the manufacturers an algorithm for the approval of the novel candidate vaccine during an epidemic is proposed. This algorithm if adopted, would expedite the development of Novel Candidate Vaccine in India. [ABSTRACT FROM AUTHOR]

The coronavirus disease 2019 (COVID-19) pandemic highlighted the world's level of preparedness in managing public health emergencies (PHEs). It revealed the critical need for timely medical therapeutics, especially vaccines. To expedite response, many nations, including India, adopted emergency approval mechanisms and offered new ways of review, such as the rolling review along with the accelerated review procedure. This response resulted in reallocating internal resources and adopting new policies and measures, such as integrating digital technology with regulatory submissions and flexibility in statistical approaches. The present review focuses on the utilization of the New Drugs and Clinical Trials Rules 2019 for granting emergency approval to COVID-19 vaccines by the Drug Controller General of India (DCGI) and explores the legislative basis for such authorization during the PHE. The review aims to elucidate key intricacies and challenges inherent in the existing 'emergency use' framework within the Indian regulatory landscape. It assesses three critical facets of the 'emergency use' paradigm: the definition of the term, establishment of a transparent decision-making process, and formulation of rules governing termination or expiration of the emergency status. It makes policy recommendations regarding the 'emergency use' framework to respond to new, emerging, or re-emerging public health threats of the future. [ABSTRACT FROM AUTHOR]

Background: The vaccine is a means to control and eradicate infectious diseases and also to strengthen health systems. There should be a complete ecosystem in a well-defined, transparent, and predictable regulatory system for the development of novel candidate vaccines. There is no specified regulatory pathway provided under the law for the approval of the novel candidate vaccine in the country leading to delays or long developmental timelines. Materials and Methods: A survey was conducted among the experts in the vaccine Industry to identify the gaps and challenges faced by them during development. In this study, a questionnaire has been formulated consisting of questions on the gaps in the regulatory system which came to the fore during the COVID-19 pandemic such as the availability of detailed guidelines for the development, rolling reviews, Immune correlates of protection, animal rule, adaptive clinical study pathway, algorithm/alternate development pathway. They were also requested to choose the areas among the given list requiring a detailed guidance document and also to state three challenges faced for expediting the development of a novel vaccine. Results and Discussion: The results were collated and presented in the form of pie and bar charts and the challenges were summarised in tabular format. The results would provide a roadmap to the Policymakers on the future course of action. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has highlighted the importance of global health diplomacy (GHD), with India emerging as a key player. India's commitment to GHD is demonstrated by its active participation in regional and multilateral projects, pharmaceutical expertise, and large-scale manufacturing capabilities, which include the production and distribution of COVID-19 vaccines and essential medicines. India has supported nations in need through bilateral and multilateral platforms, providing vaccines to countries experiencing shortages and offering technical assistance and capacity-building programs to improve healthcare infrastructure and response capabilities. India's unique approach to GHD, rooted in humanitarian diplomacy, emphasized collaboration and empathy and stressed the well-being of humanity by embracing the philosophy of "Vasudhaiva Kutumbakam," which translates to "the world is one family." Against this background, this paper's main focus is to analyze the rise of India's GHD amidst the COVID-19 pandemic and its leadership in addressing various global challenges. India has demonstrated its commitment to global solidarity by offering medical supplies, equipment, and expertise to more than 100 countries. India's rising global leadership can be attributed to its proactive approach, humanitarian diplomacy, and significant contributions to global health initiatives. [ABSTRACT FROM AUTHOR]

Backgrounds: The Universal Immunization Program of India is one of the most cost-effective interventions in public health. Missing or delaying vaccination may elicit an uncertain immune response in the body, making the population susceptible to vaccine-preventable diseases. The objectives of this study were to determine the coverage of newborn immunization for birth doses under the National Immunization Schedule and its epidemiological determinants in the rural areas of the Dehradun district, Uttarakhand. Materials and Methods: A community-based cross-sectional study was conducted for a period of one year with a sample size of 570. World Health Organization (WHO) 30 Cluster sampling technique was used with 19 children in each cluster. The data on determinants were collected using a semi-structured, pre-designed schedule through a house-to-house survey. Multivariate analysis was conducted to identify factors associated with immunization coverage, taking the significance level as P < 0.05. Results: The coverage of the Bacillus Calmette-Guérin vaccine, oral polio vaccine zero dose and hepatitis B birth dose were 100%, 91.9%, and 58.8%, respectively in the study area with an overall prevalence of incomplete coverage of newborn immunization as 42.5%. The most cited reason for children being unimmunized with birth doses was the unavailability of vaccines at the birthplace center (29.6%). Conclusions: The prevalence of incomplete coverage of newborn immunization was quite high, which was undermining the holistic approach of the National Immunization Program. Vaccine availability and accessibility at the birthplace with capacity building and training of the healthcare workers may be considered to ensure coverage of birth doses. [ABSTRACT FROM AUTHOR]

In recent years, India has established itself as the world's 'pharmacy hub', and this claim was proven once again when it delivered COVID-19 vaccines to its citizens, neighbouring nations and across the globe. Following the philosophy of humanitarianism through the principle of 'Vasudhaiva Kutumbakam', India has decided to provide the COVID-19 health assistance to its immediate neighbouring countries. India's immediate neighbourhood refers to the countries that are geographically adjacent to it. In addition, India's vaccine diplomacy has exposed geopolitical fault lines in South Asia as China's vaccine diplomacy aims to outpace India in the region. Against this background, the main objective of this paper is to explain and examine India's vaccine diplomacy as an instrument of its 'Neighbourhood First' policy during the COVID-19 pandemic. It argues that India's health-focused approach has proved effective and aligned with its national interests. This review demonstrates that India's health diplomacy has had an impact on medical and humanitarian assistance reciprocation at the regional and international levels. As a result of this strategy, during the second wave of the pandemic, India received medical devices and vaccines from other countries in dealing with COVID-19. [ABSTRACT FROM AUTHOR]

Background: Pentavalent vaccines (DTP-HepB-Hib) have been introduced in many countries in their routine public immunization programmes to protect against diphtheria (D), tetanus (T), pertussis (P), hepatitis B (Hep B) and Hemophilus influenzae type b (Hib) diseases. This study compared the safety and immunogenicity of a new formulation of a whole-cell Bordetella pertussis (wP) based pentavalent vaccine (DTwP-HepB-Hib). The new formulation was developed using well-characterized hepatitis B and pertussis whole cell vaccine components. Methods: This was a phase III, observer-blind, randomized, non-inferiority, multi-center study conducted in India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator formulations at 6–8, 10–12 and 14–16 weeks of age. Results: The investigational formulation of DTwP-HepB-Hib vaccine was non-inferior to the licensed formulation in terms of hepatitis B seroprotection rate (% of subjects with HepB antibodies ≥10mIU/mL were 99.1% versus 99.0%, respectively, corresponding to a difference of 0.1% (95% CI, -2.47 to 2.68)) and pertussis immune responses (adjusted geometric mean concentrations of antibodies for anti-PT were 76.7 EU/mL versus 63.3 EU/mL, with a ratio of aGMTs of 1.21 (95% CI, 0.89–1.64), and for anti-FIM were 1079 EU/mL versus 1129 EU/mL, with a ratio of aGMTs of 0.95 (95% CI, 0.73–1.24), respectively). The immune responses to other valences (D, T, and Hib) in the two formulations were also similar. The safety profile of both formulations was found to be similar and were well tolerated. Conclusions: The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants. Clinical trial registration: Clinical Trials Registry India number: CTRI/2018/12/016692. [ABSTRACT FROM AUTHOR]

Background: India had an estimated 2.9 million tuberculosis cases and 506 thousand deaths in 2021. Novel vaccines effective in adolescents and adults could reduce this burden. M72/AS01E and BCG-revaccination have recently completed phase IIb trials and estimates of their population-level impact are needed. We estimated the potential health and economic impact of M72/AS01E and BCG-revaccination in India and investigated the impact of variation in vaccine characteristics and delivery strategies. Methods: We developed an age-stratified compartmental tuberculosis transmission model for India calibrated to country-specific epidemiology. We projected baseline epidemiology to 2050 assuming no-new-vaccine introduction, and M72/AS01E and BCG-revaccination scenarios over 2025–2050 exploring uncertainty in product characteristics (vaccine efficacy, mechanism of effect, infection status required for vaccine efficacy, duration of protection) and implementation (achieved vaccine coverage and ages targeted). We estimated reductions in tuberculosis cases and deaths by each scenario compared to the no-new-vaccine baseline, as well as costs and cost-effectiveness from health-system and societal perspectives. Results: M72/AS01E scenarios were predicted to avert 40% more tuberculosis cases and deaths by 2050 compared to BCG-revaccination scenarios. Cost-effectiveness ratios for M72/AS01E vaccines were around seven times higher than BCG-revaccination, but nearly all scenarios were cost-effective. The estimated average incremental cost was US$190 million for M72/AS01E and US$23 million for BCG-revaccination per year. Sources of uncertainty included whether M72/AS01E was efficacious in uninfected individuals at vaccination, and if BCG-revaccination could prevent disease. Conclusions: M72/AS01E and BCG-revaccination could be impactful and cost-effective in India. However, there is great uncertainty in impact, especially given the unknowns surrounding the mechanism of effect and infection status required for vaccine efficacy. Greater investment in vaccine development and delivery is needed to resolve these unknowns in vaccine product characteristics. [ABSTRACT FROM AUTHOR]

[Display omitted] Infections with SARS-CoV-2 variants and declining immunity after primary vaccination, encouraged the use of booster doses. Some countries changed their immunization programmes to boost with vaccines different from the ones in their original schedule, based on results from immunogenicity and effectiveness studies. This study reports immunological analysis of samples collected in a phase 4 randomized trial, where participants who had previously received two primary doses of ChAdOx1 nCov-19 (ChAd) or inactivated BBV152 vaccine were randomized to receive either ChAd or BBV152 booster and further categorized as: Group 1 (two primary doses of ChAd - ChAd booster), Group 2 (two primary doses of ChAd - BBV152 booster), Group 3 (two primary doses of BBV152 - ChAd booster), and Group 4 (two primary doses of BBV152 - BBV152 booster). SARS-CoV-2 specific cellular and humoral responses at day 0 (pre-boost samples 12–36 weeks after the second primary dose), and at day 28 post booster, were measured in a subset of participants (ChAd recipients, n = 37 and BBV152 recipients, n = 36). Additionally, on day180 post-booster humoral responses were assessed for the entire cohort (N = 378). Primary vaccination with 2 doses of BBV152 generated higher memory-B cells (median% 0.41 vs 0.35) and cytokine producing CD8-Tcells (median% 0.09 vs 0.04) while lower anti-spike IgG levels (medianAU/ml: 12,433 vs 27,074) as compared to ChAd. Irrespective of the primary vaccine received, ChAd boosted individuals generated higher memory-B cell frequencies and anti-spike IgG levels as compared to BBV152 booster. The percentage ACE-2 inhibition against Omicron and its sub-variants was higher in Group 3 (median > 60 %) as compared to other groups (median < 25 %). At day180 post booster the hierarchy of the antibody amounts was Group 1 ∼ Group 2 ∼ Group 3 > Group 4. Sustained humoral and robust cellular immune response to SARS-CoV-2 can be obtained with ChAd booster irrespective of the primary vaccination regimen. The trial is registered with ISRTCN (CTRI/2021/08/035648). [ABSTRACT FROM AUTHOR]

Background: The objective was studying the antibody response following immunization with COVID-19 vaccines. Material and Methods: It was a longitudinal study of healthcare workers (HCWs). Two groups were taken, Group 1 had taken first dose of the COVID-19 vaccine, at least 3 weeks have passed. Group 2 had taken two doses of COVID-19 vaccine and at least 2 weeks have passed. A quantitative test for antibodies to SARS-CoV-2 spike protein was done. Follow-up of both groups was done after 3 months of collection of the first sample. Results: The antibody titre of the 57 HCWs in Group 1, decreased significantly 125 days after the first dose [median = 2,013 U/ml] as compared to the titre 30 days after the first dose of Covishield vaccine[median = 9,965.26 U/ml]. The median interval between two doses of vaccine was 34 days. In Group 2, the antibody titre of the 60 HCWs in Group 2, decreased significantly 114 days after second dose[median = 1,411 U/ml] as compared to the titre 19.5 days after second dose of Covishield vaccine [median = 2,377.5]. There was no significant difference in the antibody titre in follow-up samples of HCWs with and without side effects. Conclusion: The antibody titre decreases after 13 to 17 weeks post the second dose of Covishield vaccination. The decision of the Government of India to increase the interval between two doses of Covishield is justified. Low antibody titre can be the reason for breakthrough infections. The antibody titre was not related to side effects post-vaccination. [ABSTRACT FROM AUTHOR]

Background The World Health Organization recommends vaccines for prevention and control of typhoid fever, especially where antimicrobial-resistant typhoid circulates. In 2018, the Navi Mumbai Municipal Corporation (NMMC) implemented a typhoid conjugate vaccine (TCV) campaign. The campaign targeted all children aged 9 months through 14 years within NMMC boundaries (approximately 320 000 children) over 2 vaccination phases. The phase 1 campaign occurred from 14 July 2018 through 25 August 2018 (71% coverage, approximately 113 420 children). We evaluated the phase 1 campaign's programmatic effectiveness in reducing typhoid cases at the community level. Methods We established prospective, blood culture–based surveillance at 6 hospitals in Navi Mumbai and offered blood cultures to children who presented with fever ≥3 days. We used a cluster-randomized (by administrative boundary) test-negative design to estimate the effectiveness of the vaccination campaign on pediatric typhoid cases. We matched test-positive, culture-confirmed typhoid cases with up to 3 test-negative, culture-negative controls by age and date of blood culture and assessed community vaccine campaign phase as an exposure using conditional logistic regression. Results Between 1 September 2018 and 31 March 2021, we identified 81 typhoid cases and matched these with 238 controls. Cases were 0.44 times as likely to live in vaccine campaign communities (programmatic effectiveness, 56%; 95% confidence interval [CI], 25% to 74%; P =.002). Cases aged ≥5 years were 0.37 times as likely (95% CI,.19 to.70; P =.002) and cases during the first year of surveillance were 0.30 times as likely (95% CI,.14 to.64; P =.002) to live in vaccine campaign communities. Conclusions Our findings support the use of TCV mass vaccination campaigns as effective population-based tools to combat typhoid fever. [ABSTRACT FROM AUTHOR]

Background: Coronavirus disease 2019 (COVID-19) has imposed a serious health impact afflicting millions of people and halting global progress significantly. Albeit vaccines for COVID-19 emerged as a potent approach to overcome the morbidity, its suspicion had been persisting across diverse categories of people, including healthcare students. Since studies exploring the acceptance of vaccines among healthcare students from India were limited, this study has been formulated to evaluate the knowledge, attitude and acceptance of COVID-19 vaccines among healthcare students of a tertiary care hospital. Materials and Methods: This was a self-reporting questionnaire-based cross-sectional study conducted via online platforms. By convenience sampling method, participants were enrolled. Primary outcomes were expressed as frequency and Chi-square test was used for comparison between groups. Results: Out of 562 participants, there were 268 medical, 90 dental, 70 nursing and 134 allied health science students. Female participants (65.1%) were more compared to male participants (35.9%) and the mean age of participants was 19 years. Medical students had significantly better knowledge about vaccine doses (98.5%), route of administration (85.4%) and priority candidates for vaccines (95.9%) than students of other courses. Overall, 438 (77.9%) students were interested to receive COVID-19 vaccines. Fear of adverse effects (44.7%) was the major concern for vaccine administration among study participants. Medical course [Odds Ratio (OR) 3.95; 95% Confidence Interval (CI) 2.22-7.06] and family history of COVID-19 disease (OR 2.57; 95% C:1.28-5.17) positively influenced the willingness of students for vaccines. Conclusion: Maximum participants were convinced of COVID-19 vaccination and medical students exhibited better vaccine knowledge. This knowledge gap among healthcare students in diverse courses should be addressed via consistent vaccine sensitization programs. [ABSTRACT FROM AUTHOR]

Vaccines were crucial in controlling the Covid-19 pandemic. As more vaccines receive regulatory approval, stakeholders will be faced with several options and must make an appropriate choice for themselves. We proposed a multi-criteria decision analysis (MCDA) framework to guide decision-makers in comparing vaccines for the Indian context. We adhered to the ISPOR guidance for the MCDA process. Seven vaccine options were compared under ten criteria. Through three virtual workshops, we obtained opinions and weights from citizens, private-sector hospitals, and public health organisations. Available evidence was rescaled and incorporated into the performance matrix. The final score for each vaccine was calculated for the different groups. We performed different sensitivity analyses to assess the consistency of the rank list. The cost, efficacy and operational score of the vaccines had the highest weights among the stakeholders. From the six scenario groups, Janssen had the highest score in four. This was driven by the advantage of having a single dose of vaccination. In the probabilistic sensitivity analysis for the overall group, Covaxin, Janssen, and Sputnik were the first three options. The participants expressed that availability, WHO approvals and safety, among others, would be crucial when considering vaccines. The MCDA process has not been capitalised on in healthcare decision-making in India and LMICs. Considering the available data and stakeholder preference at the time of the study, Covaxin, Janssen, and Sputnik were preferred options. The choice framework with the dynamic performance matrix is a valuable tool that could be adapted to different population groups and extended based on increasing vaccine options and emerging evidence. *ISPOR – The Professional Society for Health Economics and Outcomes Research. [ABSTRACT FROM AUTHOR]

Background: The HPV vaccine is used as one of the main prevention tools for HPV-related cancers globally, yet it is not part of the Indian National Immunization program. In light of the introduction of the indigenous vaccine, we examine the effectiveness of health education about uptake, acceptance, and awareness. Methods: Research was performed in the following databases: PubMed, CINAHL, Scopus, and Embase to identify studies between 2008 and 2022. Studies were included if: they were conducted in India including primary data research and health education intervention, and participants were between 9 and 29 years old. Results: Out of the 10.952 results, 7 studies were included. Four studies focused on adolescent girls, aged from 9 to 20 years old, and 3 on university students aged from 17 to 26 years. Five studies were implemented in urban areas and 2 in rural areas. Health education interventions proved to be effective in increasing uptake, awareness, and acceptance of the HPV vaccine. The barriers included among others: cost, lack of awareness, and cultural barriers. Conclusion: Observations from this study outline immediate action for policymakers to educate and encourage the young population toward HPV vaccination. Future programs should be aimed at different population groups and be adjusted according to their special characteristics and needs. Attention should be given to the male population and marginalized groups. The involvement of various stakeholders proved to be beneficial, and it is highly recommended. [ABSTRACT FROM AUTHOR]

Ensuring a more equitable distribution of vaccines worldwide is an effective strategy to control global pandemics and support economic recovery. We analyze the socioeconomic effects - defined as health gains, lockdown-easing effect, and supply-chain rebuilding benefit - of a set of idealized COVID-19 vaccine distribution scenarios. We find that an equitable vaccine distribution across the world would increase global economic benefits by 11.7% ($950 billion per year), compared to a scenario focusing on vaccinating the entire population within vaccine-producing countries first and then distributing vaccines to non-vaccine-producing countries. With limited doses among low-income countries, prioritizing the elderly who are at high risk of dying, together with the key front-line workforce who are at high risk of exposure is projected to be economically beneficial (e.g., 0.9%~3.4% annual GDP in India). Our results reveal how equitable distributions would cascade more protection of vaccines to people and ways to improve vaccine equity and accessibility globally through international collaboration. A more equitable global distribution of vaccines can benefit the world, while a multilateral benefit-sharing instrument needs to be developed to remove some of the disincentives for early equitable vaccines distribution globally. [ABSTRACT FROM AUTHOR]

Introduction: Patients with cirrhosis have a higher risk of severe COVID-19 and mortality and are high-priority patients for vaccination. However, cirrhotics were excluded from the phase 2/3 vaccine trials. Hence, we aimed to assess the antibody response and safety of Covishield (ChAdOx1nCoV-19) among patients with cirrhosis. Methods: Patients who attended the tele-hepatology services at our institute from March 2020 to June 2021 and diagnosed with cirrhosis as per their medical records were telephonically interviewed in July 2021 using a pre-specified questionnaire. Patients who had completed 2 doses of ChAdOx1-nCOV (with the 2nd dose administered at least 2 weeks back) and without history of documented COVID-19 infection (pre- or post-vaccination) were tested for antibodies against the spike protein. Seropositive patients were divided into high, moderate, and low antibody responses based on the signal/cut-off. Results: We interviewed 784 patients with cirrhosis. At least 1 dose of ChAdOx1-nCOV was received by 231 patients among whom 134 (58%) had received 2 doses. Documented COVID-19 was reported in 3.9% patients who received at least 1 dose of ChAdOx1-nCOV including breakthrough infections in 3.7% patients vaccinated with 2 doses. Local and systemic adverse events were reported by 42% and 22.1% patients. None developed anaphylaxis, acute decompensation, acute-on-chronic liver failure, or other serious adverse events requiring hospitalization. Seroconversion was documented in 81 (92%) out of 88 patients. No difference was observed in level of antibody response between patients with compensated and decompensated cirrhosis (p = 0.12). Conclusion: Our preliminary data suggest that ChAdOx1-nCOV is safe with high seroconversion rates in patients with cirrhosis. [ABSTRACT FROM AUTHOR]

Introduction: There are limited data available on the long-term presence of SARS-CoV-2-specific binding antibodies and neutralizing antibodies in circulation among the elderly population. This study aims to examine levels of anti-SARS-CoV-2 antibodies in vaccines who have completed at least 6 months since the second vaccine dose. A cross-sectional study was conducted from November 2021 to January 2022 among 199 vaccines aged 60 years and above residing in Belagavi city, who received two doses of the Covishield vaccine. Methods: Antibody response to SARS-COV-2 virus whole cell antigen was measured by a kit COVID KAWACH IgG Micro LISA (J Mitra and Company, India) in 199 participants who had completed at least 6 months after receiving the second dose of Covishield vaccine. The antibody response was measured as a ratio of optical density (OD) in the participant's sample to the mean OD in negative control test by normal (T/N). Independent Kruskal–Wallis test was applied to test the difference between the T/N ratio by months of vaccination since the second dose and by the age group strata. Results: The median T/N values among participants who completed 6, 7, 8, and 9 months since the second vaccine dose were 14.17, 10.46, 7.93, and 5.11, respectively, and this decline in T/N values was statistically significant. Antibody response values showed a decline with increasing age for participants in the age strata 60–69, 70–79, and 80 and above, respectively. Conclusions: A significant decline was observed in antibody response over 9 months supporting the administration of booster dose of vaccine. [ABSTRACT FROM AUTHOR]

Background: Countries around the world are now racing to vaccinate people against SARS-CoV-2, the virus that causes COVID-19.The Government of India also rolled out its vaccination drive from 16th January '2021. Aims: To estimate the antibody response of the COVID-19 vaccine in the form of SARS-COV-2 IgG antibodies in vaccinated healthcare workers. Methods: Prospective follow-up was study conducted on healthcare workers (HCWs) of a Medical college in Dehradun, Uttarakhand. Healthcare workers who have been vaccinated for COVID-19 were tested for SARS-CoV-2-IgG antibodies at regular intervals i.e at 4 weeks after the 1st dose and then again at 4 weeks after the 2nd dose. The third sample was taken 6 months after the 2nd dose. Results: A total of 302 HCWs were enrolled in the study who gave their samples for IgG antibody estimation after the covishield vaccine. After 4 weeks of completion of both doses, 96% HCWs formed SARS-COV-2 IgG antibodies, whereas 4% didn't. Then after 6 months of follow-up, 14% HCWs have become negative for antibodies and better immunity is seen in people who also got infected with COVID-19 during this time. Conclusion: This study concludes that the immunity gained after vaccination is waning off in around 6 months and there is a need for a booster dose, especially for people at high risk. The infection control practices still play a crucial role in the prevention of this deadly disease. [ABSTRACT FROM AUTHOR]

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines Patent Pool (MPP) to share the IP rights for Paxlovid, the company's highly effective COVID-19 medicine. Based on a careful examination of Pfizer's agreement, this Article argues that the MPP presents an effective alternative to the waiver approach and concludes that the Pfizer-MPP model has the potential to reach an equilibrium between access and innovation. [ABSTRACT FROM AUTHOR]

Background: The global pharma sector is fast shifting from generics to biologics and biosimilars with the first approval in Europe in 2006 followed by US approval in 2015. In the form of Hepatitis B vaccine, India saw its first recombinant biologics approval in 2000. Around 20% of generic medications and 62% of vaccines are now supplied by the Indian pharmaceutical industry. It is this good position in biologics and biosimilars production that could potentially improve healthcare via decreased treatment cost. India has witnessed large investments in biosimilars over the years. Numerous India-bred new players, e.g., Enzene Biosciences Ltd., are keen on biosimilars and have joined the race alongside the emerging giants, e.g., Biocon and Dr. Reddy's. A very positive sign was the remarkable disposition during the COVID-19 pandemic by Bharat Biotech and the Serum Institute of India. India's biopharmaceutical industry has been instrumental in producing and supplying preventives and therapeutics to fight COVID-19. Despite a weak supply chain and workforce pressure, the production was augmented to provide reasonably priced high-quality medications to more than 133 nations. Biosimilars could cost-effectively treat chronic diseases involving expensive conventional therapies, including diabetes, respiratory ailments, cancer, and connective tissue diseases. Biologics and biosimilars have been and are being tested to treat and manage COVID-19 symptoms characterized by inflammation and respiratory distress. Purpose of review: Although India boasts many universities, research centers, and a relatively skilled workforce, its global University–Industry collaboration ranking is 24, IPR ranking remains 47 and innovation ranking 39. This reveals a wide industry-academia gap to bridge. There are gaps in effective translational research in India that must be promptly and appropriately addressed. Innovation demands strong and effective collaborations among universities, techno-incubators, and industries. Methodology: Many successful research findings in academia do not get translation opportunities supposedly due to low industrial collaboration, low IP knowledge, and publication pressure with stringent timelines. In light of this, a detailed review of literature, including policy papers, government initiatives, and corporate reviews, was carried out, and the compilation and synthesis of the secondary data were meticulously summarized for the easy comprehension of the facts and roadmap ahead. For easy comprehension, charts, figures, and compiled tables are presented. Results: This review assesses India's situation in the biosimilar space, the gaps and areas to improve for Indian investment strategies, development, and innovation, addressing need for a more skilled workforce, industrial collaboration, and business models. Conclusions: This review also proposes forward an approach to empowering technopreneurs to develop MSMEs for large-scale operations to support India in taking innovative thoughts to the global level to ultimately realize a self-reliant India. The limitations of the compilation are also highlighted towards the end. [ABSTRACT FROM AUTHOR]

(i) Background: ChAdOx1 nCoV-19 (Covishield®) vaccine is widely used in India. We studied the Covishield® induced antibody response and its durability among health care workers (HCWs) (ii) Method: HCWs received two doses (0.5 mL) four weeks apart. Blood specimens, collected before each dose, day (D) 60, D150 and D270 after second dose, were tested for anti-spike antibody (ASAb) titre and neutralising antibody (%) (NAb) using Elecsys Anti-SARS-CoV-2 S (Roche) and SARS-CoV-2 NAb ELISA Kit (Invitrogen), respectively. Data are expressed as proportions and median (interquartile range) and compared using non-parametric (iii) Result: Among 135 HCWs (83 males; age 45 (37–53); 36 had pre-existing ASAb), 29 (21.5%) acquired COVID-19 after 60 (39–68) days of vaccination. ASAb titre before second dose and at D60, D150, D270 were 77.2 (19.4–329.4), 512 (114.5–9212), 149 (51.6–2283) and 2079 (433.9–8644) U/mL, respectively. Compared to those without pre-existing ASAb, titres were significantly higher before second dose (5929 vs. 41, p < 0.001), D60 (3395 vs. 234, p = 0.007) and D150 (1805 vs. 103, p < 0.001) in participants with pre-existing ASAb; NAb were also higher (80 vs. 18, p < 0.001) before second dose. Between those who acquired infection or not after vaccination, ASAb titres were comparable before second dose (77 vs. 78, p = 0.362) but significantly higher at D60 (14,019 vs. 317, p < 0.001) and D150 (2062 vs. 121, p = 0.002) in the former group, though NAb percentage were higher at D60 (87 vs. 27, p < 0.001) and D150 (79 vs. 25, p = 0.007) only (iv) Conclusions: Covishield® induces a higher antibody titre in those with pre-existing ASAb. The vaccine induced antibody starts falling 5 months after vaccination. [ABSTRACT FROM AUTHOR]

Background: COVID-19 has largely affected humans with high infection spread and mortality rates globally including India with no specific vaccine or therapy proven effective for its management as the immune response to COVID-19 is not well understood. Covishield has been largely distributed and administered in Indian subjects. However, its efficacy and safety are still unclear raising doubts. Aim: The present study aimed to assess the efficacy, safety, and immunogenicity of the Covishield vaccine in healthcare personnel in India. Methods: In 244 healthcare workers, SARS CoV2 IgG antibodies were assessed before and following the vaccination with two doses of Covishield given at 4 to 6 weeks apart. The efficacy of the vaccine and adverse effects after immunization were evaluated till two months after vaccination. The most common side-effect seen after the 1st dose was pain at the site of injection reported in 53.27% (n=130) study subjects followed by fever in 27.86% (n=68) study subjects, body ache in 22.95% (n=56) study subjects Results: Before vaccination, IgG was positive in 21.31% (n=52) study subjects and was negative in 78.68% (n=192) study subjects. Post-vaccination, IgG-positive status was seen in 69.67% (n=170) study subjects and was not seen in 30.32% (n=74) study subjects. In the infected group having 62 subjects, post-vaccination IgG positive was seen in 96.77% (n=60) study subjects and not seen in 3.22% (n=2) study subjects. In the uninfected group including the 182 subjects, post-vaccination IgG positive was seen in 60.43% (n=110) study subjects and was not seen in 39.56% (n=72) study subjects respectively. After 2nd dose, the most common side-effect was pain at the site of injection seen in 24.59% (n=60) study subjects followed by headache in 12.29% (n=30) study subjects, fever in 7.37% (n=18) study subjects, body ache in 3.27% (n=8) participants, low backache and fatigue in 1.63% (n=4) study subjects each and local swelling in 0.81% (n=2) study subjects respectively. All the side effects had a non-significant difference except body ache which was significantly higher after 1st dose with p=0.02. Conclusion: Covishield vaccine has acceptable safety profile levels with increased seropositivity with more intervals in the two doses of the Covishield vaccine. Covishield does not prevent breakthrough infection. However, it can reduce the infection severity of COVID-19. [ABSTRACT FROM AUTHOR]

Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL® (Sanofi-Pasteur) in 1:1:1 ratio. They were followed for solicited reactions for 10 days and unsolicited events for 28 days and serious adverse events for 3 months. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, 28. A total of 60 adults were enrolled in the study. The proportion of participants with solicited reactions was 10%, 40%, and 25% in SII YFV SC, SII YFV IM, and STAMARIL® arms, respectively. No causally related unsolicited events or any serious adverse event was reported. After vaccination, the seroconversion was 94.44%, 100%, and 100%, in the three arms respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found safe and immunogenic by IM as well as SC routes. The vaccine can be tested in further phases of clinical studies. [ABSTRACT FROM AUTHOR]

A lack of a universal adult immunization scheme in India poses a challenge to achieve universal health coverage. Healthcare disparity is one of the biggest challenges in low- and middle-income countries such as India. We aimed to estimate the disparities in coverage of various adult vaccines among older adults in India using nationally representative data. An observational analysis among 31,464 participants aged ≥60 years from the Longitudinal Ageing Study in India, 2017–2018, was conducted. Vaccination coverage across wealth quintiles and selected non-communicable diseases were reported as frequencies and weighted proportions along with their 95% confidence intervals as a measure of uncertainty. The highest coverage was of the diphtheria and tetanus vaccine (2.75%) followed by typhoid (1.84%), hepatitis B (1.82%), influenza (1.59%), and pneumococcal (0.74%). The most affluent groups had a higher coverage of all vaccines. Participants having high cholesterol, psychiatric conditions, and cancer had the highest coverage of all vaccines. Overall, a very low coverage of all vaccines was observed. The coverage was influenced by social determinants of health, depicting a disparity in accessing immunization. Hence, at-risk groups such as the deprived and multimorbid patients need to be covered under the ambit of free immunization to achieve universal health coverage. [ABSTRACT FROM AUTHOR]

An introduction to articles in the issue is presented on topics including policy approaches for global wastewater surveillance, a vaccination campaign for COVID-19, and repairs and maintenance of medical devices.

Hepatitis poses a significant challenge globally, with its diverse strains and modes of transmission. The complexity lies in preventing its spread, ensuring early diagnosis, and promoting vaccination. Overcoming this challenge requires comprehensive public health efforts, awareness campaigns, and accessible healthcare services to address the burden of hepatitis effectively. This editorial focuses on raising awareness among the population, which is crucial for combating the spread of the disease. By educating individuals about the modes of transmission, preventive measures, and the importance of vaccination, we can empower them to protect themselves and others. Increasing awareness can lead to early detection, timely treatment, and the adoption of safe practices, ultimately reducing the burden of hepatitis on individuals and communities. Promoting hepatitis awareness is vital to ensuring better health outcomes and preventing the further spread of this global health concern. [ABSTRACT FROM AUTHOR]

Background: Minor adverse event following immunizations (AEFIs) are often underreported and self-treated. This study aimed to collect information regarding any and every probable adverse event experienced by the recipient of Covishield vaccine up to 10 days following the first and second dose of vaccine. To find the incidence of minor adverse events following Covishield vaccination; draw an association between adverse events and individuals' demographic factors and comorbidities; and report new adverse events, if any. Materials and Methods: A descriptive observational study was conducted among 409 participants randomly sampled from the Vaccination Centre at a Tertiary Care Hospital, Mumbai. Participants were followed up post their first and second doses to enquire about adverse events. Results: Most commonly reported adverse events included injection site pain, tenderness, chills, fatigue, fever, and myalgia. Females reported more adverse events compared to men (p < 0.05). Younger individuals (18–24) experienced adverse events more as compared to individuals above 40 years of age (p < 0.005). Reported adverse events were lesser after the second dose in comparison with the first dose. Few participants reported dysgeusia. Conclusions: Covishield vaccination has a mild AEFI profile, most commonly: injection site pain, tenderness, chills, and fatigue. It is hoped that the findings of this study will dispel anxiety around the adverse events of vaccination and reduce any persisting vaccine hesitancy. Effective communication with the population on vaccination will enable individuals to make educated and informed decisions. [ABSTRACT FROM AUTHOR]

Background: Vaccines against COVID-19 plays an important role in limiting the spread of SARS-CoV-2 infections and also in curbing mortality and morbidity due to COVID-19. Objective: To estimate the anti-spike antibody response after receiving the second dose of SARS-CoV-2 vaccines amongst health care workers of a tertiary care hospital in Tripura, India. Materials and Method: A cross- sectional study was conducted from 1 July to 20 August 2021 at Agartala Government Medical College and GBP Hospital, Agartala among 561 health care workers who had received first and second doses of SARS-CoV-2 vaccines and had completed 14 days after receiving the second dose. Results: The present study showed that health care workers who had received both doses of COVID-19 vaccine had 99.5% seropositivity to anti-spike antibody. The median SARS-CoV-2 anti-spike antibody titter was 250 with an IQR (211.55–250). Seropositivity rate was higher among Covishield recipients (99.8% [550/551]) as compared to Covaxin recipients (80% [8/10]) and it was found to be statistically significant (P = 0.000). Conclusion: The present study suggests that a good immune response was elicited against spike antigen of SARS-CoV-2 after two complete doses of Covishield (ChAdOx1-nCoV-19) or Covaxin (BBV152). [ABSTRACT FROM AUTHOR]

By the time India had recovered from COVID-19 surge and gained a headway in mass vaccination in May 2021, China's vaccine diplomacy had surpassed the Indian vaccine diplomacy. Analysing media coverage of India's vaccine diplomacy A year into the outbreak of the novel coronavirus across the world, India started the distribution of the COVID-19 vaccine in the early 2021, joining other countries that engaged with vaccine diplomacy. Texas-India vaccine diplomacy announces Covid-19 vaccine for $1.5 per dose. [Extracted from the article]

The Covid-19 outbreak hit us as a serious health crisis with vaccination to be seen as the only way out of it. And media can play the role of an advocate to fight against this epidemic by spreading important awareness regarding various protocols and vaccination strategies. Since breakthrough infections are becoming highly common, a two dose vaccine regime may be the need of the hour even for individuals with a pre-existing illness to build better immunity. Thus in this paper, our aim is to analyse a mathematical model with two dose vaccination strategy in the presence of media and breakthrough infections. An SIV1V2R model is formulated and the dynamical analysis is done. The basic reproduction number is obtained and the local stability analysis of both the disease-free and endemic equilibrium point is discussed based on reproduction number. The global stability of the endemic equilibrium point is done by graph theoretic approach. Finally, the numerical validation of the analytic solution is done using MATLAB using the real data of India for some important parameters to address a few vital questions which involves the role of media on the vaccination strategy. And sensitive model parameters effecting the basic reproduction number and endemic equilibrium points are identified using sensitivity analysis techniques like PRCC(partial rank correlation coefficient). Thus, the outcomes demonstrated the trend a two-dose vaccine model can follow and how the effect of media can help bring down the infections. This model provides support that two dose vaccination against COVID-19 with media presence for awareness is highly effective in controlling this epidemic. [ABSTRACT FROM AUTHOR]

Background: Vaccines are considered as the one of the main pillars in halting and ending the presently on-going coronavirus disease (COVID-19 disease) pandemic which has spread globally since it was first detected in Wuhan, China in December 2019. In the absence of specific therapy, infection prevention practices and mass vaccination remains the mainstay in controlling the disease. Objectives: Objective of the study was to assess COVID-19 vaccination status, socio-demographic and clinical profile among healthcare workers diagnosed with COVID-19. Methodology: A cross-sectional survey from 1st March 2021 to 30th June 2021 among healthcare workers who were diagnosed with COVID-19 in a tertiary care institute of Uttarakhand, India was conducted, and universal sampling was used. Institutional Ethics Committee approved this study. Results: Total 662 healthcare workers were diagnosed with COVID-19. 429 (64.8%) of these COVID-19 diagnosed healthcare workers had received either single (129,30%) or both dose (300,70%) of COVID-19 vaccine while remaining 233 (35.2%) belonged to non-vaccinated group. History of exposure to COVID-19 positive patients was higher in vaccinated (66.4%) than in non-vaccinated group (55%) (p = 0.004). Hospitalisation was found to be higher among non-vaccinated (5.6%) than vaccinated group (2.3%) (p = 0.029). Conclusions: This study concludes that being vaccinated against COVID-19 disease provides protection against severe infection and reduces the need for hospitalization. [ABSTRACT FROM AUTHOR]

Viral hepatitis (Hepatitis B Virus (HBV) & Hepatitis C Virus (HCV)) related liver disease is a leading cause of morbidity and mortality especially in the patients with advanced renal failure who are treated with dialysis, and this is due to high number of blood transfusion sessions and/or cross contamination from the dialysis circuits. Aims & Objectives: This study aimed to determine the prevalence of HBV and HCV infections in patients with advanced renal failure (ARF). Materials & Methods: A cross-sectional study was done in joint collaboration of Department of Nephrology and Department of Gastroenterology, KGMU, Lucknow, from June 2018 to June 2020 among, CRF patients. Clinical data such as age, gender, duration of dialysis; number of transfusions, Serum sample was collected from each patient. Serological markers for HBV and HCV were determined with ELISA by using commercial diagnostic kits. HCV-RNA and HBV-DNA were determined quantitatively by polymerase chain reaction (PCR) assay. Results: A total 934 patients with advanced renal failure attended the nephrology OPD. Out of 934 patients, 65 (6.96%) patients screened positive for HBV/HCV infection. The results of this study also showed that the prevalence of viral hepatitis infection in the haemodialysis (HD) and without HD patients is 8.25% and 6.3% respectively. Conclusion: It has been found that viral infections, particularly HBV and HCV infections are common in advanced renal failure patients who are on HD. [ABSTRACT FROM AUTHOR]

We systematically reviewed and summarized studies focusing on Bharat Biotech's Whole Virion Inactivated Corona Virus Antigen BBV152 (Covaxin), which is India's indigenous response to fighting the SARS-CoV-2 pandemic. Studies were searched for data on the efficacy, immunogenicity, and safety profile of BBV152. All relevant studies published up to March 22, 2022, were screened from major databases, and 25 studies were eventually inducted into the systematic review. The studies focused on the virus antigen (6 μg) adjuvanted with aluminium hydroxide gel and/or Imidazo quinolin gallamide (IMDG), aTLR7/8 agonist. Pre-clinical, phase I, and II clinical trials showed appreciable immunogenicity. Both neutralizing and binding antibody titers were significant and T cell responses were Th1-biased. Phase III trials on the 6 μg +Algel-IMDG formulation showed a 93.4% efficacy against severe COVID-19. Data from the trials revealed an acceptable safety profile withmostlymild-moderate local and systemic adverse events. No serious adverse events or fatalities were seen, and most studies reportedmilder and lesser adverse events with Covaxin when compared with other vaccines, especially Oxford-Astra Zeneca's AZD1222 (Covishield). The immunogenicity performance of Covaxin, which provided significant protection only after the second dose, was mediocre and it was consistently surpassed by Covishield. One study reported adjusted effectiveness against symptomatic infection to be just 50% at 2 weeks after the second dose. Nonetheless, appreciable results were seen in previously infected individuals administered both doses. There was some evidence of coverage against the Alpha, Beta, and Delta variants. However, neither Covaxin nor Covishield showed sufficient protection against the Omicron variant. Two studies reported super-additive results on mixing Covaxin with Covishield. Further exploration of heterologous prime-boost vaccination with a combination of an inactivated vaccine and an adenoviral vector-based vaccine for tackling future variants may be beneficial. [ABSTRACT FROM AUTHOR]

The biggest-ever outbreak of monkeypox disease in non-endemic countries started in May, 2022. Though no monkeypox case has been reported from India, till mid-June, 2022, yet, considering the rate of spread to the non-endemic countries, there is an urgent need of better understanding of the monkeypox virus and disease epidemiology to help clinicians, public health specialists, and policymakers to be prepared for any eventuality. This review summarises the monkeypox disease epidemiology, clinical features, therapies, vaccines and outlines the measures for preparedness and response for a possible outbreak. The disease is known to cause severe outcome in children, pregnant women, and immunocompromised hosts and this group need to be given special attention. The monkeypox disease outbreak (2022) in non-endemic countries should be used as an opportunity by India and other low and middle income countries to strengthen public health surveillance and health system capacity for outbreak and epidemic preparedness and response. [ABSTRACT FROM AUTHOR]

Despite high level vaccination and the availability of two different types of vaccines, whole cell (wP) and acellular vaccines (aP), the resurgence of pertussis has been reported in many countries. Antigenic variation within circulating and vaccine strains is the most documented reason reported for the resurgence of pertussis. Research on genetic divergence among circulating and vaccine strains has largely been reported in countries using aP vaccines. There are inadequate data available for antigenic variation in B. pertussis from wP-using countries. India has used wP for more than 40 years in their primary immunization program. The present study reports five clinical isolates of B. pertussis from samples of pediatric patients with pertussis symptoms observed in India. Genotypic and phenotypic characterization of clinical isolates were performed by serotyping, genotyping, whole genome analyses and comparative genomics. All clinical isolates showed serotype 1, 2 and 3 based on the presence of fimbriae 2 and 3. Genotyping showed genetic similarities in allele types for five aP genes within vaccine strains and clinical isolates reported from India. The presence of the ptxP3 genotype was observed in two out of five clinical isolates. Whole-genome sequencing was performed for clinical isolates using the hybrid strategy of combining Illumina (short reads) and oxford nanopore (long reads) sequencing strategies. Clinical isolates (n = 5) and vaccine strains (n = 7) genomes of B. pertussis from India were compared with 744 B. pertussis closed genomes available in the public databases. The phylogenomic comparison of B. pertussis genomes reported from India will be advantageous in better understanding pertussis resurgence reported globally with respect to pathogen adaptation. [ABSTRACT FROM AUTHOR]

The study aimed to assess the adverse events following COVID‐19 vaccine (Covaxin) immunization at a tertiary care institution and also assess the predictors of the adverse events following immunization (AEFI). The prospective observational study was conducted in a tertiary care institute among the Covaxin beneficiaries between June 28 and September 6, 2021. A total of 1826 participants were assessed for any local or systemic adverse events after seven days of vaccination. A telephonic interview was conducted, and the beneficiaries were assessed according to the adverse event grading. A total of 1826 participants were assessed for AEFI, and 544 (29.8%) reported at least one of the AEFI. No severe adverse events were reported, and about 1.6% had moderate AEFI. Pain at the injection site (14.6%), fever (9.7%), and myalgia (5.9%) were the common adverse events reported by the participants. AEFI incidence was higher in the first dose (38.1%) when compared to the second dose (26.4%), and this finding was significant with a p < 0.001. The major factors associated with AEFI were female sex, history of an allergic reaction, presence of comorbidities, acute infection in the past 3 months, and intake of chronic medications. Precaution needs to be taken while vaccinating individuals having allergies, comorbidities, acute infection in the last 3 months, and individuals on chronic medication. Highlights: The study assessed adverse events following immunization of the COVID‐19 vaccine in a large‐scale sample.Adverse events following immunization were common after Covaxin (BBV152) vaccination, but a majority of the adverse events were mild.Adverse events were higher in the first dose as compared to the second dose.Females, individuals with a history of allergy, co‐morbidities, acute infection in the past 3 months, and individuals taking chronic disease medication were having a higher chance of adverse events. [ABSTRACT FROM AUTHOR]

While government shared API guidelines to enable varied stakeholders like hospitals to develop and rollout software solutions compatible with Co-WIN, tech-savvy beneficiaries leveraged some of these applications to book vaccination slots (Palit, [19]). India started its vaccination drive with two vaccines (Covishield and Covaxin) on more than 23,000 vaccination sites (Chakravarti, [4]), including community and commercial centers. India launched the COVID Vaccine Intelligence Network (Co-WIN) communication platform in January 2021. [Extracted from the article]

Background Compared with ice-based vaccine carriers (IBVCs), iceless vaccine carrier (ILVC) last-mile delivery could optimize vaccine effectiveness by reducing spoilage. We estimated ILVC-associated spoilage costs averted and cost effectiveness. Methods IBVC vaccine spoilage costs were estimated for six vaccines. ILVC incremental costs were based on yearly ILVC cost over total doses. Cost effectiveness was estimated via Markov modeling of rotavirus vaccine. Results The spoilage cost using IBVCs was US$9 603 294. Using ILVCs, the incremental cost per vaccine dose was US$0.026, the cost-benefit ratio was 0.28, the number of averted disability-adjusted life years was 0.03 per child and there was a saving of US$0.80 per child vaccinated. Conclusions ILVCs may bring cost savings and health gains compared with IBVCs. [ABSTRACT FROM AUTHOR]

In India, Omicron (B1.1.529), a variant of concern of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has challenged the existing drug treatments options and available vaccines. Extensive search has been done to review updated information through original research articles, meta-analysis, and case reports available at EMBASE, SCOPUS, and Google Scholar, for treatment and preventive strategies against Omicron. Excessive mutations in SARS-CoV-2 (Omicron) led to immune escape witnessed for monoclonal antibodies, leaving very limited drug options to treat Omicron infected patients. Protection offered by existing vaccines appeared as a matter of concern as far as efficacy against Omicron is concerned. Although vaccination will not prevent re-infection in actively and passively immunized individual, but will prevent serious respiratory illness and death. The current review article imparts knowledge regarding pharmacotherapeutic agents, showing promise against Omicron. The present review also highlights updated data on newer vaccine candidates for their safety and efficacy for Omicron, based on postmarketing surveillance and Phase III clinical trials across the globe. There is a need to generate more data on drugs as well as vaccines specifically targeting Omicron, in order to contain SARS-CoV-2 new variant. [ABSTRACT FROM AUTHOR]

Background: The world has been suffering from the COVID-19 pandemic (officially declared by WHO in March 2020), caused by the severe acute respiratory β-coronavirus 2 (SARS-CoV-2) since the last week of December 2019. The disease was initially designated as a Public Health Emergency of International Concern on January 30, 2020. In order to protect the health of mass public, an array of research on drugs and vaccines against SARS-CoV-2 has been conducted globally. However, the emerging variants of SARS-CoV-2, i.e., Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2) variants which evolved in late 2020 and the Omicron variant (B.1.1.529) which emerged in November 2021 along with its subvariant BA.2 which was first identified in India and South Africa in late December 2021, have raised the doubt about the efficiency of the currently used vaccines especially in terms of the consistent potential to produce neutralizing antibodies targeting the viral spike (S) protein. The present review discussed the functional details of major vaccines regarding their efficiency against such variants during the pandemic. Overall, the mRNA vaccines have shown around 94% effectiveness; the adenovector vaccine showed approximately 70% efficacy, whereas Sputnik V vaccines showed around 92% effectiveness; the inactivated whole-virus vaccine CoronaVac/PiCoVacc and BBIBP-CorV showed a varying effectiveness of 65–86% according to the geographic locations; the subunit vaccine NVX-CoV2373 has shown 60–89% effectiveness along with the global regions against the wild-type SARS-CoV-2 strain. However, reduced effectiveness of these vaccines against the SARS-CoV-2 variants was noticed which is suggestive for the further administration of booster dose. Short conclusion: Maximum variants of SARS-CoV-2 emerged during the second wave of COVID-19; and extensive studies on the viral genomic sequences from all geographical locations around the world have been conducted by an array of groups to assess the possible occurrence of mutations(s) specially within the receptor binding domain of the viral spike (S) protein. Mutational similarities and the new or critical mutations within all variants have been clearly identified so far. The study of effectiveness of the currently used vaccines is also ongoing. The persistence of memory B cell action and the other immune components as well as the administration of booster dose is expected to mitigate the disease. [ABSTRACT FROM AUTHOR]

India's mass vaccination efforts have been slow due to high levels of vaccine hesitancy. This study uses data from an online discrete choice experiment with 1371 respondents to rigorously examine the factors shaping vaccine preference in the country. We find that vaccine efficacy, presence of side effects, protection duration, distance to vaccination centre and vaccination rates within social network play a critical role in determining vaccine demand. We apply a non-parametric model to uncover heterogeneity in the effects of these factors. We derive two novel insights from this analysis. First, even though, on average, domestically developed vaccines are preferred, around 30% of the sample favours foreign-developed vaccines. Second, vaccine preference of around 15% of the sample is highly sensitive to the presence of side effects and vaccination uptake among their peer group. These results provide insights for the ongoing policy debate around vaccine adoption in India. [ABSTRACT FROM AUTHOR]

With more than four million deaths and 200 million confirmed cases globally (WHO, 2021b), Covid-19 catastrophe and its second wave infringed nations beyond anticipation. The solace came with Covid-19 Vaccines, although, societal perceptions associated with vaccine proved a colossal test. With secondary data, this research attempts to identify how India, responded to such a ferocious infectious disease and how it initiated Covid-19 vaccine immunization drive by operationalizing existing capacities. The research delineates capacity building challenges and effectiveness of measures adopted by the Indian government. As the gigantic immunization drive is ongoing in India, it anatomizes learnings for practitioners and academic research. [ABSTRACT FROM AUTHOR]

Introduction: Health-care workers (HCWs) have been designated as the highest priority group to receive the coronavirus (CoV) vaccine. The study aimed to assess the awareness and perception about the CoV vaccine and the factors associated with the acceptance or rejection of vaccines among HCWs in India. Materials and Methods: An online cross-sectional study using a convenience sampling method was conducted between January 5 and January 14, 2021, just before the initiation of CoV vaccination among HCWs in India. Questions to assess awareness and perception were developed based on the information available on the public health websites. HCWs' willingness to accept the vaccines was also studied along with the factors associated with acceptance or rejection of CoV vaccination. Results: The study received responses from 496 HCWs. Awareness about the CoV vaccine was low, with a mean score of 5.44 (standard deviation = 2.91). Willingness to accept CoV vaccination was found in 63.51% of HCWs with the main reason to protect their family and colleagues (43.73%). The majority of HCWs agreed with the emergency authorization of CoV vaccines (65.93%) and agreed that vaccines will break the chain of transmission of infection (65.73%). Perception of vaccine effectiveness (odds ratio [OR] = 8.52, P = 0.000) and higher awareness (OR = 2.86, P = 0.000) were significantly associated with willingness to accept CoV vaccination. Conclusion: HCWs have the responsibility to disseminate correct information and risks about vaccinations among the public. Health authorities should continue encouraging the increase of the knowledge and awareness of the utility of vaccines among HCWs. [ABSTRACT FROM AUTHOR]

Cervical cancer is a leading cause of cancer-associated mortality among women in India, with 96,922 new cases and 60,078 deaths each year, almost one-fifth of the global burden. In 2018, Sikkim state in India introduced human papillomavirus (HPV) vaccine for 9–13-year-old girls, primarily through school-based vaccination, targeting approximately 25,000 girls. We documented the program's decision-making and implementation processes. We conducted a post-introduction evaluation in 2019, concurrent with the second dose campaign, by interviewing key stakeholders (state, district, and local level), reviewing planning documents, and observing cold chain sites in two purposefully-sampled community areas in each of the four districts of Sikkim. Using standard questionnaires, we interviewed health and education officials, school personnel, health workers, community leaders, and age-eligible girls on program decision-making, planning, training, vaccine delivery, logistics, and communication. We conducted 279 interviews and 29 observations in eight community areas across four districts of Sikkim. Based on reported administrative data, Sikkim achieved >95% HPV vaccination coverage among targeted girls for both doses via two campaigns; no severe adverse events were reported. HPV vaccination was well accepted by all stakeholders; minimal refusal was reported. Factors identified for successful vaccine introduction included strong political commitment, statewide mandatory school enrollment, collaboration between health and education departments at all levels, and robust social mobilization strategies. Sikkim successfully introduced the HPV vaccine to multiple-age cohorts of girls via school-based vaccination, demonstrating a model that could be replicated in other regions in India or similar low- and middle-income country settings. [ABSTRACT FROM AUTHOR]