Revisiting regulatory framework in India for accelerated vaccine development in pandemics with an evidence-based fast-tracking strategy

Dinda, Amit Kumar; Tripathi, Santanu Kumar; John, Bobby

doi:10.4103/ijmr.ijmr_3640_20

Cited by 7 publications

(10 citation statements)

References 6 publications

(8 reference statements)

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“…We considered three different population groups for discussion as listed in figure 1, and in line with the ground reality in India. 17 Consistent with ongoing practice, we assumed that key workers would receive vaccine first due to obvious ethical consideration (i.e. we excluded alternative scenarios where other groups might be prioritised over key workers).…”

Section: Methodsmentioning

confidence: 99%

India’s Pragmatic Vaccination Strategy Against Covid-19: A Mathematical Modelling Based Analysis

Mandal

Arinaminpathy

Bhargava

et al. 2021

Preprint

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Objectives To investigate the impact of targeted vaccination strategies on morbidity and mortality due to COVID-19, as well as on the incidence of SARS-CoV-2, in India. Design Mathematical modelling. Settings Indian epidemic of COVID-19 and vulnerable population. Data sources Country specific and age-segregated pattern of social contact, case fatality rate and demographic data obtained from peer-reviewed literature and public domain. Model An age-structured dynamical model describing SARS-CoV-2 transmission in India incorporating uncertainty in natural history parameters was constructed. Interventions Comparison of different vaccine strategies by targeting priority groups such as key workers including health care professionals, individuals with comorbidities (24 - 60 year), and all above 60. Main outcome measures Incidence reduction and averted deaths in different scenarios, assuming that the current restrictions are fully lifted as vaccination is implemented. Results The priority groups together account for about 18% of India's population. An infection preventing vaccine with 60% efficacy covering all these groups would reduce peak symptomatic incidence by 20.6% (95% uncertainty intervals (CrI) 16.7 - 25.4), and cumulative mortality by 29.7% (95% CrI 25.8- 33.8). A similar vaccine with ability to prevent symptoms (but not infection) will reduce peak incidence of symptomatic cases by 10.4% (95% CrI 8.4 - 13.0), and cumulative mortality by 32.9% (95% CrI 28.6 - 37.3). In the event of insufficient vaccine supply to cover all priority groups, model projections suggest that after keyworkers, vaccine strategy should prioritise all who are > 60, and subsequently individuals with comorbidities. In settings with weakest transmission, such as sparsely-populated rural areas, those with comorbidities should be prioritised after keyworkers. Conclusions An appropriately targeted vaccination strategy would witness substantial mitigation of impact of COVID-19 in a country like India with wide heterogenity. 'Smart vaccination', based on public health considerations, rather than mass vaccination, appears prudent.

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Section: Methodsmentioning

confidence: 99%

India’s Pragmatic Vaccination Strategy Against Covid-19: A Mathematical Modelling Based Analysis

Mandal

Arinaminpathy

Bhargava

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…We considered three different population groups for discussion as listed in figure 1 and in line with the ground reality in India. 17 Consistent with ongoing practice, we assumed that keyworkers would receive vaccine first due to obvious ethical consideration (ie, we excluded alternative scenarios where other groups might be prioritised over keyworkers). Holding this as a given, we examined the conditions under which those over 60 years of age should subsequently be prioritised over those with comorbidities and vice versa.…”

Section: Methodsmentioning

confidence: 99%

“…In particular, we examined which population groups should receive the vaccination first, under different scenarios for vaccine efficacy and for the basic reproduction number, R 0 (the latter as estimated in the absence of any infection-induced or vaccine-induced immunity). We considered three different population groups for discussion as listed in figure 1 and in line with the ground reality in India 17. Consistent with ongoing practice, we assumed that keyworkers would receive vaccine first due to obvious ethical consideration (ie, we excluded alternative scenarios where other groups might be prioritised over keyworkers).…”

Section: Methodsmentioning

confidence: 99%

India’s pragmatic vaccination strategy against COVID-19: a mathematical modelling-based analysis

et al. 2021

View full text Add to dashboard Cite

ObjectivesTo investigate the impact of targeted vaccination strategies on morbidity and mortality due to COVID-19, as well as on the incidence of SARS-CoV-2, in India.DesignMathematical modelling.SettingsIndian epidemic of COVID-19 and vulnerable population.Data sourcesCountry-specific and age-segregated pattern of social contact, case fatality rate and demographic data obtained from peer-reviewed literature and public domain.ModelAn age-structured dynamical model describing SARS-CoV-2 transmission in India incorporating uncertainty in natural history parameters was constructed.InterventionsComparison of different vaccine strategies by targeting priority groups such as keyworkers including healthcare professionals, individuals with comorbidities (24–60 years old) and all above 60.Main outcome measuresIncidence reduction and averted deaths in different scenarios, assuming that the current restrictions are fully lifted as vaccination is implemented.ResultsThe priority groups together account for about 18% of India’s population. An infection-preventing vaccine with 60% efficacy covering all these groups would reduce peak symptomatic incidence by 20.6% (95% uncertainty intervals (UI) 16.7–25.4) and cumulative mortality by 29.7% (95% CrI 25.8–33.8). A similar vaccine with ability to prevent symptoms (but not infection) will reduce peak incidence of symptomatic cases by 10.4% (95% CrI 8.4–13.0) and cumulative mortality by 32.9% (95% CrI 28.6–37.3). In the event of insufficient vaccine supply to cover all priority groups, model projections suggest that after keyworkers, vaccine strategy should prioritise all who are >60 and subsequently individuals with comorbidities. In settings with weakest transmission, such as sparsely populated rural areas, those with comorbidities should be prioritised after keyworkers.ConclusionsAn appropriately targeted vaccination strategy would witness substantial mitigation of impact of COVID-19 in a country like India with wide heterogeneity. ‘Smart vaccination’, based on public health considerations, rather than mass vaccination, appears prudent.

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“…Vaccine development is a complex and time-consuming process. However, to control the pandemic, it is important to develop an effective vaccine candidate 2 . Various approaches are being tried to fast track the development of safe and efficacious COVID-19 vaccines without compromising scientific quality and ethics.…”

mentioning

confidence: 99%

“…One of such approaches is the use of well-established platforms, which have reduced the time taken to develop candidates and also helped in building trust since the beginning. DNA and RNA platforms are best suited for fast development, followed by subunit protein vaccines 2 3 4 5 . An important aspect of vaccine development is to assess the safety and protective efficacy of different candidates by conducting large animal challenge studies.…”

mentioning

confidence: 99%

Comparison of the immunogenicity & protective efficacy of various SARS-CoV-2 vaccine candidates in non-human primates

Mukhopadhyay

Yadav

Gupta

et al. 2021

Indian Journal of Medical Research

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Background & objectives: The COVID-19 pandemic has emerged as a global public health crisis and research groups worldwide are engaged in developing vaccine candidates to curb its transmission, with a few vaccines having progressed to advanced stages of clinical trials. The aim of this systematic review was to compare immunogenicity and protective efficacy of various SARS-CoV-2 vaccine candidates tested in non-human primate (NHP) models. Methods: Literature on effect of SARS-CoV-2 vaccines in NHP models reported on PubMed and preprint platforms (medRxiv and bioRxiv) till October 22, 2020, was searched with the following terms: coronavirus vaccine, COVID-19 vaccine, SARS-CoV-2 vaccine, nonhuman primate, and rhesus macaque. Results: Our search yielded 19 studies, which reported immune response elicited by 18 vaccine candidates in NHP. All the vaccines induced detectable neutralizing antibody (NAb) titres in the serum of vaccinated animals, with some showing effective viral clearance from various organs. The vaccinated animals also showed nil to mild histopathological changes in their lungs compared to placebo groups in the trials that performed necropsy. Interpretation & conclusions: Our findings highlighted onset of quick immunogenicity and protective efficacy of mRNA-1273, followed by Ad26.CoV2.S, NVX-CoV2373, BNT162b2, RBD and BBV152 vaccine candidates in preclinical trials as compared to the others. NHP data also showed correlation with clinical trial data available for a few vaccines. Preclinical trials of COVID-19 vaccine candidates in NHPs yielded promising results, with some candidates faring better than others.

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Revisiting regulatory framework in India for accelerated vaccine development in pandemics with an evidence-based fast-tracking strategy

Cited by 7 publications

References 6 publications

India’s Pragmatic Vaccination Strategy Against Covid-19: A Mathematical Modelling Based Analysis

India’s Pragmatic Vaccination Strategy Against Covid-19: A Mathematical Modelling Based Analysis

India’s pragmatic vaccination strategy against COVID-19: a mathematical modelling-based analysis

Comparison of the immunogenicity & protective efficacy of various SARS-CoV-2 vaccine candidates in non-human primates

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