The clinical development process for a novel preventive vaccine

Singh, Kavita; Mehta, Shailesh

doi:10.4103/0022-3859.173187

Cited by 111 publications

(110 citation statements)

References 37 publications

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“…Phase 3 - Efficacy: This is a large-scale trial where the vaccine is given to thousands of people to evaluate efficacy. Vaccine efficacy (VE) is defined as the percentage by which the rate of disease incidence is reduced in vaccinated groups as compared to placebo ( 25 ). Incidence of disease at the time of Phase 3 trials impacts the sample size.…”

Section: Covid-19 Vaccine Developmentmentioning

confidence: 99%

A Review of the Progress and Challenges of Developing a Vaccine for COVID-19

et al. 2020

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A novel coronavirus, which has been designated as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first detected in December 2019 in Wuhan China and causes the highly infectious disease referred to as COVID-19. COVID-19 has now spread worldwide to become a global pandemic affecting over 24 million people as of August 26th, 2020 and claimed the life of more than 800,000 people worldwide. COVID-19 is asymptomatic for some individuals and for others it can cause symptoms ranging from flu-like to acute respiratory distress syndrome (ARDS), pneumonia and death. Although it is anticipated that an effective vaccine will be available to protect against COVID-19, at present the world is relying on social distancing and hygiene measures and repurposed drugs. There is a worldwide effort to develop an effective vaccine against SARS-CoV-2 and, as of late August 2020, there are 30 vaccines in clinical trials with over 200 in various stages of development. This review will focus on the eight vaccine candidates that entered Phase 1 clinical trials in mid-May, including AstraZeneca/Oxford's AZD1222, Moderna's mRNA-1273 and Sinovac's CoronaVac vaccines, which are currently in advanced stages of vaccine development. In addition to reviewing the different stages of vaccine development, vaccine platforms and vaccine candidates, this review also discusses the biological and immunological basis required of a SARS-CoV-2 vaccine, the importance of a collaborative international effort, the ethical implications of vaccine development, the efficacy needed for an immunogenic vaccine, vaccine coverage, the potential limitations and challenges of vaccine development. Although the demand for a vaccine far surpasses the production capacity, it will be beneficial to have a limited number of vaccines available for the more vulnerable population by the end of 2020 and for the rest of the global population by the end of 2021.

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Section: Covid-19 Vaccine Developmentmentioning

confidence: 99%

A Review of the Progress and Challenges of Developing a Vaccine for COVID-19

et al. 2020

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“…Current meningococcal conjugate vaccines are available in monovalent, quadrivalent and combination forms. These vaccines target specific age groups based on epidemiological data on disease incidence and efficacy is confirmed through clinical testing [ 12 ].…”

Section: Current Vaccines Against Neisseria Meningitidismentioning

confidence: 99%

Meningococcal Vaccines: Current Status and Emerging Strategies

2018

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Neisseria meningitidis causes most cases of bacterial meningitis. Meningococcal meningitis is a public health burden to both developed and developing countries throughout the world. There are a number of vaccines (polysaccharide-based, glycoconjugate, protein-based and combined conjugate vaccines) that are approved to target five of the six disease-causing serogroups of the pathogen. Immunization strategies have been effective at helping to decrease the global incidence of meningococcal meningitis. Researchers continue to enhance these efforts through discovery of new antigen targets that may lead to a broadly protective vaccine and development of new methods of homogenous vaccine production. This review describes current meningococcal vaccines and discusses some recent research discoveries that may transform vaccine development against N. meningitidis in the future.

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“…[22] These speeds to clinical material production provide huge advantage to clinical investigation of multiple vaccine candidates in face of a pandemic. During clinical development, the highest costs and longest durations are encountered in phase III clinical trials and the highest failure rates tend to occur in phase II clinical trials where the efficacy of the vaccines is assessed, [14,20,27,28] cf. Figure 1A.…”

Section: Development Timelinementioning

confidence: 99%

Rapid development and deployment of high‐volume vaccines for pandemic response

Kis

Kontoravdi

Dey

et al. 2020

J Adv Manuf & Process

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Overcoming pandemics, such as the current Covid-19 outbreak, requires the manufacture of several billion doses of vaccines within months. This is an extremely challenging task given the constraints in small-scale manufacturing for clinical trials, clinical testing timelines involving multiple phases and largescale drug substance and drug product manufacturing. To tackle these challenges, regulatory processes are fast-tracked, and rapid-response manufacturing platform technologies are used. Here, we evaluate the current progress, challenges ahead and potential solutions for providing vaccines for pandemic response at an unprecedented scale and rate. Emerging rapid-response vaccine platform technologies, especially RNA platforms, offer a high productivity estimated at over 1 billion doses per year with a small manufacturing footprint and low capital cost facilities. The self-amplifying RNA (saRNA) drug product cost is estimated at below 1 USD/dose. These manufacturing processes and facilities can be decentralized to facilitate production, distribution, but also raw material supply. The RNA platform technology can be complemented by an a priori Quality by Design analysis aided by computational modeling in order to assure product quality and further speed up the regulatory approval processes when these platforms are used for epidemic or pandemic response in the future.

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The clinical development process for a novel preventive vaccine

Cited by 111 publications

References 37 publications

A Review of the Progress and Challenges of Developing a Vaccine for COVID-19

A Review of the Progress and Challenges of Developing a Vaccine for COVID-19

Meningococcal Vaccines: Current Status and Emerging Strategies

Rapid development and deployment of high‐volume vaccines for pandemic response

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