Services Marketing of COVID-19 Vaccines in the
Present Scenario

The global COVID-19 vaccines market is projected to reach USD 1,401 million by 2025 from USD 2,273 million in 2022, at a CAGR of -14.9% during the forecast period. The growth of the COVID vaccines market is attributed majorly to the rising number of people infected with COVID-19 and increasing funding for vaccine development. On the other hand, the global COVID-19 drugs market is projected to reach USD 2 million by 2025 from USD 165 million in 2020, at a CAGR of -57.8% during the forecast period. The growth of the COVID drugs market is primarily attributed to use of repurposed drugs for compassionate use, and the emergence of alternative therapies such as convalescent plasma therapy which were earlier used for treating epidemic diseases such as SARS, MERS, and H1N1. Moreover, collaborations between global organizations and governments of various nations to promote the supply of essential drugs and medical supplies are fueling the market growth. Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. The Herculean effort means that a fast-tracked vaccine could come to market anywhere from the end of 2020 to the middle of 2021. To date, just two coronavirus vaccine has been approved. Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of the Russian Federation on 11 August. Experts have raised considerable concern about the vaccine’s safety and efficacy given it has not yet entered Phase 3 clinical trials. A second vaccine in Russia, EpiVacCorona, has also been granted regulatory approval, also without entering Phase 3 clinical trials. Operation Warp Speed (OWS) is a collaboration of several US federal government departments including Health and Human Services and its subagencies, Agriculture, Energy and Veterans Affairs and the private sector. OWS has selected three vaccine candidates to fund for Phase 3 trials: Moderna’s mRNA-1273, University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech's BNT162. Within OWS, the US National Institutes of Health (NIH) has partnered with more than 18 biopharmaceutical companies to accelerate development of drug and vaccine candidates for COVID-19 (ACTIV). The COVID-19 Prevention Trials Network (COVPN) has also been established, which combines clinical trial networks funded by the National Institute of Allergy and Infectious Diseases (NIAID): the HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN), Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS Clinical Trials Group.

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Self-Replicating RNA Viruses for Vaccine Development Against Infectious Diseases and Cancer

10.20944/preprints202107.0261.v1 ◽

2021 ◽

Author(s):

Kenneth Lundstrom

Keyword(s):

Clinical Trials ◽

Infectious Diseases ◽

Immune Responses ◽

Measles Virus ◽

Viral Vectors ◽

Ebola Virus ◽

Vaccine Development ◽

Rna Viruses ◽

Vaccine Candidates ◽

Vector Systems

Alphaviruses, flaviviruses, measles viruses and rhabdoviruses are enveloped single-stranded RNA viruses, which have been engineered as expression vector systems for recombinant protein expression and vaccine development. Due to the presence of non-structural genes encoding the replicase complex, a 200,000-fold amplification of viral RNA occurs in the cytoplasm of infected cells providing extreme transgene expression levels, which is why they are named self-replicating RNA viruses. Expression of surface proteins of pathogens causing infectious disease and tumor antigens provide the basis for vaccine development against infectious diseases and cancer. The self-replicating RNA viral vectors can be administered as replicon RNA, recombinant viral particles, or layered DNA/RNA replicons. Self-replicating RNA viral vectors have been applied for vaccine development against influenza virus, HIV, hepatitis B virus, human papilloma virus, Ebola virus and recently coronaviruses, especially SARS-CoV-2 the causative agent of the COVID-19 pandemic. Measles virus and rhabdovirus vector-based SARS-CoV-2 vaccine candidates have been subjected to clinical trials. Moreover, RNA vaccine candidates based on self-amplifying alphaviruses have also been evaluated in clinical settings. Various cancers such as brain, breast, lung, ovarian, prostate cancer and melanoma have also been targeted for vaccine development. Robust immune responses and protection have been demonstrated in animal models. Clinical trials have shown good safety and target-specific immune responses. Ervebo, the VSV-based vaccine against Ebola virus disease has been approved for human use.

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SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates

npj Vaccines ◽

10.1038/s41541-021-00292-w ◽

2021 ◽

Vol 6 (1) ◽

Cited By ~ 3

Author(s):

Nikolaos C. Kyriakidis ◽

Andrés López-Cortés ◽

Eduardo Vásconez González ◽

Alejandra Barreto Grimaldos ◽

Esteban Ortiz Prado

Keyword(s):

Neutralizing Antibodies ◽

Large Scale ◽

Vaccine Development ◽

Rna Virus ◽

Protein S ◽

Effective Vaccine ◽

Phase 3 ◽

Vaccine Candidates ◽

Advantages And Disadvantages ◽

The World

AbstractThe new SARS-CoV-2 virus is an RNA virus that belongs to the Coronaviridae family and causes COVID-19 disease. The newly sequenced virus appears to originate in China and rapidly spread throughout the world, becoming a pandemic that, until January 5th, 2021, has caused more than 1,866,000 deaths. Hence, laboratories worldwide are developing an effective vaccine against this disease, which will be essential to reduce morbidity and mortality. Currently, there more than 64 vaccine candidates, most of them aiming to induce neutralizing antibodies against the spike protein (S). These antibodies will prevent uptake through the human ACE-2 receptor, thereby limiting viral entrance. Different vaccine platforms are being used for vaccine development, each one presenting several advantages and disadvantages. Thus far, thirteen vaccine candidates are being tested in Phase 3 clinical trials; therefore, it is closer to receiving approval or authorization for large-scale immunizations.

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Progress and challenges in TB vaccine development

F1000Research ◽

10.12688/f1000research.13588.1 ◽

2018 ◽

Vol 7 ◽

pp. 199 ◽

Cited By ~ 51

Author(s):

Gerald Voss ◽

Danilo Casimiro ◽

Olivier Neyrolles ◽

Ann Williams ◽

Stefan H.E. Kaufmann ◽

...

Keyword(s):

Clinical Trials ◽

Vaccine Development ◽

Scientific Progress ◽

Human Infection ◽

Experimental Medicine ◽

Vaccine Platform ◽

Vaccine Candidates ◽

Clinical Endpoints ◽

Immune Correlates ◽

Efficacy Trials

The Bacille Calmette Guerin (BCG) vaccine can provide decades of protection against tuberculosis (TB) disease, and although imperfect, BCG is proof that vaccine mediated protection against TB is a possibility. A new TB vaccine is, therefore, an inevitability; the question is how long will it take us to get there? We have made substantial progress in the development of vaccine platforms, in the identification of antigens and of immune correlates of risk of TB disease. We have also standardized animal models to enable head-to-head comparison and selection of candidate TB vaccines for further development. To extend our understanding of the safety and immunogenicity of TB vaccines we have performed experimental medicine studies to explore route of administration and have begun to develop controlled human infection models. Driven by a desire to reduce the length and cost of human efficacy trials we have applied novel approaches to later stage clinical development, exploring alternative clinical endpoints to prevention of disease outcomes. Here, global leaders in TB vaccine development discuss the progress made and the challenges that remain. What emerges is that, despite scientific progress, few vaccine candidates have entered clinical trials in the last 5 years and few vaccines in clinical trials have progressed to efficacy trials. Crucially, we have undervalued the knowledge gained from our “failed” trials and fostered a culture of risk aversion that has limited new funding for clinical TB vaccine development. The unintended consequence of this abundance of caution is lack of diversity of new TB vaccine candidates and stagnation of the clinical pipeline. We have a variety of new vaccine platform technologies, mycobacterial antigens and animal and human models. However, we will not encourage progression of vaccine candidates into clinical trials unless we evaluate and embrace risk in pursuit of vaccine development.

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An Overview of the Progress Made on the Coronavirus Vaccine

E3S Web of Conferences ◽

10.1051/e3sconf/202018503042 ◽

2020 ◽

Vol 185 ◽

pp. 03042

Author(s):

Yu Fang

Keyword(s):

United States ◽

Infectious Diseases ◽

Incidence Rate ◽

Scientific Reasoning ◽

Vaccine Development ◽

The United States ◽

Ideal Solution ◽

Vaccine Candidates ◽

Number Of Individuals

The Coronavirus Disease-2019 (COVID-19) pandemic has led to a critical economic crash around the globe, affecting billions of people worldwide. Without a cure, the number of cases continues to increase exponentially. Countries, including the United States, Brazil, and India, currently lead in the number of cases with numbers soaring in the millions. Immunization is crucial to preventing the spread of infectious diseases and can help a large number of individuals quickly while keeping current cases under control. Following the publication of the genome sequence of SARS-CoV-2, vaccine development has been accelerated at an unprecedented rate. 115 vaccine candidates are currently under study with the hope of finding an ideal solution and mitigating the Coronavirus incidence rate. With some vaccine candidates having more potential than others, this review focuses on the characterization of different vaccine options. The analysis of probable vaccines, including mRNA vaccines and adenovirus vaccines, is conducted, and the scientific reasoning behind the vaccines is also discussed. In this review, the latest strategy vaccine is introduced and the effective vaccines are analysed.

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Review of Current Vaccine Development Strategies to Prevent Coronavirus Disease 2019 (COVID-19)

Toxicologic Pathology ◽

10.1177/0192623320959090 ◽

2020 ◽

Vol 48 (7) ◽

pp. 800-809 ◽

Cited By ~ 4

Author(s):

Bindu M. Bennet ◽

Jayanthi Wolf ◽

Rodrigo Laureano ◽

Rani S. Sellers

Keyword(s):

Clinical Trials ◽

Scientific Community ◽

Safety Assessment ◽

Vaccine Development ◽

Safety Data ◽

Efficacy And Safety ◽

Clinical Safety ◽

Safety And Efficacy ◽

Vaccine Candidates ◽

Current Vaccine

The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) outbreak that started in Wuhan, China, in 2019 resulted in a pandemic not seen for a century, and there is an urgent need to develop safe and efficacious vaccines. The scientific community has made tremendous efforts to understand the disease, and unparalleled efforts are ongoing to develop vaccines and treatments. Toxicologists and pathologists are involved in these efforts to test the efficacy and safety of vaccine candidates. Presently, there are several SARS-CoV-2 vaccines in clinical trials, and the pace of vaccine development has been highly accelerated to meet the urgent need. By 2021, efficacy and safety data from clinical trials are expected, and potentially a vaccine will be available for those most at risk. This review focuses on the ongoing SARS-CoV-2 vaccine development efforts with emphasis on the nonclinical safety assessment and discusses emerging preliminary data from nonclinical and clinical studies. It also provides a brief overview on vaccines for other coronaviruses, since experience gained from these can be useful in the development of SARS-CoV-2 vaccines. This review will also explain why, despite this unprecedented pace of vaccine development, rigorous standards are in place to ensure nonclinical and clinical safety and efficacy. [Box: see text]

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Current advances in novel SARS-CoV-2 disease (COVID-19) treatment and intervention strategies

Coronaviruses ◽

10.2174/2666796701999201116125249 ◽

2020 ◽

Vol 01 ◽

Author(s):

Mohammad Khalid Parvez ◽

Kartika Padhan

Keyword(s):

Clinical Trials ◽

Ebola Virus ◽

Management Strategies ◽

Intervention Strategies ◽

Phase Iii ◽

World Health ◽

Plasma Therapy ◽

Health Crisis ◽

Vaccine Candidates ◽

Poor Countries

Background: Down the seven months of the novel SARS-CoV-2 disease (COVID-19) outbreak in China and its global spread, there is a remarkable understanding of its epidemiology, pathobiology and clinical management strategies. While countering a heavy toll on health and economy, world’s regional authorities are enforcing safety guidelines and providing patient care. Currently, there is no globally approved treatment or intervention for COVID-19. Methods: A structured online literature search for peer-reviewed articles was conducted on the PubMed, Europe PMC, Google, WHO, CDC, FDA and ClinicalTrials portals, using phrases such as COVID-19 treatment and intervention, COVID-19 drugs and COVID-19 vaccines. Results: Analysis of the retrieved data showed that as a part of ‘Solidarity Clinical Trials’, hundreds of treatment and intervention strategies, including antiviral drugs, cytokine antagonists, convalescent plasma therapy and vaccine candidates have been registered, worldwide. Of these, while remdesivir the anti-Ebola virus drug has been granted approval as ‘emergency use’ drug in USA, favipiravir, the anti-flu drug has been recently approved in Russia. Tocilizumab and sarilumab, the cytokine (IL-6) antagonists have entered Phase-II/III clinical trials in hospitalized COVID-19 patients. Among the leading vaccine candidates, an mRNA-1273 vaccine along with Pfizer mRNA candidate and Oxford ChAdOx1vaccine have entered Phase-III trial. Conclusion: The world health authorities have strongly and quickly responded to COVID-19 pandemic. Nonetheless, it is imperative for world bodies to unite in combating this health crisis by developing costeffective drugs and vaccines, and making them accessible to resource-poor countries.

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Separating myths from reality for vaccines causing adverse events following immunization: an interview with Manish Sadarangani

Future Microbiology ◽

10.2217/fmb-2019-0187 ◽

2019 ◽

Vol 14 (11) ◽

pp. 925-926

Author(s):

Manish Sadarangani

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Infectious Diseases ◽

Meningococcal Disease ◽

Assistant Professor ◽

Vaccine Candidates ◽

Vaccine Preventable Diseases ◽

Group B ◽

The Uk ◽

Hospital Research

Dr Manish Sadarangani is Director of the Vaccine Evaluation Center at the BC Children's Hospital Research Institute and an Assistant Professor in the Division of Infectious Diseases, UBC Department of Pediatrics. He completed his undergraduate medical and pediatric training in Cambridge, Oxford and London in the UK. He then completed his DPhil with the Oxford Vaccine Group in the UK, developing novel vaccine candidates for protection against capsular group B meningococcal disease, and completed a fellowship in pediatric infectious diseases in Vancouver in 2013 before returning to Oxford to work as a pediatric infectious diseases physician. His research links clinical trials with basic microbiology, immunology and epidemiology to address clinically relevant problems related to immunization and vaccine-preventable diseases.

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Sex Differences in Immunity: Implications for the Development of Novel Vaccines Against Emerging Pathogens

Frontiers in Immunology ◽

10.3389/fimmu.2020.601170 ◽

2021 ◽

Vol 11 ◽

Author(s):

Anahita Fathi ◽

Marylyn M. Addo ◽

Christine Dahlke

Keyword(s):

Clinical Trials ◽

Sex Differences ◽

Ebola Virus ◽

Vaccine Development ◽

Virus Disease ◽

Emerging Infectious Diseases ◽

Vaccine Safety ◽

Emerging Infections ◽

Emerging Pathogens ◽

Vaccine Candidates

Vaccines are one of the greatest public health achievements and have saved millions of lives. They represent a key countermeasure to limit epidemics caused by emerging infectious diseases. The Ebola virus disease crisis in West Africa dramatically revealed the need for a rapid and strategic development of vaccines to effectively control outbreaks. Seven years later, in light of the SARS-CoV-2 pandemic, this need has never been as urgent as it is today. Vaccine development and implementation of clinical trials have been greatly accelerated, but still lack strategic design and evaluation. Responses to vaccination can vary widely across individuals based on factors like age, microbiome, co-morbidities and sex. The latter aspect has received more and more attention in recent years and a growing body of data provide evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. As these differences might have a significant impact on the resulting optimal vaccine regimen, sex-based differences should already be considered and investigated in pre-clinical and clinical trials. In this Review, we will highlight the clinical observations of sex-specific differences in response to vaccination, delineate sex differences in immune mechanisms, and will discuss the possible resulting implications for development of vaccine candidates against emerging infections. As multiple vaccine candidates against COVID-19 that target the same antigen are tested, vaccine development may undergo a decisive change, since we now have the opportunity to better understand mechanisms that influence vaccine-induced reactogenicity and effectiveness of different vaccines.

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The Drug Repurposing for COVID-19 Clinical Trials Provide Very Effective Therapeutic Combinations: Lessons Learned From Major Clinical Studies

Frontiers in Pharmacology ◽

10.3389/fphar.2021.704205 ◽

2021 ◽

Vol 12 ◽

Author(s):

Chiranjib Chakraborty ◽

Ashish Ranjan Sharma ◽

Manojit Bhattacharya ◽

Govindasamy Agoramoorthy ◽

Sang-Soo Lee

Keyword(s):

Clinical Trials ◽

Single Molecule ◽

Vaccine Development ◽

Drug Repurposing ◽

Lessons Learned ◽

Successful Outcome ◽

Plasma Therapy ◽

Therapeutic Outcomes ◽

Therapeutic Molecules ◽

In The Beginning

SARS-CoV-2 has spread across the globe in no time. In the beginning, people suffered due to the absence of efficacious drugs required to treat severely ill patients. Nevertheless, still, there are no established therapeutic molecules against the SARS-CoV-2. Therefore, repurposing of the drugs started against SARS-CoV-2, due to which several drugs were approved for the treatment of COVID-19 patients. This paper reviewed the treatment regime for COVID-19 through drug repurposing from December 8, 2019 (the day when WHO recognized COVID-19 as a pandemic) until today. We have reviewed all the clinical trials from RECOVERY trials, ACTT-1 and ACTT-2 study group, and other major clinical trial platforms published in highly reputed journals such as NEJM, Lancet, etc. In addition to single-molecule therapy, several combination therapies were also evaluated to understand the treatment of COVID-19 from these significant clinical trials. To date, several lessons have been learned on the therapeutic outcomes for COVID-19. The paper also outlines the experiences gained during the repurposing of therapeutic molecules (hydroxychloroquine, ritonavir/ lopinavir, favipiravir, remdesivir, ivermectin, dexamethasone, camostatmesylate, and heparin), immunotherapeutic molecules (tocilizumab, mavrilimumab, baricitinib, and interferons), combination therapy, and convalescent plasma therapy to treat COVID-19 patients. We summarized that anti-viral therapeutic (remdesivir) and immunotherapeutic (tocilizumab, dexamethasone, and baricitinib) therapy showed some beneficial outcomes. Until March 2021, 4952 clinical trials have been registered in ClinicalTrials.gov toward the drug and vaccine development for COVID-19. More than 100 countries have participated in contributing to these clinical trials. Other than the registered clinical trials (medium to large-size), several small-size clinical trials have also been conducted from time to time to evaluate the treatment of COVID-19. Four molecules showed beneficial therapeutic to treat COVID-19 patients. The short-term repurposing of the existing drug may provide a successful outcome for COVID-19 patients. Therefore, more clinical trials can be initiated using potential anti-viral molecules by evaluating in different phases of clinical trials.

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Tuberculosis Vaccine Development: Progress in Clinical Evaluation

Clinical Microbiology Reviews ◽

10.1128/cmr.00100-19 ◽

2019 ◽

Vol 33 (1) ◽

Cited By ~ 16

Author(s):

Suraj B. Sable ◽

James E. Posey ◽

Thomas J. Scriba

Keyword(s):

Clinical Trials ◽

Clinical Evaluation ◽

Vaccine Development ◽

Effective Vaccine ◽

Natural Immunity ◽

Content Type ◽

Vaccine Candidates ◽

Current Vaccine ◽

Development Trajectory ◽

Airborne Disease

SUMMARY Tuberculosis (TB) is the leading killer among all infectious diseases worldwide despite extensive use of the Mycobacterium bovis bacille Calmette-Guérin (BCG) vaccine. A safer and more effective vaccine than BCG is urgently required. More than a dozen TB vaccine candidates are under active evaluation in clinical trials aimed to prevent infection, disease, and recurrence. After decades of extensive research, renewed promise of an effective vaccine against this ancient airborne disease has recently emerged. In two innovative phase 2b vaccine clinical trials, one for the prevention of Mycobacterium tuberculosis infection in healthy adolescents and another for the prevention of TB disease in M. tuberculosis-infected adults, efficacy signals were observed. These breakthroughs, based on the greatly expanded knowledge of the M. tuberculosis infection spectrum, immunology of TB, and vaccine platforms, have reinvigorated the TB vaccine field. Here, we review our current understanding of natural immunity to TB, limitations in BCG immunity that are guiding vaccinologists to design novel TB vaccine candidates and concepts, and the desired attributes of a modern TB vaccine. We provide an overview of the progress of TB vaccine candidates in clinical evaluation, perspectives on the challenges faced by current vaccine concepts, and potential avenues to build on recent successes and accelerate the TB vaccine research-and-development trajectory.

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