ABSTRACT
In the current context of the pandemic triggered by SARS-COV-2, the immunization of the population through vaccination is recognized as a public health priority. In the case of SARSCOV2, the genetic sequencing was done quickly, in one month. Since then, worldwide research has focused on obtaining a vaccine. This has a major economic impact because new technological platforms and advanced genetic engineering procedures are required to obtain a COVID19 vaccine. The most difficult scientific challenge for this future vaccine obtained in the laboratory is the proof of clinical safety and efficacy. The biggest challenge of manufacturing is the construction and validation of production platforms capable of making the vaccine on a large scale.
Subject(s)
Betacoronavirus/immunology , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines , COVID-19 , COVID-19 Vaccines , Coronavirus Infections/classification , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Drug Compounding/methods , Drug Compounding/standards , Drug Compounding/trends , Drug Development/methods , Drug Development/standards , Drug Development/trends , Humans , Patient Safety , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , SARS-CoV-2 , Treatment Outcome , Vaccination/adverse effects , Vaccine Potency , Viral Vaccines/classification , Viral Vaccines/standards , Viral Vaccines/supply & distribution , Viral Vaccines/therapeutic useSubject(s)
Clinical Trials as Topic , Coronavirus Infections/prevention & control , Disclosure , Drug Industry , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Public Opinion , Trust , Viral Vaccines , COVID-19 , COVID-19 Vaccines , China , Clinical Trial Protocols as Topic , Clinical Trials as Topic/ethics , Clinical Trials as Topic/standards , Confidentiality/ethics , Confidentiality/legislation & jurisprudence , Coronavirus Infections/epidemiology , Disclosure/ethics , Disclosure/legislation & jurisprudence , Drug Industry/ethics , Drug Industry/legislation & jurisprudence , Drug Industry/standards , Humans , Pneumonia, Viral/epidemiology , Politics , Russia , Safety , United States , Viral Vaccines/adverse effects , Viral Vaccines/pharmacology , Viral Vaccines/standards , Viral Vaccines/therapeutic useSubject(s)
Clinical Trials as Topic , Coronavirus Infections/prevention & control , Drug Approval/legislation & jurisprudence , Drug Industry , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Politics , Research Personnel , Safety , Viral Vaccines/adverse effects , COVID-19 , COVID-19 Vaccines , Clinical Trial Protocols as Topic , Clinical Trials as Topic/ethics , Clinical Trials as Topic/methods , Clinical Trials as Topic/standards , Coronavirus Infections/epidemiology , Disclosure , Drug Industry/ethics , Drug Industry/legislation & jurisprudence , Drug Industry/standards , Humans , Myelitis, Transverse/etiology , Pneumonia, Viral/epidemiology , Public Opinion , Research Personnel/psychology , Sample Size , United Kingdom , United States , United States Food and Drug Administration/legislation & jurisprudence , Viral Vaccines/standardsABSTRACT
Vaccine production is quadrupling rapidly, creating supply chain challenges.
Subject(s)
Bacterial Vaccines/supply & distribution , COVID-19 Vaccines/supply & distribution , COVID-19/epidemiology , Vaccine-Preventable Diseases/prevention & control , Viral Vaccines/supply & distribution , Adolescent , Bacterial Vaccines/economics , Bacterial Vaccines/standards , COVID-19/prevention & control , COVID-19 Vaccines/economics , COVID-19 Vaccines/standards , Humans , Infant , Quality Control , Viral Vaccines/economics , Viral Vaccines/standardsABSTRACT
Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this live virus risks inducing severe disease and possibly even death. However, we argue that such studies, by accelerating vaccine evaluation, could reduce the global burden of coronavirus-related mortality and morbidity. Volunteers in such studies could autonomously authorize the risks to themselves, and their net risk could be acceptable if participants comprise healthy young adults, who are at relatively low risk of serious disease following natural infection, if they have a high baseline risk of natural infection, and if during the trial they receive frequent monitoring and, following any infection, the best available care.
Subject(s)
Clinical Trials as Topic/standards , Coronavirus Infections/prevention & control , Drug Development/trends , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/standards , Betacoronavirus/immunology , COVID-19 , COVID-19 Vaccines , Humans , Licensure , SARS-CoV-2Subject(s)
Coronavirus Infections/immunology , Pneumonia, Viral/immunology , Viral Vaccines/immunology , Antibodies, Monoclonal/immunology , Antibodies, Monoclonal/therapeutic use , Antibodies, Neutralizing/immunology , Antibodies, Neutralizing/therapeutic use , COVID-19 , COVID-19 Vaccines , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Dexamethasone/pharmacology , Dexamethasone/therapeutic use , Drug Approval , Humans , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , T-Lymphocytes/immunology , Time Factors , Viral Vaccines/adverse effects , Viral Vaccines/standards , World Health OrganizationSubject(s)
Betacoronavirus , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines , Animals , Betacoronavirus/genetics , Betacoronavirus/immunology , Biotechnology , COVID-19 , COVID-19 Vaccines , Clinical Trials, Phase III as Topic , Coronavirus Infections/immunology , Coronavirus Infections/virology , Disease Models, Animal , Drug Development/methods , Drug Development/trends , Genetic Vectors , Global Health , Host Microbial Interactions/immunology , Humans , Immunity, Cellular , Immunity, Herd , Immunity, Humoral , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , SARS-CoV-2 , Safety , Spike Glycoprotein, Coronavirus/genetics , Spike Glycoprotein, Coronavirus/immunology , Translational Research, Biomedical , Vaccines, DNA/genetics , Vaccines, DNA/isolation & purification , Vaccines, Synthetic/genetics , Vaccines, Synthetic/isolation & purification , Viral Vaccines/administration & dosage , Viral Vaccines/isolation & purification , Viral Vaccines/standardsSubject(s)
Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Vaccination/methods , Viral Vaccines/supply & distribution , Adult , Betacoronavirus/immunology , COVID-19 , COVID-19 Vaccines , Child , Coronavirus Infections/economics , Coronavirus Infections/immunology , Developed Countries , Developing Countries , Humans , International Cooperation , Pandemics/economics , Personal Protective Equipment/economics , Personal Protective Equipment/supply & distribution , Pilot Projects , Pneumonia, Viral/economics , Pneumonia, Viral/immunology , SARS-CoV-2 , Time Factors , Uncertainty , Vaccination/economics , Vaccination/legislation & jurisprudence , Viral Vaccines/adverse effects , Viral Vaccines/economics , Viral Vaccines/standards , World Health Organization/organization & administrationSubject(s)
Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Trust , Viral Vaccines/standards , Betacoronavirus , COVID-19 , COVID-19 Vaccines , Clinical Trials, Phase III as Topic , Disclosure , Humans , Information Dissemination , SARS-CoV-2 , SafetySubject(s)
Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Randomized Controlled Trials as Topic , Viral Vaccines , Access to Information , Betacoronavirus/immunology , COVID-19 , COVID-19 Vaccines , Clinical Protocols/standards , Coronavirus Infections/epidemiology , Drug Development/methods , Drug Development/trends , Humans , Pneumonia, Viral/epidemiology , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Research Design , Risk Assessment , SARS-CoV-2 , Viral Vaccines/pharmacology , Viral Vaccines/standardsSubject(s)
Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Confidentiality , Viral Vaccines/adverse effects , Viral Vaccines/standards , COVID-19 , COVID-19 Vaccines , Clinical Trials as Topic/methods , Coronavirus Infections/prevention & control , Humans , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Time Factors , Trust , United KingdomSubject(s)
Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , Uncertainty , Viral Vaccines/supply & distribution , Viral Vaccines/standards , Adenoviridae/genetics , Administration, Intranasal , Animals , Biotechnology , COVID-19 , COVID-19 Vaccines , Clinical Trials as Topic/economics , Clinical Trials as Topic/organization & administration , Coronavirus Infections/immunology , Coronavirus Infections/virology , Disease Models, Animal , Drug Industry , Humans , Immunity, Mucosal/immunology , Influenza Vaccines/immunology , Mice , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , Treatment Outcome , Viral Vaccines/administration & dosage , Viral Vaccines/immunologySubject(s)
Advisory Committees , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , United States Food and Drug Administration , Viral Vaccines/administration & dosage , Viral Vaccines/standards , Betacoronavirus , COVID-19 , COVID-19 Vaccines , Centers for Disease Control and Prevention, U.S. , Humans , Information Dissemination , SARS-CoV-2 , Safety , Trust , United States , Vaccination/psychologySubject(s)
Coronavirus Infections/prevention & control , Drug Approval , Drug Industry/trends , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/standards , Betacoronavirus , COVID-19 , COVID-19 Vaccines , Humans , Politics , SARS-CoV-2 , United States , United States Food and Drug AdministrationSubject(s)
Politics , United States Food and Drug Administration/ethics , United States Food and Drug Administration/legislation & jurisprudence , Advisory Committees/ethics , Advisory Committees/organization & administration , COVID-19 Vaccines , Coronavirus Infections/prevention & control , Humans , National Institutes of Health (U.S.)/legislation & jurisprudence , Trust , United States , Viral Vaccines/standardsABSTRACT
Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.
Subject(s)
Coronavirus Infections/prevention & control , Drug Approval/legislation & jurisprudence , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Risk Assessment , Viral Vaccines/standards , Betacoronavirus/drug effects , Betacoronavirus/immunology , Betacoronavirus/pathogenicity , COVID-19 , COVID-19 Vaccines , Civil Defense , Coronavirus Infections/epidemiology , Coronavirus Infections/immunology , Coronavirus Infections/virology , Government Regulation , Humans , Immunogenicity, Vaccine , International Cooperation , Patient Safety , Pneumonia, Viral/epidemiology , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , SARS-CoV-2 , Vaccines, Inactivated , Viral Vaccines/administration & dosage , Viral Vaccines/biosynthesisSubject(s)
Consumer Product Safety , Coronavirus Infections/prevention & control , Government Regulation , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/standards , COVID-19 , COVID-19 Vaccines , Coronavirus Infections/immunology , Humans , Pneumonia, Viral/immunology , United States , United States Food and Drug AdministrationSubject(s)
Coronavirus Infections/prevention & control , Drug Approval , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/standards , Viral Vaccines/therapeutic use , Betacoronavirus/immunology , COVID-19 , COVID-19 Vaccines , Child , Clinical Trials as Topic , Drug Industry , Humans , Patient Safety , SARS-CoV-2 , United States , United States Food and Drug AdministrationABSTRACT
INTRODUCTION: Given the continuing COVID-19 pandemic and much of the U.S. implementing social distancing owing to the lack of alternatives, there has been a push to develop a vaccine to eliminate the need for social distancing. METHODS: In 2020, the team developed a computational model of the U.S. simulating the spread of COVID-19 coronavirus and vaccination. RESULTS: Simulation experiments revealed that to prevent an epidemic (reduce the peak by >99%), the vaccine efficacy has to be at least 60% when vaccination coverage is 100% (reproduction number=2.5-3.5). This vaccine efficacy threshold rises to 70% when coverage drops to 75% and up to 80% when coverage drops to 60% when reproduction number is 2.5, rising to 80% when coverage drops to 75% when the reproduction number is 3.5. To extinguish an ongoing epidemic, the vaccine efficacy has to be at least 60% when coverage is 100% and at least 80% when coverage drops to 75% to reduce the peak by 85%-86%, 61%-62%, and 32% when vaccination occurs after 5%, 15%, and 30% of the population, respectively, have already been exposed to COVID-19 coronavirus. A vaccine with an efficacy between 60% and 80% could still obviate the need for other measures under certain circumstances such as much higher, and in some cases, potentially unachievable, vaccination coverages. CONCLUSIONS: This study found that the vaccine has to have an efficacy of at least 70% to prevent an epidemic and of at least 80% to largely extinguish an epidemic without any other measures (e.g., social distancing).