Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 28
Filter
2.
J Infect Dis ; 221(11): 1752-1756, 2020 05 11.
Article in English | MEDLINE | ID: covidwho-1109241

ABSTRACT

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-2
16.
Vaccine ; 38(39): 6184-6189, 2020 09 03.
Article in English | MEDLINE | ID: covidwho-701883

ABSTRACT

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/biosynthesis
19.
Am J Prev Med ; 59(4): 493-503, 2020 10.
Article in English | MEDLINE | ID: covidwho-645862

ABSTRACT

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).


Subject(s)
Communicable Disease Control , Computer Simulation , Coronavirus Infections , Pandemics , Pneumonia, Viral , Vaccination , Viral Vaccines/pharmacology , Betacoronavirus/isolation & purification , COVID-19 , COVID-19 Vaccines , Communicable Disease Control/methods , Communicable Disease Control/statistics & numerical data , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Disease Eradication/methods , Disease Eradication/statistics & numerical data , Humans , Needs Assessment , Pandemics/prevention & control , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , SARS-CoV-2 , Treatment Outcome , United States/epidemiology , Vaccination/methods , Vaccination/statistics & numerical data , Vaccination Coverage , Viral Vaccines/standards
20.
Vaccine ; 38(34): 5556-5561, 2020 07 22.
Article in English | MEDLINE | ID: covidwho-617212

ABSTRACT

Nucleic acid (DNA and RNA) vaccines are among the most advanced 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 nucleic acid vaccines. This will facilitate the assessment by key stakeholders of potential safety issues and understanding of overall benefit-risk. The structured assessment provided by the template can also help improve communication and public acceptance of licensed nucleic acid vaccines.


Subject(s)
Risk Assessment/methods , Vaccines, DNA/adverse effects , Vaccines, DNA/standards , Viral Vaccines/genetics , Viral Vaccines/standards , COVID-19 Vaccines , Coronavirus Infections/genetics , Coronavirus Infections/prevention & control , Humans , Public Opinion , Risk Assessment/standards , Vaccines, DNA/genetics , Viral Vaccines/adverse effects
SELECTION OF CITATIONS
SEARCH DETAIL