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THAN: A harmonized and collaborative approach to clinical trials, expansion and distribution of candidate vaccines to prevent COVID-19 is essential, scientific leaders write in a perspective published today in Science.
As the COVID-19 pandemic continues, the government, industry, and academia have come up with a variety of candidate vaccines.
The authors note that more than one effective vaccine approach will likely be required to successfully protect the global community from SARS-CoV-2, the virus that causes COVID-19. They describe a strategic approach to research and development that would generate essential data for multiple candidate vaccines in parallel.
Director of the National Institutes of Health Francis S. Collins, MD, Ph.D., Director of the National Institute of Allergy and Infectious Diseases (NIAID) Anthony S. Fauci, MD, Lawrence Corey, MD, professor in the Division of Vaccines and Infectious Diseases from the Fred Hutchinson Cancer Research Center in Seattle and Dr. John R. Mascola, director of the NIAID Vaccine Research Center, are the co-authors of the commentary.
The perspective looks at various vaccine candidates and key development considerations, including the characteristics of various vaccine platforms in terms of previous business experience, scalability, and the types of immune responses generated. It also emphasizes that no single vaccine or vaccine platform is likely to meet the global need, highlighting the need for a coordinated strategic approach to vaccine development.
The authors emphasize that researchers need to learn more about what constitutes a lasting protective immune response against COVID-19. They review the considerations for vaccine efficacy trials, explaining how trials for various candidate vaccines can be conducted in parallel to generate essential safety and efficacy data and accelerate the licensing and distribution of COVID-19 vaccines.
The authors propose specific approaches to harmonize clinical trials for multiple vaccine products, including the use of common clinical trial designs, clinical endpoints, standardized immune trials, and a common Data Safety and Monitoring Board.
The authors emphasize that the development of COVID-19 vaccines will require unprecedented cooperation from governments, academic institutions, industry, and global philanthropic partners.
The public-private partnership ACTIV (Accelerating Therapeutic Vaccines and Interventions COVID-19) led by NIH aims to facilitate such collaboration with discussions and collaborations on trial designs and data sharing.
Protecting the entire global community from COVID-19 through vaccination will require significant manufacturing capacity, according to the authors.
They emphasize the need to finance the necessary biofabrication infrastructure and point to potential obstacles to eventual vaccine delivery, including costs, distribution systems, and cold chain requirements. The authors conclude that strategic collaboration between the public and private sectors to effectively accelerate the development of the COVID-19 vaccine is essential.
WHO: NIH Director Francis S. Collins, MD, Ph.D., NIAID Director Anthony S. Fauci, MD, and NIAID Vaccine Research Center Director John Mascola, MD are available to make comments.
Source:
NIH / National Institute of Allergy and Infectious Diseases
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