europeanpharmaceuticalreviewMay 14, 2020
Tag: COVID-19 vaccine , clinical testing , SARS-CoV-2
Scientific leaders have published a new commentary in Science, calling for a harmonised and collaborative approach to the clinical testing, scale-up and distribution of candidate vaccines to prevent COVID-19.
According to the authors from the US National Institutes of Health (NIH), as the COVID-19 pandemic continues, government, industry and academia have introduced a variety of vaccine candidates, of which more than one 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 R&D that would generate essential data for multiple candidates in parallel.
The perspective discusses diverse vaccine candidates and key considerations for development, including the characteristics of various platforms in terms of prior commercial experience, scalability and the types of immune responses generated.
The authors stress that researchers need to learn more about what constitutes a durable protective immune response against COVID-19. They review considerations for vaccine efficacy trials, explaining how trials for several candidate vaccines can be conducted in parallel to generate essential safety and efficacy data and accelerate the licensure and distribution of COVID-19 vaccines. The authors also propose specific approaches to co-ordinate the clinical testing of multiple vaccine products, including using common clinical trials designs, clinical endpoints, standardised immune assays and a common Data Safety and Monitoring Board.
The commentary piece emphasises that developing COVID-19 vaccines will require unprecedented co-operation from governments, academic institutions, industry and global philanthropic partners.
Protecting the entire global community from COVID-19 through vaccination will require significant manufacturing capacity, write the authors. They highlight the need to fund the necessary biomanufacturing infrastructure and note possible hurdles in the eventual delivery of vaccines, including cost, distribution systems and cold chain requirements. The authors conclude that strategic collaboration among public and private sectors to effectively accelerate COVID-19 vaccine development is essential.
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