Research Roundup: Volunteering to be infected with COVID-19 for science and more coronavirus vaccine R&D news
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US science leaders, including Dr. Lawrence Corey of the Fred Hutchinson Cancer Research Center, Dr. John Mascola and Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases, and Dr. Francis Collins, director of the National Institutes of Health, penned an article in Science Magazine, emphasizing that “the global need for vaccine and the wide geographic diversity of the pandemic require more than one effective vaccine approach,” and that unprecedented collaboration among industry, government, and academia will be essential to meet this need. The authors were encouraged that several different vaccine platforms are moving toward clinical evaluation, citing their different characteristics, such as safety, manufacturing flexibility, and cold chain requirements, that could make them suitable for meeting global needs. They cited the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership as allowing for discussions and consensus on clinical trial design, data sharing, and close public-private collaboration. The authors emphasized that “the ability to manufacture hundreds of millions to billions of doses of vaccine requires the vaccine-manufacturing capacity of the entire world” and that “there is an immediate need to fund the necessary biomanufacturing infrastructure, including the fill/finish steps that provide vialed vaccine products for distribution.”
At least 16,000 people, mostly young adults, have signed onto a registry saying they would be willing to be infected with COVID-19 in clinical trials to help accelerate vaccine development. Typically, bioethicists consider it unethical to do human-challenge studies with deadly pathogens that have no approved treatment or cure because of safety risks to patients. The conventional method is vaccinating volunteers during ongoing outbreaks and tracking them for months to monitor infection rates. If human-challenge trials could happen for COVID-19, it could potentially accelerate vaccine development by several months. Researchers note, however, that launching human challenge trials take several months, and that planning should begin now if that’s a route scientists are willing to consider. Requests for human challenge studies must be approved by national regulatory and/or scientific agencies, and not all requests are granted.
The Coalition for Epidemic Preparedness Innovations (CEPI), in its single largest investment to date, is providing US$384 million to advance Novavax’s NVX-CoV2373 SARS-CoV-2 vaccine candidate. Novavax will use the funding to further clinical development and expand large-scale manufacturing capacity for the candidate in multiple countries. Novavax plans to be capable of producing 100 million doses by the end of 2020 and potentially 1 billion by the end of 2021.