GSK/NIH 'SAM' Strategy May Reap Benefits Beyond Zika
GlaxoSmithKline PLC and the National Institute of Allergy and Infectious Diseases have entered into a partnership to develop a Zika vaccine based on the company's self-amplifying mRNA technology – a collaboration that could yield biomedical research and development benefits far beyond the current epidemic.
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Nothing's even in Phase II yet, but sponsors and US government researchers remain optimistic.
That’s not because the agency doesn’t want to get products cleared as fast as possible, Luciana Borio says; it’s because the pathway remains elusive for many pandemic treatments in the absence of surrogates due to largely undeveloped science.
FDA and NIH officials propose three strategies for clinical trials, saying it will be challenging to identify the most promising candidates; Sanofi and Walter Reed researchers note challenges in vaccine development, including manufacturing scale up.