With phase III COVID-19 vaccine trials each enrolling 30,000 participants or more in the U.S. and randomizing half of them to a placebo arm, only 150 incidents of the coronavirus infection are needed in a trial to show if the vaccine is at least 50% effective, NIH Director Francis Collins testified at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9.
A phase III trial of AZD-1222, an experimental coronavirus vaccine developed by Astrazeneca plc and Oxford University, has been paused due to an unexplained illness that occurred in the U.K., the company said on Sept. 8.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Apros, Ascendis, Beigene, Biomarin, Canbridge, Moleculin, Nanomab, Peptilogics, Precision, Reneo, Sellas.
DUBLIN – Spybiotech Ltd. has secured a first vaccine deal for its proprietary Spytag/Spycatcher protein conjugation technology. The Serum Institute of India Pvt. Co. Ltd. (SIIPL) is employing the technology in a COVID-19 virus-like-particle (VLP)-based vaccine, which recently entered a phase I/II trial in Australia. An initial data readout is expected in October or November.
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