International – Vaccine makers call for alternative study designs for COVID vaccines

Regulators need to facilitate new ways of clinically validating COVID-19 vaccines now that effective shots are being given around the world, Thomas Triomphe, executive vice president of Sanofi Pasteur, testified at a joint meeting of the European Parliament’s Committee on Industry, Research and Energy (ITRE) and the Committee on the Environment, Public Health and Food Safety (ENVI).
 
With over a dozen vaccines authorized or approved around the world, a significant number of adults will be vaccinated by the time developers of early-stage candidates, including oral and intranasal prospects from smaller companies, start planning their pivotal trials. Triomphe called on the European Medicines Agency (EMA) and its peers to provide routes to market for developers of vaccines that are yet to reach Phase 3. 
 
Sanofi Pasteur fell behind in the vaccine race last year when lackluster clinical data on its GlaxoSmithKline-partnered program forced a formulation change. Having suffered the setback, the company now finds itself gearing up to run a Phase 3 clinical trial at a time when millions are being vaccinated weekly…