Nine biopharmaceutical firms vowed Tuesday not to seek premature government approval for a coronavirus vaccine and signed a pledge to reflect their commitment.
The companies — AstraZeneca, BioNTech, Moderna, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson and Merck — signed the pledge, which says, “We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”
The companies pledged to “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as the Food and Drug Administration,” CNN reported.
FDA Commissioner Stephen Hahn said last week that emergency use authorization or approval for the virus vaccine could occur before Phase 3 trials are done.
Pfizer and Moderna have a vaccine in late-stage Phase 3 clinical trials in the U.S., with Johnson & Johnson on the cusp of that phase.
