Nine vaccine developers from the U.S. and Europe have signed a pledge to uphold scientific standards for their investigational immunizations for COVID-19, following a rise in concerns that safety and efficacy of the vaccine may be compromised in the rush to get it approved and distributed quickly.
The companies pledged to follow "guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices." Under the agreement, the developers promise to:
- continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes
- only submit for approval or emergency use authorization after demonstrating safety and efficacy through a phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA
- work to ensure a sufficient supply and range of vaccine options, including those suitable for global access
Signers of the pledge include Pfizer, GlaxoSmithKline, AstraZeneca, Johnson & Johnson, Merck, Moderna, Novavax, Sanofi, and BioNTech.
Sources: Reuters, September 8, 2020; Moderna news release, September 8, 2020.
