Nine vaccine makers have signed a joint pledge holding themselves to “high ethical standards and sound scientific principles” in the development and testing of potential vaccines for Covid-19. Also pledged to apply for government approval of a vaccine only “after demonstrating safety and efficacy through a Phase 3 clinical study.” The companies that signed the pledge include AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavaz, Pfizer and Sanofi.
The vaccine makers' news release called their pledge “historic” because it is unusual for competing companies to work together.
The statement came at a time when President Donald Trump continues to push for quick approval of a Covid vaccine. A research assistant professor of government and a policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth College, Herschel Nachlis believes that political pressure on the FDA is not uncommon. He was quoted as saying, “Regulatory decisions are often combinations of both policy and politics, and this time will be no different.”
He, however, said the vaccine makers seem to understand the need for Covid-19 vaccine decisions to be based on the quality of the data and the integrity of the regulatory processes. He said, “An important feature of the pledge is that firms are saying that they will not be pressured into submitting bad data, or into submitting data that does not show evidence of vaccines' safety and efficacy, to the FDA.”
Pfizer and BioNTech, AstraZeneca and the University of Oxford, and Moderna and the US National Institute of Allergy and Infectious Diseases have candidate vaccines in Phase 3 trials. Meanwhile, Johnson & Johnson plans to start its Phase 3. These studies will enroll thousands of volunteers and are the only way to know whether a Covid-19 vaccine is both safe, and effective.
