USA – Drugmakers, FDA try to build public confidence in COVID vaccine decisions

The CEOs of nine pharmaceutical companies working to develop vaccines for coronavirus disease (COVID-19) on Tuesday pledged not to seek approval or emergency use authorization (EUA) for a vaccine until they have demonstrated safety and efficacy through Phase 3 clinical trials.
 
The CEOs, who head vaccine front-runners AstraZeneca, Moderna and partners Pfizer and BioNTech, as well as GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi, also say they will put patient safety first and will “adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes,” according to a joint statement.
 
The pledge comes amid concerns that the US Food and Drug Administration (FDA), under pressure from President Donald Trump, could prematurely greenlight a vaccine for COVID-19. Such concerns have been heightened amid Trump’s repeated claims that a vaccine could be available before the November election and FDA’s controversial issuance of EUAs for hydroxychloroquine and chloroquine and convalescent plasma to treat COVID-19. (RELATED: FDA revokes EUA for hydroxychloroquine, chloroquineRegulatory Focus 15 June 2020; Lawmakers, experts raise questions after convalescent plasma EUARegulatory Focus 25 August 2020)…