PoliticoWhite House pressure for coronavirus vaccine raises risk US will approve one that doesn’t work
- Health experts fear regulators will be pushed to approve first candidate to show promise, without proof of effective, reliable protection
- Drug makers and agencies have already begun rewriting rules of vaccine research
This story is published in a content partnership with POLITICO. It was originally reported by Sarah Owermohle on politico.com on June 15, 2020
US President Donald Trump has promised that there will be a coronavirus vaccine before the year is out. But public health experts are growing increasingly worried that the White House will pressure regulators to approve the first vaccine candidate to show promise – without proof that it provides effective, reliable protection against the virus.
Drug makers and health agencies have already begun rewriting the rules of vaccine research, launching candidates into clinical trials at record speed in search of a pandemic-ending shot. Data on the vaccines’ safety is already trickling in.
But no candidate is yet ready for the final step of the development process: a months-long trial in tens of thousands of volunteers to prove once and for all whether the shot works.
That tight timing, coupled with the high-pressure political environment, has experts concerned that the Food and Drug Administration could grant emergency-use authorisation (EUA) to one or more vaccines before clinical trials have definitively determined whether they can prevent infection.
Taking that step also could make millions of doses available outside clinical trials, making it hard to enrol enough people in the trials to get the data ultimately needed to show the vaccine works. It could also squeeze other – potentially better – candidates out of the market.