Drugmakers and health agencies have already begun rewriting the rules of vaccine research.
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.
Drugmakers 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 authorization 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 of clinical trials, making it hard to enroll 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. Continue reading.