Clinical trials are an arduous, costly process in the United States, primarily because every time a drug has side effects or harm not predicted by clinical trials, lawyers sue and then Congress tells FDA to make clinical trials needed for approval more costly and expensive.
In the FDA of February, 2020, a clinical trial of a COVID-19 vaccine would have been predicted to take a decade and cost $500,000,000, by which time the next coronavirus pandemic will have hit and we'd need to start over again. In May of 2020, Republicans and Democrats are falling over themselves to demand a vaccine be rushed to market and companies are showing just how nimble they can be once government gets out of the way. As a result of this new urgency worldwide, over 100 candidate vaccines are in development and 8 have started trials.
Early results from the first trial in Wuhan, China, home of the outbreak, using the vaccine created by CanSino have been released, and it has been found safe. But don't get too excited, safety and dosing is all it can show. And we still can't even be sure of that for six months. It was a non-randomized trial of 108 people, fairly young (mean age of 36), who got a low dose, medium dose, or high dose. After 28 days, the only side effects were what people claim from lots of things; headache, fatigue, etc. but no serious reactions.
Phase II is where they have to see if it works better than placebos - products like Zicam, Chris Cuomo's light energy pills, all of homeopathy - and then it would have to go into Phase III to see if it really, really works, and then if it passes it might get temporary contingency approval until post-marketing data is in.
After the polio vaccine was found to be safe in the 1950s, millions of parents got in line with their kids to try it despite it not having passed clinical trials. Obviously COVID-19 is nowhere near the concern of polio, it hasn't even reached death total of the flu in an average year, but that so many are now asking the awkward questions of government - like why drug approval is so much more costly and time-consuming when that shows no less risk of adverse reactions - may mean the one good thing SARS-CoV-2 accomplishes is to get public demand for reform of our regulatory process.
