THE OCTOBER VACCINE SURPRISE
Expect a COVID-19 vaccine “October surprise” this election season... So far, the COVID-19 pandemic has led to roughly 6 million U.S. infections, with a 2.5% case fatality rate. The contagion reaches across friends and family, spreading at an alarming pace. A vaccine is thought of as an end point – a “way out” of this mess we’ve made. That may or may not be true... But both politically and for the sake of the economy, few are interested in waiting to see how effective the vaccine will be... just as long as we have one. I’ve been a market analyst for 20 years, largely focused on medical advances, new drugs and treatments, and technology breakthroughs. And in my years of experience with the biotech space, I’ve seen what it takes for drugmakers and other companies to combat the worst threats to our health. The global coronavirus pandemic is kicking several of these battles into high gear now. And that means investors need to know what’s happening in this part of the market... and what a vaccine really means. You see, questions will remain this October... Will the vaccine work? Maybe. Will it be painful? Potentially, yes, very much so. Will it be permanently harmful? Probably not. So overall, any one of these vaccines is probably a better deal than getting COVID-19. That’s all we know so far... And that’s all we will know next month, too.
Even in the face of the COVID-19 pandemic, pivotal trials for a vaccine take six months. We will have a large sample of people’s reactions to a first and second vaccination – most take two doses for full protection. However, that is not a proxy for effectiveness. A vaccine that wins early approval and later proves to be ineffective will burn the goodwill of the people – especially if this worthless vaccine came with side effects. Nevertheless, you can expect an “emergency use authorization” by the U.S. Food and Drug Administration (“FDA”) by October 20, 2020. The reason behind this date is the “animal rule.” This rule is the reason why drug companies can develop a vaccine for a lethal contagion without risking people’s lives... at least at first. Some contagious infections are so lethal or difficult to treat that it would be unethical to test them on living volunteers. Instead, we use two stand-ins: non-human primates (generally monkeys or chimps) and one other kind of animal that gets the disease. In part, this is why the U.S. government builds massive biocontainment labs: to run animal experiments while protecting the scientists. The key experiment is called a challenge trial... You give the vaccine to the animals, then challenge them with the live virus. Ideally, you’d want the animals that got the vaccine to be fully protected and show no signs of sickness. Still, if the vaccinated animals get sick but have a less severe form
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