American Consequences - September 2020

In short, although we can approve a vaccine for its political importance, medically, we will know very little until the spring. As for efficacy, we won’t have this data by October. Like I said, we will use the animal rule instead. Unfortunately, people can be a lot older or a lot more obese than lab animals. Hopefully, any “October surprise” vaccine will take side effects into account... But either way, with one major exception, this is going to be an opt-in vaccine. Even doctors and nurses will not have to take it. They can always change hospitals or professions. However, soldiers don’t get that choice. So we expect the initial emergency use approval for a vaccine to largely apply to the young and healthy – focused on U.S. military personnel. After all, the Department of Defense needs FDA approval before vaccinating our troops. That’s to keep up with the Russian and Chinese militaries. Finally, let’s talk distribution... Military issues aside, the first folks eligible for a vaccine will be doctors, nurses, first For example, drug developer Moderna reported that three of 15 patients in its Phase I trial reported serious adverse events requiring an emergency room visit at the highest dose. And although the dose has been lowered for the Phase III trials, that’s still a major warning sign about the safety of Moderna’s vaccine.

responders like paramedics, and other medical aides in nursing homes and other care facilities. These vaccinations can start by the end of 2020... but likely only with about half a million doses by then. The bulk of our health care workers won’t be protected until Spring 2021. National distribution may start in the second quarter of 2021. But it might not finish until sometime in 2023. In other words, it’s unlikely that millions of Americans will be able to stop by their local Walgreens or CVS pharmacy and get a free COVID-19 vaccine this December. The good news is that by the time a vaccine is available to you – say, sometime next summer – we will have strong evidence of its safety and efficacy. The more sobering news is that until that time, you can expect local, state, and international mask mandates, since COVID-19 is an airborne, lethal contagion that especially threatens people over the age of 50. In short, although we can approve a vaccine for its political importance, medically, we will know very little until the spring. And nationally, it won’t protect us for another year, at least. Full distribution and herd immunity are at least two years away. Bottom line, vaccinating 200 million Americans is possible... But it’s not fast, nor easy.

American Consequences


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