American Consequences - September 2020

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. a vaccine. That’s because these antibody drugs are additional safety nets in case the COVID-19 vaccine is less effective in people than in animals. trials in late summer and work fast. Indeed, if more patients improve when given antibodies versus a matching control group, you can see an antibody work within days. So when the vaccine advisory committee of the FDA meets, knowing that there is an effective antibody drug will also help approve The truth is that the translation from animals to people is never perfect. A good rule of thumb in biotech is that every drug candidate works in mice, but only 1% of them win FDA approval. Still, knowing that there is an antibody drug – or a cocktail that includes a mix of antibody drugs – offers a promising safety net. The U.S. and global biotech manufacturers are highly effective, overall. Given time, they can make powerful, safe, and effective drugs... The problem with COVID-19 is that the epidemic moves so fast, we need to stop it quickly – so this is clipping off drug development time.

of the disease, that’s helpful. For example, a sickness but not a fatal case. Scientists also challenge another equal number of animals who don’t receive the vaccine. That proves the virus is live and lets researchers compare how both groups react. From there, it’s a subtraction: how well did the vaccinated animals do compared with unvaccinated controls. That’s the protocol. Researchers do try to look at side effects in the animals, too. But animals are hard to read. And they can’t report how they’re feeling. So that’s how a vaccine can work well in animals, but still have significant questions when it comes to human side effects. The U.S. Centers for Disease Control and Prevention (“CDC”) recently summarized the first 1.3 million U.S. cases of COVID-19. Of those cases, there were 72,000 deaths. For 40-year-olds, the CDC found a 1% risk of death from COVID-19. For 50-year-olds, the risk is 2%. For 60-year-olds, it’s 7%. For 70-year-olds, it’s 17%. And for the 80-plus bracket, there’s a 32% risk of death. It’s easy to see that the older you are, the more at risk you are. And so far, COVID-19 therapies have been slow to roll out. Still, we might see some of those get added on to an October vaccine surprise... In particular, watch for specialized antibody drugs that are made in bioreactors but can be added to the veins of severely ill patients. These antibody drugs specifically target the virus that is causing COVID-19. The drugs start clinical

American Consequences


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