Think a vaccine will be ready this autumn? Think again…
By Dave Lashmet
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…
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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 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.
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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 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 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.
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.
In sum, this explains why we can get a vaccine for COVID-19 approved by the U.S. FDA for emergency use by October 20, 2020.
But it leaves a major question unanswered: What are the side effects that someone would face when they get this vaccine?
See, when doctors talk side effects for vaccines, they are weighing the side effects against the disease the vaccine is designed to prevent.
For example, look at the newly approved Ebola vaccine…
Made by pharma giant Merck, it won FDA approval in December 2019. Ebola can have a case fatality rate of 50%… It kills quickly, and it spreads broadly. Compared with that, severe side effects are acceptable… 18% of vaccine recipients reported joint pain and 9% reported new arthritis symptoms from the vaccine. None of the controls reported any extra arthritis symptoms. So while these are serious side effects, they’re also better than dying.
For COVID-19, which is a lot less fatal in the aggregate – running at about a 2.5% case fatality rate – we can’t accept as high of a threshold for severe side effects.
And yet we are seeing serious side effects in some early-stage COVID-19 vaccine trials…
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.
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 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.
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Dave Lashmet spent a decade teaching and writing about medicine and technology at major research universities, and he’s done follow-up research at some of the most important facilities in North America. He is also an inventor on multiple U.S. patents. Dave writes Venture Technology, an exclusive letter that takes a “venture capitalist” approach to investing… seeking out small-cap speculative stocks with strong catalysts and outstanding breakout growth potential.