Will COVID-19 Speed Up the Drug-Approval Process?

The question of when we will have a COVID vaccine is as much a regulatory question as it is a scientific one. So it might be more helpful to reframe the question as, when will the FDA approve any vaccine?

The FDA has dual mandates, safety and efficacy. Does it work, and is it safe? And the FDA is faced with making difficult trade-offs. The difference between a poison and a cure can be quite small—chemotherapy being a well-known example.

In practice, the FDA swings a bit like a pendulum between prioritizing safety and prioritizing efficacy. After a negative safety problem, they move towards higher safety requirements, which by definition decreases the number of new drugs that are released. Once that happens, disease advocacy groups head to DC and exert pressure for more drugs, to swing the pendulum back towards efficacy, towards more new treatments.

The traditional drug discovery process is quite long, and so you’re often going back and forth with the FDA for more than a decade to get a drug approved. During that time you witness firsthand as the goalposts move, as the agency responds to events outside of your control.

As a side note, it’s important to note that science does not exist in a perfect bubble, as much as we would like to believe it does. The industry is filled with people who are susceptible to the same human pressures as everybody else. We never have perfect information. We never have enough data. So we’re left needing to make trade-offs.

And indeed, I would argue that the reality of necessary trade-offs has been largely ignored during the COVID debate, although we are starting to see that change.

On my first day of teaching this quarter at Booth, I raised the question of whether or not government policies were trading a known negative, which is a self-imposed recession, for an unknown positive, which was the efficacy of lockdowns. And those are important questions to ask, and that’s the same question of safety versus efficacy, but on a larger scale.

So going back to the FDA and the COVID vaccine: Beyond safety and efficacy, when evaluating a new drug for approval, they also look at need, and they factor in standard of care. With COVID, we have a very high need, and there is no standard of care. There are no treatments. So that significantly lowers the bar for approval. And indeed it is lowered at well below what anyone thought possible six months ago.

At Nymirum, the drug discovery company where I’m CEO, we focus on targeting RNA. Our technology was initially developed while working on the HIV RNA virus, and as all coronaviruses are RNA viruses, our technology is well-suited to this issue.

As a result, we were contacted by someone affiliated with one of the larger government agencies and asked about working on the SARS-CoV-2 virus, which is the virus that causes COVID. Specifically, we were asked how long it would take us to develop a drug if all restrictions were removed and all resources were made available. So we spent the weekend going over our plan again and again.

As a drug developer, it’s a fascinating question. It’s a great process to have to work through. And the number we came down to was two and a half years, and that was a number that just felt ridiculously fast. Indeed, it felt a bit absurd even to say that number. But when I did, they had a great response: He said, “No, you’re not hearing me. Don’t worry about the FDA or a budget. What is the absolute fastest it could be done? Could you do it by this fall?” That was a great question—removing the restrictors we’re used to working with and thinking outside of the current framework.

The vaccine developers seem to have been given a very similar challenge. And at Moderna in particular, they have indeed been given the funding, and they have been given a very close partnership with government agencies to work on the vaccine cure in the next six to nine months. The list of additional drug companies that are announcing their own vaccine programs seems to increase daily.

So to answer the question of whether the FDA will approve a vaccine in the next six to 12 months, I believe it’s likely that they will. But moving from 10 plus years of safety and efficacy data down to six to nine months will, by definition, give us a lot less data to look at. So the next question is, will enough people take it?

It’s worth pointing out that those primarily at risk from COVID, people over 65, are the same group with the lowest response rates to vaccines. So the next question is, will enough younger people, who are at lower risk from COVID, be willing to take a drug that is more risky, that has less data than we normally have? And that is probably the most important question for those of us asking when this pandemic will end.