Are We Headed To a Coronavirus Apocalypse In the Fall?

A laboratory technician of biotechnology company mAbxience is seen working, amid the outbreak of the coronavirus disease (COVID-19), in Buenos Aires, Argentina August 13, 2020. REUTERS/Agustin Marcarian
August 16, 2020 Topic: Security Region: Americas Blog Brand: The Reboot Tags: CoronavirusCOVID-19PandemicSchoolsFDA

Are We Headed To a Coronavirus Apocalypse In the Fall?

One former FDA head has some thoughts.

Strain: Some of the things that make us great as a nation have caused us to do poorly. Some of the things that make us bad as a nation have caused us to do poorly.

Scott, do you think we should have mask mandates everywhere and people who violate them should be fined? There was an op-ed in the Washington Post today calling for that exact thing. There are mask mandates, but there’s really very little downside other than public scorn for not wearing a mask. Should people be fined or even jailed?

Gottlieb: Well, I think we should be implementing a mask mandate, and I think there needs to be enforcement. You can give people a warning and then give them a fine. Look, we require people to wear seatbelts, and we give them tickets if they don’t have a seatbelt on. And that’s largely to protect them and lower insurance premiums. You wearing a seatbelt isn’t necessarily protecting other people from you. But this is a situation where you’re not only protecting yourself, you’re providing a protection to society as a whole. I don’t know why we can mandate and enforce seatbelt requirements and people comply with them largely, but there’s this sort of political aversion to the mask, other than for the fact that the masks got sort of pitched in a political context in the outset, unfortunately, and got equated with people’s exercise of their liberty.

And it’s uncomfortable to wear a mask. So I understand people not wanting to be told they have to wear a mask when it’s 95 degrees in Phoenix, but the masks should be enforced in the settings in which the masks provide protection: indoor congregate settings. If you’re walking on the street and you’re distanced from everyone, that’s not a setting where you necessarily need to enforce a mask mandate. Inside, yeah, absolutely. I’ll just say, Jim, I’m talking to a lot of CEOs, and I think you’re going to see more of a mask mandate in the country driven by the private sector as more and more businesses require masks inside their establishment, that effectively requires people to have a mask when they go out of their home and put it on largely in the highest risk settings, which is when you’re in an indoor congregate space.

Mike, what absolutely needs to be in this next congressional phase for economic support bill?

Strain: Well, some key provisions of the CARES Act that were passed in March are expiring. So we need to address expiring provisions, including insurance benefits. Schools that are planning on reopening that need money to retrofit classrooms and get better HVAC systems and those sorts of things — we need to provide them with that money. But general support to state and local governments are going to be critically important. The next phase of the small business support program is going to be important. The good news is the Congress is talking about all the things that need to be in there. Whether or not Congress is going to execute it is the question.

Rick, are these colleges with big, giant endowments going to get away with having college kids go to school online and still charging them full tuition?

Hess: It looks that way. It’s unbelievable. Mostly what they’re selling is access to the post-graduation job market and prestige. And the idea that you’re paying $40,000 to $60,000 to sit in your parents’ basement and watch YouTube videos is mind blowing, but it seems to be happening.

Scott, are we being too optimistic about vaccines? It seems like we hear the best case scenario and we assume that should be our baseline expectation. Or, might we get a vaccine in early 2021, which seems to be the optimistic scenario?

Gottlieb: Yeah. So I’m on a board of Pfizer, I’ll just mention that, which obviously has one of the vaccines that’s in advanced development right now, in phase three clinical trials. I think a reasonable base case is that we could have a vaccine in early 2021. That’s an optimistic scenario, but it’s not an unreasonable scenario if things go right, if the clinical trials demonstrate that the vaccines are safe and effective. If manufacturing is scaled — and it’s currently being scaled, these companies are manufacturing at risk right now — but if they’re able to successfully manufacture these products, you could have a situation where you have a vaccine in early 2021 that’s licensed by the FDA for general use or use in large, select populations, maybe older populations.

I think having a vaccine available before that is… I wouldn’t say unlikely, but if it’s going to be available before that, it would be available under an emergency use authorization for a very select population. So you could see a scenario where the pivotal trials read out sometime in October or November, because the trials might go quickly because we have so much infection around this country. They’ll enroll quickly. They’ll read out quickly because you’ll have a lot of events in the trials. You learn that the vaccines are effective. You don’t have longer term follow-up data, but you might authorize the use of the vaccines under an emergency use authorization for, let’s say, frontline healthcare workers, maybe in the context of a large registry where you give it to healthcare workers, but you enroll them in a registry where you continue to follow them and collect safety information, as well as efficacy information.

That might be a path that we have. Right now, these vaccine trials are 30,000 patients each. A lot of vaccine trials are 70,000 — sometimes 80,000 — patients or more, but only a portion of it is a prospectively randomized trial. The other arm of the trial will be just a large prospective enrollment registry, where you’re just trying to gather more data. You’re trying to expose more people to the product, get more information about long term safety. So you could see those large scale registries roll out after the pivotal trials are unveiled in October or November as a way to both provide access, as well as continue to collect information in advance of licensing and for general use. But getting back to your original question, I think that an optimistic scenario is you’d have a vaccine licensed for general use or authorized for more widespread use in early 2021. That’s an optimistic sort of base.

And then how long to get everybody vaccinated?

Gottlieb: Well, I think it would go quick. I don’t think that there’s going to be a logistical problem. We’ll have enough glass and syringes to vaccinate people. In 2009, we were able to vaccinate people with a trivalent flu vaccine, and then a month later turn around and vaccinate the entire population with a monovalent vaccine for H1N1. So everyone effectively got two flu vaccines that season. If we were able to do it in 2009, we’re going to be capable of doing it now, especially with all the best planning that we’ve put into this. I think that the question is, how quickly would people take up the vaccine? And that’s going to turn on how effective the data is, how much confidence people have in the process, how we approach it politically in terms of whether people have confidence that the process was objective and rigorous.

But I think that there would be a sort of pent up demand. I think there would be enough people who would want to go out and get vaccinated that you’d get a sufficient number who got the vaccine, that it would provide the sort of societal benefit. You don’t need to vaccinate everyone. A lot of people will have had coronavirus by then. So if you can get 30–40 percent vaccination rates, that’s pretty good. And that probably is sufficient to sort of quell this epidemic.

Strain: Scott, what kind of a signal is it when a vaccine makes it to the phase three trial? Does that mean that it’s very likely that it’s going to work? Does that mean that they don’t know? All these vaccines that are at the phase three, should I be thinking, “Okay, they’re going to work”?

Gottlieb: There are data on what the rate of success is once something has progressed to phase three clinical trials. I’d have look back, but probably a higher proportion of vaccines that are progressed into phase two clinical trials have succeeded relative to drugs. And a high proportion overall of products that get into a pivotal trial ultimately succeed.

I think probably you’d have to assign lower odds in this setting — in part because the development programs were accelerated, in part because there are a lot of unknowns about this virus, and in part because the phase one and phase two programs for the most part (and this isn’t uniform across all the sponsors but for some of the companies) were smaller. And so they didn’t test as many doses. They didn’t test as many vaccine constructs in an effort to try to advance these quickly, and so you’d have to impute a little bit more uncertainty going into the phase three as a result of that.