Vaccines Could Start rolling out This fall. we’re not ready for how Complicated it will Be.

IJune 18, 2020 t’s ’ d difficult ffi l to untangle lh the science of fh the Covid-19 pandemic from the politics. Exhibit A is hydroxychloroquine. After the president repeatedly advocated for the malaria drug, the Food and Drug Administration issued an emergency use authorization to increase access to it during the pandemic. This week, the FDA revoked that authorization based on its review of the scientific evidence. To get a better sense of what to expect from both the science and the politics of the pandemic, I called Luciana Borio, a physician whose work on protecting the public from infectious disease took her all the way to the White House, where she served on the National Security Council during the Trump administration. She was also the acting chief scientist at the FDA. Here are Borio’s key takeaways:

If there are vaccines available this fall, they will not be available to everyone. “People who are medically at risk or in critical infrastructure, they usually go first,” Borio said. There is a “pile of confusion”over what treatments work in part because standards for clinical studies have slipped. The U.S. government led an effort during the Ebola epidemic to improve scientific standards. That was then. Now a “disturbing” number of studies “do not yield results that can be interpreted, neither with respect to safety or efficacy.” America has blindly reacted to China rather than devising its own pandemic strategy. Just look at lockdowns. “The magic is about social distancing. Locking down is just a totalitarian way of achieving that.”

We spoke twice this week, before and after former National Security Adviser John Bolton published a defense of his 2018 decision to disband the global-health team Borio served on. Borio left the government in March 2019 and now works for In-Q-Tel, a nonprofit that invests in technologies for the U.S. intelligence community. My conversations with Borio are condensed in the following transcript, which has also been edited for clarity. Asked for comment, an FDA press officer referred to a recent speech by Commissioner Stephen Hahn, who said: “Good science as the basis for decisionmaking has been a hallmark of my career, and is a value that I hold deeply.” he Wall Street Journal published an excerpt of Bolton’s book in which he described his changes to the National Security Council team you served on as “streamlining.” He said most of the globalhealth staff kept doing the same work afterward. What’s your reaction?

Luciana Borio: The work continued in earnest, and the idea that the streamlining led to an erosion in the work that was being undertaken is just not right. I can’t comment for what happened after I left.

Let’s look ahead. Several companies are reporting progress on their vaccines. By the fall, some vaccines may be ready for emergency use. What is that going to actually look like? Moderna is proceeding to a Phase 3 trial, the latest-stage clinical development, in July. Johnson & Johnson is going to start its Phase 1 clinical trials in July. There is the Oxford

AstraZeneca Ast partnership that is already in Phase Pha 2/3. By the time they the are manufactured in real amounts, hopefully we’ll we’ know through these clinical clin trials, which are highly hig efficient and very definitive defi in terms of giving us a signal of safety and efficacy, whether this vaccine vac v has been effective to roll out. Now, who receives rece the initial doses depends dep on how much vaccine vac is available. Generally speaking, you like to be able to give the initial doses for individuals that are at highest risk of exposure or highest risk of getting sick or seriously ill. People who are medically at risk or in critical infrastructure, they usually go first.

Who actually are those kinds of people? It’s subject to definition by both federal and state governments. But that generally includes things like utility workers and medical professionals. There’s opportunity to adapt to what defines critical infrastructure. We saw this time around how important grocery workers became. Delivery workers became really important. Meat-packing industry workers and those in the agricultural sector that are supplying our food are very critical. So in the next few months, we’re likely to have a scenario where we’re reasonably confident that some vaccines work, but they won’t be available to everybody all at once, right? They won’t.

That period is going to be complicated. This rollout would be complicated no matter what. It will be complicated because we’ll have staggered vaccine availability, since multiple technologies are being developed. Most vaccines are going to be two doses. Some of them employ novel technology that hasn’t been proven before. This is not going to be an easy rollout from either a communications perspective or a logistics perspective.

I think it’s fair to say that most people today, given the communications that they have heard from the U.S. government, do not understand what this will entail. The communications have been very high-level and very limited. It’s not a criticism. It’s just a fact that it’s a complicated enterprise.

There is no guarantee that these vaccines actually are going to work, especially the ones that are in most advanced stages right now. How do you make sense of vaccine news— including reports that don’t show the strong results you’re describing—if you’re someone who doesn’t understand the science?

It is complicated. I think it’s fair for investigators to release provisional information before publication in a peer-reviewed journal when there is the potential to impact so many lives. The reservation around this type of approach, though, is that so many studies have been done so poorly. The vast majority of clinical studies that were done represent a failure of the system that regulates and conducts clinical studies; the failure of academic institutions; the failure of institutional-review boards that are supposed to watch out for the interests of human subjects; the failure of regulatory agencies; the failure of funders. You end up with the situation that we’ve seen, which is a lot of announcements and press releases based on very flawed studies, and the general public is not able to distinguish between what’s a high-quality study and what’s flawed. That’s something that we need to change for the future. It’s very disturbing to see that the vast majority of clinical studies that were conducted to date were not interpretable.