Any day now, Moderna will likely announce that it's recruited all 30,000 volunteers in one of the world's largest ongoing tests of an experimental coronavirus vaccine. For Larry Corey, a virologist and former president of the Fred Hutchinson Cancer Research Center, reaching the trial's enrollment goal will represent a major milestone.
Corey has spent decades coordinating global efforts to develop and test HIV vaccines, which is why the National Institutes of Health tapped him earlier this year to help spearhead a similar, but hyper-compressed search for a coronavirus vaccine. He is co-leading the resulting initiative, called the Covid-19 Prevention Trials Network, or CoVPN, which has merged together multiple existing clinical trial networks in an effort to simultaneously run several large trials of would-be coronavirus shots.
CoVPN is attempting to achieve, in months, enrollment goals that took Corey's HIV Vaccine Trials Network multiple years. So far, it's largely been successful, even as the pandemic has stressed many of the institutions relied upon to recruit and run these studies.
Still, the effort has hit a few speed bumps. Some sites weren't activated as quickly as hoped, Corey said. Logistical issues, like figuring out vastly different data recording systems, have slowed things down. Two large trials operating under the CoVPN banner, testing vaccines from AstraZeneca and Johnson & Johnson, have been paused for safety reviews.
"Some days there are enormous problems to solve," Corey said in an interview. "But we have a lot of really bright people working incredibly hard to make this program work."
Their work will be in the spotlight Thursday as the Food and Drug Administration convenes a panel of experts to discuss coronavirus vaccines. Though no specific approval applications are up for consideration, the meeting will have important implications for all of the vaccines the CoVPN is assisting with, among them Moderna's shot. The discussion will also be relevant for partners Pfizer and BioNTech, which could be the first to produce results from a large-scale efficacy trial, but are working on their own.
With the FDA meeting days away and crucial issues to solve in the weeks ahead, BioPharma Dive spoke with Corey about what he's watching. The following conversation has been edited and condensed for clarity.
What will you be paying attention to at this week's advisory panel?
COREY: My main issue is making sure we can make adequate vaccine policy out of these studies. To me, the main question the studies want to answer and the American people want to hear is: Does the vaccine prevent hospitalization or medically complicated disease? Have we accrued enough data to understand that and feel comfortable about that, as it relates to granting an emergency use authorization? [The bar for that information] is not really well articulated in the FDA's draft guidelines.
What will you be looking for when we see the first results from a large-scale efficacy trial?
COREY: What's the percent reduction in disease severity? Do we collect enough data to say that the vaccine alters medically complicated or medically attended disease? Do we have some sense that the vaccine will prevent hospitalization or progression to severe disease? And does it do so in the elderly, and in people who are African American and Hispanic? Because those are the target populations that we want to get to.
Are two months of safety follow up, as the FDA has required, sufficient to support an emergency approval?
COREY: It's a reasonably adequate bar for a short term desire to get a vaccination program started. My main thing is to make sure the effectiveness is truly actionable, not just from available vaccine dosage, but from vaccine effect, so that people will see true benefit in getting vaccinated.
Are you concerned whether the FDA will be able to make that call independently, without political interference, once it has results?
COREY: I certainly feel that, if they have been truthful with the public with what they've said, then the answer is yes. There's always going to be interpretation of how much data is needed. I hope that if there is an emergency use authorization, that they recognize that you do that only if it's actionable, that we have enough vaccine to do something with it. Because saying something without doing it, to me, makes no sense.
As time goes on, polls seem to show that fewer people are willing to get vaccinated. What's the reason and how do we turn sentiment around?
COREY: There has been so much sense of politicization of the outcome. The trust of our entire clinical trials apparatus has been sort of lost or undermined by a lot of political talk about timing and trying to game the system. The system is tried and true, and it's run by scientists, physicians and independent groups of people who have built something that has been reliable for decades.
In the end, I'm hopeful that if vaccines are highly effective, we will be able to show that not only publicly, but also to the medical community that is associated with individuals in the country. The grasping of the scientific and medical community that immunization will be helpful will, I think, in real life, turn the tide, so that people see that they will benefit from this.
Two trials in the CoVPN network, run by AstraZeneca and J&J, have now been paused for safety reviews. AstraZeneca's has remained on hold. What are your takeaways?
COREY: The fact that pauses are occurring in clinical trials, especially vaccine clinical trials in which you're putting through large numbers of people, it's not surprising. Adverse events are seen in all trials and pauses occur in most trials in which there's rapid enrollment like this. The fact that it gets this kind of attention, and then gets on the front pages of the newspaper, is the unusual thing.
To me, it's saying the system is working. Despite the political pressure, despite the fishbowl, if something medically important happens, it gets reported in a timely manner, and the systems of evaluating it thoroughly with the data safety monitoring board and regulatory agency are put into place. Therefore, there is a pause, and you have a lot of smart people looking at it to determine what the issues are.
That's played out in the AstraZeneca one, which has been a very prolonged pause. It's very unusual to have a trial pause this long. It's clear that there are some issues there that a lot of smart people are taking a real hard look at.