Novavax Researcher Says No Chance Of A 'Shortcut' In Vaccine Safety

Sep 25, 2020
Originally published on September 26, 2020 8:51 pm

Novavax, a vaccine maker in Maryland, is becoming the 10th coronavirus vaccine candidate to enter the final phase of testing, called phase 3.

The trial is taking place in the U.K., where researchers plan to enroll up to 10,000 adults of various ages in the next four to six weeks. Half the participants will get a placebo and half will get the company's vaccine.

At least a quarter of participants will be over the age of 65, the company says, and it will also "prioritize groups that are most affected by COVID-19, including racial and ethnic minorities."

The company expects to start a U.S. trial with 30,000 volunteers in mid-October.

Companies are working to develop vaccines at an unprecedented pace. Many Americans are concerned about the safety of a fast-tracked process, done under the purview of a president who contradicts his own health officials.

Novavax was one of nine companies to publicly pledge to not submit their vaccines for Food and Drug Administration review until they've been shown to be safe in trials. Novavax has never before brought a vaccine to market.

"I don't think that there's going to be any chance that there's going to be some shortcut made," says Gregory Glenn, Novavax president of research and development.

He talks with NPR's All Things Considered about why the vaccine trial is taking place in the U.K. and how to reassure Americans that any vaccine will be safe. Here are excerpts:

Why did you choose the U.K. for your vaccine trial, especially rather than here in the U.S., where Novavax is based?

We went to the U.K. because they have a very good trial network and we felt that the attack rate would be high, the transmission would zoom up in the wintertime, which it looks like it's going to do. ...

If we succeed there, we will get a license for our vaccine in the U.K. and Europe, and then that opens the door for many countries that otherwise would not require testing, but normally they would rely on the package of information either from the FDA or Europe for them to deploy their vaccine in their own country. So this opens up the door for a lot of the world in terms of a regulatory approval and licensure for them to take advantage of a highly competent regulatory authority that we have in the U.K.

And the U.K. infection rate zooming up, as you put it, is a good thing for you because you're looking for places in the world where a lot of people are infected and your vaccine might work on them.

Exactly. The way it happens in the trial is you need cases, right? So you obviously couldn't prove anything if there are no cases. The more cases in your trial setting, the faster you accumulate the evidence that the vaccine works.

The CEO of Novavax was one of nine pharmaceutical executives who came together to reassure the public in a published statement that their vaccines will be safe and effective, not a rush job that would potentially harm anyone's health. It is stunning in a way that they would feel they have to do that. Would you comment on the fact that they felt they had to?

Look, I have mixed feelings because our M.O. here is to be transparent. We know the FDA [has] a formula that they're not going to deviate from. So I don't think that there's going to be any chance that there's going to be some shortcut made. But there's so much worry in so many areas about vaccination that ... it's reasonable to reassure the public that's the case.

And it's interesting now that this is such a high-profile topic. People are interested in the details, which they never were. They didn't know how vaccines work. They didn't know how you did, that you even did trials to show how they work, etc. So there's a lot of scrutiny on that. And anything we can do to help the public confidence is good.

But this is also a vaccine trial that has been more politicized, maybe, than any other one. I'm interested in how the politics of this are affecting the business and science aspect of this for you.

I kind of ignore it all. My team is focused on generating convincing evidence that the vaccine is safe. The FDA has laid out the pathway to approval. There's nothing unclear about what has to be done. I'm a pediatrician. I believe vaccinations have very positively impacted the world. And so that's how I look at the day. My day is, I'm going to get up and create that evidence that will lead to utilization and saving the world.

Art Silverman and Christopher Intagliata produced and edited the audio interview.

Copyright 2020 NPR. To see more, visit https://www.npr.org.

SACHA PFEIFFER, HOST:

There are now 10 coronavirus vaccines in the final phase of testing around the world. A vaccine candidate from the U.S. company Novavax became the 10th yesterday when the company announced it will enroll 10,000 volunteers in the United Kingdom to test its vaccine in Phase 3 trials. Dr. Gregory Glenn is president of research and development at Novavax, and he joins me now.

Dr. Glenn, welcome.

GREGORY GLENN: Thank you.

PFEIFFER: Why did you choose the U.K. for your vaccine trial, especially rather than here in the U.S., where Novavax is based?

GLENN: We went to the U.K. because they have a very good trial network, and we felt that the attack rate would be high - the transmission would zoom up in the wintertime, which it looks like it's going to do.

PFEIFFER: And the U.K. infection rate zooming up, as you put it, is a good thing for you because you're looking for places in the world where a lot of people are infected and your vaccine might work on them.

GLENN: Exactly. The way it happens in the trial is you need cases, right? So you obviously couldn't prove anything if there are no cases. The more cases in your trial setting, the faster you accumulate the evidence that the vaccine works.

PFEIFFER: So not great for the U.K. that their infection rate is high, good for you and your vaccine trial.

GLENN: Yes. Unfortunately that is the situation with people who work in infectious diseases. We like to be around illnesses, unfortunately. That's where the action is to prove that these vaccines work.

PFEIFFER: Does Novavax have plans to eventually do vaccine trials in the U.S.?

GLENN: Yes. So we expect to start a U.S. trial in a few weeks. And so that would be, you know, about 150 sites, a 30,000-person trial. You know, we're very fixed and focused on getting that trial started and, you know, doing it well.

PFEIFFER: What's your best estimate of when a Novavax U.S. vaccine trial might start?

GLENN: Mid-October.

PFEIFFER: Oh, really? Fairly soon.

GLENN: Very soon, yes.

PFEIFFER: Dr. Glenn, the CEO of Novavax was one of nine pharmaceutical executives who came together to reassure the public in a published statement that their vaccines will be safe and effective, not a rush job that would potentially harm anyone's health. It is stunning in a way that they would feel they have to do that.

GLENN: Look; I have mixed feelings because our MO here is to be transparent. We know the FDA is - they have a formula that they're not going to deviate from. So I don't think that there's going to be any chance that there's going to be some shortcut made.

PFEIFFER: But this is also a vaccine trial that has been more politicized maybe than any other one. I'm interested in how the politics of this are affecting the business and science aspect of this for you.

GLENN: I kind of ignore it all. My team is focused on generating convincing evidence that the vaccine is safe. The FDA has laid out the pathway to approval. There's nothing unclear about what has to be done. And so my day is, I'm going to get up and create that evidence that will lead to utilization and saving the world. So, you know, there's a lot of - there is - you know, and people ask me a lot of things about X and Y and Z, and I just kind of point back to we're going to do - let our science be really strong, our data really strong that support deployment of the vaccine. And I think at the end of day that - you know, that will be the most important contribution we can make.

PFEIFFER: You truly believe you can be immune to political pressure.

GLENN: (Laughter) You know, me, yes. I'm the head of R&D. Yes. You know, it's - yes, absolutely. The FDA - you know, I think we can count on the FDA. They are really super-experienced people. You know, what might happen around deployment may be another issue, and that is complicated. But I think, you know, for me, for conduct my daily conduct, I'm after generating the kind of information that no one's going to argue with.

PFEIFFER: A more personal question about the vaccine race aspect of developing a vaccine because lives worldwide are on the line, and so is the economy since these coronavirus shutdowns are devastating for businesses - so on one hand, you have to be a clear-eyed, objective scientist about the data and the facts and your findings. But how do you balance that with the human element to this? Lives are riding on this.

GLENN: Yeah. No, I wish I was superhuman. I get depressed. I feel, first, the pressure, and then I see the tragedies. I see the disruption. And it's pointing back to get busy. You know, get something done. I'm a pediatrician by training. I mean, there's a lot of other things I'd like to be doing right now with my life, and here I am. I mean, I've never worked so hard in my life. It's like I've lived seven lifetimes since January.

PFEIFFER: Well, it's quite a thing to be involved in.

GLENN: It really is amazing. The mobilization of all these companies to do this in this period of time is going to be some incredible story. And I get to live - every day we're solving problems that are big - science problems, logistics problems. The level of collaboration within my group is just fantastic. So even though we're under fire all the time every day, you can imagine both the kinds of things you're talking about and many other things, yet we have a common purpose, and we know we've got a really good vaccine. We're convinced that we can lift this cloud off the globe, and so it gets us up out of bed in the morning. But it can be a struggle.

PFEIFFER: It's quite a rollercoaster.

GLENN: Yeah.

PFEIFFER: Dr. Gregory Glenn is president of research and development at Novavax.

Dr. Glenn, thank you for making time for us.

GLENN: Great. Thank you. Thanks for your interest, Sacha.

(SOUNDBITE OF TRENT REZNOR AND ATTICUS ROSS'S "PIECES FORM THE WHOLE") Transcript provided by NPR, Copyright NPR.