Houston Chronicle Sunday

‘I thinkwe’re in for it’: Hotez bracing for the winter surge

- By Lisa Gray STAFF WRITER

New vaccines are on the horizon — but is it too late to blunt the pandemic’s winter surge? Might Houston fare better than the rest of Texas? And why could a traditiona­l-method vaccine be better for kids?

To answer these questions, we once again check in with vaccine researcher Peter Hotez, one of the country’s best explainers of COVID-19 science. He’s a professor and dean of the National School of Tropical Medicine at Baylor College of Medicine, and he codirects the Texas Children’s Hospital Center for Vaccine Developmen­t, where his lab team is developing

COVID-19 vaccines.

This interview was edited for length and clarity.

Q: There’s been a lot of news about vaccines recently. What are your thoughts?

A: There’s good news in that we’ll have at least two vaccines that look like they have excellent efficacy. All we really knew before was from company press releases, which is never satisfacto­ry. But it looks like the FDA has now reviewed that document for the dossier for Pfizer, and has decided to bring it in front of VRBPAC — the Vaccines and Related Biological Products Advisory Committee. That’s the committee that decides whether to give a vaccine the thumbs up, the green light to move forward.

From my experience, FDA would not bring it to VRBAC unless they felt pretty confident of the dossier. So it’ll probably get the green light, and then we’ll start releasing our first vaccine to the public, just like they’ve done in the UK. And hopefully the week after, the Moderna vaccine comes along.

But we’re not going to be able to vaccinate the U.S. population on the two mRNA vaccines alone. The technology is still too new, in terms of scaling up, production and a few other issues.

So we’re going to need

other vaccines. To vaccinate a significan­t percentage of the U.S. population, I think we’ll need at least four or five.

Those other vaccines are coming as well. There were issues around the AstraZenec­a-Oxford vaccine, so the FDA may want to see additional trials. There’ll be the Johnson & Johnson vaccine. There’ll be Novavax vaccine. And the vaccine from our lab looks really promising. In India it’s being scaled up for production and tested.

One of the advantages of our vaccine is, it might be especially suitable for kids because it’s a proven technology. We’ve made vaccines this way for almost 40 years. That technology has been used for decades to vaccinate children against hepatitis B, so there’s a known safety profile, and parents might feel more comfortabl­e using it. Our lab is exploring how we can get our vaccine not only to low- and middle income countries, but also for use in the U.S. and Europe as well.

So this a very exciting time.

Q: Could you explain the difference between the kind of traditiona­l vaccine your lab is working on and the mRNA vaccines?

A: Ours is a very old, tested vaccine technology, the same one used to make the hepatitis B vaccine all over the world. It’s a recombinan­t protein made through fermentati­on technology and yeast. You grow yeast in a bioreactor, and it’s geneticall­y engineered to release the recombinan­t protein, and then you purify it. It’s a very successful technology, one of the most widely used vaccines in kids for decades with no untoward effect. So that’s exciting that we have that vaccine.

Also, our vaccine will be very low-cost, around a dollar a dose, so we’re hoping it really comes in to be used globally. But we don’t see why it couldn’t come into the U.S. at some point, particular­ly for kids — or maybe as a booster shot if the other vaccines, like the mRNA or the adenovirus-based vaccines, do not have much in the way of durability of protection.

The RNA vaccine technology is exciting. It moves fast: You can

get to the clinic very quickly, because you can make a piece of RNA in a day. Then, if you have the right packaging, you can potentiall­y move very, very rapidly towards making a vaccine to a new virus pathogen.

The only thing we don’t know is the durability of its protection. Does it protect for three months or three years or 30 years? We don’t know. We also don’t know if there are going to be any longterm safety issues. So far, we’ve not seen them in the 44,000person trial. But when you’re rolling out a brand-new technology, it’s hard to know what to expect. So when bumps in the road happen, as will happen in any new vaccine program, that tends to slow you down.

For instance … we’re hearing in the U.K. that there were two individual­s who got vaccinated who had what sounds like a severe allergic reaction. That didn’t seem to happen in the clinical trial. So what does that mean? Well, if it was a vaccine technology we had decades of experience with, we’d feel comfortabl­e just perseverin­g, but moving out ahead with this brand-new technology gives you pause for concern.

So even though you get a lot of upfront speed with the RNA technology, because it’s new you get slowed down at the tail end — and that’s where traditiona­l vaccines can move quickly.

Every vaccine technology has advantages and disadvanta­ges. That’s the rationale with Operation Warp Speed: We have several different technologi­es out there — mRNA and adenovirus and particle vaccines, recombinan­t vaccines. The idea is to get multiple shots on goal in case some of those vaccines have to drop out.

Q: Including kids, what percentage of the U.S. population do we need to vaccinate?

A: We did some studies with City University in New York that show it’s pretty high. We need 60 to 80 percent of the population vaccinated.

There are two things you’d like a vaccine to do. The first is, to keep you out of the hospital or the intensive care unit. These vaccines will do that. The second thing is, to interrupt virus transmissi­on — and that’s what requires 60 to 80 percent of the population to be vaccinated.

In the U.S., we still have a

significan­t number of people who are saying they’re holding off or waiting or may not take it at all. I think you’re starting to see a number of opposing forces come into play. On the one hand, as people hear about the high levels of efficacy of these vaccines, and they see colleagues get vaccinated without any ill effects, the percentage of people who are willing to get vaccinated will increase.

On the other hand, the U.S. doesn’t have any real communicat­ion plan about the vaccines, so when people hear about things like those two allergic reactions without much explanatio­n, a lot of people are going to decide to hold off. The number of people willing to get vaccinated is going to go up and down with the news cycle.

OperationW­arp Speed has never really had a communicat­ion strategy. It’s been all about the scientific rigor of the studies and the integrity of the trials — they have done a good job with that — but there hasn’t been anything resembling consistent communicat­ion. They’re going to have to fix that. Otherwise, as bumps in the road continue, more and more people will drop out.

And then of course, you’ve got a very aggressive anti-vaccine movement that says stuff like that the mRNA vaccines are going to create geneticall­y modified humans — that’s the new one out there. The crazier something sounds, the more people seem to believe it, like that the vaccine links with 5G networks. I can’t

even figure out some of the things that they’re saying. So we have to launch a counteroff­ensive against the anti-vaccine groups as well.

Q: Don’t vaccines usually takemuch longer to develop than these have? Hasn’t the COVID-19 vaccines’ developmen­t been different than, say, developmen­t of themeasles vaccine?

A: Let’s look at measles. So measles virus was first isolated in the ’50s by John Enders, Sam

Katz and others from Boston Children’s Hospital and Harvard Medical School. Then it was adapted into the first prototype vaccine, which was a killed vaccine that had problems. It got refined into an attenuated vaccines in the ’60s. So that was a decade of research.

My friend and colleague Paul Offit writes that he thinks the world’s record for vaccine developmen­t is four years from first isolation. That’s the mumps vaccine, so that’s probably about right.

Our schistosom­iasis vaccine is more typical of vaccine timeframes. Our lab started working on that in 2004, and it’s only now in Phase Two trials. Part of that time is due to resource constraint­s: It never got financed to move as quickly as we could have.

But I like to keep on pointing out that this idea that we developed the SARS-CoV-2 vaccine in five months is a false narrative perpetuate­d by the pharma companies or out of the White House.

I mean, OperationW­arp Speed is a great program. Don’t get me wrong. But it’s the culminatin­g event of a 17-year program.

Q: I wanted to get you to give us an overviewof howthe U.S., Texas and Houston are doing right now as far as the spread of COVID. What are you keeping an eye on?

A:

Nationally, we’re doing terribly: 200,000 new cases a day, and 2,000 to 3,000 deaths per day. COVID-19 is now the single leading cause of death in the United States on a daily basis. ICUs are being overwhelme­d.

This is a public health calamity of the worst order.

By next week 300,000 Americans will have lost their lives, and the numbers will keep climbing. We’ll be at 400,000 by the inaugurati­on. That’s the number of American GIs who perished in WorldWar II. You cannot have a worse outcome than that.

Texas, unfortunat­ely, is one of the states worst affected. I think right now it has the largest number of COVID-19 cases of any state in the country. We’re not No. 1 in deaths in part because of that terrible early epidemic in New York, where so many people died, but we may get there. Right now it’s looking dire inWest Texas and up in the Panhandle. At the hospitals in far western Texas, El Paso, and Lubbock, it’s really terrible, and I would imagine it’s going to get pretty bad in the Dallas-FortWorth area and in Austin.

I’m hoping because of the warmer climate in Houston, where people are outdoors more in winter, maybe we won’t get hit as hard. But it’s going up. All the numbers are in the wrong direction in terms of new cases and positivity, and now admissions and the hospitals.

One thing will help us do better: We’re blessed in Houston to have the Texas Medical Center. As my friend and boss, Texas Children’s CEO MarkWallac­e, says, the Texas Medical Center has a lot of heft. We’re not in danger of running out of beds. But we still could have exhausted staff.

Still, I am worried about a lot of community transmissi­on really accelerati­ng.

 ?? Yi-Chin Lee / Staff photograph­er ?? Peter Hotez is co-director of Texas Children’s Hospital’s Center for Vaccine Developmen­t, where his lab team is developing COVID-19 vaccines.
Yi-Chin Lee / Staff photograph­er Peter Hotez is co-director of Texas Children’s Hospital’s Center for Vaccine Developmen­t, where his lab team is developing COVID-19 vaccines.
 ?? Graeme Robertson / AFP via Getty Images ?? The FDA has cleared the way for Pfizer-BioNTech’s imminent rollout in coming weeks.
Graeme Robertson / AFP via Getty Images The FDA has cleared the way for Pfizer-BioNTech’s imminent rollout in coming weeks.

Newspapers in English

Newspapers from United States