‘Warp speed’ is too slow for scientists testing COVID-19 vaccine on themselves – WHYY

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In late March, officials in the United States were still talking about the coronavirus lockdown in terms of weeks instead of months. People were wiping down their groceries with disinfectant spray and basically scared to step outside.

It was then that biologist Preston Estep sat alone in a Boston lab with a coronavirus vaccine his team had developed over just a few weeks.

I took a small dose first, he said. You know, I usually do this even with pharmaceutical therapeutics, I always take a small dose first just in case there was some sort of negative reaction.

Estep took maybe a tenth of the total dose, waited a few hours, and then took the rest.

I just felt really good, really positive about taking that first step, taking that first shot of vaccine, he said. And when I say shot, I mean a nasal spritz up the nose. So less dramatic than sticking a needle in oneself.

What drove Estep here, sniffing his home-made vaccine?

It was the way people were dying. He was devastated by the thought of people dying alone.

Basically, older people were being quarantined away from their families, and they were being left to die alone in sealed rooms, Estep said.

Couple that with the rosiest vaccine estimates coming from the government at the time: If everything went right, wed have a vaccine, and a way out of this, in 12 to 18 months.

These were people suffering and dying alone, hundreds, and then thousands of them. And I just couldnt stand the idea that we were gonna wait a year and a half while these sorts of scenarios played out, he said.

Estep is a geneticist by training, not an infectious-disease specialist. But hes Harvard-trained and highly connected in scientific circles. A world renowned geneticist, George Church, was one of the first to take a version of his vaccine.

I had studied with some of the smartest and most capable and amazing scientists in the world, and Id seen people do some pretty amazing things, he said. Ive been up close and personal to some radical breakthroughs and important scientific work thats happened very quickly.

The way he explained it, its not so much that he was convinced he could do something about the coronavirus. More like, he just wasnt convinced he would be totally useless.

He assembled the Rapid Deployment Vaccine Collaborative, RadVac, essentially a posse of scientists that hed known from previous work. Estep said they werent only brilliant, they had a healthy conception of risk calculation. He needed risk takers because, in his mind, self-experimentation was the only way to move faster than the virus.

I knew that we were on uncharted territory. This was previously only sort of a theoretical challenge that was going to hit civilization at some point that there would be a worldwide pandemic, he said. But I knew that my colleagues that I originally reached out to had thought about these kinds of things.

Estep found it wasnt all that hard to get the band back together. Scientists like many of the rest of us had their careers upended by March of this year. A lot of them were out of work or at least cut off from whatever they were researching at the time, thanks to coronavirus restrictions. One of his collaborators had a lab space.

So we had a fully stocked professional biotech lab basically ready to go, that had sufficient equipment, he said.

And they were off.

Look into vaccine development in general and you discover that its not all that hard to create one from a technical standpoint. Its not of the same engineering order as, say, making a nuclear reactor.

Estep found there was already decades-old technology that had been tested in humans that he could use to deliver the vaccine in a nasal spray.

You can form gel nanoparticles that are about the size of a virus that cross the mucous membrane because of both the size and the chemical properties, he said. And it acts as an ideal intranasal delivery vehicle.

There are basically five ingredients to form those particles that are readily available. To elicit an immune response, Esteps team used little bits of artificially synthesized protein that mimic bits of the coronavirus.

It basically all came together very quickly within a week or two, he said. I had a basic design that used these synthetic pieces, these little tiny non-infectious pieces of the virus, that I could order, you know, online.

So if creating a vaccine is the easy part, its testing it that gets tricky. You have to figure out if its safe and effective before distributing it to literally every living human being on the planet.

The only ethical test subject, he figured, was himself.

Since taking that first dose in March, Estep and his collaborators have developed seven more versions of the vaccine, and have tried them all.

So we volunteered ourselves as the designers of the vaccine, Estep said. We decided that the only way to create that rapid feedback loop of design iterations and testing was to use it on ourselves.

Design, test, look for the immune response, improve, design and then repeat. Estep said this model makes him more nimble than the big pharmaceutical groups, able to incorporate more of what is learned about the virus into designs in real time instead of being locked into a vaccine thats months old and that has to go through months-long regulatory and safety hurdles.

What the world calls warp speed the way pharmaceutical giants and governments are working together to create a vaccine in 18 months rather than the usual span of several years to Estep is slow motion.

I think we do need to get a vaccine out as quickly as possible, said Paul Offit, vaccine researcher and director of the Vaccine Education Center at Childrens Hospital of Philadelphia. That said, we need to make sure that the vaccine works and that its safe.

Offit said much of todays vaccine regulation architecture stems from a 1955 disaster known as the Cutter Incident.

Jonas Salk made his polio vaccine in 1955 by taking the virus and inactivating it with a chemical, [and] five companies stepped forward to make it. One company made it badly, Cutter Laboratories of Berkeley, California, he said. They had failed to fully inactivate the polio virus that was in that vaccine. As a consequence, about 120,000 children were inoculated with live, fully virulent polio virus, Offit said. Investigations later showed that the contaminated vaccine had caused about 40,000 cases of polio, in which, about 200 children were paralyzed and 10 children were killed. I think it was probably the worst biological disaster in this countrys history.

Offit said its an unfortunate part of cutting-edge medicine, especially medicine distributed to hundreds of millions of people.

The history of, frankly, medical breakthroughs is littered with those kinds of stories, he said.

The Cutter Incident harmed far more people than others, but Offit mentioned another vaccine from the 60s that looked like a real winner initially. It was from the National Institutes of Health and had great results in animal models, with good initial data all around.

[But] when they put it into a Phase Three [trial], they found the children who got that vaccine were more likely to develop pneumonia, more likely to be hospitalized and, in the case of two children, more likely to die than children who didnt get that vaccine, he said.

All this serves to explain why the safety protocols exist in the first place, Offit said, adding that warp speed doesnt really touch the safety and efficacy hurdles that slow down vaccine development.

Instead, it simply removes much of the financial risk facing vaccine makers.

Theyve said, Look, well pay for the Phase Three trials, which cost hundreds of millions of dollars; well pay for the mass production, even not knowing whether or not the vaccine is safe, not knowing whether the vaccine is effective. Well take the risk for that, he said, with we meaning the federal government. Well make hundreds of millions of doses not knowing whether this vaccine works and is safe, and if it doesnt work and isnt safe, then well just throw those millions of doses away. No pharmaceutical company would ever do that, Offit said.

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'Warp speed' is too slow for scientists testing COVID-19 vaccine on themselves - WHYY