Why we shouldn't rush vaccines before they're ready

Getting the process, and the science, right takes time. But doing it right the first time could help for many years come.

Welcome to Not a Doctor, the only newsletter about health and science that makes toddlers shriek (hopefully with joy).

I’m Melody Schreiber, a journalist and the editor of What We Didn’t Expect: Personal Stories About Premature Birth (out in November!). I’m not a doctor, or a scientist, or really an expert of any kind. I just like to ask questions and try to find the answers to them.

Today, we’re talking vaccines!

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Sputnik V

On Tuesday, Russia announced that it had approved the world’s first SARS-CoV-2 vaccine, and it was ready for injection among those most vulnerable to the virus, including the elderly and health workers. Mass production of the vaccine will begin in September, and the vaccine should be widely available in January. But Russian President Vladimir Putin said his daughter had already received it, and he hopes to “start a massive release of this vaccine soon.”

There’s just one hitch: the vaccine has been barely tested in humans. Only 76 people received it in the phase-2 trial, and the phase-3 trial began this week with only 2,000 people.

(As for the “world’s first”: China announced back in June that its first Covid vaccine was approved for use in members of the military while undergoing phase-3 trials.)

Here’s why rushing this process is dangerous.

1. The vaccine could have side effects

The initial phase-2 tests seemed to go okay, but those tests are usually conducted to find the right dose. Phase-3 tests are much better at showing how people react to the dose. Testing in 76 people is not nearly enough to understand how the virus will affect huge swaths of the population. Even 2,000 people isn’t that much; phase-3 trials in the U.S. will enroll 30,000 people.

Even if most people don’t experience moderate or severe side effects — and, of course, that’s a big “if” — there could be rarer side effects among, say, 1 percent of the population. That’s why having as many people as possible in phase-3 trials helps; researchers have better odds of seeing how the vaccine works in many types of immune systems.

2. The vaccine might not work

And then there’s the fact that the vaccine could simply not protect people against the virus — especially among the elderly, one of the vulnerable populations targeted for the vaccine’s early release, but also a population in which vaccines typically don’t work as well.

But it’s very possible the vaccine isn’t protective for most people. And that can be dangerous when people think they’re protected and they’re not. They might take risks they otherwise wouldn’t — potentially leading to more disease and death than if we had no vaccine at all.

3. The vaccine could make things worse

“I’m thinking there’s probably like a 20 percent chance [the vaccine] will make things worse,” Alexey Chumakov, a Russian health researcher, told Science. 

Beyond the reasons above, the vaccine itself could also make people sicker with Covid-19.

The Russian vaccine uses an adenovirus — another respiratory illness, like a common cold — as a platform. Back in 2007, researchers stopped a trial for an HIV vaccine when they found the adenovirus platform actually made people more likely to get sick.

4. This would all be bad (very, very bad) for public trust

If one (or all) of the above scenarios unfold, it could make people (quite understandably) hesitant about this and other vaccines. They might decide it’s not worth the risk, or they don’t work anyway, so why bother?

In addition, even if the vaccine is proven to work safely, simply moving quickly is enough to provide fodder for those who say vaccines aren’t regulated closely enough.

Back in March, I wrote about why speeding up trials can be a very risky proposition. Skipping over animal trials in the U.S., for instance, made some people skeptical about the process for creating and approving new vaccines.

“I think that everyone is very panicked, and I think that we are running a real risk of creating more problems, years in the future,” Nicholas Evans, an assistant professor in the Department of Philosophy at the University of Massachusetts Lowell, told me. 

Photo: SELF Magazine

Does new technology help or hurt in this process?

This week, I also wrote about the way many of the new vaccines, including Russia’s, are being created using customizable “platforms.” Are we pinning all our hopes (and money) on an untested technology? Or could this usher in a new era of faster vaccines?

(I also spoke about this story with C-SPAN Radio on Tuesday, prompting my three-year-old to run through the kitchen shrieking [with joy, I hope] at the sound of my voice on the radio.)

The experts I spoke to said it was probably a bit of both. Platform vaccines could be the future of addressing disease outbreaks very quickly and quashing pandemics before they even take off. But first, we need to get the technology right — a painstaking process, given that only 6 percent of new vaccines are developed successfully.

Getting things right takes time. It can’t happen if we have political pressure to rush the vaccine to market too soon. President Trump has intimated that he would like to have a vaccine ready for use by Election Day, before phase-3 trials are complete. But doing that would be incalculably dangerous.

“What I’m very concerned about is that there will be political pressure to approve a vaccine prior to having that type of safety and efficacy data,” Dr. Angela Rasmussen, a virologist at Columbia University, told me.

“That’s going to really erode people’s trust in the entire process. And then we’re going to be in really bad shape…. If people don’t trust the process, if you don’t trust the vaccines, more and more people are not going to get the vaccines, and then we will really have no hope of ever being without the coronavirus circulating among us.”

Platform vaccines could be a way forward — both in this pandemic and in the future. But we have to take our time and do it right.

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Before I go, I wanted to talk about the last update I sent — the one about different mask materials. I edited that post to clarify how the study was conducted. The study didn’t find that all neck gaiters were worse than nothing at all, as some news outlets reported; it found that one type of gaiter, which was made of thin-looking material, was less effective.

Also, notably, the study had only one participant trying all different mask types. The idea was to design a study to compare different designs and materials, upon which future research could build. But n=1 is not an ideal study design!!!

I wrote about the study because I think it’s an important first step in comparing different designs and materials. If a loosely fitting bandana or a thin neck gaiter don’t help — if, in fact, they are worse, even just for certain Super Spitting Individuals — that is good to know. It’s also very good to know that a well-fitting mask made of thicker, tightly woven material likely works better than looser, thinner options.

If there’s one thing I know about science, it is always evolving. No study is definitive. But in a time like now, where we need information as soon as possible, they can help to know what our options are, and what might help us respond quickly and effectively.

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As always, please leave a comment or reply to this email if there’s something I’ve overlooked or something you’d like clarification on. You can also follow me on Twitter and Instagram, if you’re into that kind of thing.

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