What's So Hard About Developing A COVID-19 Vaccine? We Asked A Scientist.

As the coronavirus pandemic continues to spread around the globe, the best hope for truly getting it under control is a vaccine that would protect people from contracting COVID-19. Scientists in the U.S., China, the U.K. and elsewhere are racing to develop a vaccine and there have been some promising signs that one of the many vaccine candidates under development may prove effective against the virus.

In the U.S., President Donald Trump has predicted a vaccine will arrive before the end of the year. Dr. Anthony Fauci, director of the National Institutes of Health’s National Institute of Allergy and Infectious Disease, has said it’s a question of “when and not if” a vaccine against this coronavirus, known as SARS-CoV-2, will be developed, and also predicted that could happen before year’s end.

With COVID-19 taking lives and crushing economies around the world, stopping the spread would provide tremendous relief. But the progress of science is characterized more by failure than success. Researchers are working on almost 200 potential vaccines for this coronavirus, and there’s no guarantee any of them will ever work, let alone one that’s ready for wide use within months.

Creating a safe, effective vaccine that quickly would be unprecedented. In addition, no one has ever attempted to produce a new vaccine, distribute it to every corner of the world and carry out an immunization campaign on this scale and with this much speed.

To get a better understanding of the challenges facing vaccine researchers, HuffPost spoke to Vincent Racaniello, a professor of microbiology and immunology at Columbia University’s Vagelos College of Physicians and Surgeons in New York.

Is it realistic to expect a vaccine for the novel coronavirus by this winter?

No, I think it’s highly unrealistic to expect a vaccine by the end of 2020. We haven’t made any vaccine in that short of time. That would be a year from January, when we first saw circulation in the U.S. Eighteen months is optimistic. What would be more realistic, in my view, would be next summer. But, you know, vaccines can take five to 10 years and longer. The polio vaccine took 50 years to develop. Certainly, we’ve advanced in our technology so we can do it faster now, but I would say, no, the end of this year is completely not feasible, in my view. However, I would love to be surprised.

How would a SARS-CoV-2 vaccine work to prevent people from becoming ill?

What vaccines do is they’re introduced into you ― they can be injected, or they can be taken orally, or through any number of other routes ― and they turn on your immune system to make a response to the virus that’s in question, in this case SARS-CoV-2, without making you sick. Then you have an immune response and, most importantly, your immune response comes with a wonderful feature called “memory,” so it remembers what it’s encountered so that whenever it sees that agent again, it will respond. So that’s what a vaccine tries to do ― it tries to produce immune memory without any of the pathogenic or disease consequences of a real infection.

Is this similar to what the human immune system does itself when it fights off infections?

Absolutely. If you get influenza or a common cold virus or any other virus ― if you survive, of course ― then you have immune memory, and then whenever you encounter the virus again, you should mount a nice response and you should prevent infection entirely. You won’t even know that you’ve encountered the virus.

What are the primary challenges to developing new vaccines for any disease?

There are many, but the main one is understanding what’s needed to protect you from infection. We’ve been talking very generally about the immune response but, in fact, there are different components. There are cells and proteins involved, and so we need to know which is important for the particular virus. That’s one of the reasons that it took 50 years to make a polio vaccine, because people had to figure out what was important. Now, for this new virus, we don’t have the time to do that, so we’re making a lot of assumptions about what’s important, and we hope that they’re right.

How do governments, pharmaceutical companies, academic institutions and scientists decide how to prioritize the development of vaccines for some diseases over others?

I hate to say, this is very sad and this is an indictment of the whole system for making vaccines, but the main priority is profit.

The companies that make vaccines, they’re all for-profit companies and they need to see that they can make a profit off of their vaccine. So all the vaccines that we have are there because many, many people are infected with viruses like influenza, measles, mumps, rubella, shingles and polio. They infect a lot of people and the companies can make money from them.

However, there are many diseases out there that are far less prevalent but nevertheless they kill people. Companies aren’t interested in making vaccines for those diseases because there’s no profit to be made. I think that’s a fatal flaw with our vaccine system that has to be fixed and it’s why we don’t have a vaccine ready for this particular virus. We could’ve, but no company was interested. Same for antiviral medications. That’s why we’re in this situation we’re in right now.

One could think of creative ways to get around that. Governments can get involved, for sure. We’re hobbled in this country by the political paralysis of our government and its unwillingness to invest in science completely, so that’s stymied that. Now, since this SARS-CoV-2 has emerged, there are new nonprofits that have popped up saying, “We’re going to fund vaccine development.” In the end, it’s just a matter of someone raising money, and there’s plenty of money out there to do this. Think about the money we’re spending on recovery in the U.S. ― trillions. If a fraction of that money had been spent on developing a vaccine, we’d be out of this problem.

There are no vaccines available for any strains of the coronavirus, including the one that causes COVID-19. Why is that?

After SARS-1 in 2003, it went away. We were able to stop it. The virus disappeared. So most companies said, “We’re not interested in making a vaccine. There’s no market.” But a few academics went ahead and they made an experimental SARS vaccine, but it never got beyond that because there’s no financial support.

It’s not hard. In fact, it would’ve been not very hard to make a vaccine that could protect against many coronaviruses that come out of bats. But again, no financial backing for that and, even more, no research support. In the U.S., the NIH was not willing to support that kind of fundamental research because its budget is too limited.

There are many novel coronavirus vaccine candidates in development. What will determine which, if any, are used?

Unfortunately, they’re mostly not even in phase 1 in people. A handful are in phase 1 and a couple in phase 2. Those have been pushed and those are going to be the ones that finish first, so they’ll have an advantage. Now, whether they work or not is important, obviously, so if they don’t work, that’s the end of that and the others are going to have to catch up.

The others are not even out of the laboratory. Some of those may never get out of the lab. It may turn out there are too many problems developing those. Others might, but as companies see that other companies have a head start, they might decide not to put resources in it because they’ll lose money. Many of these companies have never made vaccines before. Very few companies have, and I think that’s a factor. If you haven’t made a vaccine, you’re going to have more problems because you don’t know what you’re doing.

All of those things are factors, and then of course production is a factor. I hope we have more than two vaccines because I don’t see how you could make 7 billion vaccine doses with just two companies. I think we need at least 10 vaccines to be able to cover the whole planet.

What are the potential downsides of deploying vaccines developed quickly during an emergency like the SARS-CoV-2 pandemic?

We could take a lesson from the polio vaccine in the 1950s. It was only about 50% effective, yet that’s what they had so they went ahead with it. And that meant that a lot of kids whose parents lined them up for shots weren’t protected. It also meant that companies had rushed production. In fact, a lot of kids got polio from that early vaccine because it wasn’t made properly. You could imagine that these early SARS-CoV-2 vaccines, because they’re rushed through, are not as optimal as they could be and they’re not going to be as effective. In most cases, the vaccine candidates are not infectious so I’m not too worried about them causing the actual disease.

If you try to scale up vaccine production for hundreds of millions of doses, things could go wrong. Normally, we take a lot of time to do this. Everyone is being assured that we’re doing things in a safe way, but I think there’s still room for things to go wrong when you rush things.

People say, “Well, if they’re rushing it, I’m not going to take it,” and I think that’s a valid concern. What I often say is if you rush a vaccine and there’s a problem and you hurt people, then you will never get people to take it for many years. Once there’s a negative view of a vaccine because of some side effect, then people are very reluctant to take it. We have to make very sure that this is safe. We cannot make shortcuts. We have to test it in enough people ― thousands of people ― to make sure there are no side effects.

If a novel coronavirus vaccine were developed, what would need to happen for it to be deployed widely and safely?

You need a lot of doses, first of all, because I do not want it to be distributed only to wealthy countries. That’s not the point of vaccines. The developed nations are making the vaccine, but they have to understand they have to share it with everyone, and I do hope that happens here. That’s my primary concern.

You have to make enough of it. If we only have one vaccine that turns out to work, it’s going to be really hard to make enough doses for everyone. Another issue is these vaccines are going to have to be cold, probably frozen, and not everywhere has that capability. Finally, what about the delivery? Most of these vaccines need to be injected. That means you need at least 7 billion needles. I don’t even know if we have 7 billion needles in the world, so I hope someone’s thinking about that ahead of time. And you need people to inject them. You can’t just do it yourself. You need a trained health care worker, which isn’t available everywhere.

Has a vaccination campaign of this scale ever been attempted?

No, never. We’ve never had to immunize everyone. We’ve always had select groups, like for childhood disease where we do mass campaigns. There is no precedent for this, for having to immunize every person on the planet.

This transcript has been edited for length and clarity.