Six COVID-19 vaccines already in phase III of trials, but the biggest challenge is still ahead

Drug companies are already preparing for the challenge of manufacturing billions of vaccine doses

Today's expression: Line up
Explore more: Lesson #284
August 10, 2020:

There are currently 165 COVID-19 vaccines being tested around the world. Testing new vaccines is usually a long, multi-phase process, but six vaccines are already in phase III of trials. Developing an effective vaccine will certainly be a huge accomplishment, but drug companies fear manufacturing billions of doses may be the biggest challenge of all. Plus, learn the phrasal verb “line up.”

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The question on everyone’s mind: what’s the status of the coronavirus vaccine?

Lesson summary

Hi again and welcome to today’s Plain English lesson. I’m Jeff; the producer is JR; and today’s full lesson can be found at PlainEnglish.com/284.

On today’s lesson, you’ll learn about how drug companies test new vaccines and we’ll also be talking about the logistical challenge around producing the billions of doses that will eventually be necessary. Later on in the lesson, we’ll talk about the phrasal verb “line up” and we have a quote of the week for you.

Let’s get going!

Race for coronavirus vaccine heats up

Over 165 potential coronavirus vaccines are being investigated and six have progressed to advanced, large-scale clinical trials. But several hurdles remain before the world’s population can be vaccinated.

Start with the vaccine development itself. We first began talking about the race for a vaccine—can you believe it?—in February. That was Lesson 230. Since then, several drug companies and researchers have made significant progress on developing a vaccine.

Each vaccine has to go through a multi-phase process. Before being tested on humans, a potential vaccine is administered to animals to see if it stimulates the animal’s immune system; the animals in this stage are often either mice or monkeys. In this stage, researchers are simply asking, is this potential vaccine doing what we think it should do? All vaccines are intended to trigger our immune systems, so that our immune systems are strong and prepared to fight an infection should we get it. So any candidate vaccine must at least trigger the right immune system response.

If it looks like it produces an immune system response in animals, then it can begin the first phase of human trials with a small number of people. This stage is intended to confirm whether humans have a similar response as the mice or the monkeys had. If human immune system is stimulated, that’s good news, but it still doesn’t say whether the vaccine is effective; it only answers whether your immune system is activated and ready to fight the disease.

In the second phase, scientists ask whether the immune response does what we want it to do. In this phase, they recruit people who may have the disease in question or are at risk of getting the disease. They administer the vaccine to people in groups and study how different groups, such as children or the elderly, respond to the vaccine.

If it does appear effective and reasonably safe, then the drug is ready for the third phase: a large-scale trial. In a large-scale trial, the scientists will look for two things. First, is the drug effective over a larger group of people? And second, are any side effects present? Only after passing this third phase can a vaccine proceed to get governmental approval, which is itself a long process.

There are about 165 vaccines being tested around the world, according to the latest estimates, and six are in phase III. Most of the vaccines in large-scale trials are being developed by teams: usually a pharmaceutical company together with a university or a nonprofit. Many of the teams are funded by governments. The US, for example, is directly funding one of the vaccines and has placed a multi-billion-dollar advance order for another. Japan is doing something similar.

There is reason to be optimistic about the development of a vaccine, but that’s not where the story ends. Developing a vaccine is hard work, but the prize for discovering a vaccine is the challenge of then producing it and distributing it in high enough quantities. This will be a monumental challenge.

Any vaccine manufacturer first has to line up the raw materials for the vaccine. These are things like enzymes, proteins and extracts. These materials may be freely available during trials, but may not be available to produce the billions of doses needed to serve the world’s population. In fact, the CEO of one of the drug companies with a Phase III candidate says that sourcing raw materials is what worries her the most.

Next will be the logistical challenge of manufacturing the vaccine and keeping it fresh. The manufacturing process of some vaccines requires new machinery that has to be developed; drug companies are building the machinery even before getting approval for the vaccines, hoping to speed up the production process.

Distribution is another challenge. Think about packaging: how many glass vials will be necessary? There needs to be the correct type and amount of medical glass to store the vaccine. A vaccine will be distributed, at first, by air. Logistics providers will need to arrange for air freight capacity to reach all corners of the globe. Refrigerated warehouse space and refrigerated shipping would be required. These are available, at least in developed economies, but often not in the right quantities and not always in the right places.

And then there’s the so-called “last mile.” Who will get the first does, and how will they be administered? Experts predict that coronavirus vaccines would be administered in special stations outside hospitals at first, but countries would have to determine who gets the first vaccines and how to control the overwhelming demand for them. Health care workers, the elderly, and others most at risk will probably get the first chance at a new vaccine once it’s available.

Like the race to the moon

What a challenge. This is like the race to the moon in 1969. I really think that. The money is available. The scientific challenge is being met. The logistical challenge, I think, too, will be met—maybe not perfectly, but I think it will work. I know a lot of you work in the supply chain. I’ve heard from listeners in Europe and Latin America who work in logistics and the supply chain. I just can’t even fathom how this is going to work. But they’re getting ready. They’re preparing. I think we’re going to look back on this as a towering achievement for humanity.

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Expression: Line up