What Will It Take to Develop a Vaccine for the Virus that Causes COVID-19?

Drugmakers, researchers, and other groups are racing against the clock to develop a vaccine for SARS-CoV-2, the virus that causes COVID-19. To understand what goes into efforts to develop vaccines, GLG’s Pooja Shah spoke with Luc Debruyne, the former President of Global Vaccines at GSK and a current board member of GreenLight Biosciences and VIB. He is Strategy Advisor to the CEO of Coalition Epidemic Preparedness Innovations (CEPI). His comments, edited for length and clarity, are below.

What is the typical process to manufacture, trial, and distribute a vaccine for viruses, and how will it differ for this vaccine?

The traditional process to discover, develop, and then produce a vaccine can take many years. For example, the shingles vaccination, Shingrix, took 20 years. We don’t have time to wait 20 years for a SARS-CoV-2 specific vaccine. That means that we’ll have to accelerate together with regulators. Typically, the U.S., Europe, and China would ask different approval criteria, but since we’re in an outbreak situation, companies will work with authorities to ask mostly the same criteria.

The good news is that progress has been made quickly. With new technologies and China releasing the genetic sequence of the virus, many companies, biotechs, and institutions started working on vaccine constructs. They still need to produce and test it – a lot of work still needs to be done. The preclinical phase – the laboratory testing and animal testing – usually takes between six months and two years. The real challenge in vaccine development and/or clinical trials is targeting maximum protection with minimal side effects. Vaccines can have slight rare side effects, but to detect those you need massive numbers to study. The goal is to have a vaccine that has been tested, is safe and efficacious, and is scalable to millions of doses within a period of 12 to 18 months. So acceleration is absolutely needed.

Who do you think has the best chance of getting the vaccine to market the quickest? What are the key factors influencing that?

The word we need to forget for a while until we deal with this is “competition.” There is no competition. When I was at GSK looking for an Ebola vaccine, it was a collaborative effort. J&J and Merck also worked on it. The race was against the virus, not against each other. At this moment, you don’t know if you’ll ever make money with that vaccine, and that’s not the priority. Will there potentially be a commercial COVID-19 vaccine in the future? Possibly, because if it’s coming back, then it might be that everybody every year or every five years gets the vaccine. We don’t know that today.

Will the vaccine still have importance in controlling infection when it’s available?

It’s absolutely necessary that a vaccine is developed as soon as possible because the trajectory of this virus is unknown. Initially, it was expected that the virus could have a seasonal spread, meaning that, like flu, it goes away and it comes back, and during warmer periods it doesn’t survive. That hypothesis is already cancelled because we see in Hong Kong and Singapore, hot and humid areas, that the virus does survive and does infect people. We don’t know how long this whole situation will last.

How many mutations can a protein accumulate before it’s no longer covered by a vaccine?

If you take HIV or flu as examples of mutating viruses, compare it to an umbrella. There’s the stalk and the umbrella itself. The stalk of the flu or HIV always remains the same, but it changes the color of its umbrella all the time and tries to fool the immune system. That’s why research now is focused on finding out how to attack that stalk. In the meantime, what vaccine developers do is change one of the strains every year to be sure that they adapt to the color of that umbrella. What COVID-19 will do might be similar, but we don’t know. We need to study how it evolves because there’s no historic knowledge about this COVID-19 virus and how or if it will mutate.

If a vaccine becomes available, how much of the population will get vaccinated, given availability and price across the U.S., Europe, the UK, and Asia?

It’s clear that the vaccine will not be available in millions of doses on day one, so they will have to ensure that healthcare workers and those who need it most, meaning elderly people, are vaccinated first. Classic vaccines with classic production processes are normally produced in one specific factory because it’s such a complex process and you need well-trained people. What we’re doing now is working with developers so that technical transfers can happen with more producers who can then produce at the same time. That’s a huge challenge. That’s why CEPI, with the help of the World Bank and the World Economic Forum, are calling for $2 billion so we can ensure or at least plan for rapid ramping up and scaling up of vaccine production across the world.

Regeneron announced it has identified virus-neutralizing antibodies and is working with Sanofi and Kevzara^®. Will a cure be available earlier than a vaccine, and is research focusing more on one rather than the other?

No, it’s two parallel streams. With the coalition and other research institutes, it’s primarily focused on vaccines, but the Wellcome Trust and the Bill & Melinda Gates Foundation have launched an initiative to accelerate the research into therapeutics and diagnostics, and also ensure that these are available across the world. Hopefully, they will be faster than vaccines, but they started from scratch because it’s never been studied.

Is there a scenario in which we can’t come up with a vaccine at all?

That’s a doomsday scenario. I would not bet on that one. I think there is enough expertise and experience in the world to make sure that there are two or three vaccines that work. Will they work 100%? We don’t know. If they work 70%, that would be great – it would reduce mortality massively. If you target them to risk populations and healthcare workers, that’s a massive step forward. I’m an optimist – I’m sure we will get a vaccine.

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About Luc Debruyne

Luc Debruyne is a business leader with more than 30 years’ experience in the life sciences industry. Luc is currently serving as a board member of GreenLight Biosciences, Inc. and VIB (Flemish Life Sciences Institute), as well as a strategic advisor to the CEO of the Coalition for Epidemic Preparedness Innovations (CEPI).

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This article is adapted from GLG’s March 18, 2020, teleconference “COVID-19 Virus Vaccines – What’s Next?” If you would like access to this teleconference, or you would like to speak with Luc Debruyne or any of our more than 700,000 experts, contact us.

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