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Expert Vaccine Update: Valneva

CEO of international biotech company sheds light on current COVID-19 vaccine development

Every day, the headlines are blaring with vaccine information: "Moderna's mRNA vaccine is being approved in this country," "Pfizer and BioNTech's mRNA vaccine has been injected in seniors in the UK," "AstraZeneca ships their vaccine to this country," and much more. This is hopeful news, but it can also be initially disorienting. If you are being bombarded by all these technical terms and overwhelming information, the best place to get accurate information is from the source.

I was able to meet with Thomas Lingelbach, CEO of Valneva SE. Valneva is an international biotech company that develops and commercializes vaccines for infectious diseases with major unmet needs. Unlike the new mRNA vaccines, Valneva is working on a COVID-19 vaccine that works in the traditional method—similar to how flu vaccines work. Lingelbach was able to shed light on current vaccine development and update the progress of Valneva's VLA2001 vaccine.

Image courtesy of Getty Images.

The following is an edited transcript of my interview with Thomas Ligenbach of Valneva SE. Some information has been edited for brevity and clarity. No unauthorized copying or reproduction of this material is permitted.

Interview with Thomas Lingelbach

Valneva is working on many different vaccines for diseases ranging from cholera to the Zika virus. Compared to all your other endeavours, how has the progress of the research, production, and testing stages for the COVID-19 VLA2001 vaccine been different?

We had worked on industrialization matters before we even had the first data in mice. We have set up the process for manufacturing before any clinical data. We have established the development stages long before any initial research. Many things that typically go in parallel, we have really done sequentially.

Valneva is a fully integrated vaccine company, specialized vaccine creator. We felt that we should contribute to the world's largest problem at this point and apply our knowledge, capabilities, and capacities to develop a vaccine. And this is something that was our major driver. And so we have applied the best platform that we have and started developing a vaccine against covid-19.

When does Valneva plan on starting clinical trials, and how will you go about them?

Valneva is the only company in the US and Europe working on a more conventional inactivated virus vaccine approach. So we are approximately six months later than the front runners. We are about to enter a combined clinical phase one and two studies in the next weeks before Christmas. And this will be a study that will be pretty rushed, starting with a short 150 people running tests to determine the final dose and then right into a phase two setting with more than 4000 people.

Is the approach that Valneva is taking for your COVID-19 vaccine similar to the one used in flu vaccinations?

In a way, yes. I would say in reality, most of our flu vaccines are inactivated vaccines. Like most other vaccines, the vast majority of the vaccines available today in the viral vaccines phase are inactivated vaccines. Be it vaccines against Hepatitis A against Japanese encephalitis; these are all inactivated virus vaccines. It's a conventional approach, but it's an approach that has proven to be safe for almost one hundred years. Therefore, many data points exist for those types of vaccines used in specially targeted populations, such as pregnant women or elderly or immunocompromised people. And so we see really our vaccine as complementary to not competing with the current front-runners.

What kind of results do you expect to see with Valneva's traditional vaccine approach?

Well, that's a good question. First of all, I would say, what do all those data tell us? It tells us that COVID-19 is a vaccine-preventable disease, which is great. It's great for society. It's great for all of us. Every single approach does the same thing, generating neutralizing antibodies that have the ability to neutralize and kill the virus and create T cells that generate a certain memory that is needed for longer antibody persistence. So essentially, every single approach does the same, depending on how optimal you have picked the dose and how optimal you have picked the schedule. Typical dose-finding and typical schedule-finding are all that we are currently shortcutting in the vaccine development against COVID-19. So I would personally expect that we're going to see all vaccines with efficacy rates above 80%, and this would include ours. And as I said, it depends a little bit on how close one has been to the optimal dose and optimal schedule, which is, of course, for a vaccine approach that is not a super important mRNA approach. That's something where we have to wait and see how this is going to work on.

How has the progress been so far with the vaccine, and what do you expect to see in the clinical trials?

We have done the first phase of preclinical development in parallel, we have completed the industrialization of the product. We have started to set up producing material and the scaled-up process to its final scale in the final facility. We have now initiated expanding those manufacturing facilities for truck substances and our manufacturing site in Scotland for the final product and our site in Sweden. And yeah, that's where we stand, so ready to go. Our objective is to initiate full commercial production as of January 1st. Literally running the clinical development in parallel to the manufacturing already. That's part of our agreement with the UK government. The UK government included or has included our approach to the portfolio of different COVID-19 approaches with prophylactic solutions in the UK. And as part of that, we have agreed on a capital investment plan. We have agreed on a clinical development plan. We are assuming that we will get conditional approval in the UK in the third quarter of next year. And this will then be followed by supplying the product in the first quarter. So that's our current working hypothesis under the UK government contract. We are working with other states and other countries to see where we can potentially supply our vaccine in 2022.

How has the partnership with the UK government gone? How has this partnership helped Valneva as a company?

We are sharing the risk of clinical development. The risk of building and upscaling the facilities. This is a true partnership so that there is financial support by the UK government to have us doing those activities before even knowing that the product is going to work. And if we then supply at the price that we have publicly disclosed, then, of course, those are pre investments by the UK government will be reimbursed. And that's basically how the model and how the partnership with the UK government works. We have an excellent partnership with the UK government. We work together daily. And again, as I said earlier, we are part of a portfolio approach. This allows the UK government to apply the best possible vaccination strategy in the country in terms of when to use which vaccine and how and towards which target.

Some vaccine contenders like the Pfizer and Moderna vaccines have to be stored at very cool temperatures. Is there a specific temperature that your vaccine has to be stored?

No. More than 90% of the worldwide vaccine distribution is handled through normal fridge temperatures, not ambient, but standard fridges practice. And this is also how our vaccine works. It's a conventional approach. It's a classical approach, and hence also nothing particular in terms of supply chain and logistics. So pretty straightforward and certainly in a pandemic situation, also quite an amount of time on the table at any temperature even. But this is something that has to be tested on the standard. And the standard approach is, as I said.

What are your thoughts on the accelerated pace of COVID-19 vaccine production across the world? Do you think it's safe to get a vaccine developed in under a year?

I believe that at least the vast majority of companies in this challenge have pledged science and safety. No one will jeopardize safety, at least the relatively short term safety—surveillance is part of any of those initial approvals. Of course, everyone takes a risk that we don't know about: long term safety, antibody systems, or efficiency over time. This is the risk we are all taking. This is also why many worldwide companies are currently talking about conditional approval, emergency approval. There are certain risks, but I don't think that there are major risks that we take on safety, at least not in the target populations tested clinically. Of course, using the vaccine outside of those target populations and under different health conditions is something that I have some questions about.

What is Valneva doing specifically to ensure the widespread and safe distribution of the vaccine?

As I mentioned already, in our forthcoming phase one trial, we go all the way up to the food safety database that is required for regular licensure of inactivated vaccines. And some forget the inactivated vaccines are a very proven and established entity. For this type of vaccine, you need the safety database of at least three thousand people for regular licensure. Then, we will work with the authorities early next year to agree on the final efficacy readout that we use to achieve the first regulatory licensure that would allow us to distribute the product. We would try to make our technology available as well as we can. We want our capital investment in some capacity. Expansion is done. We're going to have an annual capacity of more than 200 million doses out of Scotland. We will partner with low-middle income countries, and we have a lot of discussions ongoing because this is the main thing about more conventional technology. Many of those companies have respective manufacturing platforms that one could use. And so that's basically what we're looking at at this point.

What challenges does the current state of COVID-19 globally pose for vaccine producers such as Valneva?

First of all, it is the same challenge that every business is facing, namely a balancing business continuity with employee welfare is certainly a challenge. On the one hand side, we want to work 24/7 to get the vaccine done. On the other hand, we need to make sure that we protect our employees in this pandemic, and we can, and we make sure that there is the right and necessary precaution, that's for me, priority number one. Priority number two is trying to accelerate, trying to accept shortcuts here and there, trying to accept certain risks but also continuously assessing risks: patient risk, regulatory risk, industrial risk. There is business risk, but the patient's risk is a different thing. I'm constantly making sure that what is being done and how it's being done reflects that. Finally, we mustn't be only a company that is developing innovative vaccines in areas of high unmet medical need; we are also a company that is commercializing vaccines. Our commercial vaccine portfolio includes travellers' vaccines primarily. And in a situation where no one is travelling, we need to deal with the loss of revenues and operating margins, with shifting people, partially laying off people. The challenge is that, again, many corporations do face the current environment. At the end of the day, other businesses have to deal with employee insecurity and the job market for vaccine companies.

I've heard a lot from the public about vaccine reluctance, where people are not trusting vaccinations regardless of whether they come to them or not. I've heard this mostly for the mRNA vaccines, but what are your thoughts on this kind of vaccine reluctance from the public?

You are talking to someone who is now, in the meantime, now 30 years in vaccines, who devoted his professional life to vaccine manufacturing development. I'm a strong believer in prophylaxis. I have to believe that from an economic point of view, there's no better solution than prevention. Hence I have given up on educating people who don't want to be vaccinated about vaccination. Because what I have learned is it's very, very difficult if people don't want to listen to data and facts. And then it's a different story.

Featured image courtesy of Wix.

Article Author: Ria Patel

Article Editor: Sherilyn Wen, Maria Giroux