Biontech CEO Sahin: Vaccine effect could last for more than a...

Professor Sahin, in January you switched your corporate focus from cancer therapy to vaccine development – at a time when barely anyone was able to grasp what was going on in the Chinese city Wuhan. Are you a clairvoyant?

No. But I like to read scientific literature and think about their meaning for our work. At the end of January, a scientific study characterizing the outbreak of infections within a family who had been to Wuhan was released. I concluded that this virus was going to develop into a pandemic. And that's why we held ourselves responsible to act on it here, because we have the abilities to develop vaccines.

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You have named your project „Speed of Light“. What made you pick this name with such confidence?

It was about a certain attitude. Vaccine development normally requires a lot of time. The pressing question was, of course, how we can develop a vaccine by the end of the year and not by 2023, 2024? The only option is to relinquish all but the essentials to reduce latency and slack. And to establish this attitude in our team and beyond we chose the name „Speed of light“. Light is never still, it is constantly moving.

The world is now eagerly awaiting a vaccine. How do you handle the pressure that has built up on yourself and your company?

As pharmacists we always have a high responsibility. It doesn't matter whether the medication you're developing is designed for a single patient or a much larger group. You focus on the work. We don't have the option to grapple with that in our daily lives.

Now we're increasing the pressure and ask the most pressing question: When will we get the vaccine? When do you expect the approval?

A very important, essential requirement is the tolerability of the vaccine amongst a very large group of tested people. This is achieved through so-called Phase-III-Studies. Then you have to prove that the vaccine is meeting its purpose and capable of preventing illness. That is the efficacy. We are expecting the first test results by the start of November. It won't be long until we see if the vaccine could be able to provide protection.

According to "The Times“ the British Government is expecting the vaccine to be available before Christmas. German Health Secretary Jens Spahn has also been recently saying that the approval of the vaccine is imminent.

We will have the results on tolerability and efficacy by mid-November. If they are positive we will submit our findings to the FDA. We have already started submitting data for revision in Europe. The authorities could decide on an emergency approval in the U.S. Or a conditional approval in the E.U. The next question is: Can we deliver vaccines? We have already started production, they are stored with us and is undergoing quality checks. The release will only occur once there is indeed an approval. All these steps could technically still occur this year, but this is at the discretion of the authorities.

The skepticism towards the speed of development is also based on a lack of knowledge about the long-term effects.

We have studied this vaccine on up to 44,000 subjects. We will have tolerability results for a large part of those vaccinated by the second half of November. Most side-effects of vaccines generally occur in the first days and up until six weeks. All afterwards will of course also have to be studied. We will keep tracing subjects for two years, for example. This system of pharmacovigilance is to ensure that every medication continues to undergo checks after its approval.

So this is a case of promptness over thoroughness?

Definitely not, we do not skip anything. I like to compare it to an airport. Someone is asking to be processed faster as they would otherwise miss their flight. They are led through checks by staff. Every check is being made, but they are not standing in line. For example: We are in a „rolling process“ for preparation of a possible approval with the EMA (European Medicines Agency). This means as soon as we have new data we submit them so they can be checked immediately.

Once we have the vaccine: How often do we need to be vaccinated?

We don't know how long the immunisation lasts yet. We expect immunity for one year, maybe even longer. The results will have to show.

Truthfully: Have you already tested the vaccine yourself?

No. The guidelines for clinical studies provide requirements on who can receive the vaccine and they definitely do not include those who develop it. I would like to have it, but I'm not allowed yet.

You don't have it yet, but many people wish they did. The high-risk groups for example. Can we lift the restrictions once these are vaccinated?

I think the availability of effective vaccines could quickly help us with the most important issues we are facing right now. We first must ensure that those at the greatest risk for a severe infection receive the vaccine first. I do not expect that we will be able to return to complete normality, but a normalized life by summer next year. The success depends on the efficacy of the vaccines and their availability through several companies during the first months of 2021.

You are refering to companies in different countries. Donald Trump has used the vaccine in his election campaign in the U.S. This is putting pressure on your partner, pharmaceutical company Pfizer...

This cooperation is important to us as we don't have worldwide sales and distribution as a smaller company. One of our conditions was that it remains clear at all times that it is our vaccine. A Biontech-vaccine that is developed under cooperation with Pfizer. The contracts are accordingly, no one can simply decide something without the other. We expected that one of the parties could get into a difficult political situation, but we have showed multiple times that we don't cave in to pressure.

Biontech turned from a start-up into one of the most valuable companies in Germany. A market capitalization of nearly 17 billion Euros, four times as high as Lufthansa's. Does this not make you feel light-headed?

No. Our goal is not to achieve maximal market capitalization. We founded Biontech because we wanted to build a global pharmaceutical giant. We want to revolutionize the way cancer is treated and we know that certain problems are only solved through innovation. That's where our focus lies.

Has your focus on the vaccine set back your cancer therapy?

We did lose some time because of Covid. Not because we focused on a vaccine, but because we couldn't admit more patients into the trial, for example. But we are making some progress here as well, after all.

How long can the CEO of such a company still be a scientist?

I cannot tell. 90 percent of our success is based on science and medical development. That's why a scientist is the head of this company.

And the most important question: Can Biontech still fail in its vaccine development?

Per definition: yes, because the result of our clinical trial could be negative – regardless from what we have observed. We are highly encouraged by our results so far, but in the end it's the medical and biological reality that counts. We will know more in two weeks.