On Tuesday, Johnson & Johnson announced that it would be testing a corona vaccine candidate on humans for the first time in September, and that it would produce the first batches in early 2021 if successful. If the vaccine works, the US pharmaceutical company is committed to producing one billion doses of vaccine at cost price. The company will not sell any exclusive rights to the vaccine to any country, J&J research chief Paul Stoffels emphasized in an interview with Tagesspiegel.
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The vaccine must first be made available to medical personnel and risk groups. By mid-2021, the company would have produced ten million cans at best, predicts Stoffels. In view of the drug developments that would otherwise take years and decades, this is now “turbo speed”.
The interview in full:
Mr. Stoffels, you worked as a young doctor on HIV vaccines and as Johnson & Johnson’s Chief Scientific Officer on Ebola vaccines. Now you are facing Sars-CoV-2, a completely new one virusthat caused the first pandemic of this century. How difficult is the current situation from a research perspective?
The situation is very difficult at the moment. It feels like an “Ebola light” –virus spread across the world. Fortunately, Sars-CoV-2 is a lot less deadly than Ebola – but unfortunately still dangerous because it’s much more infectious.
Nevertheless, you are optimistic to develop a vaccine that protects against infection and thus against the Covid 19 disease caused by it. A few days ago, you mentioned November as the start of the first clinical trial with a potential vaccine candidate. Now announce that you may be able to start in September.
We already have comparable vaccine candidates against Ebola, HIV, RSV and the Zikavirus developed. In total, 50,000 people were vaccinated with the same raw material in these studies that we will now use. We already have a lot of data on the safety of the vaccine candidate, because the necessary preclinical studies in non-human primates and animals have already been carried out. Thanks to the close cooperation with the authorities, we can now move much faster.
At the same time, we increased our production capacities. For a few days now we have identified a “lead candidate” for vaccine development, it is now being produced. With this priority setting, we can research are now moving forward quickly, so we are confident that we can start clinical trials in September.
Where do you want to conduct these first clinical tests?
The clinical trials consist of two parts: we will test healthy volunteers in non-infected areas so that we have a good idea of whether the vaccine will trigger any side effects in humans. The clinical studies to prove efficacy, however, are only possible in areas with a high infection rate. In the second half of 2020, we will start preparing clinical trials in different parts of the world. We could do this in North and South America, but also anywhere else in the world. It is important to recruit a large number of people very quickly in a zone with a large number of infected people. This is the only way to obtain meaningful controlled clinical studies.
It could be very difficult to find a region with a low infection rate very soon, right?
Yes. But it wouldn’t be a problem in the Phase 1 trial. With a low number of infections, we can recruit enough non-infected people, we have practice in that. For example, in the development of HIV or cancer therapies, we have already carried out studies for which we were able to recruit enough study participants within a few days, once 120 in a day. It is always possible to speed things up.
Background information on the corona virus:
You have experience with the basic structure of the vaccine, a so-called adenovirus. In this “vector” you insert parts of viruses, so-called antigens, which are then presented to the immune system and mediate the immune response. But have you ever used coronavirus antigens in clinical trials in clinical trials?
We conducted animal experiments with coronavirus antigens based on this platform technology, AdVac, which showed a very good antibody response. So we’re pretty confident. In animal experiments, the vaccine reacts in the same way as the Ebola and other vaccines. Of course, we have not yet carried out any major animal experiments for SARS-CoV-2. But everything we see so far goes in the same direction as the previous successful vaccine developments.
But isn’t it possible that the corona virus is somehow different? It is at least very different from Ebola or HIV.
It differs at least in the way it infects people, namely preferably via the respiratory tract. Zika is transmitted by mosquitoes, Ebola has a different transmission path, the RS virus as well. The question we have to answer is: Does our vaccine protect against infection and / or does it protect against a serious illness? Many vaccines, for example against influenza, protect against serious illnesses, not necessarily against infection.
What kind of antigens do you use? Are you trying out different parts of the virus envelope?
We use the same target, the spike protein from the surface of the virus. But we took ten different pieces of it: longer, shorter, wider, and so on. From this, the “lead candidate” was selected, with which we are now continuing to work. We are also looking at which of these candidates is most useful for production in our cell lines. Because sometimes, if these vectors contain more or fewer pieces of protein, this could be an obstacle to the production process.
Then the cells don’t grow fast enough to produce enough vaccine?
Yes. And this depends on several characteristics of the part of the virus that you bring into the adenovirus, the vaccine backbone. We are therefore investigating the effectiveness of the vaccine candidates in the animal model and, in parallel, the production of the vector. This is important because there is a difference between cell lines that produce little and those that produce a lot. This means that in the same production facility one can produce one million doses with one vaccine candidate and ten million with another. And in this situation, it is not only important to find the most effective vaccine, but also the vaccine with the highest production efficiency.
Isn’t it a high risk for a company to build new production capacities for a vaccine that does not yet exist or whose protective effect has not yet been proven?
We have a vaccine production facility in Leiden, the Netherlands, that can produce 300 million doses a year. We’ll start evaluating upscaling because we still have to do the process development and make sure it works the same way as the other vaccines. But if we want to cover a large part of the world, 300 million doses a year are not enough. That is why we are already going to build additional production facilities. Certainly one in the US, but we are currently evaluating facilities in other parts of the world and discussing partnerships with other vaccine companies. But please let me remind you: we have only been in this completely new situation for ten weeks. Ten weeks to develop a completely new vaccine: this is unprecedented, it has never been done before.
You plan to deliver the first batches in early 2021. But how many? 300 million already Vaccination doses?
No, no, that’s not how it works. We could make four to eight million doses of vaccine per batch. New batches will come out every month, and hopefully we could have hundreds of millions of vaccine doses by the end of 2021. But by mid-2021 we will definitely not have more than ten million cans.
What about other vaccine developments, such as that of the German network of scientists, including Marylyn Addo and Christian Drosten, who have a backbone related to smallpox, the Modified Vaccinia virus Ankara (MVA), use and already have experience with the MERS corona virus? And then there are the companies CureVac, BioNTech and Moderna, which develop RNA vaccines against Sars-CoV-2.
Competition is good because the faster we have a vaccine, the faster it will be available. And I really hope that one of them is much faster and can make a lot more vaccines than we can. But so far there are no RNA vaccines on the market. The US government joins us because we have proven four times that the vaccines we have developed are safe and effective, and that we are able to produce large quantities. It may not be the most innovative technique, but it is a very solid one. Everyone in this pandemic has someone at risk, family members, older parents, seriously ill people. We need a vaccine as soon as possible, no matter where it comes from.
[AninterviewwithKlausCichutekthepresidentofthe[EinInterviewmitKlausCichutekdemPräsidentendes Authority responsible for vaccine approvals, the Paul Ehrlich Institute read here]
The Ebola vaccine needs two injections within eight weeks to develop its full protective effect. Isn’t that a disadvantage, after all, is it about immunizing the world’s population as quickly as possible?
That is a question for the clinical studies. To ensure long vaccination protection, you have to vaccinate two or more times. A single vaccination does protect you, but not for long. You have to freshen up later. We think we don’t need the refresher for immediate, short-term protection, but we’ll test both vaccination strategies, the one and multiple vaccination protocols. Our goal is to achieve long-term vaccination protection. Healthcare workers, for example, need long-term protection, not just a few months. That’s why we prefer the Prime Boost protocol, which provides booster shots.
Your phone rang three times during our conversation. What is it like to be the global research director of a large pharmaceutical company during such a pandemic? Does it feel a bit like the Hollywood movie “Outbreak” that everyone has probably seen by now?
No, it’s not like Hollywood. It is our job to manufacture vaccines and medicines – but whatever else takes years is happening at turbo speed. My working day is currently 14 to 16 hours, and it’s all about speeding up the process. I have been in the early, difficult days of the HIV epidemic research worked. Back then we learned to be quick and coordinate thousands of people in different departments of the company and in research institutes. They all have their skills, know their way around, and my job is to give them the space and the financial scope to work.
And of course I also coordinate cooperation with governments. I recently met U.S. President Donald Trump to discuss U.S. involvement, and I am in constant communication with the FDA in the U.S. and the EMA in Europe. I have also spoken to Minister of Health Jens Spahn. It was always about how vaccinations can be used in Europe, the United States, Africa and other parts of the world. The coordination and coordination effort at scientific, regulatory, state and of course financial level is enormous.
Does this mean that the vaccine will first be used in the United States, as Trump has publicly requested, then perhaps in Europe and only later in Africa and other regions of the world?
No. Our vaccine is developed in Leiden, the Netherlands. We have always aspired to work with the whole world – for the whole world. Even if the United States is instrumental in funding the new vaccine, we all have operational freedom and can guarantee global access. Of course we are talking to the western governments about funding this extraordinary venture, but we also have responsibility for the countries with low and middle income per capita. The Global Vaccine Alliance GAVI is an organization that organizes access to vaccines worldwide.
But we have to keep one thing in mind: we have been developing this vaccine for just ten weeks. We must now concentrate on this and test whether it is safe and effective. Only then can we talk about distribution. And it is not a question of which countries get the vaccine first, but who in the countries: First of all, medical personnel need the vaccine because it is at the highest risk of infection. Then come the older and pre-ill people who do that virus is particularly often seriously ill. The world must agree that these groups of people must be cared for first. And only then people like you and me.
If J&J is successful, will the company keep its promise and provide the vaccine at cost price?
Yes. We – and I mean everyone at Johnson & Johnson – agree that we don’t develop the Covid-19 vaccine to make a profit.