BioNTech SE (BNTX) Earnings Call Transcript & Summary

Welcome to our digital press conference to provide an update on the Omicron variant. We will start with a presentation by our CEO and Co-Founder, Ugur Sahin, followed by a Q&A session. Ugur, let me hand over to you.

Thank you, Natasha. Hi, everyone. We are here today to present our first preliminary data from a laboratory test evaluating the authorization of the new Omicron spike variant in laboratory assays. So let me start just with the short disclosures and with some background information. The Omicron -- new Omicron variant, also known as B11529, has multiple mutation at sites which are known to be relevant for binding of the neutralizing antibodies in the spike protein. In total, total, there are 34 to 35 mutations. These mutations are at sites of the receptor binding domain, which directly binds to the ACE2 receptor on target cells as well as in the [ internal ] domain, which is known to harbor also neutralizing antibody sites. Many of these mutations, which are present in this new variant are also present in variants, which have been described before. There are shared mutations, particularly with the B.1.1.7 Alpha variant at size which are known to be important for neutralization, but also shared mutations with other variants, for example, the Beta and the currently spreading and mostly present Delta variant. The Omicron variant in addition to this shared mutations has a number of additional mutations in the spike protein in total 35 mutations in the most prevalent, currently spreading value. And of course, the presence of these mutations in -- at antibody binding sites, plus the information that this variant appeared to spread, particularly in previously infected people provides a concern if currently vaccinated individuals will be still protected against an infection. So just to provide a background information about the basics of vaccine-induced protection. The mRNA vaccines similar to many other type of vaccines induce 2 types of immune responses: on the one side, these are neutralizing antibodies, which can bind to spike protein and prevent the uptake of the virus in target cells. This neutralizing antibodies are considered to be correlates for prevention of SARS-CoV-2 infection as well as correlates of prevention of COVID-19 disease of any severity. We have a second layer of immune response, which are virus-specific CD4 and CD8 T cells. And this epitopes, the epitopes recognized by these T cells are different epitopes than the epitopes recognized by neutralizing antibodies. T cells are considered to recognize and kill virus infected cells and are considered to prevent severe COVID-19. It is important also to understand that even in the presence of reduced immune responses, there are memory T cell and B cell responses and memory T cell and B cell responses might be particularly important in individuals who do not have sufficient antibody and T cell levels to rapidly respond to a virus infection and thereby reduce the severity of a potential disease. So what we are going to present today are laboratory in vitro pseudovirus neutralization assays. These assays are performed to evaluate the effectiveness of the BNT162b2 vaccines against the Omicron variant. So we started to set up these assays directly after the declaration of the Omicron variance. And we have tested now sera from individuals who received 2 doses after BNT162b2 vaccine of 3 doses of the BNT162 vaccine, the third dose also known as a booster dose. In total, we tested about 19 to 20 sera. So this is a preliminary assay with a small to middle-sized sample collection, and the samples were collected from individuals 3 weeks after receiving the second dose or 1 month after receiving the third dose of the Pfizer BioNTech vaccine. Each serum was tested for neutralizing antibodies against the wild-type SARS-CoV-2 spike protein from the ancestral strain as well against pseudovirus virus carrying the Omicron spike variant. The results that we are going to show today are preliminary. We continue to assess more samples including samples from later time point. And it is important to evaluate this type of information together with real-word effectiveness data. Only in combination, we will understand the relevance of this data and potential protection against Omicron mediated disease and severe disease. So these are the key findings from the virus neutralization studies. So on the left side, you can see the data obtained with sera from individuals who had received 2 vaccinations. These are sera about 2 to 3 weeks after the second vaccination, so at a time point when the immune neutralizing immune response is really high. So in the dataset, we see that we have a virus neutralization titer of around 155 million for the ancestral strain spike protein, which is consistent with data that we had observed in the past in a number of independent studies. We see also that we have a dramatic reduction of the neutralization titer against the Omicron variant, which is about 25% or less than to the ancestral strain. We also see the reduced neutralization against the Beta variant, which we had reported previously, which show a reduction of 5 fold. And in comparison to the Beta variant, Omicron is a much stronger antibody escape variant. So based on the data, it is -- we -- this data would predict that individuals who have received 2 vaccines will most likely not have a significant prevention from infection or any type of disease, but we also know that these individuals will have memory T cells and memory B cell as well as T cell responses, which are expected, which may prevent severe disease. On the right side, you see on the data of individuals -- of sera from individuals who have received 3 vaccinations. These are sera obtained 1 month after vaccination. It is obvious, again, that the titers against Omicron variant are lower as compared to the ancestral strain. But it is also evident that the titers are much higher and the reduction as compared to the ancestral strain is significantly lower as compared to the twofold of sera from individuals who have received 2 vaccines. The level of virus neutralizing antibodies are actually in the range of the levels of individuals who have received 2 vaccines against the ancestral strain. And just to remind you, the levels -- this type of levels were for the ancestral strain were correlated with a high level of protection against any type of SARS-CoV-2 mediated disease. So the interpretation of this data is that based on the levels that we have observed in this preliminary studies, we expect significant protection against any type of COVID-19 mediated by Omicron in individuals who have received the third vaccine. What is also important is, and I have stated that already in the beginning, the immune response and immune protection is not only mediated by neutralizing antibodies, but also by CD4 and CD8 T cells. What we have done is we investigated the epitopes that we have identified in the Pfizer BioNTech laboratories, the CD8 epitopes and checked whether the identified CD8 epitopes, which is -- which represent a fraction of total CD8 epitopes because they are more CD epitopes, but we focused here on the CD8 epitopes, which were identified in our laboratories. We have identified 31 epitopes, and we see that the vast majority of these epitopes are not mutated and still unaffected in the Omicron variant, about 80% of the epitopes do not carry mutations. And therefore, we believe that T cell responses induced by vaccination and particularly increased by the third dose will still be active also against the Omicron variant. What is also important is that we, in parallel, had started -- or we had started with a variant evaluation studies, already 9 months ago, to prepare ourselves for a potential change of a vaccine and to enable introduction of a variant vaccine. We have so far clinical trials running against a number of variants, against the Beta variant, against the Alpha variant, against the Delta variant as well as against the mix of the Alpha and the Delta variant. We have seen in the studies that also variant vaccines are equally well tolerated with similar symptoms and tolerability as compared to the original BioNTech vaccine. And what we have also observed that a booster dose with this variant vaccines on top -- in individuals who had previously received 2 doses of the BioNTech Pfizer vaccine induces strong neutralizing antibody responses, equal or even higher than those observed with boostering with BioNTech vaccine. Particularly interesting is that boostering individuals who have received a boostering with the Alpha variant have significantly increased more than 400% increase neutralizing antibody levels against the Omicron variant, which would be in line with the fact that the Alpha -- that the Omicron variant, shares multiple mutations with the Omicron variant. On the bottom, you can see the overall change process for technically introducing a variant vaccine, which starts with the sequence of the spike protein, with the preparation of a DNA template, which will be used for manufacturing of the mRNA. The mRNA needs then to be formulated as a lipid nanoparticle. All quality assays need to be adapted to this new variant. And if the quality assays were performed in line with the expected quality, the material can be released and can be supplied, pending regulatory supply -- regulatory approval. So the summary is -- Ozlem, could you take over to summarize the findings and the next steps?

Sure. So to summarize Ugur's key statements. Firstly, as Ugur pointed out, our preliminary laboratory studies demonstrate that 3 doses of our vaccine, neutralize Omicron variant, whereas 2 doses show significantly reduced neutralization of this new variant. Our data also indicates that the first dose of our vaccine increases the neutralization antibody titers against the Omicron variant by 25-fold as compared to 2 doses of our vaccine. And these titers, which we observed after the third vaccination against the Omicron variant are comparable with the titers we observed after the second vaccination with our vaccine against the wild-type variant. And as you know, those titers have been associated with high levels of protection by our Phase III study. Then third, due to the presence of B and T cell memory in vaccinated individuals and as 80%, meaning the vast majority, of epitopes in the spike protein recognized by CD8 T cells are not affected by the new mutations in the Omicron variant, we expect that 2 doses of our vaccine may still induce protection against severe disease with Omicron variant. These results are preliminary. We continue, together with our partner, Pfizer, to collect more laboratory data, and importantly, also to evaluate real-world effectiveness data to assess protection against Omicron variant and to inform the most effective path forward. So what exactly are the next steps? Broad booster campaigns with current version of our vaccine around the world could help to better protect people and to get through the winter season. We, together with our partner, Pfizer, continue the development of variant-specific vaccine against Omicron, which we recently initiated in case it is needed with the aim to induce high levels of protection against disease as well as prolonged duration of protection. First, batches of potential Omicron-based vaccine are planned to be delivery ready by March next year, pending regulatory authorization. In addition to that, we have ongoing several clinical trials with variant-specific vaccines against other variants, which we started some time ago against Alpha, Beta, Delta and Alpha Delta multi-variant mixes, where we continue to collect safety and tolerability data, which can also inform the Omicron-adapted vaccine.

Thank you, Ozlem.

Thank you. We will now start with the Q&A session with Ugur Sahin; our Chief Medical Officer and Co-Founder, Ozlem Tureci; and Chief Operating Officer, Sierk Poetting. Please submit your questions in the forum below the screening window. So the first question is from the Washington Post. How does the new data influence thinking about the necessity or not of an Omicron-specific vaccine? What other data will influence the decision about whether a revised shot is necessary.

The new data, which is very preliminary and initial data shows us that the first line of defense with 2 doses of vaccination might be compromised and 3 doses of vaccination are required to restore protection. And it also alerts us to look deeper into data and to collect further data. So this is not the basis to decide preemptively to generate the necessity of Omicron-adapted vaccine. It, however, means that we have to assess further laboratory data, and most importantly, also real-world data, which will emerge within the next couple of weeks. We expect from all parts from the world and will help us together with experts to decide the path forward.

And in the meantime, of course, we continue with high speed the development of a potential Omicron vaccine to be ready if the vaccine is really needed.

The next question was submitted by the associated press. Are you surprised either positively or negatively by the results you found. What does this tell us about the drivers and its ability to adapt to avoid vaccine-induced immune responses? Does it give any indication of how often people are likely to need both booster shots going forward?

So this Omicron variant came as a surprise because -- also in the past, we had observed variants with multiple mutations, but the number of mutations in the Omicron variant is really a jump, an increase from usually 10, 15 mutations that we had observed in the past to more than 34, 35 mutations that we are seeing now on the Omicron variant. And it is still not a complete escape variant. It is a partial escape variant. That means the virus can be neutralized by high titers of neutralizing antibodies. And it indicates the data, real world data, which are coming from South Africa indicate that it appears to spread faster in at least in previously infected individuals. So we need to be cautious and continue to observe the situation. And in parallel, assume that a variant vaccine might be needed.

We will continue with a question from The Wall Street Journal. Are you still working on an Omicron-variant vaccine? Or does this mean that will no longer be necessary because boosting with the original is enough?

As already pointed out, data is preliminary and next weeks will -- in the next weeks, more data will emerge in order to answer the question whether or not or when we need an Omicron vaccine. And until we have clear data and also the input of experts by analyzing the data that an Omicron-adapted vaccine is not needed, we continue under the assumption that it would be needed full speed to develop a vaccine for that case.

The next question is from the telegraph. Do we have any information on whether the T cell response to Omicron is as robust as it was against other variants and people who have been double vaccinated and had a booster?

Yes. We have shown some data based on bioinformatic analysis of T cell epitopes and analysis of T cell epitopes that we had discovered previously. And as already mentioned, 80% of the T cell epitopes that are induced CD8 T cell epitopes that are induced by the current vaccine are still present in the Omicron variant. And since every individual has usually multiple CD8 T cell epitopes being recognized, we assume that there will be a robust T cell response also against the Omicron variant.

The next question is from Nature. When do you expect to have direct measurement of vaccine effectiveness against Omicron?

Yes. It depends how fast the virus spreads as well. So currently, the number of cases, even though they are daily increasing are too low to assess real-world effectiveness. The real-world effectiveness will be -- could be measured, particularly if the virus enters regions, which have the digital infrastructure to assess the infections in individuals who have received 2 or 3 vaccinations or no vaccinations. So I believe we have to wait about -- in the range of 6 to 8 weeks until such data could mature.

So the next question is from the [ German Outlet ID ]. How long will it take to design and to provide a new COVID vaccine?

It -- so the design has already happened. We are already developing Omicron-adapted vaccine and are in the midst of development. The time lines are such that we are -- we would be delivery ready with Omicron-adapted vaccine by March next year, pending regulatory authorization.

Next question is from a [ German Outlet ] side. What exactly is the process to develop an adapted vaccine to the new variant? What steps this process includes -- And how far on...

So the next question is from the German Outlet Side. What exactly is the process to develop and adapt a vaccine to the new variant? What steps -- does this process include? And how far along is BioNTech currently in the development of an adapted version for Omicron?

Yes. So you basically have to find the new sequence. You have to find a new target and produce this vaccine candidate for -- that takes around about 6 weeks. So from that, you then construct the so-called DNA plasmid, which is the blueprint that you can copy off the mRNA in the production process. So in 6 weeks, we are likely to have this blueprint. We will then produce this plasmid and then get this into commercial production. That's why including adoption of the assays and so on, we will be ready with the first production or we'll have the first batch ready in March, pending authorization, regulatory authorization.

And this would be a commercial batch. We will have clinical batches already in January available to assess the quality of the vaccine and to the first kind of preclinical evaluations.

We'll continue with a question from Reuters. What do the findings that tell you about the best interval between the second and third shot of Comirnaty if Omicron becomes the dominant variant. It would seem that an earlier third shot is warranted if 2-shot protection is much lower.

So the new data sets, of course, will result in discussions to prepone the third shot. So some regions, for example, U.K. had already decided last week to introduce the short dose in individuals who have at least an interval of 3 months after the second dose. And we believe that this is the right way to go to enable that particularly if the Omicron variant is now further spreading a better level of protection in the winter season.

Following a question from Barren's. Do these results imply that our vaccine should be considered a 3-dose primary series rather than a 2 dose plus a booster?

Yes, particularly with the data now coming for the Omicron variant, it is very clear. This -- our vaccine for the Omicron variant should be a 3-dose vaccine.

Okay. We'll continue with another question from Reuters. Did the pseudovirus have all the Omicron mutations are only the most important ones. Other researchers have worked with replicated real Omicron virus. Why don't you opt for a pseudovirus? And could that decision have an impact on the results?

So it is correct that there are different type of assays, which are used by different groups. So some groups used the original virus for evaluating, neutralizing antibody responses. We have seen in the past that the type of assay that we are using correlates very well with the results obtained by other type of assays, and particularly also correlates very well with real-world protection data. The constructs that we have used for evaluating and neutralization, contain a full set of mutations in the most updated data bank version of the Omicron Variant.

The next question is from the Financial Times. What is your best estimate of the drop in vaccine efficacy against infection under a 2-dose regimen vaccine -- a vaccine regimen against Omicron? How difficult will it be to ramp-up production of a new variant specific vaccine? Are there constraints to do shortages of plasmid DNA or ability to scale that up?

Do you want to take that, the first question and the second question could be a Sierk.

Yes. So with regard to efficacy, I can take that one. We really don't want to speculate. We cannot deduce based on neutralization data, what do you to expect in terms of efficacy or real-world effectiveness, but we will have this data as already pointed out in a couple of weeks.

Yes, when it comes to the scale-up process, we are, as Ozlem said, until we stop, we will continue with and the development and the production of the new variant. That also means we are already freeing up capacity for plasmid production where we should have enough actually switch to this Omicron variant. We are also providing space in our production lines already for commercial production. Do we switch the whole production over to an Omicron? That depends on the spread of the Omicron virus. So basically, right now, we will max out the capacity and switch into Omicron and leave our flexibility open. And as you have seen before, the production process itself, once you have the plasmid is exactly the same that we have already established. So mRNA production as well as lipid formulation and fill and finish is the same process. The only difference is the plasmid starting material in this whole production process.

Thank you. The next question is from the Asset. Does the new vaccine required a major adjustment in production? And will you then stop producing Comirnaty?

Yes. As I just answered in the question before. So we will -- we don't know how the Omicron variant is spreading. So that's why we produce -- we start producing it, and then we'll see how much of the production we have to switch. We also will find ways if needed to increase production to produce more of the Omicron potentially in parallel with the current variant. The production process itself actually will stay the same. The only thing that will change is the plasmid to the blueprint of the new variant. But apart from that, all the production steps mRNA, lipid formulation, and then fill and finish will be exactly the same.

And we have, of course, started with this process. And so far, there is no indication that manufacturing plasmid DNA for the Omicron spike variant is more complicated than against the wild-type variant and also mRNA batches were produced at the research with scale. So we are confident that the process will be -- will also work because we tested the process already for several other variants and do not see any type of challenges for this variant.

We will continue with a question from Bloomberg. A German study this morning showed some antibody levels versus Omicron were greatly reduced just 3 months after boosting. What do you make of this data? How quick do you think the drop-off in protection will be from the original shot? And secondly, if Omicron proves to be as mild as some early reports indicate, will we need a vaccine against it at all?

Can you repeat the last part of the question?

Yes. If Omicron proves to be as mild as some early reports indicate, will we need a vaccine against it at all?

Okay. So first of all, our data is based on one -- sera obtained 1 month after the booster, and we are going to further assess sera from later time points. So I can't answer the question how long the duration of the neutralization is that we have observed, but that will most likely come in the next 2 weeks. And the second question is, of course, indeed related to the overall dataset that Ozlem has mentioned, we need really the overall data set we have to understand under how fast the virus is spreading and we have to understand the type of disease used in different subpopulations. And with this information, we can make a firm decision whether a new vaccine is needed or not.

Thank you. The next question is from the [ German Outlet SVR ]. How are your data comparable to the Frankfurt study data, 25% neutralization, 3 months after booster with virus isolate not pseudovirus?

Okay. So this is additional data sets with a different type of assay. And that's also the reason why we several times cautiously state that the data that we are generating are preliminary data. So the Frankfurt data are as preliminary as our datasets. And in the next 2 weeks, we will get more data sets from different laboratories, which will provide us a better understanding of the level of titers in different time points after the boost. That's the first set of data, which will be important. And most importantly, we will also get rebuilt effectiveness data, which are at the end of the day, the type of data which provide the best information.

The next question was submitted by the Daily Telegraph. If Omicron is most similar to Alpha, is it fair to say that those who caught Alpha will have better protection against Omicron than people triple jabbed with the Wuhan spike protein of the vaccine or those who caught Delta or ancestral strain?

This is also a scientific interesting scientific question. It would be speculative to answer that now, but I'm sure that there will be studies coming up in the next weeks, which investigates this question.

We'll continue with a question from The Wall Street Journal. Just the fact that an Alpha boost for Instant gives 100%, 60% increase in neutralization against Omicron mean that immune and printing is not happening here? In other words, boosting with a variant vaccine doesn't simply reawaken the body's first immune response, but does, in fact, fine-tune immunity towards the variant impression?

So this is also an important scientific question and the data that we have observed. And again, this is preliminary data is encouraging that immune response indeed can be fine-tuned, but we need much more data in the coming weeks and months to evaluate this.

We'll continue your question from [indiscernible]. Are there any signs with Omicron for a typical virus history, more infectious, but less dangerous?

I think we can't assess at the moment, the situation because the data obtained so far for Omicron are from heavily endemic regions from a different population with a different age distribution, and we have to learn what is happening here in Europe and in the United States. And we have to wait at least 2, 3, 4 weeks to understand the frequency of severe disease and special symptoms induced by this new variant.

The next question was submitted by [ indiscernible ] Blood. Would Omicron vaccine be less effective against the currently dominating variance? And when would, in your opinion, the best point in time be to switch?

It's an important question. It really again depends on the further spread of the Omicron variant, whether it is becoming the dominant ones and eradicating the currently most dominant Delta variant or not. So there are a number of factors. And most importantly, we will be able to consider all these factors. So that means if it's really needed, we would be able to come up with a variant vaccine, which includes Delta as well as Omicron. And if it's not needed, we might just stay with the current vaccine or continue next season with Omicron vaccine depending on the further spread of the new variant.

Thank you. We'll continue with a question from CNBC. Do you think children will also require 3 doses? Or do they produce stronger immune responses such that 2 doses of the original vaccine could set this against Omicron?

Again, this will depend on a better understanding of the virus, the type of diseases it induces, the role current vaccine booster can play in terms of duration as well. So we have to wait for more data.

Yes. And generate also neutralization data using sera from children who had received 2 vaccines.

Related to that, a question from RD. How would our kids protected against the current variance?

So we have to wait for the real-world data. So we know that children have in -- at the age of 12 to 15 years, have higher titers, neutralizing antibody titers as compared to adults. We have to see whether these higher titers translate into more stronger titers against Omicron variant. I assume the data will be available sometime next week.

Thank you. We'll continue with a question from Endpoints. In terms of stepping the next variant, is it more important to get first and second shots into arms or third shots boosters? Do you know how many people who have received Pfizer BioNTech Booster have still died from COVID-19?

So the last question is I can just refer to real-world data, where individuals, particularly in Israel were evaluated in a way that individuals who receive the third dose versus individuals who receive just 2 doses were evaluated for infection and severity of disease. And it is very clear that the third dose provides an excellent additive protection of 95% against any severity of disease. We have also together, with Pfizer, generated in a randomized phase free clinical trial data showing 95% efficacy -- relative efficacy of a third dose as compared to a second dose. So the third dose has really an absolute added value. It prevents not only infection and any type of disease, but it also increases the protections against severe disease.

Thank you. We'll continue with a question from CNBC. When the first commercial batch is available in March, how many doses would that be? We heard from Albert Bourla that 4 billion doses can be produced next year regardless of which vaccine design is used, but how long would ramping manufacturing take for the new design?

Yes, that's a very good question. So basically, we would start the production. The first batches could be produced in March. When I say the first batch is available. That doesn't mean we can do several in parallel. So we are talking, depending on the spread, we could do in the first month, several million doses potentially, how we scale this up and how we switch our $4 billion capacity towards Omicron is then dependent on the spread and where it's really needed.

And this data will emerge within the next couple of weeks so that we can until March tweak whatever we need.

And at the same time, we are also starting to see -- to look for additional capacities already whether there are any ways to increase production capacity in the network for this potential additional variant to produce.

We'll continue with the manufacturing question submitted by the Suddeutsche Zeitung. Will Omicron change your plans for the production in South Africa.

No. No, we will continue with our program for South Africa as planned.

We'll continue with a question from the Guardian. At one point on the 100-day pipeline to a variant vaccine, do the companies need to make a decision to commit to going ahead or not? And if the latest results are confirmed in further studies, would there still be a motivation for rolling out an updated vaccine?

So again, this is really, really important that we act in a scientific-sound fashion. Scientific sound means that we align our thinking on the most recent datasets and collect all type of information and come up with an aligned strategy, a strategy which is not only aligned with the companies but also aligned with regulators, and of course, of the governments who are in charge of rolling out the vaccine supply.

We'll continue with a question from CNBC. Would it take longer to develop a multivalent Delta and Omicron vaccine?

We don't think that it will take longer since we also in the -- in one of our clinical trials showed that this is feasible. We have performed a clinical trial that we combined the Alpha variant with the Delta variant. So also one option, which we believe is not very likely could be an Omicron Delta variant vaccine. But let's really answer this question if we have a better understanding how Omicron spreads and the Delta remains to be present -- co-present and requires any type of adaptation.

We'll continue with a question from Suddeutsche Zeitung. Can you explain why 3 doses of the vaccine neutralize the Omicron variant, while 2 doses show significantly reduced neutralization titers. Is this only a question of quantity of antibodies or also a type of antibodies?

So this is a good question. We don't know that to be frank. So we know that a boost not only increases the breadth of antibody responses but also has an impact on the affinity of this antibody. So B cell continue to hypermutate and thereby, this type of affinity increase might be responsible for better binding also to variants, but this is still emerging science and not definite not something that we can definitively answer at the moment.

The next question was submitted by [ Wharthus ]. You highlighted the performance of the Alpha variant vaccine versus the Omicron variant. Is there any consideration to moving forward with a booster instead of an Omicron-specific vaccine? How much time could that save? Would there be any significant downsides?

So adapting the vaccine to Alpha versus an Omicron vaccine is the same time line. So it would not make sense if we really need to adapt the vaccine, the rationale would be most likely to go with an Omicron-variant vaccine, if this is needed.

Thank you. We'll continue with the question from [ German Outlet ] When will you submit the data from variant vaccines conducted earlier to the authorities and how will that assist in the approval process of the Omicron vaccine?

So we are already in exchange with the authorities for the variant studies. And this is more or less a continued process where we update about the ongoing studies and align with authorities what kind of data is still needed to provide a potential change -- to agree on a potential change process.

Thank you. [ related to that ] -- in your discussions with governments and regulators, what additional data and thresholds are they looking for to decide whether an Omicron-specific candidate will be needed? When do you expect to have those results?

So again, to repeat, we will generate data, and we will see, of course, in the next days, in the next weeks, in the next months, data coming from multiple groups. And this information will mature and will provide us the decision basis to come to a conclusion if a variant vaccine is needed and how fast it is needed, and this is an ongoing process. Today's announcement is the first set of preliminary data indicating the direction we need to go. But we need more data, more robust data from different groups and from different regions to come to a conclusion.

Thank you. We'll continue with a question from [ Politico ]. Will you be replicating the Omicron-neutralization studies with live Omicron virus?

Yes, we will do that.

The next question from Norway. Would you take a third booster shot now or wait for the Omicron-specific vaccine?

So the answer for that is in our eyes very clear. So we -- the data that we have has clearly indicates the value of a third dose. And we should be really clear about that, that an Omicron vaccine, even if we start supply in March, will not be broadly available. We will start with the first 25-50, maybe 75 million doses. But the best would be -- to ensure better protection is to have a booster shot and thereby have an improved antibody levels and improved T cell levels, which are correlated with better protection against the current Delta variant, and we believe that will also translate to a better protection against the Omicron variant.

Thank you. The next question was submitted by the German Asset. But will you produce in South Africa from the start on the Omicron vaccine?

Yes, we don't know that yet. So basically, the first step we are implementing in South Africa is a fill and finish process and the drug. The formulated mRNA comes from our Marburg facility. So we can send any material to South Africa and fill and finish it at the site. So in that sense, we don't know yet, and we'll decide and due course.

Thank you. We'll continue with a question from the Business Insider. If neutralizing titers weighing from a third dose with Omicron at a similar rate as seen with a second dose against other variants, what will that mean for the durability of protection from 3 doses? And what is the likelihood that a fourth dose will be needed in 2022.

So this is an excellent question. And indeed, we have to investigate this question. And this question will be addressed on the one side by doing additional studies, authorization studies, with time point -- with later time points, and on the other side, by assessing data -- real-world data, which will inform us about the protection -- duration of protection. And if the duration of protection is too short, one option would be indeed if at the time point Omicron variant vaccine is not available a third shot. So that means a second booster.

Thank you. We'll continue with the question for Sierk. Booster doses are not available in all countries at this time. Is the internal expansion of manufacturing focused on getting more doses in areas where they currently are not?

Yes, the distribution is basically a government business right now, and we try to produce as much as possible. So that's why we are expanding. I mean we said we have a network of 4 billion for next year, 3 billion this year, which is where we are on track. We are trying to find more capacity above the 4 billion for next year. So in that sense, we are trying to produce as much as possible and then the distribution by the government contracts takes place.

Thank you. The next question was submitted by [ Fokkers ]. What is your opinion on mandatory vaccination as it is planned in Austria and Germany?

This is not for us to comment. This is a public health guided and society to be answered question.

Okay. So now we have the last question submitted to us by CNBC. Do you think children will also require 3 doses or do they produce stronger immune responses such as 2 doses of the original vaccine could surface against Omicron?

So we will most likely have data available on the neutralization titers in vaccinated children. And based on that, we might be able to answer this question.

Thank you. We're closing the session now.

Thank you.

Thank you.

Thank you.