After interim analysis CureVac defends its vaccine

Status: 06/18/2021 10:19 a.m.

Although an interim analysis of the CureVac vaccine only showed an effectiveness of 47 percent, company boss Haas does not want to know anything about a failure. He is hoping for further tests so that the vaccine will be ready for the market after all. The negative news for the Tübingen company CureVac continues. At first, the company lagged behind the competition in developing its corona vaccine. Then the company went late to the crucial phase 3 to test its vaccine – at that time there were already several variants of the coronavirus. The next bad news followed yesterday: CureVac announced in a mandatory stock market announcement that, according to an interim analysis, its corona vaccine had a preliminary effectiveness of 47 percent against Covid 19 disease “of any severity” have. The value is significantly higher for the other preparations approved in the EU.

“Wild type hardly plays a role anymore”

Company boss Franz-Werner Haas has now gone on the offensive. He defended the company’s corona vaccine against the dpa news agency. No other vaccine has been tested on so many virus variants, he said.

“In fact, it is actually not correct to compare the number of the provisional effectiveness of our corona vaccine and the numbers of the effectiveness of other vaccines”said Haas. The study on the corona vaccine candidate CVnCov contained 29 virus variants. The original virus, the wild type, hardly plays a role anymore. “The efficacy figures for the other vaccines would probably look different if their studies had been carried out at a later date.”

Degree in three weeks

The Tübingen-based company would like to complete the analysis of the data from the final study phase in the next two to three weeks. Haas was convinced that the effectiveness of the vaccine would change again. As soon as this has been completed, CureVac will advise the EMA as to whether further data is required.

The company remains convinced that it will bring its vaccine to approval. According to Haas, even a possibly relatively low effectiveness should not stand in the way. “In view of the pandemic, it can only be said: If there is an effective vaccine, it should also be used.” Haas also referred to the numerous developing countries in which little or no corona vaccines are currently available. The scientific director of the vaccine study at CureVac, Peter Kremsner, believes that it will certainly be possible to make the vaccine operational. In an interview with the BR he said: “That will work for sure. From my point of view, this will not be possible in the next few weeks. But it will be possible to prepare the vaccine so that it can be very effective.”

“It was a noble cause”

The SPD health expert Karl Lauterbach estimates that the setback when entering the market will contribute to the vaccination campaign losing pace for two to three weeks. The promise of the federal government to make a vaccination offer to all adults by the end of the summer is not at risk. “We will reach herd immunity in mid-September”said Lauterbach in the daily topics .

Lauterbach pointed out that the CureVac serum is the “noble” I wanted to be a cheap and very effective vaccine. It would have been predestined for poorer countries. The EU had promised 400 million doses of CureVac to poorer countries. Lauterbach assessed it as a tragedy that this delivery has now been canceled.

No withdrawal of the investor

The announcement of the preliminary effectiveness had caused a drastic plunge in the stock exchange price of CureVac. Investor Dietmar Hopp still believes in the company. He will definitely stay as an investor, he said “Munich Mercury”. He is a firm believer in the company.

The federal government is also holding on to its stake in CureVac, as the Ministry of Economic Affairs said. Last year, he entered CureVac through the KfW development bank with 300 million euros and, according to KfW, holds a share of 16 percent. The federal government has no influence on the operational business, explained the ministry spokeswoman

CureVac Story of a disappointed hope

Status: 06/17/2021 8:30 p.m.

While the world is now being vaccinated with BioNTech, the vaccine from CureVac has proven to be ineffective. How could the two great German hopefuls develop so differently?

By Thomas Aders and Sebastian Deliga, SWR

At first it was a German head-to-head race between the Mainz-based pharmaceutical company BioNTech and the Tübingen researchers from CureVac. Both use the same technology “Messenger RNA”, the share prices of both companies initially took off on the stock exchanges, and both have professional and global partners. The Mainz-based company was able to bring the US pharmaceutical giant Pfizer on board, while the Tübingen-based company found what they were looking for at Bayer. And not only that: At the beginning of September, a man came to visit Tübingen, whose name makes technology enthusiasts, e-mobility enthusiasts and stock market speculators enthusiastic: Tesla boss Elon Musk. Even before he paid his respects to Chancellor Angela Merkel in Berlin, he stopped by CureVac. For the production of their vaccines, the people of Tübingen used the technology of the medium-sized company Grohmann in the Eifel, which in turn has been part of the Tesla empire since 2017.

The field of support from both companies was also in competition: in Tübingen, SAP boss Dietmar Hopp became the majority owner, in Mainz the twins Thomas and Andreas Strüngmann, who had become rich in the pharmaceutical business, and the Bill & Melinda Gates Foundation were behind BioNTech boss Ugur Sahin. From the outside, it was still the duel between digitization pioneer Hopp and oncology professor Sahin. Both were believed to be successful.

But since the beginning of 2021, the people of Baden-Württemberg have stumbled in the race against the Rhineland-Palatinate; while the BioNTech drug was approved by the authorities, CureVac has still not fully completed the third phase of its vaccine testing. Today’s publication of the inferior efficacy of the Tübingen vaccine candidate CVnCOV of only 47 percent – in contrast to 90 percent for BioNTech / Pfizer – was the end of hopes for mass production soon and the end of hopes for strong profits on the stock market; the price of CureVac has more than halved.

Why does the vaccine protect so poorly against Covid-19?

When the Tübingen-based company delayed the crucial phase 3 and tested the vaccine, there were already several mutations of the corona virus. That made research much more difficult. Virologist Martin Stürmer from the University of Frankfurt also sees this as one of the problems: “BioNTech, AstraZeneca and Co. – they only had to deal with B.1.1.7 (the Alpha variant, first developed in England).” In addition, it was the Tübingen’s unwritten law to administer RNA as pure as possible and not chemically treated. This also had fatal consequences for CureVac, because the competition achieved a much higher concentration by modifying the messenger RNA. The head of the CureVac vaccination study, Peter Kremsner: “BioNTech and Moderna were able to dose three to ten times as high because they chemically changed the RNA. At CureVac, the dogma was that the RNA should be injected as unchanged as possible, which is basically correct, but unfortunately it did not work.” The goal of the Tübingen was a noble one. And the SPD politician and epidemiologist Karl Lauterbach is talking about the company’s fate today tagesschau.de “terribly sorry”. He always admired the particularly ethical and moral standards of the Tübingen population. But Lauterbach no longer sees any basis for hope either. Even if CureVac starts all over again, the competitors from BioNTech or Johnson & Johnson, for example, have made further progress in their research. So the Tübingen train left for many.

What does this mean for the vaccination campaign in Germany and Europe?

Epidemiologist Lauterbach very much regrets the bitter fate of CureVac, but he sees the German vaccination campaign as hardly endangered in the Tübingen disaster. Several other vaccines worked to a great extent in his opinion, and in his view today’s setback would result in a delay of no more than three weeks. “By the end of September we will probably have a vaccination rate of 70 percent, and thus herd immunity.” The Federal Ministry of Health is also anything but panicked. Got the latest news about CureVac “no impact on the pace of our vaccination campaign”. Brussels does not want to comment directly on the CureVac disaster, that is a matter for the European Medicines Agency (EMA) in Amsterdam, which decides on the approval of vaccine preparations. However, the EU has apparently taken precautions in the event that CureVac fails: The contract with the Tübingen region includes “Termination clauses in the event that the vaccine is not approved by the EMA”. There are also rather composed comments from Parliament: of course, the results at CureVac are inadequate “a big disappointment”, said MEP Peter Liese. “The goal of offering people in Germany and Europe a vaccination offer by the end of the summer is still realistic.” This is due to the positive developments at BioNTech and Johnson & Johnson. Additional information is interesting in Peter Liese’s statement: CureVac CEO Franz-Werner Haas had already promised him in December that his company would work with other manufacturers, “if your vaccine doesn’t work”. With today’s publication of this conversation note, the pressure on the Tübingen-based company and its partner Bayer should now have increased rapidly to cooperate quickly with successful competitors from Mainz and to convert their own capacities to the production of BioNTech.

Did the state lose money promoting CureVac?

“The federal government is participating in this promising company because it expects it to accelerate developments and to enable CureVac financially to exploit the potential of its technology.” Federal Minister of Economics Peter Altmaier said that almost exactly a year ago. The federal government then invested 300 million euros in the Tübingen-based company. In addition, there was the Federal Ministry of Research, which made a commitment for funding of 251.6 million euros.

All in all, a good half a billion euros. So is the money gone now? The answer: only in part. On the one hand, the federal government received a share in the company for its investment. And although CureVac’s price has slumped by more than half today, the value of that portion is still likely to be significantly higher than when the company went public. And on the other hand, of the promised 251.6 million, only 102.8 million euros have actually flowed so far, as the Ministry of Research tagesschau.de confirmed today. The rest will probably be withheld as the payout “depending on the progress of the project” is. Regardless of the possible “Losses” The question arises, however, what would have happened if the federal government had not invested a cent in promising companies such as CureVac or BioNTech. An outcry would probably have gone through the republic, even though an alleged takeover offer by ex-US President Donald Trump turned out to be a hoax. The situation in the crisis year 2020 was dramatic, according to SPD health expert Lauterbach. “It was an extremely noble attempt by our German companies to develop a new type of Covid vaccine and make it available to the whole world. The investments were right, although in the case of CureVac there was no success.”

CureVac vaccine not very effective Crash of a Bearer of hope

Status: 06/17/2021 12:31 p.m.

CureVac’s vaccine proves far less effective than hoped, with the biotech company’s stock plummeting. What does this mean for the vaccination campaign and German taxpayers?

From Angela Göpfert, tagesschau.de

For the company CureVac and its owners, dramatic scenes have taken place in the past few hours. The price of the Tübingen-based company listed on the US technology exchange Nasdaq had already halved in after-hours trading on the US stock exchange on Wednesday. This morning, the CureVac share then rushed in German retail by up to 52.4 percent.

Eight billion euros destroyed on the stock exchange

This destroyed around eight billion euros in market value within a few minutes. This melted down from over 15 to a good seven billion euros. The drastic course reaction shows how surprisingly, despite all previous doubts, such devastating study data as CureVac has now presented, came in the end – and how serious the consequences could be.

On Wednesday night, CureVac announced that its first-generation vaccine candidate was CVnCoV only an effectiveness of 47 percent against a Covid 19 disease of any severity. The company thus missed the intended statistical success criteria for approval.

Completely out of the vaccination campaign?

The study is to be continued, and the degree of effectiveness could change with higher case numbers. However, if the current trend continues, approval is unlikely. In this case, experts say CVnCoV would be a total flop for the company. For the German vaccination campaign, CureVac is therefore canceled until further notice. “According to these study results, it will be extremely difficult for CureVac to play a role at all in the current vaccination campaign”, told LBBW analyst Timo Kürschner tagesschau.de . According to the federal government, the setback for the Tübingen company does not upset the vaccinations in Germany. “This announcement has no effect on the speed of our vaccination campaign”said a spokesman for the federal health ministry.

Other manufacturers are still catching up

Industry observers believe that speed is just as important in vaccine development as it is in drug development. “Late bloomers like CureVac only have a chance if they have a better effect profile or fewer side effects”, explains pharmaceutical expert Kürschner.

“The more time that elapses, the more efficient the production of vaccines that have already been approved will be”says the pharmaceutical expert. “BioNTech & Co. are then more and more able to serve the required delivery quantities.” His conclusion: “We could get to a point where you actually no longer need the CureVac vaccine because the vaccination campaign is already so advanced.”

Hundreds of millions from the federal government

The severe setback for CureVac meanwhile has effects beyond the current vaccination campaign. It meets the German taxpayers – after all, the federal government has a stake of around 16 percent in the company and has supported vaccine development with a special program worth several hundred million euros. It is also a debacle for SAP co-founder Dietmar Hopp, who holds almost 50 percent of the shares.

Last but not least, the CureVac price disaster hits the countless private investors who have invested their money in the share. The paper of the company, which is legally based in the Netherlands, has been one of the most traded foreign stocks in the past few weeks on the Stuttgart Stock Exchange, where many private investors cavort.

Recently increased warning signs

Recently, there had been more and more indications that the CureVac vaccine could fail for the time being. Even when Health Minister Jens Spahn, according to media reports, deleted CureVac from the federal government’s planning for the current vaccination campaign, this could hardly affect the share.

The high market capitalization compared to rival companies was also a warning sign: Before the current price crash, CureVac had a higher market value than Novavax. The US manufacturer had already reported a Phase III study on Monday, according to which its vaccine had a has a high effectiveness of 90 percent .

Often high risk in the industry

For CureVac and its owners this is now the “Worst case” of a biotech company. At the same time, the CureVac case also shows the general risks facing the industry. Companies in this industry usually have very few active ingredients in their pipeline. If one then fails – for whatever reason – it often has fatal consequences for the entire company.

LBBW expert Kürschner also sees CureVac “a prime example of the risks involved in investing in biotech companies”. However, Kürschner does not fear negative consequences of the CureVac events for the German biotech industry. After all, there is a positive counterexample in the country. “I’m sure: BioNTech’s success story will outshine the rather negative course at CureVac.”

Corona vaccine CVnCoV Bad Intermediate result for CureVac

As of: 06/17/2021 6:42 a.m.

Setback for CureVac: The corona vaccine CVnCoV only showed an effectiveness of 47 percent in the second interim analysis, said the Tübingen-based company. The study is to be continued. CureVac’s corona vaccine candidate CVnCoV missed the statistical targets in a second interim analysis. The Tübingen-based company announced this in a mandatory notification. There it says: “In a previously unprecedented environment with at least 13 variants within the subset of study participants examined in this interim analysis, CVnCoV achieved a preliminary effectiveness of 47 percent against COVID-19 disease of any severity and thus did not meet the specified statistical success criteria.” Initial analyzes have shown that the effectiveness depends on the age group examined and the virus strains, the company continues. The vaccine candidate is in the final stage of clinical development. CEO Franz-Werner Haas announced that one had hoped for stronger results in the interim analysis. But continue the current study until the final analysis.

Actually soon approval is planned

Until the beginning of June it had been said that the company expected – depending on the clinical trial data – the approval of its vaccine candidate in the EU at least for the second quarter. But shortly afterwards it became known that the proceedings would be further delayed.

CureVac, which works with Bayer, had long been considered one of the hopes in the competitive race for approval of the first corona vaccines. But while vaccines have been administered by numerous competitors worldwide for months, the Tübingen-based company is still collecting data – and recently had repeatedly put off shareholders and observers.

From Michael Heussen, WDR The apparent contradiction between accepted genetic engineering in the medical field and the controversial so-called green genetic engineering in agriculture was the topic of the run-up to the Bayer Group’s Annual General Meeting today. The discussion was held by Klaus Müller, Member of the Board of Directors of the consumer association, and Matthias Berninger, chief lobbyist at Bayer. Both sat together as young MPs for the Greens in the Bundestag in the 1990s before they parted ways. Now they were invited to the virtual Bayer podium together.

Waiting for the CureVac vaccine

Bayer has entered into a cooperation with the Tübingen vaccine developer CureVac. The vaccine is to be brought onto the market at the end of the year. The goal is to produce 160 million vaccine doses in the coming year, said Berninger, including at the Bayer plant in Wuppertal. This is new territory for the pharmaceutical giant, which has not yet produced any human vaccines. 40,000 test subjects have been recruited for clinical phase III, explained Florian von der Mülbe, CureVac’s Chief Production Officer: “We are about to complete the study and assume that we will be able to apply for approval in the second quarter.” The study is running in ten countries in Europe, Central and South America; half of the subjects received the vaccine, the other half a placebo. So far there have been no significant adverse reactions, according to the head of the study, Peter Kremsner from the Tübingen Tropical Institute. To answer the question why you are so late compared to other vaccine manufacturers, Berninger reached deep into the phrase box: “The best time to plant a tree was 20 years ago. The second best is today.” Von der Mülbe added that you have to be prepared for future pandemics, and that is what his company is doing: They have developed a technology that, together with the production capacities provided by Bayer, can react quickly to mutations and disease outbreaks.

Many people come across glyphosate and green genetic engineering

Bayer not only stands for the pharmaceutical sector, but has also been criticized – since the purchase of the American Monsanto group, producer of the controversial weed killer glyphosate and genetically modified seeds. Bayer spokesman Christian Maertin defends himself by asking the head of the consumer advice center why genetic engineering in the medical field is widely accepted by the population, but why green genetic engineering, which is used in agriculture, is met with so much suspicion. “As a consumer center, we have the privilege not to be for or against, but to demand responsible regulation,” replied consumer advocate Müller. It is about risk assessment, but also about retrievability. Adjacent fields should not be impaired, you have to respect the fact that many would like to live without genetic engineering: “I don’t think Bayer can see that any differently,” said Müller. Not every end justifies the means: “That is why strict approval procedures and transparency are important. I would like Bayer to commit to the precautionary principle” – that is, pollution and damage to the environment and health are avoided or reduced in advance. Müller also pointed out the mortgage, which Bayer took over with the purchase of Monsanto : Compensation payments that – in addition to the purchase price of 60 billion euros – will amount to at least a further twelve billion euros and that will damage the company’s reputation. In response to the somewhat helpless objection of the Bayer spokesman that it has been proven that green genetic engineering does no harm and that small companies are hindered by regulation, Müller drew attention to the legal disputes in the USA: Only large companies are able to do this To conduct litigation and pay such sums of money. “Not every little scrap should be able to experiment with the most important thing that we as humanity have” – ​​with food.

Sorry to the shareholders

The dramatic impact that underestimating these questions has on Bayer became clear at the subsequent Annual General Meeting. CEO Werner Baumann apologized to the shareholders for the bad stock market price: “We bear the responsibility – without ifs or buts. That is why it is important for me to emphasize right from the start: We want to regain your trust.” The vaccine against Covid-19 is a perfect example of how to move forward with new technologies and global collaboration on the big issues of the time. However, it is currently not foreseeable that the cooperation with CureVac will boost the company’s figures in the current financial year. According to several analysts, Bayer remains a candidate for a hostile takeover because of its low market value. The group is bottom of the DAX and has made a loss of more than ten billion euros. And in the context of the Annual General Meeting, the question is also raised as to whether Baumann will fulfill his contract, which runs until 2024 – or should resign early.