BioNTech Annual General Meeting Vaccine effective against mutants

Status: 06/22/2021 6:13 p.m.

BioNTech boss Sahin uses the vaccine manufacturer’s general meeting to spread good news: Production will be increased and the vaccine also protects against virus variants. In view of the growing spread of the delta variant of the coronavirus, which is considered to be more dangerous, many people are wondering how the effectiveness of the various vaccines is doing in this regard. At today’s Annual General Meeting, CEO Ugur Sahin gave the all-clear for BioNTech’s product: “There is currently no evidence that our vaccine needs to be adapted to the variants in circulation,” he said. That does not mean that the company is stopping development: According to Sahin, BioNTech is working on flexible processes in the areas of technology, production and approval.

Constant analysis

In order to be prepared and to be able to react quickly if a third dose should be required to boost existing vaccinations or to adapt to a new virus strain, BioNTech constantly analyzes the effectiveness of the vaccine against newly emerging variants, the CEO explained.

Sahin also commented on the subject of booster vaccinations: It is not yet known when and how often a booster will be necessary. But he assumes “that a third vaccination is of great value for boosting immunity,” said Sahin. Knowledge about the corona virus is steadily increasing. “We observe that immunity will decrease over time and new variants will emerge.”

Sahin against patent release

The one raised by US President Joe Biden and other politicians Request for the release of patents to enable license-free vaccine production in developing countries, the BioNTech boss rejected. It is important to be able to make the vaccine available worldwide “as quickly and as comprehensively as possible”. However, raw materials are currently the “limiting factor”, not patents.

BioNTech is working with partners to deliver the vaccine cheaply to developing countries. However, a patent release would not bring additional amounts of vaccine. The production of the vaccine is very complex and consists of around 50,000 work steps.

Production is increased

During the Annual General Meeting, Sahin also commented on production: The BioNTech boss confirmed that the company, together with its US partner Pfizer, is aiming for a production capacity of up to three billion vaccine doses this year.

In the coming year 2022 it should be more than three billion. BioNTech will manufacture at least half of this. To date, BioNTech and Pfizer have shipped more than 700 million doses of their Covid-19 vaccine to over 100 countries worldwide.

Dividend is possible

The shareholders should also benefit from the billions in sales generated with the corona vaccine. Chief Financial Officer Sierk Poetting said that in the next financial year it should be checked whether and in what amount a dividend is possible.

However, the strategic priority for 2021 is the reinvestment of the capital in order to further advance innovations in various therapeutic areas and technologies as well as our corporate development, said Poetting. The Mainz biotechnology company achieved a net profit of 1.1 billion euros on sales of 2.05 billion euros in the first quarter of this year .

New production facilities

There was also news from BioNTech outside of the Annual General Meeting. The European Medicines Agency’s Committee on Medicinal Products for Human Use gives the go-ahead for two more production facilities to manufacture the joint corona vaccine from Biontech and Pfizer.

One becomes accordingly in Reinbek, Schleswig-Holstein, operated by Allergopharma, the parent company of Dermapharm , the other in the Swiss stone from Novartis Pharma. The work can be started immediately, since no approval from the EU Commission is required

BioNTech Annual General Meeting Successful with mRNA technology

Status: 22.06.2021 10:25 a.m.

At today’s Annual General Meeting, the BioNTech top management can boast great successes. This is not only due to the corona vaccine, in which the company has left many competitors behind.

From Bianca von der Au, ARD stock exchange studio

What happened to the Tübingen-based vaccine manufacturer CureVac is actually the norm in the biotech industry: one drug candidate disappoints. Research is tedious and devours billions. The rapid success of the competitor BioNTech was more than a stroke of luck, believes asset manager Hendrik Leber from the private corporation Acatis. The Mainz biotech company did a lot of things right, he says. “BioNTech made the decision very quickly to develop a vaccine at all. And the choice of partner to work with Pfizer was an extremely good decision.” The US pharmaceutical company opened the door to the American market and at the same time pushed ahead with marketing and clinical studies at a rapid pace.

Does CureVac’s chance lie in the mutants?

The Tübingen competitor CureVac is not only lagging in terms of time, but also in terms of time Effectiveness of his vaccine after. Experts are divided as to whether this deficit can be made up at all. Pharmaceutical specialist Alexander Nuyken from the consulting company EY gives the race is not lost for CureVac – in view of the constant number of new mutations and a low vaccination rate among the world’s population.

mRNA vaccine with great potential

However, the EY expert sees enormous potential in biotechnology, especially in the field, beyond the corona vaccine novel mRNA technology , which CureVac is also researching. “It was originally not developed with Covid in mind, but for completely different therapies, such as cancer”recalls Nuyken. There is the potential to address other diseases with this technology, namely, according to the expert, “cheaper, faster and more efficient.”

There is great hope – not only among investors – that mRNA technology can develop effective agents against previously incurable diseases – not only against cancer, but also against Alzheimer’s, for example. BioNTech has been researching a vaccine against cancer for a long time and, a few days ago, treated a skin cancer patient with an mRNA vaccine for the first time in a phase II study.

Would you like more willingness to take risks?

The path to the surprising success with the corona vaccine was only possible for BioNTech thanks to patient donors in the background. EY pharma expert Nuyken believes that there is a need for greater willingness to take risks in Germany. “How do we get the good science that we undoubtedly have in Germany in companies? And how can we then further develop these companies until they are ready for the market?”the expert asks.

He sees this as the biggest hurdle in the German environment. “In contrast to the American market, we have significantly less capital that is available for the development of these companies.” So it’s no wonder that CureVac and BioNTech have been listed on the Nasdaq technology exchange in the USA in the past two years. But also in Germany, Corona and the search for a vaccine have put the biotech industry in the (spotlight) light. According to EY, the German biotechnology company is in the Corona year 2020 so much capital flowed in as never before . In CureVac, the federal government even invested 300 million euros – a risky investment

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.”

Manufacturers deliver less Vaccination campaign could stall

Status: 16.06.2021 2:47 p.m. In Germany there will be fewer BioNTech cans available next month. Johnson & Johnson is also delivering less than planned. The German vaccination campaign could suffer a setback as a result. The vaccine manufacturer BioNTech will deliver significantly less vaccine to Germany in July than in June. Instead of 5.7 million cans for the last week of June, only 3.2 million cans are planned for the first week of July (KW 27). But there could be no question of a surprising cut, said a spokesman for the Federal Ministry of Health. Rather, BioNTech preferred deliveries in June that were actually intended for later. It was always clear that the delivery volume of the Mainz manufacturer in the third quarter would be around 40.2 million vaccination doses lower than the around 50 million in the second quarter. So far there has only been a clear delivery promise for the first week of July with 3.235 million cans. After that, around 3.3 million doses per week can be expected. That was also communicated to the federal states. SPD health expert Karl Lauterbach therefore warns of a setback for the vaccination campaign: “If the BioNTech deliveries fall so sharply, it will be difficult to demonstrate herd immunity before mid-September,” he told the “Spiegel”. At the same time, it is shown that the delta variant is highly infectious and sometimes causes severe disease. “That’s scary,” said Lauterbach.

06/02/2021

6.5 million fewer doses from Johnson & Johnson

The US pharmaceutical company Johnson & Johnson (J&J) will also deliver significantly fewer vaccine doses than planned. The European Commission expects that J&J will not be able to meet its delivery targets to the EU for the second quarter. The reason for this is a decision by the European Medicines Agency (EMA), according to which 17 million doses of the vaccine cannot be used in the EU for safety reasons after cases of contamination have occurred in a US plant. The group will therefore probably not reach its delivery target of 55 million cans by the end of June, says a commission spokesman. So far, only around twelve million cans have been delivered. The Federal Ministry of Health estimates that J&J will be able to deliver around 6.5 million fewer doses to Germany than planned by the end of June because of the breakdown. “That is unfortunate, because every vaccine counts,” said a spokeswoman. The ministry expects the missing quantity to be replenished in July.

June 16, 2021

Waiting for Sputnik and Curevac

The Germans will probably have to wait even longer for the Russian vaccine Sputnik V, because, according to government circles, approval will be postponed “probably to September, maybe even to the end of the year”. The reason is that the Russian manufacturer has not yet submitted the necessary clinical trial data to the European Medicines Agency (EMA), the news agency Reuters learned from government circles. The clinical dossier was supposed to be available by June 10th. The Russian state fund RDIF, which sells Sputnik V, described the information as incorrect. All the necessary data on the clinical studies have been submitted and received positive comments. Initially, no comments were received from the EMA. The vaccine from Curevac is also not yet available. The vaccine from the Tübingen company, once praised as a bearer of hope, is still not approved. The Federal Ministry of Health has therefore canceled the delivery of 1.4 million vaccine doses originally planned for the current second quarter. According to health expert Lauterbach, the delay in approval could indicate that the effectiveness of the Curevac vaccine is not looking good.

06/07/2021

Moderna delivers a little more

Meanwhile, there are increasing complaints about the shortage of vaccines – from company doctors, general practitioners and some vaccination centers. The calls from some prime ministers for more vaccine also persist – while millions of Germans are still waiting for an initial vaccination. There is positive news from Moderna: The US manufacturer will increase its delivery volume compared to June, from 622,000 to 733,000 cans per week. In addition, Schleswig-Holstein is giving part of the AstraZeneca vaccine provided by Denmark to Hamburg. Thanks to the delivery, at least 8,000 new appointments can be made in the vaccination center in the megacity since today. The neighboring state does not manage to use the cans from Danish stock in time before the expiry date at the end of June.

background June 15, 2021

Industry collects billions Record sums for biotech companies

Status: 15.06.2021 10:46 a.m.

The successes of biotech companies such as BioNTech attract investors: The industry has a new financial record in Germany. But the exuberance could be followed by disillusionment. By Thomas Spinnler, tagesschau.de The entire biotech industry is currently benefiting greatly from the attention generated by the rapid and successful development of corona vaccines. The pandemic has given a boost to a sector that is already in the focus of many investors due to technological and medical advances in recent years. As the “Financial Times” (FT) reports, the venture capitalist Flagship Pioneering – one of the major investors in the Vaccine manufacturer Moderna – around $ 3.5 billion for a new fund. Its aim is to promote the next generation of biotech companies.

Fund tries a new model

When investing in the biotech industry, investors must calculate with particular risks. Many of the companies to invest in do not yet have a product on the market. It is uncertain whether this will ever be the case, as the path from research to a marketable product is very long and often fails.

01/06/2021

Flagship Pioneering is now trying a different way. What is special, according to “FT”, is that the fund’s goal is not the usual search for newly founded companies in which to invest. Rather, modern biotechnologies are to be developed in-house in certain segments under the umbrella of the fund. Only then are plans to set up companies as offshoots.

The profits are gushing

Unsurprisingly, financiers are on the lookout for business ideas; they smell a gigantic business. Just a look at the rapidly rising share prices of many companies in the past few months shows how convinced the market players are of a lucrative future for the sector. In fact, profits are gushing – at least for the best-known representatives who have successfully launched products. BioNTech generated a net profit of 1.1 billion euros in the first quarter of 2021. In the first quarter of 2020, the Mainz-based company had to accept a net loss of 53 million euros due to high research and development costs.

05/10/2021

The US vaccine manufacturer Moderna made in the first quarter profit – equal to a billion dollars. In the previous year, Moderna had to cope with a loss of 124 million. The turnover multiplied from eight million to 1.9 billion dollars. $ 1.7 billion of this comes from corona vaccine revenue. While Moderna shares rose by more than 200 percent in the past twelve months, BioNTech shares gained over 340 percent in the same period.

Lighthouse companies in particular benefit

In Germany, the biotech industry set a new financial record last year. As the experts from the testing and consulting company EY calculated in their Biotech Report 2021, financing in Germany reached a peak of 3.1 billion euros in 2020. A comparison with the USA shows the order of magnitude. According to EY, around $ 100 billion went into biotech financing for venture capitalists.

02/27/2021

“Covid-19 is a huge catalyst for the entire biotechnology industry,” said Alexander W. Nuyken, Head of the Life Sciences Sector in Strategy and Transactions at EY and co-author of the study. In their report, the experts at EY point out that the investments essentially relate to the flagship company BioNTech, which alone accounted for 51 percent of the financing volume in 2020. According to Nuyken, biotechnology is part of the solution to a problem that is a matter of fate for humanity. “That has come to mind.”

More help from the state?

This year it’s going on at a high pace: The “Handelsblatt” quotes from preliminary figures from the Bio Deutschland Association. Accordingly, the industry received a total of 870 million euros in capital from January to May. That is around three and a half times as much as in the same period last year. Nuyken campaigns for the state to help even more: “I hope that politicians show more will to improve framework conditions.” There is now an opportunity for the biotech scene to play a major role in this country in the long term or to play an even greater role in the future.

Hope for new products

In fact, taxpayers have already made a major contribution to making the industry so successful: Since the beginning of the pandemic, governments have allocated tens of billions to research and development on vaccines, which are now generating sales and profits for companies. However, it is uncertain whether, thanks to the many fresh billions, the supply of innovative medical products will make a leap. Nuyken warns of disappointing expectations: “If investors with no biotech experience think they can make a quick buck here, they’re wrong.” After the boom, the expert warns, disillusionment could quickly set in.

Corona pandemic Pfizer trials vaccine on young children

As of: June 9th, 2021 8:38 pm

BioNTech and Pfizer also want their vaccine approved for children under 12 years of age. The first studies on this have already started. The product will soon also be tested on babies. From Antje Passenheim, ARD Studio New York BioNTech and the pharmaceutical company Pfizer are advancing the development of their Covid-19 vaccine for use in younger children. As Pfizer announced in New York, the group has expanded its clinical study to children under twelve years of age.

Admission already in October?

In the first tests, a small number of minors were given different doses of the vaccine. According to Pfizer, around 4,500 children between the ages of six months and eleven will now take part in studies in more than 90 facilities in the United States, Finland, Poland and Spain. Tests on five to eleven year olds began this week. They receive either a placebo or two doses of ten micrograms each. This corresponds to a third of the dose that adolescents and adults receive. Pfizer expects to get US approval for five- to eleven-year-olds by October. In a few weeks, children aged six months and over will be brought in for a study. These should only receive three micrograms per vaccination. A short time later, the group wants to apply for approval for children up to five years of age.

Severe disease courses in children are rare

Pfizer sells the serum developed by BioNTech, a Mainz-based company. Since children are generally less likely to get seriously ill with Covid compared to adults, the group relies on a lower dose vaccination for younger children, which should also have fewer side effects. In the European Union, the USA and Canada, the vaccine is already approved for children from the age of twelve and is sometimes used. In the United States, nearly seven million teenagers have received at least one dose of vaccine, according to health officials.

From Notker Blechner, tagesschau.de So far it has seemed that children are largely spared from Corona. Many who were infected with Covid-19 had asymptomatic or mild disease. Serious illnesses were rare. “I haven’t had a bad case so far,” says pediatrician Axel Gerschlauer from Bonn, regional spokesman for the professional association of paediatricians. But there have also been deaths in children in connection with a corona infection. Long-term effects are even more common. More than 250 cases of the PIMS syndrome (“Pediatric Inflammatory Multisystem Syndrome”) have already been counted. This is an immune reaction that occurs a few weeks after infection, especially in children, and can be life-threatening.

Some children suffer from long-term effects

Surveys from abroad are also alarming, according to which numerous children and adolescents suffer from “long covid”, i.e. post-viral symptoms weeks or months after the infection. According to recently published data from Great Britain, 15 percent of adolescents between the ages of eleven and 16 complained of persistent headaches, sudden learning disorders or a drop in performance in sports five weeks after the corona illness. In a study by a clinic in Rome, it was even found that almost half (43 percent) of the children infected with Corona had at least one symptom that was affecting them four months later. “Children are not the drivers of the pandemic,” said Jörg Dötsch, President of the German Society for Child and Adolescent Medicine. However, since February the incidence among the youngest has also increased significantly in Germany. On the one hand, this may be due to the numerous tests that were carried out in schools. On the other hand, the proportion of people over the age of 70 in cases of illness has fallen significantly, as they have largely been vaccinated. Pediatricians consider it important to vaccinate children and adolescents as quickly as possible – especially in view of the mutated South African, British and Brazilian corona viruses. This is the only way to achieve herd immunity. Experts now believe that 80 to 90 percent of the population should be vaccinated to ensure collective protection. Because the more contagious the virus, the higher the vaccination rate must be. “If vaccination is not carried out across all population groups, extensive immunity cannot arise in the general population,” says Thomas Fischbach, President of the Association of Pediatricians. Heinz Hilgers, President of the Child Protection Association, also says: “We will not get out of this pandemic without vaccinations for children.”

Schoolchildren in Israel already vaccinated

Vaccine manufacturers understand the importance of children and teenagers. “Younger children, who make up a large part of the world’s population, play a crucial role in our fight against Covid-19,” said BioNTech and Pfizer recently. The German-American company duo wants to accelerate the development of vaccines for children and adolescents. BioNTech boss Ugur Sahin spoke of promising studies at the analysts’ balance sheet conference. A phase III study in 12 to 15 year olds was particularly successful. The vaccine has been shown to be safe and effective in this age group. None of the vaccinated 2260 participants in the study was sick with Covid-19, it said. “The first results of the study in adolescents indicate that children are particularly protected by the vaccination,” said CEO Sahin. BioNTech-Pfizer plans to apply for emergency approval in the USA and the European Medicines Agency (EMA) in the coming weeks. Pfizer boss Albert Bourla is confident that the first young Americans will be vaccinated in the US before the start of the next school year. So far, the drug has been approved for people aged 16 and over in countries such as the USA and Israel. In Israel, the first pupils under the age of 18 were vaccinated.

The very little ones still have to wait

Now there should also be clinical tests for vaccines in children between six months and eleven years. If the study is positive, the vaccine could be used in the youngest from the beginning of 2022. The US company Moderna and the British-Swedish pharmaceutical company AstraZeneca were faster. They had started testing their corona vaccines on younger children even before BioNTech-Pfizer. The results of the Moderna study for the vaccine in 12 to 17 year olds are expected in the middle of the year. The US FDA has approved Moderna tests on children aged six months to twelve years. AstraZeneca began a study of its vaccine in 6 to 17 year olds in the UK in February. Johnson & Johnson is also planning its own pediatric studies. The European Medicines Agency has obliged the four major suppliers to also test their vaccines for children.

BioNTech and Pfizer clearly ahead

But so far BioNTech-Pfizer has been ahead in the race for children’s vaccines. Analysts like Daniel Wendorff from Commerzbank are convinced of this. The Mainz vaccine is so far the only one that has been proven to be effective in 12 to 15 year olds. BioNTech and Pfizer would have such great market power anyway that the two companies could quickly increase production. When it comes to absolute vaccination doses and the availability of data, BioNTech-Pfizer is a leader, says Wendorff. The EU is increasingly relying on BioNTech-Pfizer. Brussels is about to finalize a huge order for 1.8 billion cans, the majority of which are for children and young people. The rest are booster vaccinations that are likely to be required in the years to come.

First approval in late summer?

Thomas Mertens, the chairman of the Standing Vaccination Commission (Stiko), has shown confidence that in Germany Corona vaccine available for children at the end of the year will be. Association president Dötsch even hopes that “we will get a vaccine for 12 to 15 year olds in late summer or autumn at the latest, for smaller children it will probably take longer”. However, other experts warn against being too optimistic. “Children are not little adults,” says pediatrician Gerschlauer. You can’t give them half the dose just because they’re half the size of adults. The immune system of the little ones is completely different. In addition, there is the problem that it is more difficult to find children as test subjects for studies. Smarter would like to see a vaccine approved for the youngest of our society as soon as possible. Because children in particular are the biggest losers in the corona pandemic. In his practice he currently counts more young patients with mental disorders than ever before. “Many have eating and sleeping disorders or even depression.” This is confirmed by Jörg Dötsch, President of the German Society for Child and Adolescent Medicine: “70 to 90 percent of children are under severe psychological stress from the pandemic,” he estimates. “We’re really worried about the little ones.”

From Axel John, SWR In Germany, the vaccinations against SARS-CoV-2 have been running for almost four months. It seems to be becoming increasingly clear that the vaccines from the manufacturers BioNTech / Pfizer and Moderna with the new mRNA principle work best. AstraZeneca’s preparation with its gene-based vector vaccine is only given to elderly patients after a few cases of thrombosis. The Johnson & Johnson vector vaccine also had concerns long before it has now been released . Will mRNA technology dominate the market in the future?

Initially skeptical about mRNA methods

Norbert Pfeiffer can still remember the beginning of the Covid crisis in the spring of last year. The chairman of the board of the Unimedizin Mainz had quickly heard that Özlem Türeci and Ugur Sahin work on an mRNA vaccine against corona. Pfeiffer knows the BioNTech founders well. Türeci and Sahin had worked as cancer specialists in the clinic for years. Already there they pushed their idea of ​​an mRNA process – albeit in the fight against cancer.

Messenger RNA Messenger RNA, or mRNA for short, is a messenger molecule that brings genetic information from the cell nucleus to the ribosomes. These are the areas of the cell in which – according to the instructions for the genetic information – proteins are formed. The vaccines against SARS-CoV-2 use mRNA to stimulate the human body to produce its own antibodies as “drugs” against the coronavirus. Vaccines based on mRNA can be developed, adapted and manufactured more quickly than conventional preparations such as vector or dead vaccines. “There was skepticism about the mRNA technology against corona. Conventional vaccinations, such as those against flu, have been administered with great success for decades. But vector vaccines, for example against Ebola or dengue fever, have also been in use for a long time many hoped again in the Corona crisis. But this assessment has completely reversed “, Pfeiffer draws an initial interim balance. “The mRNA active ingredient against Covid-19 was finished earlier. With around 95 percent, the vaccination with the BioNTech active ingredient is very effective. It is thus far above the other protection rates. That was not expected.” And even after the clinical tests, the mRNA vaccine has proven itself, said Pfeiffer. “Overall, the side effects were very moderate. At AstraZeneca with the vector vaccine, there were very rare exceptional cases of thrombosis. Even if this is a good vaccine, the mRNA vaccine performed better in many areas and made a breakthrough. ”

Norbert Pfeiffer still knows the BioNTech founders Türeci and Sahin from their work as cancer specialists at the University of Mainz. Image: Mainz University Hospital

Vector vaccines are, however, indispensable

But is this only a one-off success in the fight against Corona or will the mRNA process also establish itself in other areas? “I’ll compare that with the development of cameras,” explains Pfeiffer. “Cameras with film were very good 20 years ago. The first digital cameras were very expensive and could hardly keep up in terms of quality. Today there are hardly any cameras with film. Many companies have invested, researched, produced and competed. I suspect that in the mRNA process it could be similar. ” At present, mRNA vaccines could by far not meet the global demand with a world population of almost 7.8 billion people, says Pfeiffer. “They can produce, store and administer vector vaccines cheaply all over the world. The preparations are very robust. The mRNA process, on the other hand, is expensive, and the ingredients are very susceptible to fluctuations in the cold chain, for example. We can use them in the longer term Vector vaccines don’t do without. ”

“The world of vaccines will never be the same”

Different location, similar assessment: Matthias Kromayer works on the board of MIG AG. The former management consultant has a doctorate in molecular biology. MIG AG is currently investing in 30 start-ups – one focus: biotechnology. The company was one of the first donors at BioNTech. In 2008 the Mainz start-up received a good 13 million euros from MIG. The potential of the mRNA process was recognized early in Munich. “During the corona crisis, only one company from the pharmaceutical giants GlaxoSmithKline, Sanofi, Merck and Pfizer backed the right horse – namely Pfizer with BioNTech,” says Kromayer. Even before that, not much had happened in terms of research for years. The HPV vaccination against cervical cancer was the last real innovation. Vaccines have only been combined – nothing more. “Medical research has changed completely in the past year due to mRNA. The world of vaccines will never be the same again,” Kromayer is convinced. With the mRNA technology, the researchers would have a completely new approach. Every disease has a biological origin, explains Kromayer. mRNA as a messenger substance is always included in these processes, and that’s why you can start here – not only with SARS-CoV-2. Kromayer cites a current example from BioNTech: Just a few weeks ago, the company achieved the first promising results against multiple sclerosis – also using mRNA. “These are huge possibilities. The mRNA technology can also help the fastest in the fight against Corona. Should a new mutation soon appear after the British variant, you would have a new vaccine against it within 48 hours. After quality controls, the new preparation could then available after six weeks. ”

EU relies on mRNA in the long term

The subject of speed in the pandemic now also plays a major role in Brussels. After the EU Commission ordered too late and too few vaccines last year, people now seem to want to learn from their mistakes. So far, the EU has ordered 300 million cans from AstraZeneca and 200 million from Johnson & Johnson. It shouldn’t be more here, because both manufacturers offer vector vaccines.

“Only Pfizer bet on the right horse,” says MIG AG board member Matthias Kromayer. Image: MIG AG “I see no reason to saddle up again. The mRNA vaccines protect better and have fewer side effects,” explains Peter Liese. The Christian Democrat is the health policy spokesman for the EPP Group in the European Parliament. “In the long term, the main issue is how do we get the best vaccine that will protect us from further mutations in 2022? All of this speaks in favor of mRNA. The Commission should also rely on it in the long term.” This assessment fits in with the fact that the Commission only started negotiations with BioNTech / Pfizer on a third contract a few days ago. It is about 1.8 billion doses of vaccines for the years 2022 and 2023. There was no mention of other providers.

mRNA technology speeds everything up

The mRNA technology accelerates research enormously – but what does that mean for the testing authorities such as the Standing Vaccination Commission (STIKO) or the European Medicines Agency (EMA)? For medical professional Pfeiffer this is clear: “The authorities have to speed up. Further Covid mutations must be expected in the short term. The mRNA principle has already been approved and will only be sharpened for a new variant.” The same applies to other diseases – such as cancer. “If an individualized therapy is only developed for one patient using mRNA, the authorities cannot check everything again. That would take far too long for successful treatment. The principle has to be checked and approved once.” In Munich, too, analyst Kromayer speaks a lot about speed. “We would never have dreamed of this rapid development. We had the hope of getting the first approved personalized cancer vaccines based on mRNA from 2024. BioNTech and Moderna were the pacemakers in the Covid crisis. Many other companies are now turning to mRNA -Technology jump and that will speed everything up again. “

The financing of the German biotech companies rose to a record value of 3.1 billion euros last year, more than twice as much as in the previous record year 2018. However, half of this – 1.55 billion euros – went to the financing of the two vaccine developers BioNTech and CureVac. But even without these two lighthouses, the domestic biotech companies would have collected a record sum of around 1.5 billion euros, as figures from the audit firm EY show.

Biotech companies from Germany suddenly in focus

“2020 was an exceptional year in every respect for the German biotechnology industry,” explains one of the study’s authors, Alexander Nuyken. “The corona pandemic has suddenly brought biotech companies from Germany and their solutions for vaccines into focus. The financing figures are exploding.” As in 2019, two biotechnology companies from Germany took to the trading floor in 2020 – albeit not in Europe, but on the Nasdaq technology exchange in New York: CureVac and the Tübingen-based company Immatics. They received 215 and 224 million euros respectively in this way.

Reached serious size

CureVac has been particularly successful in raising venture capital. The company received a total of 560 million euros, including a state contribution from KfW over 300 million euros for the development of a corona vaccine. The company thus combined well over half of the total collected venture capital – together, the German biotech companies received 882 million euros, 84 percent more than in the previous year. Risk capital or venture capital is money that is made available for start-ups and young companies, often by investment companies, so-called venture capital funds. Overall, the German biotech companies have risen to a serious size. According to the EY figures, they generated sales of 3.2 billion euros in 2020, 43 percent more than in the previous year. The number of employees increased by 18 percent to 13,995. When it comes to spending on research and development, the listed biotechs can even report growth of two thirds to 1.4 billion euros.

Biotechs aren’t just vaccine makers

It is important to use this momentum to sustainably strengthen the biotech location and to show that the biotech industry can not only be used to fight diseases, but also offer innovative solutions for environmental, energy or nutrition issues, emphasizes EY expert Nuyken . “Biotech must be seen as a key technology in many areas, not just in the pandemic,” says Oliver Schacht, CEO of the Bio Germany industry association. Politicians must improve the conditions for financing growth. Although there is money in Germany for basic research and the early-stage financing of companies, there is a lack of large sums for the later clinical phases of drug development. Investors such as insurance companies are unlikely to invest in biotech companies, and share profits in Germany would be highly taxed.

Barrier to foreign trade regulation

In fact, the lawmakers have tightened the foreign trade regulation for fear of selling out German know-how and thus created a further barrier to investments from abroad, the EY experts also complain. Investors who are not based in the EU, for example, require a special permit with a stake of ten percent or more. According to the EY study, this is increasingly becoming an obstacle to investing urgently needed capital for the entire biotech industry. Because many European venture capital funds are based in locations outside the EU for tax reasons.

The European Union has agreed with the manufacturers BioNTech and Pfizer to deliver a further 100 million corona vaccine doses. This means that the EU will now definitely receive a total of 600 million vaccine doses for the 27 member states, announced the pharmaceutical companies. The 100 million cans already contain the 50 million that the EU announced last week that they would be delivered. The Commission had already agreed on an option for this additional vaccine at the beginning of the year, which is now being implemented.

Cans cover around two thirds of EU needs

“The additional 100 million vaccine doses from this option will help accelerate vaccination campaigns in the EU,” said BioNTech board member Sean Marett. The 600 million cans covered about two thirds of the needs of the European population. According to this, 250 million cans are to be delivered in the second quarter. That is four times as many cans as in the first quarter. EU Commission head Ursula von der Leyen also confirmed a few days ago that the Commission is holding talks with both companies about a further contract for 1.8 billion cans for delivery in the next year and the year after. The EU’s vaccination campaign has recently been criticized time and again for being too slow.

The manufacturers BioNTech and Pfizer want to deliver an additional 50 million doses of corona vaccine to Germany and the other EU countries by the end of June. This was announced by the EU Commission chief Ursula von der Leyen in Brussels. It is a delivery that will be brought forward from the fourth quarter. In the second quarter from April to June, a total of 250 million doses of vaccine would come from BioNTech / Pfizer, said von der Leyen. The delivery will be distributed to the 27 EU countries according to the proportion of the population, she added. For Germany this is 18.6 percent. The Federal Republic of Germany can therefore expect a good nine million cans from the additional delivery. This could partially offset potential failures in Johnson & Johnson’s vaccine. The US manufacturer had postponed its delivery to the EU countries on Tuesday. The background to this are reports of sinus vein thrombosis. The group is investigating the cases, and the European Medicines Agency (EMA) is also examining them. It is unclear when deliveries will resume in Europe.

Negotiations over 1.8 billion vaccine doses

Von der Leyen also announced negotiations with BioNTech / Pfizer for the delivery of a further 1.8 billion vaccine doses for the period from 2021 to 2023. These should be used for refresher courses and vaccinations for children. Part of the agreements should be a full EU manufacture, not just of the vaccine, but of all the essential ingredients, as von der Leyen said. They hope that the negotiations will be concluded quickly. Von der Leyen emphasized that they wanted to focus on vaccine technologies that had proven their worth. That speaks in favor of mRNA vaccines like those produced by BioNTech / Pfizer. AstraZeneca and Johnson & Johnson, on the other hand, use a different mode of action for their vaccines with the help of so-called adenoviruses. Von der Leyen also announced that the EU has now passed the 100 million vaccination threshold. 26 million people are now fully vaccinated with two doses. “This is a milestone that we can be proud of,” said the German politician. The Commission is doing everything possible to increase the supply of vaccines in the coming weeks and months.