Markets & Companies

Vaccine Research – an Ambitious and Important Venture

Vaccines protect the lives of millions, but developers and manufacturers are facing several challenges

20.04.2020 -

The worldwide spread of the corona virus shows once again that despite all technological progress, humanity is still exposed to health risks. The biotech and pharmaceutical industry often succeeds in developing protective vaccines against such diseases. However, the companies take a high economic risk and have to comply with strict requirements. View of an industry that plays by special rules.

It all started very small on the fish market in the Chinese city of Wuhan. When the first reports of a new type of virus made their way into the media in early January 2020, only a few suspected that it would develop into a global health challenge. At the latest when the first people fell ill with the new corona virus (image page 25) in a Bavarian company, when Italy cordoned off whole villages and areas of land and the stock markets worldwide collapsed, it was probably clear to most that this was much more than just a local fish market affair.
With the rapid spread of the corona virus, the question also arose of how mankind could protect itself against this threat. The ideal would be prophylactic vaccination. But it could take a year or two before this is developed and approved — in the best case.
Time and again, infectious diseases take hold of humanity, often resulting in thousands or even hundreds of thousands of deaths. Smallpox and measles have taken a heavy toll for many years. According to the German Robert Koch Institute, 290,000 to 650,000 people succumb to influenza, which regularly afflicts large parts of humanity, every year.

Eradication Through Vaccination
On the other hand, numerous dis­eases have been completely or largely eradicated through consistent vaccination. The last cases of smallpox were recorded in Somalia in 1977, the last case in Germany was reported in 1972. Measles has also been largely eliminated by widespread immunization.
Other infectious diseases, how­ever, are persistent, such as the annual influenza or „real“ flu. The World Health Organization (WHO) even warns of an influenza pandemic, i.e. a wide distribution on several continents simultaneously: „The world will face another influenza pandemic — the only thing we don‘t know is when it will hit and how severe it will be.”
To protect against the flu, the vaccine is adjusted annually. For example, the Paul Ehrlich Institute (cf. page 26), which is responsible for vaccines in Germany and monitors their quality, efficacy and safety, has approved a number of influenza vaccine products for the 2019/2020 season for strain adaptation.
The Chikungunya virus poses a threat of a different kind. It is transmitted by Aedes mosquitoes such as the Asian tiger mosquito and leads to Chikungunya fever in humans. The virus is mainly found in the tropics and subtropics. Since the Asian tiger mosquito now also occurs in Germany, a further spread of the virus must also be expected here.

Nothing Protects Better Than Vaccination
We can keep our distance, sneeze into our arms, wear face masks or disinfect our hands. However, nothing protects against a viral infection as effectively as vaccination. „Vaccinations are among the most important and effective preventive measures available in medicine. Modern vaccines are well tolerated and adverse drug reactions are only observed in rare cases,“ says the Robert Koch Institute.
In fact, most people come into contact with a vaccine at some point in their lives — be it a childhood vaccine, a travel vaccine, a flu vaccine or, for example, a vaccine against cervical cancer.
Vaccines can be divided into different classes: Live vaccines use attenuated pathogens as carriers, which are equipped by the researchers in such a way that the immune system is feigned to be infected, thus creating immune protection. In this way, for example, a vaccine against Ebola has been developed. In turn, dead vaccines are based on inactivated pathogens. There are also gene-based vaccines. They try to activate the body to produce viral proteins that build up immune protection. Such vaccines are not yet on the market, but could possibly be produced quite quickly.
The development of a vaccine poses particular challenges for biotech and pharmaceutical companies. On the one hand, the preparations should be available quickly after the appearance of a new pathogen. At the same time, the quality requirements for vaccines are particularly high. Since they are usually administered to healthy people, vaccines should have no or only minor side effects. The starting position is therefore completely different from that of oncological products, for example, where considerable side effects are accepted if the patient simultaneously receives a survival benefit from the product.
Furthermore, some vaccines are real multi-purpose weapons that immunize against several diseases with just one injection. Producing a vaccine that is effective against 13 different serotypes, for example, to prevent infection with pneumococci is a challenge: „It‘s like making 13 different vaccines. The production process is divided into 581 individual steps,“ says the pharmaceutical company Pfizer.

Development In Stages
The development of a vaccine is a multi-stage process. First, the virus has to be analyzed and the question needs to be answered what of it causes immune reactions. The next step is the design of the active substance: which parts of the virus and which additives should be contained in the substance? Finally, the vaccine candidate has to be first tested on animals and then on humans.
However, the development and production of a vaccine is also an economic challenge. Vaccine manufacturers run the risk of developing and producing in the void. Once a vaccine against a new type of viral disease has been developed to market maturity, it is possible that the virus is no longer virulent and hardly anyone will need the vaccine. The companies can produce in stock or for government-guaranteed quantities; it is also possible that the virus will come back to life in a year or two and the vaccines will then be needed. But a solid business base looks different.  
In the past, the high demands on vaccines have led to many companies withdrawing from this business. Globally, the vaccine market is now dominated by a good dozen companies, including GlaxoSmithKline (GSK), Merck & Co, Sanofi and Pfizer. GSK confidently claims to be one of the largest suppliers of vaccines worldwide: „We develop, manufacture and deliver more than two million doses of vaccine every day to people in 150 countries.“ The portfolio comprises approximately 40 vaccines, including preparations that protect against pneumococcus, meningitis, hepatitis, rotavirus infections, whooping cough and influenza.

"The world will face another influenza pandemic – the only thing we don't know is when it will hit and how severe it will be.”

The much smaller US company Novavax, however, argues with the strengths of its technology. „Our carefully designed genetic constructs allow us to tailor our vaccines to key components of pathogens, which we believe enhances functional immunity and leads to better protection against infection and disease.” The company also relies on speed in development: „Unlike traditional influenza vaccine manufacturing, we do not need to grow an actual influenza virus, obtain embryonated chicken eggs, adapt the virus or optimize new strains to grow in eggs. This 50-year old method requires four to six months lead time to produce a new strain of virus and significant investment in fixed production facilities.”
But the best vaccines are of no use if they are not taken. The WHO sees a great danger especially in the refusal of some to vaccine: „Vaccine hesitancy — the reluctance or refusal to vaccinate despite the availability of vaccines — threatens to reverse progress made in tackling vaccine-preventable diseases“. Vaccination, according to the WHO, currently prevents 2-3 million deaths a year. This value could be increased. If global coverage of vaccinations improved, a further 1.5 million could be avoided, according to the international health authority.
Currently, all hopes rest on the development of a coronavirus vaccine. This could also save the lives of many people.