Life-saving Corona vaccines: hope vs. research reality

Insights , Videos , Coronavirus 5/22/2020
Reading time: 6 minute(s)
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The search for a vaccine cannot – and should not – be accelerated indefinitely. Two experts explain why

Worldwide, more than 80 pharmaceutical companies and specialist laboratories are working on a vaccine against COVID-19. A breakthrough would be a game changer in the fight against the Coronavirus. This article outlines which bits of the puzzle must fall into place in order for hope to become a reality soon. Which quality standards should never be undermined on the way there?

  

The media is speculating when the coronavirus pandemic is coming to an end. Most likely it won’t be over until we find a vaccine. The good news is that around 80 different Coronavirus vaccine candidates are being pushed through development right now. However, it’s way too early to get excited about this as it might take six, twelve or even more months before a vaccine can actually reach the market. This is much longer than we would like – but much faster than the five, ten or even twenty years that many vaccines have previously taken to be approved.

  

Researchers and funders are laying the groundwork for efficacy trials, but only a handful of vaccines are likely to make the cut. This video explains in animated graphics what challenges they actually have to master. It reflects the state of research at the end of April 2020 and was created as part of our publishing partnership with Wired UK. © Wired UK

  

  

Expert interview

Over the last days, there has been a lot of newsflow about progress in the search for a coronavirus vaccine. However, there are three pre-requisites to win this race against time: never seen before collaboration between pharma companies, financial resources and flexibility at level of regulatory authorities.

  

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Stefan Schneider

Head of Life Sciences, Vontobel Research

Stefan, as a molecular biologist you have spent many years in research labs yourself. Tell us, how is it possible to accelerate development times for a vaccine so drastically? What are the crucial factors?

It is a big positive that aside the more traditional ways, there are also novel ways being explored of how to develop a vaccine. This more diversified approach should increase the chances of success. As of today, we estimate that there are about 80 different coronavirus vaccine candidates being pushed through development at maximum speed. Under normal circumstances, it would not make sense to develop so many vaccines to the same virus. But these are not normal times. As these tremendous efforts need substantial financing, governments and trusts provide strong financial support. In order to ensure the maximum benefit from these investments, collaboration is essential and information needs to flow freely in order to increase the chances of success for all projects. A recent example is the collaboration between French Sanofi and British GlaxoSmithKline – both of which belong to the few large vaccine producers of this world and as such are actually direct competitors. There is a collective will for collaboration from development through to manufacturing of a coronavirus vaccine. While clinical trials just have started, collaboration with manufacturers should ensure timely mass production.

A production chain is only as fast as its slowest link.

It is all about speed to market. Will this take a good end or do you think that this is too risky? It is not for no reason that vaccine development usually takes years or even decades…

Due to time pressure, vaccine candidates are moved faster to clinical trials, without the usual extensive pre-clinical testing. This will eventually lead to a higher attrition rate than what we normally observe for vaccine development. In addition, vaccine candidates will be tested in fewer participants what will result in fewer data available to evaluate efficacy and safety. In other words, in order to reach the market earlier, there is not sufficient time to optimize the vaccine. However, when development times are shortened, the risks are simply passed on to regulatory authorities that need to give their approval for launch. And if that would not be difficult enough, there is pressure to shorten the approval timelines that normally take about one year. Thus, the shorter the development timelines, the higher the pressure on regulatory authorities to assume risks for the approval.

“Even worse than delayed data is disordered data.”

Let’s swing over the China: the country is confronted with accusations that initially it has not shared crucial data with the rest of the world. In principle, how important is it to share data instantly?

I see here two aspects that need to balance. On one hand, it is essential that new findings are shared instantly and openly. This is ensured by media as well as other channels such as scientific journals that mostly offer all relevant content free of charge. On the other hand, despite all that demand for instantaneous information, the validity of the data needs to be ensured. At the onset of the pandemic, the world was dependent on information from China that never enjoyed great credibility. There was also criticism that important scientific findings from other parts of the world were published in peer-reviewed journals instead of directly making it available on the web. In my view, if we sacrifice the extra time for reviewing and validating scientific data, crucial information would get lost in a sea of speculations, observations and opinions. Sometimes it takes some extra time to reach a goal even faster.


Will 12 to18 months become the “new normal” timeline for vaccine development? Do you think that the current emergency approach will eventually lead to a disruption of traditional processes?

I do not think so. Especially in the case of vaccines, thorough testing – particularly for safety – is of utmost importance as these products are given to millions of healthy people.

Nonetheless, a new vaccine development technology has moved into the spotlight – the so-called “mRNA-” and “DNA-vaccines”. Contrary to traditional vaccines that use attenuated virus, this novel technology uses genetic viral material that is translated into viral protein in the body where it is recognized by the immune system as foreign. The body then mounts an immune reaction that should provide immunity to the real virus. This new type of vaccine can be developed and manufactured much faster compared to traditional vaccines. As good as this sounds, the caveat is that this novel approach has been in development for the past decades but has never worked in humans. In other words, aside the will to win, we also need some luck that this technology is just ready when we need it most.

“Too high an initial pace jeopardizes the risk/benefit assessment in the end.”

And a final question – even at the risk that your answer will have to be revised already tomorrow: Where do we currently stand? How do you judge the latest developments from “Moderna” that has received USD 483 mn from the US Biomedical Advanced Research and Development Authority (BARDA)?

Moderna’s mRNA vaccine candidate is currently the most advanced project. On Monday, May 18th, the company published interim data from a phase 1 trial. The vaccine candidate triggered binding antibodies in all participants and neutralizing antibodies were elicited in the first 8 participants analyzed. Neutralizing antibodies are those believed to be necessary to provide immunity. This are exciting news and an important step in the right direction. A phase 2 is planned with more participants and if successful, a pivotal phase 3 will start in July. If the phase 3 trial is positive, the company plans to supply a few hundred million doses of the vaccine before the end of the year. As one can see, many pieces of this puzzle still need to fall into the right place – with a first one already set.

 

  

  

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