Life-saving Corona vaccines: hope vs. research reality

Insights , Videos , Coronavirus 5/22/2020
Reading time: 9 minute(s)
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Worldwide, 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.

  

Explain video: What needs to be done to bring a vaccine to market?


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

  

  

Why the search for a vaccine can’t go any faster – and shouldn’t

Expert interview

There has been a lot of news 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.

Update: To reflect the latest developments, this article was updated to the latest facts and figures on July, 1st.

  

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PhD Stefan Schneider

Head of Life Sciences at Vontobel Research, molecular biologist and Chartered Financial Analyst (CFA)

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

It is a big step in the right direction that, alongside the more traditional methods for developing a vaccine, several novel lines of attack are also being explored. This more diversified approach should increase the chances of success. As of today, we estimate that there are more than 150 different Coronavirus vaccine candidates being pushed through development, at maximum speed. Under normal circumstances, it would not make sense to develop so many vaccines, all against the same virus. But the circumstances are not normal. First, since these tremendous efforts need substantial financing, governments and trusts are providing strong financial support. And second, in order to ensure that these investments are made in the most sensible way possible, collaboration is essential. Information needs to flow freely if we want to increase the chances of success for all of these projects. One example that you will often see referred to is the collaboration between the French company Sanofi and the British firm GlaxoSmithKline – which both belong to the few large producers of vaccines and, as such, are actually direct competitors. So collectively, there is an absolute desire to cooperate on a Coronavirus vaccine, from development all the way through to manufacturing. During clinical trials as well, collaboration is taking place between vaccine manufacturers. This means it should be possible to get mass production started as soon as one of the drug candidates has proven successful in trials.

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

Everybody is pushing for speed to market. Can this have a positive outcome, or do you think that the risks are too great? After all, there’s a reason why vaccine development usually takes years, or even decades…

Because of the time pressure we’re under, vaccine candidates are moved faster to clinical trials, with time spent in pre-clinical testing kept relatively short. This will lead to a higher rate of products dropping out of clinical development compared to what we normally observe in vaccine development. In addition, it means that vaccine candidates will be tested in fewer trial participants – and that will result in fewer data available to evaluate the efficacy and safety of the drug.

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 the regulatory authorities that need to give their approval for launch. For a vaccine, this process would normally take a year. But here, too, there is pressure to shorten the approval timelines. 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.”

Leaving the US successes behind for a moment, let’s look at China. Initially, this country was accused of being very tight-fisted in the way it shared crucial data with the rest of the world. In principle, how important is it to share data immediately?

There are two aspects here that need to be balanced. On the one hand, it is essential that new findings related to SARS-CoV-2 and COVID-19 are shared as quickly as possible, in an open and transparent way. The media help make sure this is the case, as well as other channels such as scientific journals that mostly provide all relevant content free of charge. On the other hand, no matter the time pressure, the validity of the data needs to be ensured. At the onset of the pandemic, the world was more dependent on information from China, which has never enjoyed a reputation for credibility. There was also criticism that important scientific findings from other parts of the world were being published in scientific journals instead of being made directly available on the web, which caused further delay because of the peer-review process. In my view, however, if we sacrifice the extra time for reviewing and validating scientific data, crucial information would get lost in a sea of second-class speculations, observations and opinions. Sometimes you simply need to take some extra time to reach a goal even faster.


Will 12 to 18 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 don’t 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 – i.e. weakened – virus, this new technology uses genetic viral material that is translated into viral protein in the body, where it is recognized by the immune system as foreign. This triggers an immune reaction that should provide the body with immunity to the real virus. This new type of vaccine can be developed and manufactured much faster compared to traditional vaccines. As great as this sounds, though, the caveat is that even though this novel approach has been in development for the past decades, it has never yet worked in humans. In other words, besides the will to win, we also need some luck that this new technology will actually prove effective, for the first time, in this emergency situation.

“Too great a speed at the beginning jeopardizes the risk/benefit assessment in the end.”

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

Moderna’s mRNA vaccine candidate is currently among the projects that are furthest out front in the race for a Corona vaccine. On Monday, May 18th, the company published interim data from a Phase 1 clinical trial. Their vaccine candidate triggered binding antibodies in all the participants, and neutralizing antibodies were elicited in the first 8 participants to be analyzed. Neutralizing antibodies are those believed to be necessary to provide immunity. So this is exciting news and an important step in the right direction. A Phase 2 is planned with more participants to be tested, 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 you can see, many pieces of this puzzle still need to fall into the right place – but the first, important one is already in position.

 

  

 

 

Update*

*as per the end of June 2020

The one encouraging characteristic of this virus is that it can be contained. However, if this is not done with the necessary discipline, the virus will once again take the upper hand – until we have built up so-called herd immunity.

The interesting question is, when will we have built up herd immunity?

To reach that state, a vaccine is needed. Many vaccine candidates are in development (as explained in the original interview above), with mid-2021 being the earliest that broad availability could be expected.

If that timeframe is realistic, it means that the development time will have been only one tenth as long as is normally required to develop a vaccine. This is good news – but it could have a price. As the CEO of the French pharmaceutical giant Sanofi, one of the few large vaccine producers, explained this week, the price could be that the vaccine produced so quickly will be less efficacious than what could have been achieved if more time had gone into the process. He expects the first vaccines to render immunity to only 40–50% of the people vaccinated. This is more or less in line with our estimate of 50%.

Based on this information, it is possible to calculate the time needed to achieve herd immunity of 60% – the hurdle that needs to be achieved in order to push the Coronavirus into the background. Taking the Swiss influenza vaccination rate of 50% as a proxy and assuming an efficacy of 50%, only 25% of the population would reach immunity in the first year. If in the second year, the remaining 50% of the population opt to be vaccinated – but now with an improved vaccine – assume it has an efficacy of 70% – another 35% of the population would gain immunity, for a total of 60%.

This means that at this pace – which is our best-case assumption –, it will take at least two years of vaccination (mid-2023) before we will have built up the immunity needed to regain our pre-pandemic lives. Until then, local outbreaks, re-imposed containment measures, and social distancing will be here to stay.

To ensure that we get through this three-year wait with the fewest possible setbacks, the best course of action is to continue to follow the recommendations of the Federal Office of Public Health (FOPH, or BAG in German). As observed elsewhere, the virus is still around, just waiting for us to drop our guard. In the last few days, the Swiss tracing app “SwissCovid” has been available for download. This app helps trace viral transmissions – a pre-requisite to staying on top of the pandemic. 

In general, we don’t foresee the situations as either black or white, but rather that things will remain much as they are now, i.e. local outbreaks needing local attention. The big question is whether the US can keep viral outbreaks confined to a local scale as well. If not, equity markets could likely take another hit. This question should be answered in the coming weeks.

  

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