March 11, 2020 4 min read
Since the outbreak of COVID-19, first reported on 31 December 2019, the world is waiting for a vaccine. Although scientists all over the planet are rushing to develop such a vaccine, for the anxious global population, it still is seemingly far away. But, contrary to what many believe, the challenge is clearly dual. Also, there are limits to how fast it is possible to develop a vaccine. Here we look at why!
First, scientists have to identify an active component making the vaccine effective. What may seem like looking for a needle in a haystack is, in fact, a methodical work based on massive information availability and deep knowledge in genetic mechanisms. However, just identifying an active component does not mean there is a safe and reliable vaccine. Instead, there is a potential vaccine.
To state a vaccine safe and effective, it takes clinical studies. These are typically carried out in phases, with an increasing number of test persons for each phase. During this process, the potential vaccine must prove not to be harmful, and the amount of active components to get the desired response must be established.
Such a process must take its time. Typically, it takes approximately 5 years to have a vaccine approved and ready to benefit humankind. In urgent situations – like for the COVID-19 – the process could be stressed by using a fast track approach, which may reduce development time to 18-24 months. Potential risks or side-effects are not possible to identify in a shorter time. Stressing the process further would be like making all the vaccinated into "guinea pigs."
Mostly, consumers are unaware of the manufacturing process behind, e.g. a cellphone. When the product is invented, designed, and tested, it should be mass-produced. Commonly, the prototypes and short test series are produced using methods that are not suitable for mass production. Accordingly, the eventual product availability – at a reasonable cost – is a result of a very complex and refined production process.
It is a similar situation for a coronavirus vaccine.
"The biggest challenge may be how to produce required quantities in a reasonable time."
To set up and run a vaccine production process is a big challenge. When scientists and clinical studies have shown what to produce, the industry must solve how to produce it in such quantities that there will be a sufficient dose available for everyone.
But, contrary to the testing phase of a vaccine, production can be pushed to some extent by using optimal methods and tools for shortening the manufacturing time. Such a tool could be the mixer for blending vaccine components. Selecting the optimal mixer may reduce the time to achieve the requested blend and contribute to reducing vaccine production time and improve quality.
From my long experience in vaccine production, I am familiar with the many challenges. Luckily, I also know many good solutions. Feel free to watch the video below where I explain some of these challenges.
Klaus is a biotechnical engineer specializing in vaccine technology. He has many years of experience from designing vaccine facilities and vaccine processes design and optimization. Being a WHO counselor, he has previously held key positions in international pharma and biotech companies. Klaus is a member of the Metenova board.