1ST JULY, 2020

How Innovation Is Needed To Scale Up A COVID-19 Vaccine

Novel coronavirus COVID-19 was first identified in Wuhan, China, on the 31st December 2019. With the transmission and fatality rates across the world increasing, the race was on to formulate a viable vaccine that not only protected against the coronavirus but that could be scaled up fast.

By the middle of April, over 70 vaccine candidates were being developed across the world as more and more companies and academic institutes joined the hunt. Fast forward to the present day and a handful of vaccines have started, or are about to start, volunteer human trials. Only one really needs to work, and with the whole world innovating to find it the future is bright.

Manufacturing capacity

Despite the positivity, there are essentially two huge challenges here. The first is in actually finding a COVID-19 vaccine that is safe and effective for humans. And the second is how to scale up the vaccine to such an extent that anyone in the world can access it.

A problem that the UK in particular faces is that there aren’t very many production facilities that can turn out vaccines on a grand scale. Even if more facilities can be found that will meet the sheer demands of COVID-19 vaccine production, there’s still likely to be problems. For instance, potential bottlenecks in their processes will need to be addressed to make sure that all junctions of the supply chain can keep up in order to vaccinate the whole population.

Engineering firms can get on board here, by designing programmes that can simulate the different vaccine platform scenarios whilst clinical trials continue. This means that any supply chain problems or otherwise can be ironed out in advance of regulatory approval. Additionally, these firms will be able to then advise manufacturers about effective production setup to achieve the best results.

Having the time to scale up

Timing here is crucial and the clock is ticking. In normal times, vaccine development plus pre-clinical and clinical testing can take anything from eight to fourteen years. Furthermore, production process development, building facilities and gaining validation can easily take between six and nine years. The pandemic has thrown these timescales out of the window, with teams looking to get a vaccine to mass production within 18 months. This obviously doesn’t leave much time for addressing unforeseen problems, or planning and investment.

This incredible challenge of modifying and upscaling facilities in a timeframe that was previously inconceivable is also compounded by the huge number of vaccine platform technologies being trialled. In the UK, COVID-19 vaccines are expected from two main platforms: the adenovirus (ChAd) vaccine vector originally from chimpanzees, and what’s called “RNA”. The thing is they both contain very different formulas and have different and unique upstream production and downstream requirements. Without knowing which of the two is going to be taken further, it’s incredibly difficult to get production facilities ready.

Filling vials and syringes at speed

“Filling and finishing” as it is known, occurs during the final stages of vaccine development when the finished product is put into syringes, or vials for transportation. However, this is where bottlenecks in the system are most likely to become an issue.

When the vaccine is merely at clinical trials stage, only a few thousands of doses are made at the most by small, specialist companies. But scaling this up to millions of doses will mean much larger pharmaceutical companies with huge facilities across the world will be required to fill and package them. Without new and innovative ways of making this happen, it’ll be a logistical nightmare particularly when time is of the essence.

Speaking of packaging…

This is another challenge in the race for a COVID-19 vaccine although it’s not one that people immediately think of. But the fact is, vaccines need to be packaged very specifically in order to get them to where they’re needed safely and without the chance of contamination. Whilst vaccines have of course been around for decades - safely packaged and transported around the world - never have we faced everyone on the planet needing just one type of vaccine at the same time. Designing and manufacturing enough secure, specialised packaging at once is going to be a mammoth job requiring some serious thinking outside the box.

Storing the vaccine

How a vaccine is stored, and how long it can be stored for, are further important considerations for R&D to tackle.

A pharmaceutical company in Pennsylvania called Inovio Pharmaceuticals has said that based on its own findings, its product is viable for a year if stored at room temperature. This makes it easier to transport to countries where refrigeration is a problem. However, administering the vaccine requires a small device that resembles an electric toothbrush, delivering an electrical pulse to open pores in cells through which the vaccine can enter. Producing these toothbrush-like devices on a massive scale - and having enough people trained around the world to use them - is no mean feat, further complicating the production process.

How pharmaceutical companies risk missing out on huge amounts of extra government funding thanks to R&D Tax Credits

The UK’s R&D Tax Credits scheme can be used to offset some of the costs of innovation for pharmaceutical companies based in the UK. However, understanding this complex tax relief correctly is a difficult task in itself. This is why it's highly recommended you use the services of R&D tax experts like ourselves.

The R&D Tax Credits scheme is incredibly generous, and a broad range of research and development costs can be included. With pharmaceutical companies up and down the country now frantically looking to take on the challenges a COVID-19 vaccine presents, claims can easily run into the tens or hundreds of thousands.

Can your company afford to miss out?

Take a look at our R&D Tax Credits page now for more information and how to apply. Alternatively, why not use our great value, hassle free Tax Cloud portal for businesses to maximse and secure your claim? It’s a fully guided and supported way to apply and we’re here to help you at any point along the way. Of course you can always call us too, on 0207 360 4437, or send us a message.

Barrie Dowsett, ACMA, GCMA
Author Barrie Dowsett, ACMA, GCMA CEO, Tax Cloud
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