Vaccines are at the forefront of our minds right now. Since the novel coronavirus was first declared a pandemic by the World Health Organisation in March, scientists around the world have been working to find a vaccine that could help to combat COVID-19.
With the focus now on finding a vaccine, there has been a rise in the number of vaccine-making start-ups seeking to make headway and get results. But there are challenges that this emerging industry faces.
Here’s a look at the pitfalls to be aware of and the legal implications of taking on the role of vaccine-maker in 2020.
Why vaccine start-ups are important
Before we look at the challenges they face, it’s worth considering the significance of vaccine-makers right now.
The Ebola crisis had already had a significant impact on the world of vaccines. At that time, it became clear that there was no dedicated facility in the UK for the creation of vaccines and plans to build the Vaccines Manufacturing and Innovation Centre (VMIC) got underway.
VMIC came from proposals put forward by established vaccine makers The University of Oxford, Imperial College London and the London School of Hygiene & Tropical Medicine. As the pandemic hit in 2020, the government ploughed funds into the building of the centre so that it can open in 2021 – a year earlier than planned.
But what of the start-ups? There has been a significant increase in the number of vaccine-making start-ups recently. Biotech companies such as Moderna, which went from a small-scale operation to being a $25 billion company, have been thrust into the limelight.
Their insights are crucial right now. Labs around the world are working to create something that will provide immunisation against this virus that we still know so little about.
What challenges do they face?
So, what are the major hurdles that these vaccine-making start-ups must overcome? The main one is financial. Vaccines are expensive to create. They require dedicated lab equipment and tech, the cost of the scientists who are running the tests, and the testing itself is costly.
How these start-ups are funded can be key to their success. Whether they follow in the footsteps of Affinivax, which has been given grants, seed funding, and partnered with Astellas, a Japan-based drug maker, or they follow a different path, getting the finances together is the first step towards building a business.
However, the coronavirus has had an interesting effect on these new biotech companies. Their importance in the battle against the virus has seen their shares rise. Moderna, for example, saw its shares hit an all-time high at the peak of the pandemic.
Another issue is time. Typical clinical trials can take as long a s a decade before a vaccine is deemed successful. In this time of COVID-19, time is not something we have.
And then there are the ethical concerns. How they are tested and who is tested in the trials stage is significant. For a vaccine to be licensed for use, it needs to go through research and trials. It has to pass safety tests and be tested enough to be sure it’s useable on the wider population. Therefore, selecting people to test on has to be done in a safe, ethical way.
Legal implications of establishing a vaccine start-up
But there are other issues to consider too. The health and safety of those working on the vaccines and those participating in tests must be considered. This includes everything from ensuring the lab meets the testing conditions to drawing up contracts that ensure the safety and privacy around the work being done.
In order to be successful as a vaccine start-up, investing in a robust legal team is crucial. This helps the organisation to stay on track and within legislation. For example, legal firm Withers has recently worked with a client on the creation of VaXEquity, which was launched to boost the production of a vaccine against COVID-19.
By hiring specialist legal teams, it’s possible to ensure that each stage of the start-up process is carried out in a way that’s compliant. It can also help to save time in the long run as everything is covered before any work begins.
As the world comes out of lockdown, time will tell if we can find a vaccine to prevent the virus from continuing to spread. But with start-ups joining established biotech companies and medical labs, we’re heading in the right direction.