How is a COVID-19 Vaccine Being Safely Developed?

2020 has been a significantly different year for people across the globe. For an extended period of 2020, many countries, including the United Kingdom, were forced into lockdown and almost all businesses that were not deemed essential closed. This was all due to the biggest public health crisis in modern-day history, the COVID-19 pandemic, a deadly pneumonia-like virus that attacks the immune system, with respiratory symptoms most prevalent. 

Now in September, life is still significantly different from before lockdown. Currently, almost all establishments in the UK are open, providing social distancing can take place and services can run safely. If neither of these is possible, then businesses must remain closed. An example is nightclubs, which still remain prohibited to open and will be for the foreseeable future. 

What is determining how safe it is for businesses and locations to be open to the public is a formula made from the number of daily cases and populations of specific regions. This is called the rate of infection, or commonly known as the ‘R Number’. As of the 24th of September, the R Number is currently over one (1).

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It is highly unlikely that the entire UK will be placed on another nationwide shutdown as local lockdowns have now been put in place to minimise disruption. R numbers are being measured in specific areas of the UK. Due to this, local lockdowns have been put in place in Leicester and Preston, and tighter restrictions have been applied in many locations in Northern England. If specific places are determined unsafer than others, they will likely lock down these areas rather than the entire nation.

What Damage Has The Pandemic Already Done?

On the 24th of September, there have been around 410,000 confirmed cases of COVID-19 in the UK, and almost 42,000 deaths. In terms of cases, the UK has the 13th highest number of confirmed cases and the 5th highest number of deaths globally. Overall, the effects of the virus have been devastating, however, there are still some positives. Currently, many countries across Europe, including France and Spain, are seeing a second wave of daily cases. The UK currently is experiencing slightly higher daily infection numbers, however, it has not seen a second spike of new cases or deaths at the level of other countries.

It is not just public health that the pandemic has had a devastating effect on, the UK has also suffered a huge financial loss. For the first time since 2009, the UK has entered a recession as a result of the COVID-19 pandemic. This is due to businesses being unable to operate and fewer people spending money. After the pandemic, businesses across the UK will need to strategise to retain losses and help to support the regrowth of the economy. Measures like Eat Out To Help Out and also the Stamp Duty Holiday are just some ways that the UK government has tried to stem the financial impacts of COVID-19.

While the government keeps working on a way forward, there’s a need to build urgent care facilities that will accommodate walk-in patients seven days a week.

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What Next?

Returning to pre-pandemic life will inevitably be a slow process, and realistically, we still may be quite a long way from this. For pre-lockdown life to return, the prominence of the virus across the globe must be extremely low or there is a known cure. 

The most effective way of stopping contagious viruses is by developing a vaccine. Currently, the process of developing a vaccine is underway, and nations are competing to be the first developers of a successful, usable vaccine. 

But given the need for accelerated development and distribution, what are the measures that are in place to ensure the safe production of a COVID-19 vaccine? In this article, we will not only cover the process of vaccine development but also the steps in place to ensure the public is delivering a safe vaccine.

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Step 1 – Understanding COVID-19

Before a vaccine is developed for any virus or disease, it is important that the disease is understood. This regularly involves taking samples of the virus, evaluating the symptoms of sufferers, and reviewing the effect it has on the body. Volunteers also usually take part in this process to be tested for antibodies to assist in charting the body’s current response to infection.

This process must always take place in a professional medical research environment, often in universities or within pharmaceutical companies. The reason for this is so that samples can be handled as safely as possible and volunteers can be in a safe, controlled environment. 

To take this even further there are guidelines set up by the UK government so this process is carried out safely and efficiently. During processes like these, safety is of paramount importance. 

While we are still working to fully understand the longer-term effects of COVID-19 on health, as well as the possibility of reinfection, the medical community has a good understanding of the virus to date. While there will be more information gathered in the future the foundation of knowledge gained is sufficient to provide for the next stage.

Step 2 – Creation of Initial Vaccines

Once experts have a clear understanding of viruses, initial vaccines are created to be tested. Depending on the scale of the operation to create the vaccine, there could potentially be up to 100 vaccines at this stage.

As previously mentioned, nations across the globe are competing but also collaborating to become the first to develop a vaccine for COVID-19, which has rapidly sped up this process. With multiple global institutions with different perspectives creating vaccine samples, it has helped initial development to take place much faster than usual. This is also as people from all different backgrounds have been able to have been safely tested.

The other added advantage of this global collaboration is that vaccines can be tested on a multitude of ethnicities and people of varying backgrounds. This increases the chances of a successful vaccine being created that can be distributed globally.

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Step 3 – Pre-Clinical Trials

Before clinical trials can be performed on humans, initial response tests have to be performed on animals to analyse the effects of the initial vaccines created. Although this stage is crucial, it is seen across the globe as controversial as it could have a negative or fatal effect on animals. Animal testing significantly reduces the time taken to develop a vaccine and allows safer human testing to take place. Using initial vaccines on humans could also have a negative impact on their health and potentially be fatal.

Oxford University is one of many British Institutions creating a vaccine for COVID-19. So far, the UK has passed this stage and the initial vaccine was first tested on mice, then successfully on monkeys in partnership with a Paris-based team. 

Step 4 – Clinical Trials 

Clinical trials are the stage we are currently in for the COVID-19 vaccine, although progress may move backward given the sped-up nature of development. Before any human testing clinical can occur, the research organisation requires clinical trials insurance, which covers the risks to both the business and the test subject.

Inevitably, there will be risks when testing vaccines, even if the tests have been successful in the pre-clinical trials stage.  While insurance helps mitigate risks for participants and institutions it is vital that the previous steps of development are followed correctly, and all relevant guidance from the UK government is strictly adhered to throughout the process.

The vaccines are then trialled in three different ways. The first and most important way the vaccine is tested is the safety check, to ensure that the vaccine has had no adverse effects that would endanger people.

The next way of testing the vaccine would be to test the immune response that the virus has on the body and what changes it makes. For this stage, the volunteer is closely analysed with various tests.

Lastly, the final test is to check the effectiveness of preventing the volunteer from contracting the disease. This test has to be taken out in a controlled environment as it usually involves exposing the volunteer to the disease or virus. If this process was to be carried out in an uncontrolled environment, it could have devastating consequences.

Usually, the clinical trial process takes around three years to be completed, however, with nations and organisations across the globe collaborating and pooling resources to develop the vaccine for COVID-19, this process will likely be much faster than it usually is, meaning we may develop a safe vaccine much faster than usual. 

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Step 5 – Review and Manufacturing

Before manufacturing and distributing any vaccine, the relevant research data must be reviewed to allow them to be safely distributed. For this to take place, all clinical research organisations involved must submit the data from the previous stages for review. Once they have been independently reviewed and the vaccine has been deemed safe, the vaccine will be ready for manufacturing.

Once approved, the vaccine will need to be developed and distributed. For the COVID-19 vaccine, this will be a huge challenge as a vaccine has never been required at this scale and speed. Immunising people will also take a long time. To keep people safe once the vaccine is distributed, it is likely that the most vulnerable will be immunised first, such as the elderly. This will help to reduce mortality rates and ensure the vaccine is being used to prevent deaths first, then eventually eliminate the virus afterward.

About the Author

Paul Monaco – Commercial Insurance Director at Focus Oxford Risk Management

Paul specialises in the advice and arrangement of specialist business insurance and risk management to the Life Science, Medical Device, Scientific Research and Technology Sectors from new business start-ups through to PLCs.

As well as managing and providing guidance to the experienced commercial insurance team, Paul has a large client portfolio which he looks after personally, advising in all aspects of insurance and risk management. His clients value his knowledge and friendly but professional approach.

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