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From coronavirus to clinic: how did we get a vaccine?

11th Dec 2020 - Rachel Kahn

We know a lot of people with blood cancer have questions on whether the coronavirus vaccine is safe after such a short amount of time. We hope to answer some of these questions by explaining how these vaccines have been developed.

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There are a lot of questions around whether the coronavirus vaccine is safe after such a short amount of time. This is particularly the case for people with blood cancer who can’t have some vaccines called ‘live vaccines'.

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Visit our covid hub to read detailed information about the coronavirus vaccine and blood cancer.

Covid vaccine and blood cancer

How are the coronavirus vaccines made?

Research in the lab

When coronavirus hit, it soon became clear that to get us out of this global pandemic, some sort of treatment or vaccine would be needed in every corner of the world. Huge amounts of money were poured into the development of a vaccine from Governments across the globe.

Typically, one of the biggest factors that slow down scientific progress is the lack of funding – but when it came to finding a coronavirus vaccine, this wasn’t the case.

While countries disagree on many things, we were united on one thing: we needed a vaccine.

The sheer amount of Government and private funding given to researchers to develop a vaccine has sped up the development of a coronavirus vaccine.

Normally, Governments would wait for initial trial results before deciding whether to fund the next stage of work, but this time, they invested upfront. It increased the risk of losing money, but because of the huge benefit it could bring to the global population and to the economy, it was deemed worth it.

This meant that researchers had far fewer financial hurdles to face than they usually would – thanks to huge collaborative efforts around the world.

Advances in science and technology over the past 20 years has bought us to the point where clinicians are able to apply their knowledge and develop a coronavirus vaccine quickly and safely.

This story starts in the lab…

Traditional technologies used to develop vaccines can be labour intensive, but both the Pfizer and AstraZeneca vaccines used a less time-consuming method. This involves harnessing the genetic material from the coronavirus and using it to our advantage.

Scientists worked in the lab studying elements of the virus, such as proteins found on its surface (spike proteins), to see if they were able to activate an immune response.

Once researchers in the lab are confident that the protein they have chosen is able to produce an immune response, they are quickly able to apply their previous knowledge to create a vaccine.

For example, researchers in Oxford had been working on vaccines for similar viruses (such as MERS) prior to the Covid-19 pandemic, and were therefore able to apply this knowledge. This enabled researchers to understand what likely doses of the vaccine would be needed to give to people, and how many, to stimulate an immune response. The prior knowledge and experience that researchers have from creating previous vaccines hugely speeds up the process. This allows the swift transition from testing the vaccine in labs to animals.

Understanding how coronavirus vaccines work

The Pfizer/BioNTech vaccine

This takes a piece of the coronaviruses genetic code, called RNA, and puts it in a vaccine. It’s important to note that this is not a live vaccine – it doesn’t contain any part of the coronavirus capable of causing infection.

Once injected, this code tells our cells to produce the important protein found on the surface of the coronavirus. Our immune systems respond to this and ‘remember’ what coronavirus looks like.

Importantly, RNA only lasts in our bodies for 72 hours, so it won’t hang around for a long time. Eventually, the RNA will break down and they’ll be nothing ‘foreign’ in our bodies any longer. Hopefully, at this point, our immune system will be primed in case it were to come into contact with Covid-19.

The AstraZeneca / University of Oxford vaccine

This vaccine is made from a modified version of a virus that causes the common cold in monkeys. This vaccine isn’t typically ‘live’, as genes have been removed from the virus, so it is no longer able to cause disease.

Researchers have then inserted an additional gene, which when injected, prompts our bodies to make a protein found on the coronavirus. It’s not, though, a protein that will cause infection. Our immune system should then respond to this, preventing infection in the future.

These two vaccines have been the first to apply for approval (more on this later). There are more than 200 other coronavirus vaccines in development, and the UK Governments have already ordered some of these.

Pre-clinical studies

Once the vaccine has been developed and has undergone all the necessary tests in the lab, the vaccine is tested in animals. These studies look at how animals respond to the vaccine before trialling it in humans.

These trials give researchers an idea of how safe the vaccine will be in humans, as well as how effective it is likely to be. Some animals will receive the vaccine, and some won’t. They will then be exposed to the coronavirus. Scientists will then look at whether the vaccine prevents the vaccinated mice from developing the disease. Read our policy on using animals in research.

Clinical trials

All of the coronavirus vaccines we’ve spoken about in this blog have been subject to rigorous testing in clinical trials. There are various stages of testing that need to be done, and each stage has a slightly different purpose.

This process offers evidence and gives researchers more confidence on whether the vaccine is safe. It also helps us to understand how effective the vaccine is.

Clinical trial phases

There are different phases to trials that are traditionally done one after the other. However, as the need for a coronavirus vaccine is so urgent, some research groups overlapped the phases to speed things up.

Phase I: Research teams test the vaccine in a small number of healthy people to make sure it’s safe. They also look to see if the vaccine stimulates an immune response. From there, they work out what type of dose to give people, based on what is likely to get the best immune response.

Phase II: This involves testing the vaccine in several hundred people to see whether the vaccine is effective in a larger group. They also make sure that similar response rates are achieved in the larger group in comparison to the small group. Here, the teams are also looking for any potential side effects that might be associated with the vaccine.

Phase III: A phase III trial involves thousands of individuals, and this time, looks at whether the vaccine is able to prevent someone catching coronavirus. At this stage, we know the vaccine triggers an immune response. However, it hasn’t been studied in enough people to know if it actually stops people getting coronavirus. This trial aims to understand more about this.

As the vaccine is being tested on thousands of people, it allows researchers to look for any ‘rare’ side effects. You may have heard of vaccine trials being paused momentarily. This is because someone on the trial has become ill.

The likelihood is that there are many external factors outside the trial which could have caused them to get ill. However, a full investigation is required to ensure that it wasn’t a result of the vaccine, as these are the ‘rare’ events that researchers are looking for. Once clinicians are confident that the illness isn’t a result of the vaccine, the trial can restart.

Eventually, teams will have collected enough data to do an ‘interim analysis’. This essentially means selecting a cut-off date and looking at how effective the vaccine has been up until that point.

The data will continue to be collected over time as trial participants continue to be monitored.

However, an interim analysis provides us with enough data to then present to agencies. These agencies will then decide whether it’s appropriate and safe to give to the wider population.

As far as we know, no one with blood cancer has received a coronavirus vaccine in these trials. While we think a vaccine is likely to be safe, we don’t yet know what level of protection they will offer to people with blood cancer.

This is because people with blood cancer have varying levels of immune compromise. This means their immune system doesn’t work as well as someone without blood cancer. It’s important to note that any protection offered by the vaccine is beneficial, and that its effectiveness in people with blood cancer will be studied as they start being vaccinated.

Vaccine approval

You may have heard of the ‘MHRA’ in the news. MHRA stands for the Medicines and Health Care Regulatory Agency. This Agency is completely independent of the Government and is responsible for regulating medicines, medical devices and blood transfusions in the UK.

This means it’s also responsible for approving the use of coronavirus vaccines. They make sure that medicines are safe to use. This ranges from something as simple as a plaster to the coronavirus vaccine. Once they approve something, the MHRA continues to monitor it over time.

There have been some questions around how ‘quickly’ the UK approved a vaccine for use. As the Agency who ultimately approves things like vaccines, the MHRA would have received data on the clinical trials long before they were announced in the news.

While the approval process might have seemed fast, it’s likely that the Agency has been analysing the data for a much longer period of time than we think. This is because the UK Government pre-ordered large quantities of vaccines, such as the Oxford/AstraZeneca and Pfizer vaccines. Therefore, the MHRA reviewed data from clinical trials as it became available. This is called a ‘rolling review’.

Vaccine prioritisation

Another name you might have heard about is the JCVI, which stands for the Joint Committee for Vaccination and Immunisation. This is a group of independent scientists and experts who advise health authorities on the order in which people should be vaccinated.

They have advised the Government on who should be prioritised for the vaccine, putting the 200,000 people with blood cancer who are clinically extremely vulnerable at high priority – along with people aged between 70 and 75.

There are some exceptions to this. People with blood cancer who are over 75, residents in care homes and health and social care staff. This group of people will be vaccinated sooner and comprises of many people with blood cancer.

Vaccine roll-out

The final step is for the Department of Health and Social Care and the NHS to roll out the vaccine. This is a huge logistical effort involving hospitals, GP surgeries, volunteer first aiders and much more. Everyone administering the vaccine will have received the appropriate training.

How do we know there won’t be any long-term side effects?

We can’t be certain that there won’t be any long-term side effects from the vaccine. This is because the speed of development means that people haven’t had it for as long. But, scientists and regulatory agencies are confident that the vaccine is generally safe.

The Pfizer vaccine uses RNA, a type of genetic material, to produce an immune response. We have bits of genetic material floating around in our blood all the time, and this doesn’t cause any long-term issues. Therefore, the vaccine shouldn’t either.

There’s a small possibility we may see a small number of rare side effects as the vaccine is given to more people. This is because our bodies can respond to things slightly differently. However, the likelihood of seeing a common, long-term side effect is exceptionally unlikely.

You might have heard that a few people have had allergic reactions to the vaccine. These individuals had a long-standing history of severe allergies. On the back of this, Pfizer have now recommended that people with a history of severe allergies, and have to carry an EpiPen, should not have the vaccine.

We understand that there are still many unanswered questions about the coronavirus vaccine. Below, you’ll find some answers to some of the common questions we’ve been asked:

FAQs

How will the effectiveness be monitored over time?

Public Health England plan to monitor people who have had the vaccine over time. We now know that in the general population, people will be chosen at random to be involved in this.

However, we hope they will be actively following up with people who have compromised immune systems, which would presumably include many of the 200,000 people affected by blood cancer.

We also know that blood cancer researchers are planning studies to look at how effective the vaccine is in people with blood cancer. They aim to understand if people with blood cancer need an additional dose of the vaccine, or potentially alternative treatment.

We’ll update you as and when we know more. For now, it’s still a good idea for people with blood cancer to receive the vaccine because it might offer some protection.

Why are we ahead of Europe?

Normally, the UK would have to wait for the European Medicines Agency (EMA) to approve a vaccine before making it available. However, recent changes to the law allowed the UK’s MHRA to grant temporary authorization of Covid-19 vaccines ahead of the European Union. Although, we expect approval from other countries in Europe very soon.

After I have the vaccine, can I live life normally again?

Until we know whether the vaccine is effective in people with blood cancer, and stops people spreading the virus, the UK Governments may advise people who are clinically extremely vulnerable to continue to take a precautionary approach – even after they’ve received the vaccine.

Written by:

Rachel Kahn (Research Communications Manager)

Ross Coron (Policy Officer)

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