‘I don’t think I’m brave,’ Louisa* says, matter-of-factly. ‘Bravery is the overcoming of fear – I don’t feel scared.’
The 34-year-old is used to her body being tested on. As a baby, she was one of the first in Leicestershire to take part in a heart monitor trial after her parents lost a baby to cot death. Now she’s one of thousands of volunteers taking part in the Oxford University trial to find a vaccine that could put an end to the coronavirus pandemic.
On April 23, the first European human trials began at a lab at the University of Oxford with an initial 1,110 recruits. It is one of several trials taking place across the country, with the government pledging £65m million to laboratories to find a prevention for the virus. Across the world, the vaccine is widely touted as being the best solution for returning the world to some sense of normality and, more importantly, preventing further Covid-19 related deaths.
‘A friend sent me the link to the trial’s website at the beginning of April as it needed volunteers who lived in the Thames Valley region,’ Louisa explains of how she became aware of Oxford's trial. Unable to travel for her job due to international border restrictions, the government employee is stuck at her home in London for the foreseeable.
‘I fit the criteria for the trial; I was in good health, didn’t have any plans for the next six months and wondered how many other childless women in their thirties would take part. I had no question in my mind – I had to volunteer.’
What is the current status of the vaccine trials?
At the present moment, there is no specific treatment for coronavirus. Those with symptoms – high temperature, a continuous cough, loss or change of smell or taste – are advised by the NHS to stay at home, keep hydrated, rest and take paracetamol. Those with severe symptoms should seek medical attention.
Earlier this week, the government authorised the NHS to use the world’s first coronavirus treatment proven to reduce the risk of death – a low-dose steroid (dexamethasone) which cuts the risk of death by a third for patients on ventilators, and a fifth for those on oxygen.
However, without a vaccine against SARS-CoV-2 (the coronavirus that causes Covid-19) the world will continue to be at risk of new outbreaks. The only way to dramatically reduce its threat, in addition to social distancing, is to create widespread immunity.
In March, researchers at the University of Oxford began screening healthy volunteers (aged 18-55) living in the South East of England for its trial. Recruits were only allowed to take part if they had not tested positive for Covid-19, were not pregnant, breastfeeding or intended to become pregnant, and had not received any other coronavirus or adenoviral vaccines. They also have to be in the country for the next six months and are allowed to withdraw from the trial at any time.
Over the course of the study, the university intends to recruit 10,260 volunteers, split into two groups: one half will be vaccinated with the candidate vaccine ChAdOx1 nCoV-19, while the other half will be vaccinated with a licensed vaccine that will be used as a ‘control’ for comparison. The volunteers won’t be informed which group they are in during the trial.
How does the trial work?
Volunteers are first asked to fill out an online questionnaire about their family and health history before they’re invited to visit the hospital for screening.
The hospital visit was one of the first times Louisa had left the house since lockdown began in March, other than a weekly trip to the shops for food. ‘My partner and I don’t live near friends and family so we’ve kept to ourselves for months,’ she explains.
Recalling a conversation with a friend who if she was worried about visiting the hospital at the peak of the pandemic, she says: ‘If I’m honest, I was really excited.'
'I approached the trial thinking that there was a minor risk of becoming ill and it was a way of volunteering to do something completely different.’
On the first day at the trial centre, Louisa found herself sitting in a waiting room separated two metres away from her fellow volunteers. Meanwhile, hospital staff were dressed in full PPE. ‘I didn’t get to chat to the other recruits,’ she says. ‘In normal circumstances you’d be encouraged to talk more, but social distancing made it quite unsociable.’
Volunteers were instructed to watch a video about the trial before providing blood and urine samples. Days later, Louisa was asked to return to the centre to give a second urine sample as researchers had found a small trace of blood in the first. The trial's Patient Information Sheet (PIS) states that blood in urine 'can indicate kidney disease'.
‘A doctor told me that they’re not allowed to use volunteers with any traces of blood in their urine but that it’s a common issue with samples from female recruits,’ she says. ‘I thought “if this is happening so often then why isn’t there a margin of error?”. He said it’s not uncommon to find blood in women’s urine for up to two weeks of the month and it can often come as a result of when we’re tested in our menstrual cycles.’
It’s this male bias in medical trials that motivated Louisa to get involved in the process in the first place. Years prior, she’d read Caroline Criado Perez’s book Invisible Women which explores gender data bias.
In the book, the author examines the lack of women involved in medical trials. Citing the low numbers of women who have taken part in research into SARS (2002-4) and coronary stents, the author notes: ‘Like the failure to included women in anatomy textbooks, the failure to include women in medical trials is a historical problem that has its roots in seeing the male body as the default human body.’
‘Drug trials rarely fit around women’s lives and we’re drastically underrepresented,’ adds Louisa. ‘I’d never taken part in anything like this before, mainly due to a lack of time, so I thought that this was the perfect time to help the female cause.’
The fact that there was financial compensation – it ranges from £190-£625 depending on the exact number of visits and whether any repeat or additional visits are necessary – for volunteers’ time was insignificant for Louisa. ‘It didn’t really matter to me if I got paid or not, I just wanted to help,’ she says.
The side effects
After she was given the go-ahead to take part in the trial, Louisa was invited back to the centre to be administered with one vaccine and sent home.
‘My arm hurt after the injection but that's quite common with vaccines,’ she explains. ‘I travel a lot for work and require injections all the time so I wasn’t worried about the side effects. I took it all in my stride.’
For the first four weeks after receiving the vaccine, recruits are required to fill in an online diary, record their temperature and any symptoms they feel every day. ‘The day after the vaccine I felt really groggy and unwell,’ Louisa notes. ‘I felt fluey but the symptoms only lasted 24 hours.’
The Oxford trial website warns volunteers of the aforementioned side effects in addition to slight pain and occasionally bruising after blood samples are taken.
Louisa has since returned to the centre once to provide additional blood samples and receives a weekly reminder to notify researchers if she feels unwell. Two months after receiving the injection and she hasn’t suffered any further symptoms. She'll have to wait three months to find out whether she was administered the trial vaccine or the 'control' version.
As she only experienced symptoms for a day, she suspects she may have only had the control jab. ‘If I find out I did have the trial vaccine and feeling fluey [for one day] was the only side effect, I’ll be telling everyone to go and get one when they’re allowed to.’
Unsurprisingly, she's been commended by her friends and family for making such a brave decision to be part of the trials. While scientific knowledge about the long-term impacts of Covid-19 is increasing, it is still limited. The UK might be past the peak of the pandemic, but it's certainly not in the clear. However, if anything, Louisa thinks she’s been ‘overpraised’ for her role in the trial. ‘I don’t see it as that big of a thing. I don’t think I’ve done anything that impressive.’
While she hasn’t been closely affected by the impact of the pandemic’s fatalities – there were 51,804 deaths in the UK at the time this article was written – Louisa counts her best friend as her main source inspiration for signing up to the trial.
‘She’s an ICU nurse and walked straight onto a Covid-19 ward on her first day back from maternity leave on April 3. She has two young children. When people say I’m amazing for taking part in the trial, I think of my friend – she’s the amazing one.’
To sign up to take part in a vaccine trial, find out more here.
*Name have been changed for privacy reasons.
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