What it's like volunteering for a Covid vaccine trial
The race to find a coronavirus vaccine has been under way for some time – with the first being approved in the UK this week.
But as the news about the Covid vaccine from Pfizer and BioNTech has paved the way for vaccinations to start in the coming days, other trials are continuing.
It is important work. The world will need several vaccines on tap if it is to shed the virus. And with early trials coming back positively, it is hoped many of the other candidates will win approval and become available next year.
The Covid-19 vaccine registry was launched in the summer and an army of volunteers have since put themselves forward to take part in studies.
More than 26,300 people have now signed up in the West Midlands alone – however thousands more are needed to register their interest to take part.
The Novavax phase three Covid-19 vaccine trial, which is supported by the National Institute for Health Research (NIHR), has achieved its recruitment target just two months after opening in the UK – with 15,203 volunteers from across the country recruited in record time.
It is now the largest double blind, placebo-controlled Covid vaccine trial to be undertaken in the UK so far. Novavax is potentially a big part of the UK vaccination effort. The Government has already secured 60 million doses of the Novavax vaccine, provided it meets standards on safety, effectiveness and quality.
Claire Hall, of Muxton, on the edge of Telford, is one of the thousands of volunteers taking part in this particular trial and has already been for her first two appointments at Cheadle Hospital, near Stoke-on-Trent.
The 53-year-old, who also works for the NIHR Clinical Research Network, said: "Since the Covid-19 vaccine registry was launched in the summer, it’s been part of my job to promote it far and wide so that people will register their interest in taking part in studies to find a vaccine for the virus.
"We need about 42,500 people in the West Midlands region.
"So I felt it was the right thing for me to sign up myself, and I’m glad I did."
Through the registry, she was offered a place on the vaccine trial taking place at Midlands Partnership NHS Foundation Trust.
The Novavax trial is investigating the safety, efficacy and immunogenicity of NVX-CoV2373 – a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike protein and adjuvanted with Novavax’ proprietary Matrix‑M™.
Half of the volunteers are given two intramuscular injections of the vaccine candidate, 21 days apart, while the remaining ones receive a placebo.
Claire was taken through a thorough health questionnaire as well as key points about how the study will work before she began.
"After a blood test and various observations – blood pressure, pulse, oxygen saturation – I was given an almost painless injection," she said.
"The trial is double blind, which means that I don’t know whether I received the vaccine or a placebo, and the clinicians don’t know either.
"Everything is managed via a code, to prevent any unconscious bias affecting the process.
"In a medical emergency, or if a different vaccine is approved for use before this one, they can find out very quickly which one was administered.
"I also had to learn how to do a home swab test in case I develop any Covid-19 symptoms, and download an app on to my phone to help with administering the trial."
Claire, who says Covid safety precautions were also in place during her visits, will attend several more follow-up appointments over the next year.
"To me it's incredibly important," she said.
"We all want to get back to normal as soon as we can.
"I feel very confident that support is available if I have any issues, and I can withdraw from the trial at any time if I want to, but I can’t see that happening."
Several more phase three studies for potential vaccine studies are expected to start over the next six months and researchers need more volunteers to sign up.
There have been warnings that a vaccine may not be ‘one-size-fits-all’.
Researchers have urged people to keep volunteering for studies to ensure people have access to different types of vaccines that work for them.
Claire said: "Many people are alive today because of clinical research, because of vaccines. People have had to go through those trials.
"Now it's our generation's turn to do our bit.
"Some people will think now we've had these successful results, they don't need to bother, but they really do.
"We need a range of vaccines for different people. It's far from done and dusted."
People wishing to volunteer to support clinical trials can sign up with the NHS Covid-19 vaccine research registry, developed in partnership with NHS Digital.
Anyone living in the UK can sign up online to take part in the trials through the NHS, giving permission for researchers to contact you if they think you’re a good fit. Once you sign up, you can withdraw at any time and request that your details be removed from the registry.
Visit NHS.UK/coronavirus