Leeds Covid vaccine volunteers in Novovax trial getting follow-ups with hospital staff at Thackray Museum

Some 15,000 people in the UK are taking part in the clinical trial of the Novavax jab, which is on course to become the fourth Covid vaccine approved for use in the UK.

And the largest cohort anywhere in the country is being monitored here in the city by the Research and Innovation (R&I) team at Leeds Teaching Hospitals NHS Trust.

Jamie Calderwood, lead nurse in its Covid-19 Research Delivery Team, said: "We started vaccinating people in October and we finished the day 35 follow-ups just before Christmas. I was on call over Christmas and many of my colleagues were on call for the entire three months. It was very much a sprint.

"Now we're into the marathon bit. We're onto the three-month follow-ups. We've got until the beginning of March to finish those."

Leeds was chosen to participate in clinical trials for the Novavax jab in September, with 806 volunteers from Leeds who had signed up to the NHS Vaccine Registry being selected.

"We had to think about seeing a huge number of people in a very short space of time," Mr Calderwood said. "We had done some preliminary work around another trial which didn't come off so we had some of the plans in place."

Within four weeks or so, the participants were turning up at The Edge - the University of Leeds’ sports centre that had been offered up as a host venue - to receive the first of two jabs.

Half of the volunteers received the vaccine with the others getting a placebo. They then downloaded an app to record how they were feeling and any potential Covid symptoms, before returning 21 days later for their second dose.

To assess the long-term protection, the volunteers were asked to return for assessments 35 days after their first dose, then again periodically throughout the course of a year.

It is the three-month appointments that are now taking place at the Thackray Museum, which is also acting as a hub for approved vaccinations.

Mr Calderwood said the commitment shown by the participants throughout the trial, despite long waits on some days, had been incredible.

"They don't get anything out of it - we don't pay them for taking part other than in tea and biscuits," he said. "It's incredibly humbling for us as a team.

"We've spoken to people who've been furlough and things like that. This in, their own words, their way of giving something back."

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Doctors volunteered to help support the trial by giving up annual leave or using days off to ensure the vaccines could be rapidly administered, while other teams seconded nurses to help support the work going on between October and Christmas.

And then there were the catering staff, cleaners, delivery drivers and many others who were part of what Mr Calderwood describes as "such a big team effort".

The nurse-led clinics currently being run include a general health check for participants, questions about any recent visits to their GPs or changes in medication, and answering any questions they might have.

Mr Calderwood added: "We're also talking about what the next steps are for Novavax. We can talk to the participants individually but at the moment we're not allowed to talk publicly."

The UK has secured access to 60 million doses of the vaccine, which could be available in the second half of this year if it is approved by the medicines regulator.

Set to be manufactured in Stockton-on-Tees after being developed by a US biotechnology company, it appears to be effective against both the original strain of coronavirus and a mutant strain first identified in Kent. It has also shown around 60 per cent effectiveness against the South African strain of coronavirus.

The jab, which is given as two doses, has an advantage over those from Pfizer/BioNTech and Moderna in that it can be stored in a regular fridge rather than needing ultra-cold storage.

It was reported last week that the vaccine had been shown to be 89 per cent effective in large-scale UK trials.

Dr Phil Wood, the trust's Chief Medical Officer, said: "I was delighted to hear the announcement of results by Novavax indicating that the vaccine is extremely effective. It is fantastic that we may well have another potential vaccine to prevent Covid-19.

“Of 15,000 participants in the trial, more than 800 were recruited by our research team here in Leeds. Without these volunteers from many different backgrounds and across the city region, including staff from our hospitals, it would not have been possible for these exciting results to have been produced so quickly.

“I would like to thank all those who took part, the R&I team who managed and delivered this study, plus everyone in our Estates and Facilities, Pathology, Pharmacy teams across the Trust, along with our partners at the University of Leeds and the Thackray Museum who all supported the R&I team to make this possible."

Providing people with more easy-to-access information on the vaccine programme and its progress is among the requests being made through our A Shot In The Arm campaign.

Led by the Yorkshire Evening Post and sister titles across JPIMedia, it also asks for further reassurance for local communities and urges Prime Minister Boris Johnson to deploy the country’s network of 11,000 pharmacies to ensure that every citizen is only a short walk away from a vaccination centre.

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