Clinical trials for chronic kidney disease

New partnership for pioneering kidney health research

Clinical trials to accelerate research into treating chronic kidney disease will be strengthened as a result of a new partnership between the Scottish Government, academia and industry. 

NHS Scotland, AstraZeneca and the Universities of Dundee and Glasgow will work together on new medicines to slow the progression of chronic kidney disease, reducing the risk that patients might need dialysis or kidney transplantation.

The partnership will allow for development of new treatments to treat chronic kidney disease, build infrastructure and enhance expertise in renal clinical trial delivery in Scotland with the key aim of improving patient outcomes.

Preventing progression of the disease allows people to live longer, better lives, free from other consequences of the condition such as heart failure, cardiovascular disease and stroke. This allows people to work, contribute to their communities and economy, while reducing pressure on the NHS.

Cabinet Secretary for Health and Social Care, Neil Gray, said: “This project’s ‘triple helix’ approach is a shining example of how collaboration between the NHS, Scottish Government, academia and industry can accelerate health studies. As we navigate the complex issue of chronic kidney disease, our commitment to patient-centred research remains unwavering.

“Together we can advance targeted studies into medicines that slow progression of the disease and reduce the need for dialysis or transplantation, strengthen our workforce through dedicated research fellows and specialised training, provide greater opportunities for patients, and enable Scotland to attract and deliver more innovative trials.”

Professor Dame Anna Dominiczak, Chief Scientist (Health) at Scottish Government said: “I welcome this partnership with AstraZeneca which builds upon the excellent research infrastructure and expertise we have in Scotland, to drive the development of new treatments for chronic kidney disease.

“We must all work together to improve the outcomes and life circumstances for people living with kidney disease; and this partnership enables the fusion of medical expertise, knowledge, and insight from across NHS, academia, and industry.”

Tom Keith-Roach, AstraZeneca UK President, said: “Scotland is setting a bold ambition to change the trajectory of chronic kidney disease. We are thrilled to invest in a partnership with the University of Glasgow, the University of Dundee, and the Scottish Government to speed up the study of three potential new combination medicines to treat this disease.

“The triple helix of industry, academia and NHS Scotland is a powerful force with the potential to transform care and outcomes for people.

“Furthermore, we believe Scotland is well placed to collaborate with AstraZeneca to shape our research on the world stage across a number of disease areas and attract investment to the country’s thriving Life Science sector.”

Covid: Second vaccine approved

Oxford/AstaZeneca vaccine gets the green light

The UK Government has this morning accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use.

This follows rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

The Joint Committee on Vaccination and Immunisation (JCVI) will also publish its latest advice for the priority groups to receive this vaccine.

The NHS has a clear vaccine delivery plan and decades of experience in delivering large scale vaccination programmes. It has already vaccinated hundreds of thousands of patients with the Pfizer/BioNTech vaccine and its roll out will continue. Now the NHS will begin putting their extensive preparations into action to roll out the Oxford University/AstraZeneca vaccine.

Health Minister Matt Hancock hailed the news as ‘a real British succes story’.

Throughout this global pandemic the UK Government says they have always been guided by the latest scientific advice.

Having studied evidence on both the Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, the JCVI has advised the priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible.

Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer term protection.

From today the NHS across the UK will prioritise giving the first dose of the vaccine to those in the most high-risk groups. With two vaccines now approved, we will be able to vaccinate a greater number of people who are at highest risk, protecting them from the disease and reducing mortality and hospitalisation.

The JCVI’s independent advice is that this approach will maximise the benefits of both vaccines. It will ensure that more at-risk people are able to get meaningful protection from a vaccine in the coming weeks and months, reducing deaths and starting to ease pressure on our NHS.

To aid the success of the vaccination programme, it is vital everyone continues to play their part, abides by the restrictions in their area and remembers hands, face, space so we can suppress this virus and allow the NHS to do its work without being overwhelmed.

News of the second vaccine is timely – yesterday’s coronavirus figures were particularly grim. 53,135 new cases were reported across the UK on Tuesday. 1895 of these were in Scotland – our worst daily figure since the country was first hit by the virus back in February.

First Minister Nicola Sturgeon will make a statement later today. She is expected to welcome the Oxford/AstraZeneca announcement but will appeal to Scots to strictly adhere to current coronavirus guidelines over the New Year period.

Health Secretary Jeane Freeman has welcomed news that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Oxford AstraZeneca vaccine for use in the UK.

This means we can now proceed with arrangements for doses of the vaccine, which is the second coronavirus (COVID-19) vaccine to be approved for use after the Pfizer BioNTech vaccine, to be made available to our distribution centres throughout Scotland.

The vaccine has been procured on behalf of the four nations by the UK Government, who have ordered 100 million doses, of which Scotland will get 8.2% based on its population. We will begin to roll the vaccine out from 4th January, in the settings we have already been delivering in, moving out into more community settings from the 11th January.  

For this vaccine as for Pfizer, the intention is to provide an important layer of protection to all adults but particularly those most at risk from serious illness and death from COVID-19.  With age as the greatest risk factor, the Joint Committee on Vaccination and Immunisation (JCVI) have retained the same phase 1 priority list. 

The priority now is to vaccinate as many people with their first dose as quickly as possible, working through that priority list and the advice that the second dose for both vaccines can be given up to 12 weeks after the first means we can maximise this protection quicker than planned.  The second dose remains critical for longer term protection and to complete the course.

Ms Freeman said: “At the end of a very difficult year this is a truly excellent piece of news. Oxford AstraZeneca has the major advantage of being much easier to store and transport, which means it is easier to administer in local settings. We are also expecting to receive it in significantly larger quantities than the Pfizer vaccine.

“With the four Chief Medical officers agreeing with the advice that we should prioritise delivering first vaccine doses to as many people on the JCVI Phase 1 priority list in the shortest possible timeframe, we are now able to maximise the impact of the vaccine programme in its primary aims of reducing mortality and hospitalisations for those at greatest risk.”

“When it is your turn to be vaccinated you will be contacted by your local health board and I urge you to please take up the offer.

“Vaccination is one of the most important tools we have as we work our way out of this pandemic.  But as we vaccinate as many people as quickly as supplies allow, we have a new more transmissible strain of COVID-19. 

“That makes it vital that we all continue our  work to suppress the virus in Scotland, rigorously complying with the restrictions where we live and making sure we continue to wear face coverings, maintain 2m distance from others outside our own household and wash our hands regularly.

“These three strands – following all we need to do to suppress the virus, using our expanded testing programme to identify cases and break chains of transmission and rolling out vaccination as fast as supplies allow- are the three critical actions that will see us move, step by step, to a brighter spring and summer in 2021.”

“A vaccine for the world”

Oxford University vaccine shows 70% protection with single dose – and 90% with second dose

The University of Oxford, in collaboration with AstraZeneca plc, has today announced interim trial data from its Phase III trials that show its candidate vaccine, ChAdOx1 nCoV-2019, is effective at preventing COVID-19 (SARS-CoV-2) and offers a high level of protection.

The coronavirus vaccine developed by the University of Oxford stops 70% of people developing Covid symptoms, a large-scale trial has shown, and while the Oxford vaccine offers less protection than those produced by Pfizer and Moderna – both promising 95% protection – the Oxford vaccine is much cheaper and is easier to store. This gives the Oxford – AstaZeneca vaccine an advantage over the other two when trying to reach difficult to access areas across the world.

  • Phase 3 interim analysis including 131 Covid-19 cases indicates that the vaccine is 70.4% effective when combining data from two dosing regimens
  • In the two different dose regimens vaccine efficacy was 90% in one and 62% in the other
  • Higher efficacy regimen used a halved first dose and standard second dose
  • Early indication that vaccine could reduce virus transmission from an observed reduction in asymptomatic infections
  • There were no hospitalised or severe cases in anyone who received the vaccine
  • Large safety database from over 24,000 volunteers from clinical trials in the UK, Brazil and South Africa, with follow up since April
  • Crucially, vaccine can be easily administered in existing healthcare systems, stored at ‘fridge temperature’ (2-8 °C) and distributed using existing logistics
  • Large scale manufacturing ongoing in over 10 countries to support equitable global access

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said: ‘These findings show that we have an effective vaccine that will save many lives.

“Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regimen is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world.’

Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford, said: ‘The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by SARS-CoV-2. We will continue to work to provide the detailed information to regulators.

“It has been a privilege to be part of this multi-national effort which will reap benefits for the whole world.”

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency.

“Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available supplying hundreds of millions of doses on approval.”

Welcoming news of the breakthrough, Prime Minister Boris Johnson said: “This is incredibly exciting news. There are still further safety checks ahead but these are fantastic results.”