The Coalition for Epidemic Preparedness Innovations (CEPI) will invest funding of up to $34.8 million to Barinthus Bio, in addition to funds previously committed to the University of Oxford, to develop and stockpile a ready reserve of emergency MERS vaccine candidate, VTP-500.
The project will see CEPI, Barinthus Bio, an Oxfordshire-based clinical-stage biopharmaceutical company, and the University of Oxford together take a MERS vaccine from early development through Phase II clinical trials and, if the Phase II clinical trials are successful, on into the development of an investigational ready reserve of 100,000 doses to be rapidly deployed in a clinical trial setting in the event of a substantial outbreak.
Professor Dame Sarah Gilbert, Principal Investigator at the Pandemic Sciences Institute: ‘The COVID-19 pandemic showed us the critical importance of vaccines in saving millions of lives around the world. We had a head-start in our development of the Oxford/AstraZeneca COVID-19 vaccine, thanks to the many years already spent researching a vaccine for another coronavirus, MERS. This new partnership will help ensure the world is better prepared with vaccines for future outbreaks.’
Dr Richard Hatchett, CEPI’s Chief Executive Officer said: ‘Coronaviruses are one of the most urgent infectious disease threats the world faces, so it’s vital that we get on with developing medical defences against this particularly deadly one – MERS. With this project, we will both advance scientific understanding of the coronavirus family as a whole, and at the same time bolster humanity’s ability to respond to an ever-present epidemic threat.’
Bill Enright, Barinthus Bio’s Chief Executive Officer said: ‘We are thrilled to be working with the University of Oxford and CEPI on the development of this important vaccine candidate.’
There is an active need for a MERS vaccine for at-risk populations and travellers in the Middle East. As we observed during the COVID-19 pandemic, it is critical to ensure we have the necessary countermeasures in place to protect people around the world from deadly pathogens such as MERS which have the potential for future outbreaks.’
The three-way partnership builds on the early-stage development of VTP-500, which is based on the same viral vector platform technology as the licensed Oxford-AstraZeneca COVID-19 vaccine, Vaxzevria.
VTP-500 has already completed Phase I clinical trials in Britain and Saudi Arabia, and the University of Oxford is now conducting a CEPI-funded extension to the Phase I trial in the UK to assess vaccination of older adults, the age group most in need of this vaccine. The VTP-500 programme was awarded PRIME designation earlier in December by the European Medicines Agency (EMA).
MERS is a severe respiratory infection caused by MERS-CoV, a coronavirus that was first identified in 2012 in Saudi Arabia. It has caused more than 2,600 human infections in at least 27 countries since it first emerged, and it has a case-fatality rate of more than 35%. There are as yet no licensed vaccines or treatments for MERS.
Enabling equitable access to VTP-500
CEPI, the University of Oxford and Barinthus Bio are committed to enabling equitable access to VTP-500 in line with CEPI’s Equitable Access Policy so the vaccine is first available to populations when and where it is needed to end an outbreak or curtail an epidemic, regardless of ability to pay.
If the vaccine is successful in Phase II trials, CEPI will support the production of an investigational ready reserve of 100,000 doses which can be rapidly deployed in a clinical trial setting in response to an outbreak of MERS. CEPI also can support technology transfer to an additional appropriate regional manufacturer to enable supply for low- and middle-income countries. The vaccine will be made available to low- and middle-income countries at a price no higher than the cost of manufacturing plus 10%.