30 Dec 2020
Statement from Dr. Richard Hatchett, CEO of CEPI, welcoming the announcement from the UK’s independent regulatory authority, MHRA:
“We were delighted to hear today’s (30 December) announcement that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted emergency authorisation for the University of Oxford/AstraZeneca COVID-19 vaccine.
“MHRA’s determination that the University of Oxford/AstraZeneca COVID-19 vaccine is safe and effective paves the way, we hope, for similar determinations by other stringent regulatory authorities and for WHO Prequalification in the days and weeks ahead.
“The Oxford/AstraZeneca COVID-19 vaccine is extremely attractive in that it is inexpensive, scalable, and can be stored at 2-8 degrees Celsius. These attributes will enable its use worldwide, including in low-income and middle-income countries, alongside other safe and effective COVID-19 vaccines, and the large supplies that will become available in 2021 mean that this vaccine could be a gamechanger in terms of our efforts to end the acute phase of the pandemic.
“Today’s authorization of a vaccine based on viral vector technology, as opposed to the mRNA approach employed by the Pfizer and Moderna vaccines, solidifies our belief that we will soon have a diverse array of vaccines with which to fight this devastating pandemic.
“CEPI’s earlier investments with the University of Oxford supporting the development of this technology for use against other epidemic diseases—most notably the Middle East Respiratory Syndrome, or MERS, which is caused by another coronavirus—positioned us to move at speed to meet this new threat as the COVID-19 pandemic accelerated earlier this year.
“COVAX agreements with University of Oxford and AstraZeneca and other manufacturers that were announced on 18 December ensure that we have a clear pathway forward to securing 2 billion doses for the populations at greatest risk around the world.
“To have multiple vaccines authorized before the end of 2020 is truly remarkable. This is an extraordinary moment in the history of vaccinology but also medicine more generally. What is critical now, especially in light of the emergence of new strains of COVID-19 with increased transmissibility, is that we continue to scale up and scale out production of successful vaccines to ensure that they are made available globally without delay. We must also continue to invest in vaccine R&D—specifically next-generation vaccine candidates—to ensure we have the tools to meet the needs of all segments of all populations in all countries for the long term.”
Background information: CEPI’s partnership with University of Oxford and AstraZeneca:
In 2018, CEPI partnered with the University of Oxford and Janssen Vaccines to advance the development of vaccines against diseases of epidemic potential – MERS, Lassa fever and Nipah.
In March 2020, CEPI provided the University of Oxford with catalytic funding to support the manufacture of vaccine materials required for preclinical and Phase I testing of their COVID-19 vaccine candidate.
In June 2020, CEPI expanded its partnership with University of Oxford and AstraZeneca in June to manufacture doses for distribution through the COVAX Facility.
In Dec 2020, COVAX, co-led by CEPI, Gavi, and the WHO, announced a number of updates to the initiative, including the signing of an advance purchase agreement with AstraZeneca for 170 million doses of the Oxford/ AstraZeneca vaccine. This deal is in addition to existing agreements COVAX has with the Serum Institute of India (SII) for manufacture of 200 million doses – with options for up to 900 million doses more – of either the Oxford/AstraZeneca or Novavax vaccines, via an agreement between Gavi, the Serum Institute of India, and the Bill and Melinda Gates Foundation.
For more on COVAX, please see here.
For more information on CEPI’s efforts to advance the ‘next-generation’ of Wave 2 vaccine candidates, see here.