CEPI statement on EMA recommending authorisation of Oxford/AstraZeneca COVID-19 vaccine in the EU

Statement from Dr. Melanie Saville, Director of Vaccine R&D, CEPI:

"We welcome today's (29 Jan) announcement that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for the University of Oxford/AstraZeneca COVID-19 vaccine. The EMA has determined that the vaccine is safe and effective in adults over the age of 18 and as such this is an important milestone for vaccination efforts in Europe and beyond.

"With several approved vaccines now available, and more showing encouraging late-stage trial results, the world is in a stronger position to push back against COVID-19. The Oxford/AstraZeneca COVID-19 vaccine can play a crucial role in the world's response to this pandemic. The evidence of its efficacy is robust, and it has been shown to prevent serious illness and death, which is a priority at this stage in the pandemic. In addition, it is inexpensive to produce, and can be stored at 2-8 degrees Celsius - characteristics that will enhance access and make global distribution easier, especially in low-income and middle-income countries. AstraZeneca's commitment to sell their vaccine at no profit is also testament to their commitment to ensuring the whole world benefits from these scientific advancements.

"COVAX has established agreements with University of Oxford and AstraZeneca and other manufacturers that ensure that we have a clear pathway forward to securing 2 billion doses for the populations at greatest risk around the world, as they are manufactured and become available. However, securing global vaccine supply is not the only challenge we need to overcome. The emergence of virus variants, some of which might have the ability to evade vaccine protection, pose a very real threat to our progress and underscore the need to continue invest in vaccine R&D to stay one step ahead of this virus."

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.

 

Further links:

The European Medicines Agency's (EMA) press release is available here