The European Medicines Agency (EMA) has today recommended the conditional marketing authorisation of the ChAdOx1 nCoV-19 coronavirus vaccine developed by the University of Oxford with its partner AstraZeneca. Distribution will begin across all 27 member states once the decision is ratified by the European Commission.
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- EMA recommends granting conditional marketing authorisation to prevent coronavirus disease in people from 18 years of age
- Vaccine shown to be highly effective and safe, preventing hospitalisation or death from COVID-19
- EMA joins regulators from 20 countries in 5 continents worldwide in recommending the use of the vaccine
The EMA has recommended that two standard doses of ChAdOx1 nCoV-19 be administered at a four-to 12-week interval in people aged 18 years and older. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.
Today’s approval marks a key step towards the University and AstraZeneca’s goal of providing global access to the vaccine, which has so far been shown to prevent hospitalisations or deaths from coronavirus and is being made available on a not-for-profit basis during the pandemic.
The vaccine is also easily manufactured, transported and stored at domestic fridge temperature (2-8 degrees C), so can be easily administered in existing healthcare settings, allowing for the vaccine to be deployed rapidly.
Andrew Pollard, Professor of Paediatric Infection and Immunity, and Chief Investigator on the Oxford vaccine trial, said:
‘The recommendation by the European Medicines Agency is an important milestone in extending access to the Oxford-AZ vaccine in our region and providing further endorsement that the after rigorous scrutiny of regulators the vaccine can be used to help protect populations from the pandemic coronavirus.’
Sarah Gilbert, Professor of Vaccinology, and Chief Investigator on the Oxford vaccine trial, said:
‘It is excellent news that the EMA has approved use of the SARS CoV-2 vaccine first produced in Oxford. This decision paves the way to more widespread use of the vaccine to protect people against COVID-19 and gain control of the pandemic.’
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
‘Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine, which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations. We are deeply grateful to Oxford University, participants in the clinical trials and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans.’
Professor Adrian Hill, Director of the Jenner Institute said:
‘We have been working for the past 30 years at the University of Oxford to develop vaccines using novel technologies that can protect people around the world from diseases which claim many lives each year. The work on ChAdOx1 nCoV-19 builds on many years of research by dedicated teams of researchers and clinicians, and we are delighted to see the EMA joining the MHRA and other regulators in approving its use.’
The ChAdOx1 nCoV-19 vaccine has now been recommended for use by regulators in over 40 countries, spanning five continents.