AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with vaccinations now taking place.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorisation for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunisation of individuals 18 years or older.
The authorisation recommends two doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose.
AstraZeneca is working with Public Health England and National Health Service England to support the deployment and roll out of the vaccine in the UK, in line with the MHRA and the UK’s Joint Committee on Vaccination and Immunisation dosing recommendation.
The company aims to supply millions of doses in the first quarter as part of an agreement with the government to supply up to 100 million doses in total.
CEO Pascal Soriot said: “Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit.”
Matt Hancock, UK Secretary of State for Health and Social Care, said: “This is a moment to celebrate British innovation – not only are we responsible for discovering the first treatment to reduce mortality for COVID-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease.
“It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world. I want to thank every single person who has been part of this British success story. While it is a time to be hopeful, it is so vital everyone continues to play their part to drive down infections.”
The MHRA’s decision was based on independent advice from its Commission on Human Medicines following a rolling review of trial data that included an interim analysis of the Phase III programme led by the University of Oxford. The data were also published in The Lancet on 8 December 2020.
Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials.
AstraZeneca continues to work with regulatory authorities around the world to support their ongoing rolling reviews for emergency supply or conditional marketing authorisation during the health crisis.
The company is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries.