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UK Authorizes AstraZeneca’s COVID-19 Vaccine For Emergency Use

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AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorization for emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunization of individuals 18 years or older. The authorization 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 hospitalizations 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.

“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. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.” Pascal Soriot, Chief Executive Officer

“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.” Matt Hancock, UK Secretary of State for Health and Social Care

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. This is the first authorization for this vaccine.

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 program led by the University of Oxford.

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