Drug regulators in the United Kingdom have approved a second COVID-19 vaccine for emergency use today, for the active immunisation of individuals 18 years or older. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the COVID-19 vaccine developed by Oxford University in collaboration with pharma giant AstraZeneca for emergency supply.
Vaccinations to begin in early 2021
The first doses of AstraZeneca’s COVID-19, named AZD1222, are being released today so that vaccinations may begin as early as Monday the 4th of January in 2021.
The authorisation recommends two doses administered with an interval of between four and 12 weeks. According to AstraZeneca, the dosage 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.
UK government has secured 100 million doses
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 pharmaceutical company aims to supply millions of doses in Q1 of 2021 as part of an agreement with the UK government to supply up to 100 million doses.
Pascal Soriot, Chief Executive Officer, 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. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”
The UK Secretary of State for Health and Social Care, Matt Hancock, 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.”
Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said:
“The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants. Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.”
The MHRA’s approval 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.
More safety and efficacy data for the AZD1222 vaccine will be accumulated from ongoing clinical trials. AstraZeneca continues to work with regulatory authorities globally to support their ongoing rolling reviews for emergency supply or conditional marketing authorisation during the pandemic.
Up to 3 billion doses may be produced globally in 2021
The pharma giant is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low- and middle-income countries. AstraZeneca is working with its global partners to continue expanding manufacturing capacity of up to three billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals.
The vaccine can be stored at normal refrigeration temperatures
Notably, the AstraZeneca/Oxford COVID-19 vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings. This significantly simplifies and accelerates the supply chain processes and makes logistics more cost-effective, which could be of huge benefits for low- and middle-income countries once approved by the respective regulatory bodies of the nations. AstraZeneca continues its dialogue with governments, multilateral organisations and collaborators around the globe to ensure broad and equitable access to the vaccine at no profit for the duration of the health crisis.
The AstraZeneca/Oxford COVID-19 vaccine – AZD1222
The AZD1222 vaccine was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. Following vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the UK and Brazil Phase III trials conducted by Oxford University. As announced on 23 November 2020, the primary efficacy endpoint based on a pooled analysis showed that the vaccine was 70.4% (confidence interval: 54.8% to 80.6%) effective at preventing symptomatic COVID-19 occurring more than 14 days after receiving two doses of the vaccine. A secondary efficacy endpoint of prevention of severe disease demonstrated no cases of severe infections or hospitalisations in the vaccine group.
The safety data published so far is from over 20,000 participants enrolled across four clinical trials in the UK and Brazil and South Africa. The Lancet, a respected weekly peer-reviewed medical journal, confirmed in a publication that AZD1222 was well tolerated and that there were no serious safety events confirmed related to the vaccine. The participants were from diverse racial and geographic groups who are healthy or have stable underlying medical conditions. This analysis provides safety data on 74,341 person-months of follow-up after the first dose (median 3.4 months) and 29,060 person-months of follow-up after two doses (median 2.0 months). The overall reported rates of serious adverse events were 0.7% in the vaccine group and 0.8% in the control group.
In addition to the programme led by Oxford University, AstraZeneca is conducting a large trial in the United States and around the world. In total, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally.
Headquartered in Cambridge, England, AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapeutic areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in more than100 countries and its innovative medicines are used by millions of patients around the world. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.