United Kingdom Authorizes Emergency Supply of AstraZeneca’s COVID-19 Vaccine

AstraZeneca’s vaccine for the coronavirus disease 2019 (COVID-19) has been approved in the United Kingdom for emergency supply, according to the company. The first doses are being released today with the goal of beginning vaccinations in the UK early in 2021.

The vaccine is not authorized for use in the United States.

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 age 18 years and older. This authorization recommends 2 doses administered with an interval of between 4 and 12 weeks, a regimen shown in clinical trials to be safe and effective at preventing symptomatic COVID-19. According to AstraZeneca, no severe cases of COVID-19 and no hospitalizations from the virus were reported more than 14 days after the second dose.

The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the UK and Brazil phase 3 trials conducted by Oxford University. 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 2 doses of the vaccine. A secondary efficacy endpoint of prevention of severe disease demonstrated no cases of severe infections or hospitalizations in the vaccine group.

“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,” said Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford Vaccine Trial, in a prepared statement.

According to AstraZeneca, the company 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 Immunization dosing recommendation. AstraZeneca 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.

According to AstraZeneca, the UK’s authorization for emergency supply is the first authorization for this vaccine. The company is currently conducting a large trial in the US and in other countries around the world.

The MHRA’s decision to authorize use of the vaccine 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 3 program led by the University of Oxford. Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials.

According to AstraZeneca, the company is working with global partners to continue building manufacturing capacity of up to 3 billion doses of the vaccine globally in 2021 on a rolling basis, pending regulatory approvals. The vaccine can be stored, transported and handled at normal refrigerated conditions (36-46 degrees Fahrenheit) for at least 6 months and administered within existing health care settings.

REFERENCE

AstraZeneca’s COVID-19 vaccine authorized for emergency supply in the UK [news release]. Cambridge, United Kingdom; December 30, 2020: AstraZeneca. Accessed December 30, 2020. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/astrazenecas-covid-19-vaccine-authorised-in-uk.html