AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released so that vaccinations may begin early in the New Year according to are report from AstraZeneca.
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 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.
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.
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 authorization during the health crisis. AstraZeneca 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 building 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, 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.
AZD1222 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. After 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 hospitalizations in the vaccine group.
