UK Authorizes AstraZeneca’s COVID-19 Vaccine for Emergency SupplyBy
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided authorization for emergency supply for AstraZeneca’s and the University of Oxford’s COVID-19 vaccine, making the UK the first country to authorize the vaccine. The vaccine was authorized for individuals 18 years or older.
The authorization recommends two doses administered with an interval of between four and 12 weeks. AstraZeneca is working with UK agencies, Public Health England and National Health Service England, to support the deployment and rollout of the vaccine in the UK, in line with dosing recommendation of the MHRA and the UK’s Joint Committee on Vaccination and Immunization.
AstraZeneca says it aims to supply millions of doses in the first quarter of 2021 as part of an agreement with the UK government to supply up to 100 million doses in total. The first doses were released in late December (December 30, 2020), so that vaccinations may begin early in 2021.
The company says submission of data to global regulatory authorities has already begun as part of ongoing rolling reviews. The company is also seeking emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.
Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials. In addition to a program led by Oxford University, AstraZeneca is conducting a large trial in the US and globally. In total, Oxford University and AstraZeneca expect to enroll up to 60,000 participants globally.
AstraZeneca says it 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 is an adenovirus vector-based vaccine licensed by AstraZeneca from Oxford University and is being jointly developed. It 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, the virus that causes COVID-19, if it later infects the body.
Source: AstraZeneca and UK Medicines and Healthcare products Regulatory Agency