Oxford/AstraZeneca Vaccine Granted Emergency Use Approval in UK

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) on Dec. 30, 2020 granted emergency use approval for the AZD1222 COVID-19 vaccine developed by Oxford University and AstraZeneca for individuals 18 years of age or older. Vaccinations are expected to begin in early 2021.

Phase III trials in the UK and Brazil showed that the vaccine was safe and 70.4% effective at preventing symptomatic COVID-19 more than 14 days after receiving two doses of the vaccine, AstraZeneca reported in a press statement. The developers submitted data to MHRA beginning in September 2020 under a rolling review process. The data were also published in The Lancet on Dec. 8, 2020.

The authorization recommends two doses administered with an interval of 4–12 weeks. The vaccine must be stored and transported at 2–8 °C, for up to six months and can be administered in existing healthcare settings.

In accordance with a government agreement, AstraZeneca will supply millions of doses in the first quarter of 2021 and up to 100 million doses in total. The company said it is working with its global partners to build manufacturing capacity of up to 3 billion doses of the vaccine globally in 2021, pending regulatory approvals.

MHRA’s National Institute for Biological Standards and Control will continue to conduct independent laboratory testing to ensure batches of the vaccine meet expected standards of safety and quality, MHRA reported in a press statement.

The Oxford–AstraZeneca vaccine, AZD1222, which uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus, contains the genetic material of the SARS-CoV-2 virus spike protein. The surface spike protein is produced in vaccinated people, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body, according to an AstraZeneca press statement.

MHRA granted emergency use approval to a messenger RNA vaccine from Pfizer–BioNTech on Dec. 1, 2020.

Sources: AstraZeneca and Medicines and Healthcare products Regulatory Agency