AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorization (CMA) in the European Union for active immunization to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older, according to the company.
Following review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on data from a rolling review of data from a Phase 3 trial led by the University of Oxford. Additional safety and efficacy data for the vaccine will continue to accumulate from ongoing clinical trials and is expected to be published in the coming weeks.
The CHMP recommends two doses of COVID-19 Vaccine AstraZeneca (formerly AZD1222) to be administered at a four- to 12-week interval in people aged 18 years and older. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose.
AstraZeneca is working with the EU following the approval of a CMA for active immunization to begin across member states.
Pascal Soriot, Chief Executive Officer, said: “Today’s approval underscores the value of AstraZeneca’s COVID-19 vaccine, which is not only effective and well tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations. We are deeply grateful to Oxford University, participants in the clinical trials and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans.”
The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius or 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
AstraZeneca continues to engage with governments, international organizations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.