AstraZeneca has secured a conditional marketing authorisation for its Covid-19 vaccine in the European Union (EU) for active immunisation in individuals aged 18 years and above.
The authorisation was granted after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency reviewed the primary data from the vaccine’s Phase III trial.
The Phase III programme was led by the University of Oxford. Additional safety and efficacy data of the vaccine, which will continue to gather from the ongoing clinical trials, is expected to be released in the coming weeks.
As recommended by the CHMP, people aged 18 years and older will receive two doses of COVID-19 Vaccine AstraZeneca, which was earlier known as AZD1222, at a four- to 12-week interval.
The dosage is claimed to be safe and effective in preventing symptomatic Covid-19, and no severe cases and hospitalisations were reported for over 14 days after the second dose.
The company is currently working with the EU after securing the CMA to begin the active immunisation to start across member states.
AstraZeneca CEO Pascal Soriot 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 Covid-19 vaccine can be stored, transported and handled between 2° and 8° Celsius or 36° 46° Fahrenheit for at least six months and administered within existing healthcare settings.