AstraZeneca’s Oxford University-partnered COVID-19 vaccine has scored a conditional marketing authorisation (CMA) for use in the EU for the prevention of COVID-19 in individuals aged 18 years and older.

The CMA comes on the heels of a positive opinion adopted by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), adopted on Friday.

The positive opinion was based on data from a rolling review of AZ’s trial data – including the primary analysis of the Phase III programme led by Oxford University.

The COVID-19 vaccine demonstrated an average efficacy rate of 70% in an interim analysis of phase II/III trials conducted in the UK and Brazil.

This includes one dosing regimen which showed vaccine efficacy of 90%, when AZD1222 was administered first as a half dose, followed by a full dose at least one month apart.

A second dosing regimen showed 62% efficacy when given as two full doses at least one month apart.

In the EU, the vaccine has been recommended for use in a two-dose regimen to be administered at a four- to 12-week interval.

“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,” said Pascal Soriot, chief executive officer of AZ.

“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,” he added.

The AZ vaccine can be stored, transported and handled at normal refrigerated conditions (+2°C - +8°C) for at least six months.