EMA grants AZ’s Vaxzevria COVID-19 vaccine full marketing authorisation

The European Medicines Agency (EMA) has granted AstraZeneca's (AZ) COVID-19 vaccine, Vaxzevria – ChAdOx1-S [Recombinant] – full Marketing Authorisation (MA) in the EU.

Previously, Vaxzevria was given a conditional Marketing Authorisation (cMA) due to the critical nature of the COVID-19 pandemic, and as further significant evidence of safety and efficacy benefits of Vaxzevria have been confirmed, the EMA has decided to grant a full MA.

The green light from the EMA follows the positive recommendation from its branch, the Committee for Medicinal Products for Human Use (CHMP), for a full MA.

The MA includes the use of Vaxzevria in both a primary vaccination series, and as both a heterologous – with an approved mRNA COVID-19 vaccine – or homologous – all the same vaccine – third dose booster.

A ‘viral vector’ vaccine, Vaxzevria contains a version of a virus that cannot cause disease, which means the body will know how to fight it, should it be exposed to the real virus later. The same technology has been used by scientists creating vaccines over the past 40 years in order to combat other infectious diseases, including flu, Zika, HIV and Ebola.

Vaxzevria has been shown to be effective against all forms of COVID-19, ranging from mild symptomatic cases to severe disease including hospitalisation and death, according to clinical studies and real-world evidence.

The evidence includes an expert review of data taken from 52 real-world studies that showed Vaxzevria and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalisation and death from COVID-19 following three doses. Moreover, a substantial body of evidence is available in support of boosting with Vaxzevria following all primary vaccination schedules tested to date.

Iskra Reic, executive vice president, vaccines and immune therapies, AZ, said: “The move from conditional to full marketing authorisation for Vaxzevria is an important confirmation by the EMA of the safety and efficacy of Vaxzevria, demonstrating that the benefits continue to outweigh the potential risks.

“Vaxzevria is estimated to have helped save over six million lives in the first year of vaccination, which reflects the strength of the evidence showing Vaxzevria’s protection against severe disease and death caused by COVID-19.”

With its global partners, AZ has released over three billion doses of Vaxzevria to more than 180 countries, and around two-thirds of these doses have been distributed to low- and lower-middle-income countries. It is estimated that, in the first year of its roll-out, Vaxzevria has helped save more than six million lives worldwide.