AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full Marketing Authorisation (MA) in the European Union (EU).
Vaxzevria was originally granted a conditional Marketing Authorisation (cMA) due to the urgency of the COVID-19 pandemic. As there continues to be sufficient evidence of safety and efficacy confirming the benefits of Vaxzevria, the European Medicines Agency (EMA) has now granted a full MA. This decision follows positive recommendation for a full MA by The Committee for Medicinal Products for Human Use (CHMP) of the EMA.
The MA covers 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.
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, 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.”
Vaxzevria has been demonstrated to be effective against all forms of COVID-19 from mild symptomatic to severe disease including hospitalisation and death, according to clinical studies and real-world evidence. These include an expert review of data from 52 real-world studies that showed that Vaxzevria and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalisation and death from COVID-19 following three doses.1 There is also a substantial body of evidence supporting boosting with Vaxzevria following all primary vaccination schedules tested to date.
AstraZeneca and its global partners have released over three billion doses of Vaxzevria to more than 180 countries, and approximately two-thirds of these doses have been delivered to low- and lower-middle-income countries. In the first year of its roll-out, it is estimated that Vaxzevria has helped save more than six million lives worldwide.