The EC approval follows positive CHMP recommendation in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine, granted last week
AstraZeneca has received the European Medicine Agency (EMA) approval for a third dose (booster) of Vaxzevria (ChAdOx1-S) in the European Union (EU).
With the EMA approval, Vaxzevria can now be used as a booster dose in adults who previously received primary vaccination with either Vaxzevria or an EU-approved mRNA Covid-19 vaccine.
Last week, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Vaxzevria in the EU.
The authorisation is based on CHMP’s review of a substantial body of evidence, which showed that the vaccine induced a rise in immune response after a third booster.
Vaxzevria is already authorised as a homologous booster in the UK, and other Asian and Latin American countries, and a heterologous booster in various countries other than the EU.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “Today’s marketing authorisation for AstraZeneca’s Covid-19 vaccine as a third dose booster is an important step towards our goal of providing continued protection against Covid-19 for all populations.
“Ensuring a longer duration of immune protection is essential to the long-term management of Covid-19 globally, and boosters can address the waning of protection over time that has been seen with all primary vaccine schedules to date.”
Previously called AstraZeneca Covid-19 vaccine and formerly AZD1222, Vaxzevria was created by the University of Oxford and was licenced by the UK drugmaker.
The vaccine leverages a replication-deficient chimpanzee viral vector based on a weakened version of adenovirus and contains the genetic material of the SARS-CoV-2 spike protein.
In the trial, AZD1222 showed 79% vaccine efficacy against symptomatic Covid-19, 100% efficacy against severe or critical Covid-19 and hospitalisation.
Also, it showed 100% efficacy in preventing severe Covid-19 and hospitalisation, which is a key secondary endpoint, and showed 85% vaccine efficacy in people aged 65 years and above.
Vaxzevria has been authorised for conditional marketing or emergency use in more than 125 countries and has received Emergency Use Listing (EUL) from the World Health Organization (WHO).
Furthermore, AstraZeneca has signed a sub-license agreement with Serum Institute of India (SII) to manufacture the vaccine and supply it under the name Covishield.