British drug major AstraZeneca PLC (AZN.L,AZN) announced Monday that its COVID-19 vaccine, Vaxzevria, has been granted approval in the European Union as a third dose booster in adults.
The vaccine can now be used as a third dose booster in patients previously given a primary vaccine schedule of either Vaxzevria or an EU-approved mRNA COVID-19 vaccine.
The European Medicine Agency or EMA approved the vaccine following recommendation by the Committee for Medicinal Products for Human Use or CHMP. For the decision, the Committee reviewed the substantial body of evidence demonstrating an increased immune response.
The AstraZeneca COVID-19 vaccine was invented by the University of Oxford. The vaccine has been granted a conditional marketing authorisation or emergency use in more than 125 countries. It also has Emergency Use Listing from the World Health Organization.
Vaxzevria is already authorised as a homologous booster, i.e., patients previously given a primary vaccine schedule of Vaxevria, in the UK, and several countries in Asia and Latin America. It has also been authorised as a heterologous booster, i.e., patients previously given a primary vaccine schedule of either a viral vector vaccine other than Vaxzevria or an inactivated vaccine or an mRNA COVID-19 vaccine, in a number of non-EU countries.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said, “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.”
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