AstraZeneca’s COVID-19 vaccine has been granted approval in the European Union (EU) by the European Medicine Agency (EMA) as a third dose booster in adults.
Healthcare professionals can now use the AstraZeneca COVID-19 vaccine as a third dose booster in patients previously given a primary vaccine schedule of either AstraZeneca COVID-19 vaccine or an EU-approved mRNA COVID-19 vaccine.
The authorisation is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of the substantial body of evidence demonstrating an increased immune response after a third dose booster with AstraZeneca COVID-19 vaccine following a primary vaccine schedule of either AstraZeneca COVID-19 vaccine or an mRNA COVID-19 vaccine. [1-5]
Although more than 65% of the global population has received at least one dose of a COVID-19 vaccine , there remains a significant challenge to ensure people receive both their primary vaccine schedule and third dose booster, and healthcare professionals now have greater flexibility in their choice of vaccine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca 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.”
There is a substantial body of evidence supporting AstraZeneca COVID-19 vaccine as a third dose booster following all primary vaccination schedules tested to date including AstraZeneca COVID-19 vaccine, mRNA vaccines, and CoronaVac [1,7-12].
AstraZeneca COVID-19 vaccine is already authorised as a homologous booster (patients previously given a primary vaccine schedule of AstraZeneca COVID-19 vaccine) in the UK, and several countries in Asia and Latin America. It has also been authorised as a heterologous booster (patients previously given a primary vaccine schedule of either a viral vector vaccine other than AstraZeneca COVID-19 vaccine or an inactivated vaccine or an mRNA COVID-19 vaccine) in a number of non-EU countries.
AstraZeneca COVID-19 vaccine is estimated to have helped prevent 50 million COVID-19 cases, five million hospitalisations, and saved more than one million lives worldwide, based on model outcomes assessing COVID-19 worldwide