Approval follows CHMP recommendation for use in patients previously vaccinated with AstraZeneca COVID-19 vaccine or an EU-approved mRNA COVID-19 vaccine
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 AstraZeneca’s COVID-19 vaccine as a third dose booster in patients previously given a primary vaccine schedule of either the 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’s COVID-19 vaccine following a primary vaccine schedule of either the 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 vaccine6, 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 the AstraZeneca COVID-19 vaccine as a third dose booster following all primary vaccination schedules tested to date including AstraZeneca’s COVID-19 vaccine, mRNA vaccines, and CoronaVac.1,7-12
The AstraZeneca COVID-19 vaccine is already authorised as a homologous booster (patients previously given a primary vaccine schedule of the 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 the AstraZeneca COVID-19 vaccine or an inactivated vaccine or an mRNA COVID-19 vaccine) in a number of non-EU countries.
AstraZeneca’s 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.13
AstraZeneca COVID-19 vaccine
AstraZeneca COVID-19 vaccine was invented by the University of Oxford. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
The AstraZeneca COVID-19 vaccine is a ‘viral vector’ vaccine, which means a version of a virus that cannot cause disease is used as part of the vaccine, leaving the body knowing how to fight it if it is exposed to the real virus later. This vaccine technology has been used by scientists over the past 40 years to fight other infectious diseases such as the flu, Ebola, and HIV.14
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, which accelerates the pathway to access in up to 144 countries through the COVAX Facility.
Under a sub-license agreement with AstraZeneca, the vaccine is manufactured and supplied by the Serum Institute of India under the name COVISHIELD.
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.