The European Medicines Agency has granted conditional marketing authorisation for the AstraZeneca Covid-19 Vaccine to prevent coronavirus in people from 18 years of age onwards.
It becomes the third Covid-19 vaccine that the EMA has recommended for authorisation.
The EMA said that its human medicines committee has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission.
This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns, the agency said.
AstraZeneca is to be given as two injections into the arm, the second between 4 to 12 weeks after the first.
The most common side effects with Covid-19 Vaccine AstraZeneca were usually mild or moderate and got better within a few days after vaccination.
The most common side effects are pain and tenderness at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea.
Emer Cooke, Executive Director of EMA said:
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens.”
“As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”
Combined results from four clinical trials in the United Kingdom, Brazil and South Africa showed that Covid-19 Vaccine AstraZeneca was safe and effective at preventing Covid-19 in people from 18 years of age. These studies involved around 24000 people altogether.
Half received the vaccine and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection.
The safety of the vaccine has been demonstrated across the four studies. However, the agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil).