The EMA said combined results from four separate clinical trials had demonstrated the AstraZeneca vaccine was safe and effective.
The European Medicines Agency has recommended granting a conditional marketing authorisation for the Covid-19 vaccine created by AstraZeneca.
The EMA recommended EU approval for use in people from 18 years of age.
This is the third Covid-19 vaccine the EMA has recommended for authorisation following the approval of the Pfizer/BioNTech and Moderna vaccines.
“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,” said Emer Cooke, Executive Director of EMA.
“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.”
The EMA said combined results from four separate clinical trials in the UK, Brazil and South Africa – involved around 24,000 people altogether – had demonstrated the AstraZeneca vaccine was safe and effective in preventing Covid-19 in people from 18 years of age.
It was also noted that most of the participants in these studies were between 18 and 55 years old.
The EMA said there are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group.
“However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults,” the EMA said.
“More information is expected from ongoing studies, which include a higher proportion of elderly participants.”
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