France: Europe’s drugs regulator on Friday authorized the use of the AstraZeneca AZN COVID-19 vaccine for people aged over 18.
The European Medicines Agency, or EMA, said it had assessed the quality, safety and efficacy of AstraZeneca’s shot, which the drug company has developed in partnership with the University of Oxford, and recommended it for conditional marketing authorization in the European Union.
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA [European Economic Area] member states to combat the pandemic and protect their citizens,” said Emer Cooke, the EMA’s executive director, in a statement.
The EMA has already given the green light to the vaccine developed by U.S. drug company Pfizer PFE and its German partner BioNTech BNTX , as well as the one developed by U.S. biotech Moderna MRNA .
However, on Thursday, a draft recommendation from Germany’s vaccination advisory committee recommended that the AstraZeneca–Oxford shot only be given to people aged 18 to 64, saying there was “insufficient data” to assess the vaccine efficacy in those aged 65 years and over.
The EMA acknowledged that most of the participants in the AstraZeneca vaccine trials were between 18 and 55 years old, and that there weren’t enough results in older people to provide a figure for how well it 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,” it said.
The EU signed a deal with AstraZeneca AZN in August 2020 for 300 million doses, with an option for 100 million more.