AstraZeneca-Oxford Vaccine Approved for Use by European Medicines Agency

astra zeneca approval EMA

The coronavirus vaccine developed by AstraZeneca and the University of Oxford has been approved by Europe’s drug regulator, the European Medicines Agency.

That will make it the bloc’s third certified vaccine, along with those made by the US-German enterprise BioNTech-Pfizer and the US firm Moderna.

AstraZeneca requested market authorization through the EMA on 11 January.

The approval comes at a tricky time for the EU, with its vaccination program sluggish at best, and looking very vulnerable to supply shortages.

The EU contract with AstraZeneca is an advance purchase agreement for the supply of at least 300 million doses, with doses delivered in stages.

 

In a statement this afternoon, the Amsterdam-based EMA said that it had approved the vaccine’s use for all age groups over 18, despite the decision by German authorities not to use it for over 65s.

“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.

The statement from the EMA did make note of the fact that most of the participants in these vaccine studies were between 18 and 55 years old.

It said that there are not enough results to provide a figure for how well the vaccine will work in those aged over 55.

“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.

 

 

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