AstraZeneca Covid-19 vaccine wins approval from EU regulator

The European Medicines Agency has approved AstraZeneca’s Covid-19 vaccine for use in all those aged over 18 on Friday.

It means doses can now be rolled out in Ireland as soon as deliveries are made available by the British-Swedish pharmaceutical.

The decision is a boost for vaccine programmes, after Germany’s public health agency recommended the vaccine for use only in those aged 18-64, citing a lack of data from AstraZeneca’s trials among those aged 65 and over.

“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 EMA chief Emer Cooke.

“As in previous cases, the CHMP [the committe on human medicines] has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”

In a statement, the EMA acknowledge that a low number of older people took part in AstraZeneca’s trials. However, the balance of evidence supported approving the vaccine for all age groups over 18, the regulator said.

“Protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines,” the EMA said in a statement.

“As there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.”

The recommendation will now go to the European Commission for final approval.

The recommendation comes amid a simmering row over AstraZeneca’s announcement that EU states will only get a fraction of the supplies expected in the first quarter.

Ursula von der Leyen has said it is “crystal clear” that AstraZeneca is bound by its contract to deliver coronavirus vaccine doses produced in the UK to the EU to make up for a shortfall in production in Belgium.

As a redacted version of the disputed contract was published on Friday, the commission’s president dismissed the arguments of AstraZeneca’s chief executive, Pascal Soriot, that the British government had a first claim on doses produced in Oxford and Staffordshire.

Dr von der Leyen said the Anglo-Swedish pharmaceutical company was legally obliged to use all four plants named in its contract – two in the UK, one in Belgium and a fourth in the Netherlands – to deliver on its promised order.

The European commission has paid €336 million for 400 million doses, the first 100 million of which were due to be delivered in the first quarter of this year.

Dr von der Leyen continue to demand that the British-based pharma group offer a “plausible explanation” for its looming shortfall in vaccine deliveries to the EU.