AstraZeneca Covid vaccine wins approval from EU regulator

The European Medicines Agency (EMA) has approved AstraZeneca's Covid-19 vaccine for use in all those aged over 18 on Friday. The recommendation will now go to the European Commission for final approval.

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

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.

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“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.”

German health authorities on Thursday recommended that AstraZeneca’s Covid-19 vaccine should be not be given to those aged over 65 due to a lack of data.

Only 341 people aged over 65 in AstraZeneca's trial received the vaccine, and 319 were given a placebo, meaning that too little data is available to show the vaccine's effectiveness in that age group with certainty, the vaccine committee of Germany's main public health agency the Robert Koch Institute said in a statement.

AstraZeneca's trial data is also being challenged in the United States, where a pension fund has launched a lawsuit on behalf of investors faulting the company for including too few older people, and for a mix-up in the trial in which some participants were accidentally only given a half-dose as one of their shots.

The AstraZeneca jab is seen as a crucial part in European efforts to get control of the pandemic as it is by a long way the cheapest of all the vaccines the EU has ordered – with AstraZeneca supplying it on a cost basis only – and requires less intense refrigeration than the vaccines produced by Pfizer/ BioNTech and Moderna.

The EMA 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.

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.

– Additional reporting from Reuters