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EU medicines agency approves Oxford/AstraZeneca Covid-19 vaccine for everyone over 18

The EMA’s AstraZeneca decision has been the subject of intense speculation.

Image: PA Images

Updated Jan 29th 2021, 4:05 PM

THE EU’S MEDICINES regulator has granted authorisation for the use of the Oxford-AstraZeneca Covid-19 vaccine.

The approval is the third coronavirus vaccine given the green light by the European Medicines Agency (EMA) following the approval of the Pfizer/BioNTech and Moderna vaccines.

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.

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 that four clinical trials have been carried out on the vaccine involving about 24,000 people and that it was shown to be safe.

The trials included control groups of those who received a dummy vaccine and in two of the trial an insufficient number of people subquenly contacted Covid-19, meaning the EMA could not consider those two trials when determining the efficacy of the vaccine.;

The EMA said the vaccine demonstrated a 60% efficacy in the clinical trials.

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.

The EMA’s AstraZeneca decision has been the subject of intense speculation due to the vaccine’s key role in vaccination strategies. The vaccine is delivered in two doses 4 to 12 weeks and can be stored in common refrigeration temperature ranges.

Unlike the Pfizer and Moderna vaccines that use mRNA technology, the AstraZeneca is the more common adenoviral vector vaccine and is also easier to transport. 

“This should simplify the logistics of rolling the vaccine out across the EU and hopefully can provide a boost to vaccinations in the member states,” Cooke said during a briefing this afternoon.

She added: 

But let me stress manufacturer of all vaccines is complicated technology transfer can be may be complex and may raise unanticipated issues. And we’ve all seen reports of production and supply challenges.

 

Her comments relate to the increasingly bitter dispute between AstraZeneca and the European Commission.

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The dispute arose after AstraZeneca said it would not be able to meet vaccine delivery timelines, delivering only a quarter of the doses it had promised for the first quarter of 2021.

Speaking today, chair of  Ireland’s vaccination task force Brian MacCraith said that 191,000 doses of the AstraZeneca vaccine will be delivered here in February, with just 95,000 currently confirmed for March.

About the author:

Rónán Duffy

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