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EU drugs regulator approves Oxford vaccine

It comes as the European Medicines Agency warns that vaccines are not a magic wand to defeat the pandemic.

None of the vaccines approved for use in the EU are a “magic wand” to defeat the pandemic, the head of the European Medicines Agency has warned.

On Friday, the Oxford/AstraZeneca vaccine became the third to secure EMA approval for use in the EU, along with the PfizerBioNTech and Moderna vaccines.

The AstraZeneca vaccine is considered particularly important as it is easier to store and transport, and can be administered in a single dose.

Speaking after its approval on Friday, EMA executive director Emer Cooke said more hard work is needed to develop vaccines and treatments to beat the pandemic.

She said: “We now have three vaccines that have been developed and recommended for approval against a disease that we did not know about one year ago. None of them is perfect.

“None of them has all the characteristics that we might want it to, to help us, to allow us to move completely forward.

“None of them is a magic wand on its own but together they provide tools and options to prevent different aspects of the disease.”

She added: “Every day we learn more about this disease, and we need to continue to work hard to get more vaccines and treatments available to help beat the pandemic, step by step, product by product, mutation by mutation.”

On Friday the AstraZeneca vaccine was approved for use in the EU for everyone over the age of 18.

There had been concerns its use might be limited, after German public health officials ruled out its use in people over the age of 65.

The EMA said that while the dataset of that age group who took part in clinical trials was small, “protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines”.

Ms Cooke said: “The recommendation to approve the AstraZeneca vaccine is based on data that shows the vaccine offers protection against Covid-19, with a reassuring safety profile.”

She said the AstraZeneca vaccine is easier to handle than the other mRNA-based vaccines in terms of transport and storage.

“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,” she added.

The approval has come amid an ongoing row between the EU and AstraZeneca over the promised delivery schedule of the vaccines.

On Friday, Ms Cooke reminded the pharma-giant that approval comes with “legally binding obligations”.

She said: “It provides a controlled and robust legal framework for pharmacovigilance manufacturing controls and other post-approval obligations.

“This means that there are legally binding obligations on the company for continuing manufacture, monitoring and updates.”

AstraZeneca has been asked by the EMA to conduct trials to determine its effectiveness against other variants of Covid-19.

Ms Cooke said work will continue on approval for other vaccines and treatments.

She added: “One year on, we know there are no silver bullets. But there are significant steps and miles that have been and can be delivered.

“And these are necessary to multiply the options available for healthcare systems, today’s achievement will deliver yet another option.”

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