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European Medicines Agency head hopes for decision on Astrazeneca vaccine approval 'by end of this week'

Despite the supply issues, a European approval for the Astrazeneca vaccine this Friday will pave the way for its rollout in Ireland.

EMA Executive Director Emer Cooke
EMA Executive Director Emer Cooke

THE EXECUTIVE DIRECTOR of the European Medicines Agency (EMA) has said that work is ongoing to assess the Astrazeneca Covid-19 vaccine, and it’s hoped that a decision will be made on whether to grant approval “by the end of this week”. 

Addressing the European Parliament committee on public health this afternoon, Emer Cooke referenced the shortage in supply of the Astrazeneca vaccine and said the EMA was “working” with the company and it’s hoped the problems with supply will be “short-lived”. 

If the EMA agrees to grant a conditional marketing authoritisation to the Astrazeneca vaccine this Friday, it paves the way for its rollout in Ireland. 

However, that rollout here is set to be lower than initially expected due to the company’s unexpected delay in delivering millions of doses of its Covid-19 vaccine to EU member states.  

Last Friday, the pharma giant said it would not meet its contractual delivery commitments to the European Union because of unexplained “reduced yields” in its European supply chain.

Health Minister Stephen Donnelly said last night that delivery of the vaccine in March is set to be “considerably lower than what was originally stated by the company”.

However, if approved on Friday, Ireland will receive a supply of the Astrazeneca vaccine “within the expected range” for February. 

Commenting on the already approved Pfizer/BioNTech and Moderna vaccines today, the EMA’s Cooke said that it is requiring rigorous safety and effectiveness studies of these products. 

She said that monthly safety updates are required from the companies with approved vaccines, and this is in addition to regular updates already required by legislation. 

“With respect to the transparency of this work, we’re planning to publish the first Covid-19 vaccine safety update later this week, and this is based on the monthly safety report that has been reviewed and assessed for the Pfizer vaccine,” she said. 

Cooke also said today, in response to questions from MEPs, that EMA staff are working around the clock on the process to approve vaccines. She said it wouldn’t be unusual to see staff exchanging emails in the middle of the night. 

She said that it wasn’t specifically in the remit of the EMA to boost production of a vaccine, but the agency would “do everything we can to facilitate production from a scientific and regulatory perspective”. 

She said: “The other issue that we’re working on with the companies of the national authorities is how to ensure that production capacity can be increased.

“And we’re looking at different manufacturing options which require formal manufacturing changes in order to increase the production capacity. I think you’re all aware of the problems with supply identified at a European level, due to some of the manufacturing issues. We’re working with the companies on these and we very much hope that these will be short lived.”

Cooke said the EMA is continuously monitoring the impact of new variants of Covid-19, and was requesting companies with approved vaccines to submit information on the immunse response induced by the vaccine against these new strains. 

She said the next vaccine potentially in line for approval – made by Janssen (the pharmaceutical wing of Johnson and Johnson) – is being examined on a rolling basis, but there is no indicative date for when it could reach approval stage as of yet. 

Cooke also addressed the media reports regarding the efficacy of the Astrazeneca vaccine in people aged over 65.

This morning, Germany’s health ministry joined the pharma company rubbishing reports quoting unnamed government sources that claimed the vaccine showed little efficacy for people above 65.

Cooke said that the EMA is examining the “totality of the data” provided by Astrazeneca across different age groups. She said she wouldn’t prejudge any decision on the vaccine’s approval, but said it was possible for an approval to contain a provision that the vaccine only be given to certain age groups. 

MEP Mick Wallace questioned Cooke on the speed with which the EMA is approving its vaccines, compared to the UK which has already approved the Astrazeneca vaccine as well as the Pfizer/BioNTech and Moderna vaccines. 

“Does the EMA demand more complete or higher quality data than the UK regulator?” Wallace asked. 

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mick wallace Mick Wallace Source: European Parliament

Cooke said that the mechanism used by the UK to approve vaccines was through a temporary use authorisation, which is not something within the remit of the EMA. The EMA instead provides conditional marketing authorisation to vaccines it deems safe and efficacious. 

Astrazeneca’s vaccine was already approved for use in the UK before it applied for European approval earlier this month, and Cooke said this was a reflection of the further data needed, and that this data had been provided by Astrazeneca in recent weeks. 

“We are confident that the process behind a conditional marketing authorisation provides a robust scientific review that can be relied upon in all 27 member states,” she said.

“The conditions and criteria that we use for the evaluation of the conditional marketing authorisation are the same conditions we would expect for any vaccine.”

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Sean Murray

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