Covid-19: EMA receives application for approval from Oxford/AstraZeneca vaccine makers

A healthcare worker fills a syringe with a dose of the Oxford/AstraZeneca in the UK. 

The makers of the Oxford/AstraZeneca vaccine have applied to the EU for approval.

The European Medicines Agency has confirmed that it has received an application for a conditional marketing authorisation of the jab.

The health body said that thee assessment of the vaccine will proceed under an accelerated timeline.  A decision on whether the vaccine can be used will be given on January 29.

The EMA said in a statement: “Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review.

“During this phase, EMA assessed data from laboratory studies (non-clinical data), data on the vaccine’s quality (on its ingredients and the way it is manufactured) and some evidence on safety and efficacy from a pooled analysis of interim clinical data from four ongoing clinical trials in the United Kingdom, Brazil and South Africa.” 

The EMA has previously approved the Pfizer-BioNTech vaccine, which is already being administered in Ireland.

The HSE received the first batches of the vaccine on December 26, while supplies of the Moderna vaccine are expected in Ireland this week.

The Government has pre-ordered hundreds of thousands of doses after the European Commission authorised the jab earlier this month.

If the EMA approves the Oxford/AstraZeneca vaccine "it will recommend granting a conditional marketing authorisation. 

"The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days."

A conditional marketing authorisation is used as the fast-track authorisation procedure to speed up approval of treatments and vaccines during public health emergencies.

Tánaiste Loe Varadkar described it as a “very positive development”.

He stated: “If approved this vaccine will allow significant scaling up of vaccination programme.” 

Health Minister Stephen Donnelly also described it as “some good news”.

“The EMA has confirmed this morning that the AstraZeneca application has been made and says an opinion could be issued by 29 January, which if achieved without issue should see end-Jan timeline for approval.”

Ireland is battling a surge in the number of admissions with Covid-19 to hospital but the country has “turned a corner” in the number of new infections, those modelling disease spread said.

Professor Karina Butler, chairwoman of the National Immunisation Advisory Committee, said yesterday that the authorisation process for another vaccine made by AstraZeneca had commenced and data had been submitted to European regulators.

“They anticipate that they will have a decision by the end of the month,” she said.

“Then AstraZeneca are primed to have very significant quantities of vaccine available to us at that time. That will allow acceleration for the rollout.” 

She said everything is being done to maximise the vaccine given and to ensure there is no wastage. That includes extracting an extra dose from a vial.

Last night, 4,929 new cases of Covid-19 were confirmed in Ireland along with eight additional deaths.