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AZ seeks EU approval for its Oxford University-partnered COVID-19 vaccine

CHMP could reach a decision on opinion by 29 January

The European Medicines Agency (EMA) is set to begin an ‘accelerated’ review of AstraZeneca/Oxford University’s COVID-19 vaccine.

The EMA announced today that it had received an application for conditional marketing authorisation (CMA) for AZ/Oxford’s COVID-19 vaccine.

The agency added that, following the ‘accelerated’ review, it could issue an opinion on the marketing authorisation for the vaccine by 29 January, when its Committee for Medicinal Products for Human Use (CHMP) is due to meet.

The CHMP kicked off a rolling review of the AZ/Oxford vaccine in October 2020 – meaning the agency has already reviewed some data on the vaccine.

In a ‘rolling review’, as opposed to the traditional method of having access to all data on a medicine’s safety, efficacy and quality prior to submission, the CHMP instead reviews data as and when it becomes available from ongoing studies.

This includes non-clinical data, data on the vaccine’s quality and ‘some evidence’ on safety and efficacy from a pooled analysis of interim clinical data from four ongoing trials in the UK, Brazil and South Africa.

The agency added that additional information related to quality, safety and efficacy of the vaccine requested by the CHMP has already been provided by AZ, and that it is currently assessing this data.

If the AZ/Oxford vaccine follows in the footsteps of the two COVID-19 jabs already approved in the EU, a formal authorisation from the European Commission could come shortly after.

Earlier this month, Moderna’s COVID-19 vaccine was granted a swift approval from the EC, just a day after the jab received a positive opinion from the CHMP.

In December 2020, the EC also authorised a CMA for Pfizer/BioNTech’s COVID-19 vaccine, now known as Comirnaty.

According to Politico, the UK is leading the charge in Europe in terms of the number of vaccinations it has already administered. As of 11 January, over 2.67 million people had received a vaccination in the UK.

Italy is the UK’s closest follower – in terms of how many vaccines it has administered – with 718,797 delivered so far. Germany comes next, with 688,782 with Spain and France coming in at 406,091 and 138,351 respectively.

Article by
Lucy Parsons

12th January 2021

From: Regulatory



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