AstraZeneca has submitted a full data package about the vaccine to the British medicines regulator. Credit: CDC on Unsplash.

The European Medicines Authority (EMA) has said that the drug maker AstraZeneca and the University of Oxford’s COVID-19 vaccine may not be approved in January next year.

Belgian newspaper Het Nieuwsblad quoted the EMA deputy executive director Noel Wathion as saying: “They have not even filed an application with us yet. Not even enough to warrant a conditional marketing licence.

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“We need additional data about the quality of the vaccine. And, after that, the company has to formally apply.”

Last week, AstraZeneca informed Reuters that its Covid-19 vaccine is potentially effective against the new coronavirus variant, with studies underway to fully analyse the impact of the mutation.

The company has already submitted a full data package about the vaccine to the British medicines regulator.

The local maker of the Oxford-AstraZeneca vaccine in India, Serum Institute of India (SII), anticipates emergency use approval of the vaccine by the British and Indian government soon, the news agency reported.

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On 28 December, SII CEO Adar Poonawalla said: “You will be hearing some good news from the UK very soon. By January, we should have the AstraZeneca-Oxford vaccine licensed.”

Poonawalla added that, at present, AstraZeneca has manufactured 40 to 50 million doses of the vaccine and intends to increase capacity to around 100 million a month by March next year when a new facility becomes operational.

Earlier this month, AstraZeneca reported that interim analysis from the Phase III programme of the Covid-19 vaccine, AZD1222, showed it is safe and effective at preventing symptomatic Covid-19.

In a separate development, Pfizer and BioNTech have announced that they will deliver an additional 100 million doses of their Covid-19 vaccine, COMIRNATY, to the 27 European Union (EU) member states next year.

This development comes after the European Commission exercised its option to purchase an additional 100 million doses, taking it to a total of 300 million doses to be delivered to the EU, as per the deal signed in November.