The European Medicines Authority (EMA) has said that the drug maker and the University of Oxford鈥檚 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: 鈥淭hey have not even filed an application with us yet. Not even enough to warrant a conditional marketing licence.
鈥淲e need additional data about the quality of the vaccine. And, after that, the company has to formally apply.鈥�
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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By GlobalDataOn 28 December, SII CEO Adar Poonawalla said: 鈥淵ou will be hearing some good news from the UK very soon. By January, we should have the AstraZeneca-Oxford vaccine licensed.鈥�
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, 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.
