The European Medicines Agency, which is the in-charge of authorisation and monitoring of medicinal products in EU countries, might not approve the coronavirus vaccine developed by AstraZeneca and the University of Oxford in January.
According to a report in Reuters, EMA's Deputy Executive Director Noel Wathion has said the duo has not filed an application for approval until now.
"They have not even filed an application with us yet," Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday.
Wathion said the European regulators have received only a few pieces of information about the vaccine.
"We need additional data about the quality of the vaccine. And after that, the company has to formally apply". This made it "improbable" that approval could already be granted next month, Wathion said.
However, UK's Health Minister Matt Hancock informed media that AstraZeneca had submitted a full data package about its vaccine to the British medicines regulator.
In India, the Pune-based Serum Institute of India is developing is manufacturing Oxford's vaccine. Its CEO said once the vaccine gets approval in Britain, only then it will be able to sell in the Indian market.
The Serum Institute has finished all three stages of the clinical trial and could be the first to get nod from India's drug regulator.
Lately, SII's Chief Executive Office Adar Poonawalla, told the media, "You will be hearing some good news from the UK very soon". "By January, we should have the AstraZeneca-Oxford vaccine licensed," Poonawalla added.
Serum has already manufactured 40 million to 50 million doses of the vaccine ahead of the final approval. Besides, the government has also finished a dry run in the four states to test preparedness before the roll-out of the COVID-19 vaccine.