BackOxford COVID-19 vaccine not ready for market approval, says European regulatory official
European regulators have only received some information about the vaccine, top official saidThey have not even filed an application with us yet, the regulator said
PremiumCOVID-19 vaccine developed by drug maker AstraZeneca and the University of Oxford may not get an approval from European Medicines Authority in January, the watchdog's deputy executive director Noel Wathion said, according to Reuters.
"They have not even filed an application with us yet", Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday, according to news agency. "Not even enough to warrant a conditional marketing licence", he said.
European regulators have only received some information about the vaccine, Wathion said. "We need additional data about the quality of the vaccine. And after that, the company has to formally apply," Wathion said.
AstraZeneca told Reuters last week that its COVID-19 vaccine should be effective against the new coronavirus variant, adding that studies were under way to fully probe the impact of the mutation. It has submitted a full data package about its vaccine to the British medicines regulator, British health minister said.
Serum Institute of India, the local maker of the Oxford-AstraZeneca coronavirus vaccine in India, said on Monday it expected the British and Indian government to approve the shot for emergency use in a few days, according to Reuters.
"You will be hearing some good news from the UK very soon," Adar Poonawalla, chief executive officer, Serum Institute of India, told reporters on Monday. "By January, we should have the AstraZeneca-Oxford vaccine licensed."
The company has already made 40 million to 50 million doses of the vaccine and will be able to ramp up capacity to around 100 million a month by March when a new facility comes online, Poonawalla said.
AstraZeneca chief executive Pascal Soriot also told the Sunday Times that researchers developing its vaccine have figured out a “winning formula" making the jab as effective as rival candidates.
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