AstraZeneca's Covid-19 vaccine not ready for market: European Regulator

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Shivani Negi
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AstraZeneca's Covid-19 vaccine not ready for market: European Regulator

While the country awaits UK's approval to the AstraZeneca-Oxford vaccine against the coronavirus before giving green signal to its Indian counterpart developed by Serum Institute of India which is world's largest vaccine maker by volume, a top European drug official has claimed that the vaccine is not ready to be rolled out in the market.

Noel Wathion, Deputy Executive Director, said that the European Medicines Authority (EMA) will most likely not be able to approve the covid-19 vaccine developed by the drug maker.

"They have not even filed an application with us yet", Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday. “Not even enough to warrant a conditional marketing licence”, he said. “We need additional data about the quality of the vaccine. And after that, the company has to formally apply," Wathion said.

The UK aims to start rolling out the British AstraZeneca/Oxford vaccine in market from January 4.

Meanwhile, Pune-based Serum Institute of India on Monday expressed hope that its covid vaccine Covishield will receive the regulatory approval in "few days".

"We have 40-50 million doses of Covishield stockpiled. Once we get regulatory approvals in a few days, it will be down to the government to decide how much they can take and how fast. We will be producing around 300 million doses by July 2021," Serum Institute CEO Adar Poonawalla said during a press conference.

Earlier, AstraZeneca CEO had said that their vaccine will soon be available for emergency use as they have found a winning formula which can produce up to 95 per efficacy against the virus.

The CEO had added that the vaccine will be effective against the new covid variant first found in UK.

Meanwhile, the Centre recently held two days dry run for the vaccination process successfully in four states.

India reported fresh 20,550 new coronavirus infections and 286 deaths in the past 24 hours, taking total cases tally and death tally to 1,02,44,853 and 1,48,439 on Wednesday, the Ministry of Health and Family Welfare said.

Covid-19 Vaccine AstraZeneca