AstraZeneca/Oxford vaccine not ready for approval: European watchdog
As India awaits the UK’s approval to the AstraZeneca-Oxford vaccine before giving nod for Emergency Use Authorisation to its Indian counterpart developed by Pune-based Serum Institute of India (SII), a top European drug official has claimed that the vaccine is not even ready for a conditional approval at the moment.
Noel Wathion, number two at the European Medicines Agency, told Belgian newspaper Het Nieuwsblad on Tuesday that the approval for AstraZeneca-Oxford vaccine is still “unthinkable” and Europe is not going to approve the vaccine with “winning formula” for the time being.
“They haven’t even submitted an application to us yet,” Wathion was quoted as saying in the report.
The UK aims to start rolling out the British AstraZeneca/Oxford vaccine from 4 January.
We need additional data about the quality of the vaccine. And after that, the company has to formally applyNoel Wathion
According to Wathion, “The data we have at the moment is not even enough to give the AstraZeneca vaccine a conditional authorisation”.
“We need additional data about the quality of the vaccine. And after that, the company has to formally apply,” Wathion added.
Pune-based Serum Institute of India on Monday expressed hope at the possibility of its vaccine called Covishield receiving the regulatory approval in “few days”, while emphasising that the company has a massive stockpile of 40-50 million doses.
“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.
India currently has eight COVID-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorisation in near future.
Serum Institute-Oxford’s Covishield, Bharat Biotech’s Covaxin and Pfizer vaccine are in the fray for emergency use authorisation.
The central government plans to vaccinate nearly 300 million people in the first phase of drive. It will be offered to 10 million healthcare workers, along with 20 million frontline and essential workers and 270 million elderly, mostly above the age of 50 years with comorbidities.
Two days of dry run for the vaccination process was also successfully carried out in four states.