AstraZeneca-Oxford COVID-19 vaccine not ready for approval in Europe: What about Covishield?

European watchdog says that AstraZeneca-Oxford COVID-19 vaccine is not ready for even conditional approval. What does this mean for India’s Covishield?

By: Jahnavi Sarma | | Updated: December 31, 2020 8:06 am

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.

As the country awaits the UK’s approval to the AstraZeneca-Oxford COVID-19 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. Also Read - Obesity, alcohol consumption can lower effectiveness of Covid-19 vaccines

Data not enough for even conditional approval

The UK aims to start rolling out the British AstraZeneca/Oxford vaccine from January 4. According to Wathion, “The data we have at the moment is not even enough to give the AstraZeneca vaccine a conditional authorisation”. He further adds, “We need additional data about the quality of the vaccine. And after that, the company has to formally apply.” Also Read - Almost 30% of recovered COVID-19 patients develop complications within 5 months, over 12% die

What does it mean for India’s Covishield?

Pune-based Serum Institute of India on Monday had 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 had said during a press conference. Also Read - COVID-19 vaccine side effects: Loss of sensation in arms and more reported by Pune health workers

But then, the Indian regulators are waiting for to its AstraZeneca-Oxford counterpart to be given approval first. This new development may mean that there may be a delay in grant of EUA for Covishield in India.

Other vaccines in the pipeline in India

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 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore 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.

(With inputs from IANS)

Published : December 30, 2020 12:54 pm | Updated:December 31, 2020 8:06 am

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