SII's application for Covishield vaccine emergency approval to be considered today

MHRA approved means the vaccine is both "safe and effective".

The Subject Expert Committee of the Central Drug Standard Control Organization (CDSCO) is set to meet anytime Wednesday to consider the application of Serum Institute of India's for emergency use authorization of its Covid-19 vaccine, a senior government official said. Serum Institute's chief Adar Poonawalla showed happiness over the decision. "This is great and encouraging news. We will wait for the final approval from Indian regulators," he said. The expert panel will consider the application of Adar Poonawalla's Pune firm, which has partnered with Oxford University and AstraZeneca to make the vaccine, for the emergency use authorization.

The development came after the UK became the first country in the world to approve a coronavirus vaccine developed by Oxford University and AstraZeneca, even as it battled the new highly contagious variant of the coronavirus.

Earlier this month, the CDSCO had recommended SII to submit the outcome of the assessment of UK-MHRA for grant of EUA, updated safety data of Phase II/III clinical trial and immunogenicity data from the clinical trial in UK and India to secure the approval.  

SII, the world’s largest vaccine maker has already produced around 50 million doses of the Oxford-AstraZeneca shot and is planning to increase its production up to 100 million by March next year, Mr Poonawalla had said on Monday.

MHRA approved means the vaccine is both "safe and effective". 

Covishield is similar in requiring two doses just like the Pfizer-BioNTech jabs but is more reasonable in a few aspects like easy delivery, can be stored in low temperatures, cheap and easy to produce in bulk. 

The central government plans to vaccinate nearly 30 crore people in the first phase of the drive, including one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crores elderly, mostly above the age of 50 years with comorbidities.

Also Read: UK approves Oxford-Astrazeneca Coronavirus vaccine for use

Currently, India 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.

Besides Serum Institute-Oxford's Covishield, Bharat Biotech's Covaxin and Pfizer vaccine are also in the fray for emergency use authorisation.

 

 


A. Gayatri

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