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 authorisation of its Covid-19 vaccine, Covishield, a senior government official said.
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.
In order to introduce an urgently needed vaccine against COVID-19 in India, Serum Institute of India (SII), the world's largest vaccine manufacturer, has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture Covishield.
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 authorisation, IANS reported.
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 the Phase II/III clinical trial and immunogenicity data from the clinical trial in UK and India to secure the approval.
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.
Besides Serum Institute-Oxford's Covishield, Bharat Biotech's Covaxin and Pfizer vaccine are also 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.
Serum Institute of India has already produced around 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' and plans to scale it up to 100 million by March next year, Poonawalla said on Monday.
"We have already manufactured 40-50 million dosages of the vaccine. The rollout of the vaccine is expected to be a bit slow in the initial phase due to logistics issue and is expected to pick up once things get sorted," SII CEO Adar Poonawalla told reporters.
He noted that the company plans to ramp up the vaccine production to 100 million dosages per month by March next year with the coming up of SII's third manufacturing facility.
By next month, the vaccine can also be approved in India, he noted.
Poonawalla said India would get the majority of vaccines produced next year with some part of the production also going to other markets as part of COVAX --a global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level.
(With agencies)
