SII’s application for Covid vax emergency approval to be considered today

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.

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.

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.

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.

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.

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.