Covid vaccine: India to review applications of Pfizer, Serum Institute, Bharat Biotech for emergency use authorisation

Accelerating the process of Covid-19 vaccine development, an expert committee of India's Central Drugs Standard Control Organization (CDSCO) will meet tomorrow to review the applications of pharma giants Pfizer, Serum Institute of India and Bharat Biotech for emergency use authorisation for their vaccine candidates as the second worst-hit country's total cases of the deadly virus neared one crore mark.

The decision to review the three pharma companies' applications was taken last night after the Hyderabad-based Bharat Biotech became the third firm to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously-developed vaccine Covaxin, reports our New Delhi correspondent quoting official sources.

"DCGI has already started processing the applications. The subject expert committee on Covid-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their Covid-19 vaccines on December 9," the sources said.

The expert committee will examine the applications of the three companies on the three parameters of immunogenicity, safety and efficacy before making its recommendations to DCGI for a final decision on authorisation of vaccine for emergency use, they added.

The Indian arm of US drug-maker Pfizer had on December 4 sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.

Pune-based Serum Institute of India sought such a nod for the Oxford Covid-19 vaccine, Covishield, on December 6.

As the race for vaccine picks up further momentum, India plans to give Covid-19 vaccines to nearly 80 crore people -- an estimated 60 percent of its total 130 crore population -- in the second phase of vaccination aimed at achieving herd immunity and breaking the chain of transmission of the virus, health ministry officials said.

The first phase will cover 30 crore people -- health, frontline workers and "vulnerable" sections of the population cutting across age -- and it is expected to roll out in January and last till July next year. It is possible that the second phase of vaccination would begin even before the first phase is wound up.

The second phase may cover people like drivers, teachers and media persons.