COVID-19: Covishield gets expert panel nod, ball now in DCGI Court

India on Friday stepped closer to getting its first Covid-19 vaccine with the expert committee of the national drug regulator recommending emergency use approval to the Oxford University/AstraZeneca/Serum Institute of India candidate Covishield.

The ball is now in the court of Drug Controller General of India VG Somani, who had yesterday said the New Year would bring in good news with “something in hand”.

The subject expert committee (SEC) under the Central Drug Standards Control Organisation (CDSCO) deliberated for 10 hours today on the emergency use applications submitted by the Serum Institute of India and Bharat Biotech. Sources said while Bharat Biotech was asked to submit additional phase 3 data on vaccine efficacy and safety, the licensure approval to the SII was recommended to the DCGI. The experts also took into account the Oxford vaccine candidate’s approval by the UK’s Medicines and Healthcare Products Regulatory Agency on December 30, making it the first country to license the candidate for use in those aged 18 and above.

The SII has stockpiled 100 million doses of the vaccine in anticipation of a licence even as the Centre prepares to roll out the vaccine as early as January 6.

A national-level dry run to test Co-WIN, the digital vaccine delivery platform, is due tomorrow across all states.

SII ready with 100 million doses

• The Oxford University/Serum Institute of India candidate Covishield comprises 2 doses
• The second dose has to be taken after 4 to 12 weeks
• Covishield can be stored up to six months
• The vaccine is only for those aged 18 years and above
• The Pune-based SII, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield
• The vaccine shows around 90 per cent efficacy

Bharat Biotech told to provide more data

The expert panel has held that the data provided by Bharat Biotech for its ‘Covaxin’ is not sufficient for grant of emergency use approval and has asked for more information, sources said.

UK flights from Jan 8

The govt has decided to resume partial flights between India, UK from January 8 to 23.

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