Serum Institute seeks full market authorisation for Covishield vaccine

Serum Institute of India (SII) has sought full approval for its Covid-19 vaccine, Covishield. SII has applied to the ministry of health and family welfare and the Central Drugs Standard Organisation (CDSCO) for full market authorisation for Covishield.

Adar Poonawalla, chief executive officer, SII, tweeted on Friday and said the company had supplied 1.25 billion doses of Covishield in India and the government had enough data for this permission. “The government of India now has enough data for full market authorisation,” Poonawalla said.

SII started shipping the Oxford University-AstraZeneca vaccine, Covishield, from its Pune facility from January 12, 2021, after getting emergency use authorisation from the Drugs Controller General of India (DCGI) and started exporting the vaccine on January 19.

SII has made initial investments of $270 million on its own and got $300 million from the Gates Foundation for manufacturing the Covishield vaccine. The company has ramped up capacity to make 240 million vaccines a month. The country has till date administered 145 crore doses and 128.87 crore of these were SII’s Covishield vaccines.

Full marketing authorisation for the company would mean the vaccines will remain permanent and continue beyond the pandemic. An EUA (emergency use authorisation) is a temporary authorisation and can be withdrawn anytime.

The company would be able to have better control over distribution and pricing depending on market demand. Currently, the government is the largest buyer and distributor of the vaccine. The government has also negotiated a low price for the vaccine. Covishield was granted emergency use authorisation based on limited data and fewer requirements, as it was a public health emergency. Full approval is granted after review of safety and efficacy data, risks, adverse events, compliance and facility audit.