Serum Institute Of India has applied to the country’s drug regulator and the health ministry for complete approval of its COVID-19 vaccination Covishield, according to Adar Poonawalla.

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More than 1.25 billion doses of AstraZeneca’s COVID-19 vaccine, marketed as Covishield, have been distributed in India by Serum Institute.

According to Serum Institute CEO Adar Poonawalla, the Indian government now has enough data to pursue a complete market authorization.

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At the start of the year, Serum Institute, the world’s largest vaccine manufacturer, received authorization for the emergency use of Covishield in India.

Covishield and Bharat Biotech’s inactivated vaccine Covaxin have dominated the country’s vaccination campaign thus far.

According to Poonawalla, Serum Institute has almost quadrupled its monthly capacity of AstraZeneca’s injections to as many as 240 million doses and is ready to export “large volumes” starting in January.

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A day earlier, Bharat Biotech released a press statement saying that the vaccine producer conducted phase II/III, open-label, and multicentre trials to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the age range of 2-18.

There were no major adverse events recorded in the research. 374 people had mild or moderate-severity symptoms, with 78.6% of them disappearing within a day. According to the press release, the most usually reported adverse event was pain at the injection site.

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Covaxin was approved by the Indian government earlier this month to immunise children between the age of 15 to 18 years against the coronavirus. The vaccine’s unique formulation, according to the manufacturer, allows adults and children to receive the same dose.