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Serum Institute to seek DCGI approval for two full-dose regimen of Covishield

BusinessToday.In     December 19, 2020

Pune-based vaccine giant Serum Institute of India (SII) will apply for two-dose regimen authorisation from the Drug Controller General of India (DCGI) after its partner, Oxford University, said early trial data analysis suggests the vaccine showed better response with two doses.

SII had earlier said its vaccine candidate showed 90 per cent efficacy rate at a full dose plus a half dose regimen, while a 62 per cent efficacy rate at full two-dose regimen.

Also read: After Pfizer, US clears Moderna vaccine for COVID-19

The world's biggest vaccine maker has started the process of seeking approval for a two-full dose regimen in India, Business Standard cited Suresh Jadhav, SII executive director, as saying.

Notably, Serum Institute also conducted clinical trials on two full doses. The company is presently conducting bridge phase-3 trials of its experimental vaccine Covishield on 1600 study participants in India.

SII is developing the vaccine with both Oxford and AstraZeneca. It is expected that company will get approval for emergency use soon after UK's drug regulator gives the green signal to Covishield. Officials expect the approval to come before Christmas.

Also Read: Serum Institute to supply COVID-19 vaccine at Rs 250 a dose, close to signing deal with Centre

The UK's Medicines and Healthcare Products Regulatory Agency is currently evaluating the best dosage regimen for the AstraZeneca-Oxford vaccine and reports suggest that India might give the nod soon after that.

SII and two other pharma companies, Bharat BioTech and Pfizer India, had recently applied for emergency use authorisation in India. The Subject Expert Committee (SEC), a government panel tasked with vetting coronavirus vaccines, has asked Bharat Biotech and SII to submit updated country-specific trial data of their vaccine candidates Covaxin and Covishield.

The Pune-based company is likely to sign a supply contract with the central government, under which the price of the COVID-19 vaccine may be fixed at Rs 250 per dose.  Although there is not much clarity on the number of doses that would be secured from the Serum Institute, reports say around 60 million could be made available soon. The company is likely to have around 100 million doses for the government by January-February (2021) if the Centre chooses to procure them from it.

Also read: Coronavirus vaccine: Govt seeks more data from Serum Institute, Bharat Biotech for emergency use authorisation

Also read: Expert panel to review Bharat Biotech, Pfizer, Serum Institute's vaccine applications today

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