Serum Institute gets DCGI approval to conduct phase II+III trials of Oxford vaccine COVISHIELD

The DCGI has given approval to the Serum Institute of India to conduct Phase II+III trials of the Oxford University-Astra Zeneca coronavirus vaccine
Image for representation

Image for representation

Guwahati: The Drugs Control General of India (DCGI) on Monday gave approval to the Pune-based Serum Institute of India to conduct Phase II+III clinical trials of the Oxford University-Astra Zeneca coronavirus vaccine (or COVISHIELD) in India.

The apex drug regulatory body's nod is expected to expedite the process of development of a vaccine.

The development comes after an expert committee on Friday recommended that SII be allowed to conduct these trials after it studied a revised proposal submitted by the Pune-headquartered firm.

Once the SII's trials get underway, it shall nose ahead of India's own race for a COVID-19 vaccine.

It needs mention here that the Pune-based firm has a tie-up with Swedish-British firm AstraZeneca, which developed the vaccine along with The University of Oxford, to manufacture this vaccine for low- and middle-income countries.

According to reports, the SII plans to conduct its phase II/III trials on around 1,600 participants.

"Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca #COVID19 vaccine (COVISHIELD) in India," stated the health ministry in a tweet early on Monday, confirming the development.

This comes after the Subject Expert Committee (SEC) for Covid-19 related therapies had last Tuesday recommended various amendments to SII's earlier protocol to conduct the trials here.

Following this, the SII had amended its proposal and resubmitted it for reconsideration within a day.

Among the amendments that SII had made to its protocol, it expanded the number of trial sites it is looking at around 20 facilities across India, said a senior government official.

Serum Institute of India (SII) last Monday said that the distribution of Covid-19 vaccine vials in India will be through a government network rather than private entities. The firm, known to be the largest vaccine manufacturer by volume across the world, said everyone will get the dose.

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