Serum Institute gets nod for phase 2, 3 human clinical trials of Oxford vaccine candidate

India’s apex drug regulatory body has granted approvals to Serum Institute of India to conduct late-stage human trials for the Oxford Covid-19 vaccine candidate in India. 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.

Now that the chief of the Central Drugs Standard Control Organisation has signed off on the proposal, as confirmed by the health ministry Monday, SII will be able to kick-off the trials here, effectively putting it ahead in India’s own race for a Covid-19 vaccine.

SII 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. The firm plans to conduct its phase II/III trials on around 1,600 participants, a senior government official earlier told The Indian Express.

“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.

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 these recommendations, the firm had speedily amended its proposal and resubmitted it for consideration within the course of a day, The Indian Express has learned.

The SEC, which had reconvened on Friday evening to evaluate the revised proposal, recommended that CDSCO grant permission for Serum to conduct phase II/III trials here, said two sources close to the development. Drug Controller General of India Dr VG Somani then studied the recommendations and approved the proposal.

The committee had also suggested that the authorisation to market the vaccine, which Serum is calling ‘Covishield’, be granted after considering clinical data generated both from the India trials as its international trials, said one of the sources on condition of anonymity.

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

This is because, among its earlier observations, the SEC had felt that Serum needed to take a “pan India” approach to the trial sites it was considering for its study. While it is unclear how many trial sites were proposed by SII in its earlier protocol, the firm’s CEO Adar Poonawalla had earlier told The Indian Express that it intended to conduct the trials in two cities–Pune and Mumbai.

The committee on Tuesday had recommended a total of eight amendments to SII’s late stage trial protocol. This included recommendations related to how the trials would test for the ability of the vaccine to invoke an immune response–the committee had felt the trials needed to look at the ability of the vaccine to induce a cellular immune response.

Cellular immunity includes the ability development of specific white blood T-cells that can attack and kill the virus, as T-cells usually remain in the body longer than antibodies do and act as a memory response, said two persons involved in Covid-19 vaccine development and testing on condition of anonymity.

The SEC had also sought a demarcation of the two phases proposed in the protocol and more clarity on Serum’s calculations to determine the number of volunteers it would be studying.

Indian express