An expert committee on Friday recommended that Serum Institute of India be allowed to conduct late-stage human trials for the Oxford Covid-19 vaccine candidate in India after the Pune-headquartered firm revised its proposal, The Indian Express has learnt.
If the chief of India’s apex drug regulatory body signs off on this, Serum will be able to kick off the trials here, putting it ahead in India’s own race for a Covid-19 vaccine.
The development comes three days after the Subject Expert Committee (SEC) for Covid-related therapies on Tuesday recommended amendments to Serum’s earlier protocol to conduct the trials here. Serum 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. Following these recommendations, the firm had speedily amended its proposal and resubmitted it, The Indian Express has learnt.
SEC, which had reconvened on Friday evening to evaluate the revised proposal, recommended that the Central Drugs Standard Control Organisation grant permission for Serum to conduct phase II/III trials here, said two sources close to the development. The next step will be for the Drug Controllerer General of India to study the recommendations and take a call on the proposal.
The panel also suggested that the authorisation to market the vaccine, which Serum is calling ‘Covishield’, be granted after considering data generated both from the India and international trials, said one of the sources.
The firm plans to conduct its phase II/III trials on around 1,600 participants, a government official earlier told The Indian Express.
Serum declined to comment on the development.
Among the amendments that Serum has made to its protocol is to expand the number of trial sites it is looking at to around 20 facilities across India, said a senior government official.
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. While it is unclear how many trial sites were proposed by Serum 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 recommended a total of eight amendments to Serum’s late stage trial protocol. These included recommendations related to how the trials would test for the ability of the vaccine to invoke an immune response — the committee 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 vaccine development and testing, seeking anonymity.
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