As India gears up to kick-start the bridging trial of Russia’s single-shot vaccine, Sputnik Light, the first tranche has been sent for quality and safety validation, News18.com has learnt.
The batch — manufactured by Panacea Biotec — has been sent for the checks after which the doses can be safely administered to the trial participants, the sources privy to the development said.
After ruling out the need for the conduct of Phase-3 clinical trial of Sputnik Light on June 30, the expert panel — known as subject expert committee (SEC) — gave the go-ahead to Dr. Reddy’s for conducting the trial on August 5. Hyderabad-based Dr. Reddy’s is custodian of brand Sputnik V in India.
“While samples of Sputnik Light, manufactured by domestic pharma company Panacea Biotec, have already been sent for quality, safety checks at the Central Drugs Laboratory in Kasauli, the hospitals have also been reached for setting the trial sites,” said a senior government official requesting anonymity. “The enrollment of participants for the trial is likely to start this week.”
Mail sent to Panacea Biotec did not receive any response till the time of publishing.
Process of enrolling hospitals began
Another official working at a government hospital confirmed that the department has been reached for starting the trial of Russia’s single-shot vaccine.
The official showed the mail received by CTRI — called Clinical Trial Registry, India — for verifying the hospital as a trial site. CTRI is a portal run by the Indian Council of Medical Research. It is mandatory for companies to register the trial here after receiving the necessary approvals.
According to an email sent by CTRI’s administration, seen by News18.com, said “This is in reference to the trial entitled ‘Phase III, open label, un-controlled, multicenter, bridging study to evaluate immunogenicity and safety of single dose of Sputnik Light in Indian adults and elderly for prevention of SARS-CoV-2 Infection’ submitted to the CTRI for registration which is proposed to begin patient enrollment from 17-Sep-2021.”
The hospital has been asked to provide details and approve or reject the participation. “You are requested to kindly confirm/verify the same by replying to this mail at the earliest as this is mandatory for trial registration,” the mail sent by the CTRI administration department said.
However, the spokesperson at Dr. Reddy’s Laboratories said: “We do not comment on or recommend using any information that is not available on the CTRI website.”
How did Dr. Reddy’s convince the panel for approval?
On June 30, the SEC which recommends the apex drug regulator, Drug Controller General of India (DCGI), for the approval or rejection of vaccine and drugs in India, had told Dr. Reddy’s that it didn’t find any “scientific rationale” to conduct phase 3 trials of Sputnik Light in India.
According to the panel, Sputnik Light is the same as the component-1 (dose one) of regular vaccine Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here. The panel did not find adequate data and justification for conducting a separate, similar trial.
However, in a meeting on August 5, the panel — as per the minutes of the meeting — noted that “the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of persistence of antibodies in the participants.”
SEC, after detailed deliberation, recommended grant of permission for conduct of Phase III immune-bridging clinical trial in Indian population subject to the condition that “the interim analysis can be conducted at day 42 as this data was not generated during the Sputnik V trial in India after the first dose, which was stated to be available up to day 21 only.”
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