PremiumNEW DELHI : A CDSCO panel has recommended to the Drug Controller General of India, V.G. Somani to allow Biological E Ltd to conduct phase 1 and 2 clinical trial of the covid-19 vaccine in India, a source in the know said. The vaccine has been developed by US-based Baylor College of Medicine.
A recommendation from the subject expert committee in the Central Drugs Standards Control Organisation (CDSCO) is usually followed by approval from the DCGI, and the application is currently being processed, the source said.
The SEC had issued its recommendations the clinical trial proposal in a meeting on Monday, minutes of the meeting showed.
“After detailed deliberation, committee recommended for grant of permission to conduct the Phase I/II clinical trial," the minutes read.
A spokesperson for Biological E declined to comment on the recommendation and the pending approval.
It is the fifth vaccine candidate to move into human trials. Serum Institute of India’s Covishield, co-developed by AstraZeneca plc and University of Oxford is the furthest in phase 3, while Bharat Biotech International Ltd will take its ‘Covaxin’ into the last stage next month. Zydus Cadila is currently in phase 2, or middle-stage, while Dr Reddy’s Laboratories Ltd will soon start its phase 2 and 3 trials, for which it received approval earlier this month.
Baylor College of Medicine had in August signed a licensing agreement with Biological E for the development of a safe, effective and affordable covid-19 vaccine. Under the agreement, Baylor College will facilitate the technology transfer for the recombinant protein covid-19 vaccine it has developed, while Biological E will scale-up the manufacturing process and undertake further development of the vaccine candidate, including through clinical trials in India.
Hyderabad-based Biological E had in August also signed an agreement with Janssen Pharmaceutica NV, a subisidiary of Johnson & Johnson, for contract manufacturing of the drug substance and drug product for Johnson & Johnson’s covid-19 vaccine candidate. However, this partnership did not involve Biological E conducting a clinical trial of the vaccine in India.
In a bid to increase its capacity to manufacture vaccines, the Hyderabad-based vaccine maker had acquired Akorn India Limited, a subsidiary of US-based Akorn Inc, a few days later. The acquisition will give Biological E access to Akorn India’s facilities at Paonta Sahib in Himachal Pradesh for commercial-scale manufacturing of the vaccine at the appropriate time, the vaccine maker had said.
With the Paonta Sahib plant’s annual capacity of about 135 million units, and the potential for immediate expansion of a further 30 million units, Biological E now has the capacity to produce over 1 billion doses per annum.
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