Mass production of Sputnik V likely to take several months
Dr Reddy’s Laboratories (DRL) is preparing for clinical trials of the Sputnik V in India even though major manufacturers here did not show much interest in making the vaccine candidate.
Vaccine makers here feel the Sputnik is still a work in progress and needs time to develop. “We think it needs quite a bit of work before anyone can take their technology and start manufacturing. Also, the technology that they now have needs to be developed a bit to enable large-scale manufacturing,” said a leading vaccine maker, who is in touch with the Russian authorities on Sputnik V.
The temperature requirement for the vaccine’s distribution is 2-8°C, making it suitable for distribution in India. However, sources also said the Russians have shown a presentation with two variants — one variant is frozen and may require sub-zero temperatures for transit. “We are waiting for more data from the Russian authorities. We are holding dialogues with them, but yet to take a call if we wish to partner for manufacturing,” said another vaccine maker.
G V Prasad, co-chairman and managing director, DRL, said that data on Sputnik V is positive and the technology is good and there was no reason to doubt it.
According to sources, Indian Immunologicals, Biological E, Serum Institute of India, and Cadila Healthcare have been approached by the Russian Direct Investment Fund (RDIF) and have discussed Sputnik V. Sources
revealed the trial design is not ready and hasn’t been submitted to the drug regulator here. But the clinical research organisation (CRO) has been selected.
Recruitment of volunteers (around 1,000 people trials planned in India) as well as the process of administering the twoshot vaccine will take at least a month-and-a-half after the regulator approves the trial design.
Analysing the data from these trials will take another few weeks, after which the regulator will evaluate results. DRL will be responsible for securing the necessary approvals to conduct trials here.
“The trial cost may be split in 50:50 with RDIF. The CRO has been selected but the trial design is not yet ready,” said an analyst who has spoken with the DRL
management. For now, DRL is not producing the vaccine. It will distribute it in India and other nations where it has a strong presence. It is open to manufacturing in the future if things work out.
The firm has no presence in the vaccines segment and analysts feel it might use one of its injectables plants to make the vaccine, which is an adenoviral vector-based vaccine that does not require high-level safety laboratories to make. “DRL has indicated it does not wish to compromise any of its injectables pipeline. However, if it sees significant demand for the Sputnik V, it may consider making it next year using one of its injectables plants. Then it would not require much investments,” an analyst said.