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Sputnik V to get approval in India? Expert committee meet today
If the expert committee gives its nod, then the application will be forwarded to the Drug Controller General of India (DCGI) for final approval.
The subject expert committee of the Central Drug Standards Control Organisation is scheduled to meet on Wednesday to deliberate on the application of Dr Reddy's Laboratories, seeking emergency use approval for the Russia-made Sputnik V vaccine against Covid-19. If the expert committee gives its nod, the application then will be forwarded to the Drug Controller General of India (DCGI) for final approval. If DCGI gives its approval, then Sputnik V will be the third vaccine in India to get approval for emergency use approval.
Sputnik V may become 3rd Covid vaccine approved in India. All you need to know
In other possibilities, the subject expert committee may seek some additional data from Dr Reddy's if needed.
Sputnik V, the two-dose vaccine, was developed by Russia's Gamaleya National Research Institute of Epidemiology and Microbiology in August. In September, the Russian Direct Investment Fund (RDIF) signed a pact with Dr Reddy's for local trial and distribution of the vaccine, if it gets a licence.
Dr Reddy's conducted phase two trial on 100 subjects in India and said the vaccine candidate was found safe. Now, it is conducting a phase 2 and 3 bridging study. It also doesn't have its phase 3 trial data yet.
The efficacy of this vaccine is said to be over 91 per cent, which is higher than the Covishield. Covaxin's efficacy data will be published in two weeks, Bharat Biotech has said.
Dr Reddy's applied for the emergency-use authorisation last Friday. Since its phase 3 trial data is awaited, it will have to submit safety data from the phase 2 trial conducted in India and the interim data of the phase 3 trial. Russian authorities claimed that the vaccine has been registered in around 30 countries.
If Sputnik gets approval, it will also be the first foreign vaccine to be approved in India. Before Sputnik, Pfizer had applied for emergency use authorisation but it conducted no trial in India and the storage temperature requirement of the vaccine candidate made it difficult to use in India. Sputnik V, on the other hand, can be stored at normal refrigerator temperature.
