Sputnik Light gets DCGI nod for bridging trials in India

The Drugs Controller General of India has permitted Indian pharmaceutical major Dr Reddy’s Laboratory (DRL) to carry out a bridging trial of the Sputnik Light vaccine to check if the single dose Russian Covid-19 vaccine can be introduced in India in future.

While the two-dose Sputnik vaccine has been approved for emergency use in India, the DCGI had refused to accord such an approval to its single dose counterpart in the absence of long term data on the vaccine’s immunogenicity.

The first request for the trial was declined in July but a Subject Expert Committee of the DCGI asked DRL a month later to go ahead with the exercise with the condition that the primary endpoint of the trial has to be assessed on day 42, day 90 and day 180.

Also an interim analysis is to be conducted on day 42 because such a dataset was not generated during the Sputnik V trial in India after the first dose. Data up to 21 days after the inoculation is available with the Hyderabad-based company, which is the lead agency for conducting the clinical trials for Sputnik in India, besides distributing the imported Russian vaccine.

The two-dose Sputnik-V received the Emergency Use Authorisation in India in April following which there was a soft-launch of the Russian vaccine in 50 cities in May. For the subsequent three months, the vaccine was not available in the commercial market.

Earlier this month, the company claimed that the two-shot version of the Russian vaccine is now available at many private hospitals in most of the states. So far 8.62 lakh Sputnik-V doses (first dose: 5.05 lakh and second dose 3.56 lakh) have been administered, sources in the National Health Agency told DH.

Notwithstanding the continued use of two-dose Covid-19 vaccines, a global search is on for a single dose shot for better compliance.

A recent study published in The Lancet showed that Sputnik Light - the first component of Sputnik V - showed 78.6-83.7 per cent efficacy against Covid-19, which is significantly higher than most two-shot vaccines.

Conducted on more than 415,000 people in Argentina, the study compared 40,387 people belonging to the 60-79 age group who got the Sputnik Light with 38,978 unvaccinated individuals.

Vaccine effectiveness for preventing laboratory-confirmed infections was 78.6 per cent; and for reducing hospitalisations and deaths was, respectively, 87·6 per cent and 84·8 per cent.The vaccine effectiveness was high across all subgroups, said the Lancet study.

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