Phase III Trials to Begin for Single Dose Sputnik Light Vaccine

NEW DELHI, Sept 15: As India recorded 27,176 new Covid cases on Wednesday, marginally higher than Tuesday but still less than 50,000 cases for the last consecutive 80 days, the country’s drug regulator granted permission to Dr Reddy’s Laboratories to conduct phase 3 clinical trials for Sputnik Light, the single dose and first component of the Russian made Sputnik V vaccine against Coronavirus disease (Covid-19).

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation, in its 172nd meeting last month, recommended the drugs controller to grant approval to conduct bridging studies in India for the single-dose variant of Sputnik V after going through updated safety, immunogenicity and efficacy data from phase 3 trials that happened in Russia.

The SEC in June had asked Dr Reddy’s to submit data from trials in Russia before seeking permission to conduct trials locally. Sputnik V vaccine is developed by Russia’s Gamaleya Institute with assistance from Russia’s sovereign wealth fund, Russian Direct Investment Fund (RDIF), that is also marketing the vaccine globally.

RDIF entered a partnership with Dr Reddy’s Labs to market first 250 million doses of the Russian vaccine and also conduct trials in India required for grant of regulatory approvals.

“In light of the recommendations of the SEC dated 30.06.21, the firm presented updated safety, immunogenicity and efficacy data of phase III clinical trial of SARS-CoV-2 virus vaccine (Sputnik Light)— single dose vaccine conducted in Russia along with the proposal to conduct phase III clinical trial. The committee 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,” read minutes of the meeting of the SEC.

“After detailed deliberations, the committee recommended for grant of permission for conduct of phase 3 immune-bridging clinical trial in Indian population subject to the condition that the primary endpoint should be assessed at day 42, 90 and 180, and interim analysis can be conducted at day 42…”

Sputnik V is one of the six Covid-19 vaccines that have been granted emergency use approval by India’s drugs regulator.

It is a two-dose shot (but two unidentical doses unlike other two-dose vaccines) that is 91.6% effective in preventing serious illness as was found in phase 3 clinical trials.

Starting initially in Hyderabad on May 14 this year, Dr Reddy’s did a soft launch on pilot basis in select cities to check logistical arrangements including cold chain facilities.

• Meanwhile, the southern state of Kerala continued to account for more than half of the total daily tally of new Covid cases in the country. In the last 24 hours, Kerala recorded 15,876 new Covid-19 cases and 129 deaths of the 27,176 cases of infections the country logged, which was marginally higher than 25,404 cases of infections recorded on Tuesday. About the high number of cases in Kerala, the experts said the state had passed its peak.

In the next 2 weeks, a decline in cases should start, said AIIMS Professor Dr Sanjay Rai.

The death toll climbed to 443,497 after 284 fatalities in the last 24 hours. The new fatalities included 129 from Kerala and 52 from Maharashtra.

A total of 4,43,497 deaths have been reported so far in the country including 1,38,221 from Maharashtra, 37,529 From Karnataka, 35,217 from Tamil Nadu, 25,083 from Delhi, 22,884 from Uttar Pradesh, 22,779 from Kerala and 18,599 from West Bengal.

The active cases declined to 351,087 comprising 1.05 per cent of the total infections, while the national Covid-19 recovery rate was recorded at 97.62 per cent, according to the data published on the Union health ministry. The country conducted 1,610,829 tests on Tuesday, taking the total cumulative tests conducted so far for detection of Covid-19 in the country to 546,055,796.

The daily positivity rate was recorded at 1.69 per cent. It has been less than three per cent for the last 16 days.

On the vaccination front, the cumulative doses administered in the country so far has reached 75.89 crores, according to the ministry.

(Manas Dasgupta)