The Sputnik Light Covid-19 vaccine will be launched in India by December, Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) said on Wednesday, even as questions are being raised about the neverending wait for the rollout of Sputnik V in the country. Here’s a look at what separates the two vaccines when it comes to their efficacy, dosage, clinical trials, etc.
Clinical Trials and Launch
The one-shot Sputnik Light vaccine is in the middle of clinical trials. In India, the Hyderabad-based Dr Reddy’s Laboratories is the sole distributor of Sputnik V under an agreement with the RDIF. Sputnik V vaccine, on the other hand, was first launched in India on May 1 after receiving approval from the country’s drug regulator in the second week of April. But more than six months have passed and Sputnik V has not been yet commercially available across India. Out of India’s total 116 crore vaccinations, only 11.13 lakh doses were that of Sputnik V.
The RDIF had earlier said the Sputnik Light’s one-shot regimen makes it a strong solution for countries with low vaccination rates. Sputnik Light can also be successfully used to maintain existing herd immunity as a booster shot. Last month, the RDIF had said that Sputnik Light demonstrates 70 per cent efficacy against infection with the Delta variant of coronavirus during the first three months after being vaccinated. The analysis was conducted based on data from 28,000 participants who had received a single dose of Sputnik Light, compared with a control group of 5.6 million individuals who were not vaccinated. The data used in the study was collected in July 2021 in Moscow, it added.
Sputnik V had shown 91.6 per cent efficacy in the phase 3 trial without any serious side effects, according to an interim analysis of data published in The Lancet journal on February 2, 2021. The findings were based on analysis of data from nearly 20,000 participants, three-quarters of whom received the two-dose regimen of the adenovirus-based vaccine, Gam-COVID-Vac, and one quarter received a placebo.
In India, the Hyderabad-based Dr Reddy’s Laboratories is the sole distributor of Sputnik Light under an agreement with the RDIF. Sputnik V was developed by Moscow-based Gamaleya National Research Institute of Epidemiology and Microbiology and was registered by the Ministry of Health of Russia and became the “world’s first registered vaccine against coronavirus”.
While the two-dose Sputnik V is made from two components — recombinant adenovirus vector 26 (also known as Ad26 or a prime dose) and adenovirus vector 5, Sputnik light is primarily the first shot (Ad26) of the already approved Sputnik V.
Components and Dosage
The two-dose Sputnik V is made from two components — recombinant adenovirus vector 26 (also known as Ad26 or a prime dose) and adenovirus vector 5. Both Ad26 and Ad5 are common cold viruses affecting humans. While Ad26 is the first dose of the vaccine, Ad5 is a second shot, which is given 21 days or three weeks apart. According to Dr. Reddy’s spokesperson, while the two-dose Sputnik V vaccine was launched as a soft pilot in India in May, it was rolled out commercially from July based on imported consignments from the RDIF.
Why Sputnik V Hasn’t Fully Rolled Out
Slower than anticipated production of the second dose of Sputnik V, heavy cold storage requirements, pending WHO approval, rising Covid-19 cases in Russia and low demand at private hospitals have put brakes on the complete rollout of the Russian vaccine in India.
Till early September, drugmaker Dr. Reddy’s Laboratories — the sole distributor of Sputnik V in India under an agreement with the Russian Direct Investment Fund (RDIF) — had received around 31 lakh first dose components of Sputnik V, and about 4.5 lakh doses of the second dose component from Russia.
The “mismatch” of stock of two doses had held back the rollout of Sputnik V vaccine in India.
Vaccine experts say Sputnik V’s biggest challenge lies in the production of the second dose — the one which is termed as more “complicated” by the experts in terms of producing good yields and assembly in the laboratory.
Sputnik’s biggest challenge lies in the production of the Ad5 viral vector, experts say. The poor yield of second shot is yet not resolved and it is one of the reasons why the Russian firm and Dr. Reddy’s have now shifted focus on a new single shot vaccine — Sputnik Light — which does not require the problematic second shot but only the abundantly available first dose.
A senior government official, who is a member at National Technical Advisory Group on Immunisation (NTAGI), told News18.com, “The ratio of production of the first dose to the second dose is about 5:1 as the second dose virus is slow growing. It means that only one second dose is manufactured for every 5 first doses manufactured.”
According to experts — an industry veteran, a pharma company involved in production of Sputnik V, a pharma company, which was in talks with Dr. Reddy’s to start manufacturing — the company failed to achieve expected yields of Ad5, which has affected the output, causing supply delays.
“On paper, the design is good. However, in practice, it’s manufacturability in scales is a big issue. The company promised the sky and failed,” said an industry veteran, former managing director of a top vaccine manufacturing company in India.
“In India, it entered into seven manufacturing tie-ups and only one has the vaccine experience — Panacea Biotec. Later, it went for collaboration with Serum Institute of India as well. But the output just did not happen on a scale,” he added.