Sputnik’s ‘efficacy at 95%’, to be cheaper than US vaccines – Times of India

MUMBAI: Russia’s Sputnik V Covid-19 vaccine that reported an efficacy of over 95%, will be twice as cheap as the two others– Pfizer and Moderna with similar positive results. Sputnik V, developed by Gamaleya Institute and RDIF (Russian Direct Investment Fund) will be priced under $20 per person for the two doses in global markets, including India, and may be available here by February. (Both Pfizer and Moderna vaccines use messengerRNA platform).
The vaccine is still to undergo trials in India, and will be manufactured by domestic companies. Hyderabad-based Dr Reddy’s and RDIF have entered into a partnership to conduct clinical trials and its distribution in India.
Though the vaccine has a price advantage against the above two companies, there could be a challenge in its distribution as it requires a specialised cooling chain, experts say.
The efficacy of the Sputnik V vaccine is 91.4%, based on the second analysis of interim data obtained 28 days after administering the first dose (7 days after the second dose). Preliminary data obtained 42 days after the first dose (corresponds with 21 days after the second dose) indicates an efficacy of the vaccine above 95%, a company statement said.
Sputnik V, a two-dose vaccine on the human adenoviral vector platform, will soon undergo Phase II clinical trials on 100 subjects in India, while Phase III trials will involve 1500 participants. In October, Dr Reddy’s and RDIF received approval from the Drugs Controller General of India to conduct an adaptive phase 2/3 human clinical trial for the vaccine in India. As part of the partnership, RDIF will supply 100 million doses of the vaccine to Dr Reddy’s.
Details about the vaccine, trials and manufacturers in India are still sketchy. `There are two forms of the vaccine, one of which requires -18C (liquid) and must be transported in special refrigerators. The second form is lyophilized (freeze-dry) and can be stored at +2-8C, it was invented for the remote regions of Russia. We expect that the dry version will be supplied in large quantities to many countries including India in February”, a RDIF spokesperson told TOI.
The first international deliveries of the Russian Sputnik V vaccine will be made in January 2021 based on the existing partnerships with foreign manufacturers, the statement adds.
“Transparency is needed …an international data safety monitoring board independently should analyze the data. Vaccine trust is paramount’’, former director general, Indian Council of Medical Research, NK Ganguly said, adding the vaccine was tested in only 78 patients for Phase 1/2.
The existing agreements between RDIF and leading foreign pharmaceutical companies allow the Sputnik V vaccine to be produced abroad for 500 million people per year, starting from 2021. RDIF is currently considering additional applications from a number of countries and companies to further increase capacity, a statement said. “The uniqueness of the Russian vaccine lies in the use of two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as compared to vaccines using one and the same vector for two doses” , it adds.
At present, 40,000 volunteers are taking part in the Phase III double-blind, randomized, placebo-controlled study of the vaccine in Russia, of whom over 22,000 volunteers were vaccinated with the first dose, and over 19,000 volunteers with the first and second dose. Earlier this month, the developers had announced interim data from a large trial suggesting the shot to be 92% effective.