A source in the Central Drugs Standards Control Organisation (CDSCO) said that the regulator would closely examine the safety and efficacy data when these are submitted. "Companies are all making claims of efficacy every other day. These are not yet published in peer reviewed journals. And whatever anyone may say, we do not know when the complete data would be ready for submission," the person said adding that even if the entire regulatory machinery is used to analyse only one vaccine candidate, it would take at least three weeks or so to come up with a decision.
The price of Sputnik V is less than Moderna's m-RNA vaccine which will be priced between $25-37. Dimitriev said that it is less than half the price of a vaccine with similar efficacy. AstraZeneca's vaccine is priced at $5-6 a dose.
Besides, the Russian researchers also felt that the primer-booster shot approach taken by AstraZeneca is a good one and could work well for the human-adenoviral (cold) vector based vaccine Sputnik V.
On Monday AstraZeneca said that when used in a primer-booster regimen (one half dose as first shot and the second dose is a full shot) then the Covishield, a monkey adenoviral vector (cold virus) based vaccine, showed greater efficacy of 90 per cent as against a 62 percent efficacy when two full doses are given.
Dimitriev said that the primer-booster approach towards immunising is a very 'correct' approach. "The AstraZeneca results confirm that when used in the same vector dose the vaccine is less effective. We are open to supplying our human adenoviral component to all countries who are interested in this approach," he added.
Dimitriev also said that the Russian vaccine would not only be affordable but also accessible to all. To make the logistics easy, a variant is being developed that would remain stable at 2-8 degree Celsius. This will be a lyophilised version, added Dimitriev. Lyophilisation or freeze drying as it is commonly known is a process of low temperature dehydration that involves freezing the product, lowering pressure and then removing ice by sublimation. This is in contrast to dehydration which involves evaporation of water by using heat.
So having the Sputnik V in dry form would reduce logistical hurdles significantly and improve its accessibility. It now requires a -18 degree Celsius temperature to remain stable.
Meanwhile, a second interim analysis of clinical trial data showed a 91.4 percent efficacy for the Sputnik V vaccine on day 28 after the first dose. The vaccine efficacy is over 95 percent 42 days after the first dose.
The interim research data will be published by the Gamaleya Center team in one of the leading international peer-reviewed medical journals. Following the completion of Phase III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report, it said. Currently, 40,000 volunteers are taking part in the Phase III double-blind, randomized, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia, of whom more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and second doses.
As of November 24, no unexpected adverse events were identified as part of the research. Some of those vaccinated had short-term minor adverse events such as pain at the injection point andflu-like symptoms including fever, weakness, fatigue, and headache, the RDIF claimed.
Sputnik V will be priced at less than $10 per dose
Russians think a primer-booster dose regimen is a good option
RDIF says they will supply 1 billion doses of Sputnik V in 2021 globally
Manufacturing tie-ups in India, China, Korea, Brazil etc
No adverse side effects reported so far, claims RDIF
How Sputnik V works in the body
History of use of human adenoviruses in vaccine development started in 1953
When Sputnik V is used, the coronavirus does not enter the body
Vaccine contains genetic information about spike protein of coronavirus
Body responds to the spike protein by generating immune response
Responds if real coronavirus infects at a later stage
No possibility of infection due to vaccination