The Centre has spelled out details of its vaccine procurement and distribution plan; it hopes to receive and utilise 400-500 million Covid-19 vaccine doses, under which 20-25 crore people would be getting the first shot by July 2021.
Laying out the roadmap, Union Health Minister Harsh Vardhan said they are preparing a format for the states to submit by October-end their list of high-risk population, which has to be inoculated.
During an interaction with his social media followers on 'Sunday Samvad' platform, Vardhan said vaccine procurement would be done centrally with each consignment tracked real-time until delivery to ensure it reaches those who need it the most and there is no black-marketing.
He said priority would be given to health workers engaged in COVID-19 management in getting inoculated. The frontline workers will include both government as well as private-sector doctors, nurses, paramedics, sanitary staff, ASHA workers, surveillance officers and many other occupational categories which are involved in tracing, testing and treatment of patients.
To a question regarding the phase-three clinical trial of Russia's 'Sputnik-V' vaccine in India, Vardhan clarified that the matter was still under consideration, and no decision has been taken yet.
To another question, he replied it is not possible to comment on the superiority of one vaccine over another, but it would be ensured that "even if we have multiple vaccines, they will all be safe and will elicit the requisite immune response against coronavirus."
He said all vaccines that have proven to be safe, immunogenic and efficacious in clinical trials outside India need to undergo bridging studies to prove their safety and immunogenicity in the Indian population as well, although those can be conducted with much smaller sample size and can end quickly.
It is desirable to have a single-dose vaccine, he said. However, it is often difficult to achieve desired levels of immune protection using a single dose. He added that two-dose vaccines are suitable for attaining the desired immunogenicity as the first dose gives some immune protection, and the second dose augments it further.
The minister also ruled out the human challenge experiment. “India is not planning to venture into such trials until the method is proven to have an established benefit as per global experience. India has robust processes in place to ensure the vaccines that successfully complete the clinical trials are safe and effective against the novel coronavirus. When conducted, human challenge studies should be undertaken with abundant forethought, caution, and oversight. The value of the information to be gained should clearly justify the risks to human subjects,” he added.
Human challenge trials involve exposing volunteers to dangers beyond those posed by potential side effects of the substance being tested.
VACCINE GRID: WHAT TO EXPECT
ONUS ON STATES: States being asked to identify high-risk groups that need to be inoculated; details must reach by end of October.
REAL-TIME TRACKING: Each consignment will be tracked until delivery to ensure it reaches those who need it the most and there is no black-marketing.
THREE CANDIDATES: Three vaccines have proven to safe, immunogenic and efficacious in clinical trials outside India; now, they will undergo trials in Indian conditions.
TWO-DOSE VACCINE: These are suitable for attaining desired immunogenicity as the first dose gives some immune protection, and the second dose augments it further.
SPUTINK V: Still under consideration and no decision has been taken as yet.
HUMAN CHALLENGE EXPERIMENTS: India not planning such trials until method is proven to have an established benefit globally. Such trials man involve exposing volunteers to dangers beyond those posed by potential side effects of substance being tested.