The Central government plans to receive and utilise 400-500 million doses of the COVID-19 vaccine, and about 20-25 crore people would receive vaccination by July 2021, Health Minister Dr Harsh Vardhan has said.
According to Vardhan, the health ministry is currently preparing a format in which states will be asked to submit lists of priority population groups to receive the vaccine, especially health workers engaged in the management of COVID-19.
“The list of frontline health workers will include both government as well as private sector doctors, nurses, paramedics, sanitary staff, ASHA workers, surveillance officers and many other occupational categories who are involved in tracing, testing and treatment of patients,” Vardhan said.
This exercise is targeted to be completed by end of October and states are being closely guided to submit details about cold chain facilities and other related infrastructure which will be required down to the block level.
The Centre is also working on plans for building capacities in HR, training, supervision on a massive scale. It is also keeping an eye on “immunity data” with regard to COVID-19 disease while finalizing these plans, Vardhan said.
A high level committee under the chairmanship of Niti Aayog Member (Health) Dr V.K. Paul is working on these plans.
“Vaccine procurement is being done centrally and each consignment will be tracked real time until delivery to ensure it reaches those who need it most,” the health ministry stated. Vardhan added that these committees are working on the timelines of availability of various vaccines in the country, obtaining commitments from vaccine manufacturers to make available maximum number of doses for India inventory and supply chain management and also on prioritisation of high-risk groups.
“This is work in progress,” Vardhan said, adding that it will be completed by the time the vaccines are ready to ensure the swift roll-out of the immunisation program.
Experts have been demanding that the government make public the details of their distribution plans.
Commenting on the issue of diversions or black marketing of the vaccine, the health minister said that there would be no such activity.
“Vaccines will be distributed as per pre-decided priority and in a programmed manner. To ensure transparency and accountability, details of the entire process will be shared in the coming months.” He stressed on the need to prioritize health care workers and adults or those have underlying health conditions.
Vardhan also said that it is not possible to comment on the superiority of one vaccine over the other although he would ensure “that even if we have multiple vaccines available, they will all be safe and will elicit the requisite immune response against novel coronavirus”.
He said that 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 these studies can be conducted with much smaller sample size and end quickly.
On clinical trials, Vardhan said that all proposed clinical trials in India are designed using set principles and are stringently reviewed by the Subject Expert Committee set up by the Drug Controller General of India. Recently, the DCGI has also formulated draft guidelines on regulatory requirements for licensure of COVID-19 vaccines in India.
On Phase 3 clinical trials of Russia’s “Sputnik-V” vaccine in India, Vardhan clarified that the matter is still under consideration, and no decision has been taken as yet on the trials.
Stating that adverse events developing after vaccination are common, he said that it would include local reactions such as pain at the injection site, mild fever and redness, anxiety-related such as palpitations, syncope or fainting and that these events are transient, self-limiting and do not affect the protective response of the vaccine. India is not planning to venture into human challenge 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,” he said. “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.”
For quick control of the pandemic, he weighed in on single and double dose vaccines, and said that a single-dose vaccine would be preferable for controlling the pandemic faster.
“However, it is often difficult to achieve desired levels of immune protection using a single dose. 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,” he said.
