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“I just want to make this clear that the govt has never spoken about vaccinating the entire country. It's important that we discuss such scientific issues, based on factual information only,” Bhushan said.
While answering to the question of vaccinating the entire country, Dr Balram Bhargava, Director-General of the Indian Council of Medical Research (ICMR) said that there is no need of vaccinating the whole country if a critical mass is vaccinated and the virus transmission chain is broken. He further said that the vaccination depends on the efficacy of the vaccine and for the purpose of wreaking the chain.
"Vaccination would depend on the efficacy of the vaccine and our purpose is to break the chain of Covid-19 transmission. If we're able to vaccinate critical mass of people and break virus transmission, then we may not have to vaccinate the entire population," ICMR DG said.
According to Bhushan, the condition of Covid-19 is much better in India as compared to the other big countries. As per recent reports, the cases per million in India are the lowest among all big nations of the world with just 211 cases per million of the population.
The average daily positivity rate recorded last week was 3.72 per cent, as compared to the last seven days trends in which the European countries witnessed a surge in the number of coronavirus cases.
The Health Secretary further stated that the cumulative positivity rate in India has decreased from 7.15 per cent to 6.69 per cent between November 11 and December 1.
Further talking about Serum Institute of India (SII) filing Rs 100 crore defamation suit against a volunteer who alleged that vaccination trial triggered an adverse reaction on him, Bhushan said that in any matter whatsoever, any adverse event will not affect the timeline.
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“Whenever clinical trial starts, subjects are expected to sign prior informed consent form. This is global practice; it happens across all countries. Form tells subject about possible adverse events that may happen in case one decides to participate in trial,” he said.
Bhushan stated that clinical trials are multi-centric and multi-site adding the fact that site has an Institutional Ethics Committee, which is independent of the manufacturer or government. He said, in case of an adverse event, this Committee takes note and submits its report to the Drug Controller General of India (DGCI).
“Data Safety Monitoring Board also monitors clinical trial from day to day basis and keep an eye on adverse events and report it. Drug Controller General analyses all reports and finds out whether there's a one-to-one co-relation between adverse event & vaccination,” Bhushan further added.
On the adverse effects of the human trials of the covid-19 vaccine, ICMR DG said, "Adverse events do occur with drugs or vaccines or any other health intervention. It is the role of the regulator after collating all data to ascertain or refute whether there is a causal link between the event and intervention."