The Centre on Tuesday distanced itself from the serious adverse event reported by a vaccine volunteer in Chennai recently, saying the petition filed by the individual allegedly affected by the vaccine and the threat of a countersuit of ₹100 crore by Serum Institute of India (SII) was between the two parties and the government has nothing to do with it.

Asked if the Indian Council of Medical Research (ICMR), the co-sponsor of the multi-centre trials of the AstraZeneca-Oxford University vaccine candidate, would endorse the claim by the company, the cryptic answer of Health Secretary Rajesh Bhushan was that “the ICMR has no role in either endorsing or not endorsing the legal claim filed anywhere in the country.”

The Health Secretary, along with ICMR Director-General Balram Bhargava, was addressing the media about the Covid-19 situation in the country.

‘Won’t release till safe’

Meanwhile, Serum Institute, in a public statement, clarified that it would not release for mass use its Covid-19 vaccine candidate, undergoing trials currently, “unless it is proven immunogenic”, and safe.

“We would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly... It is only after we cleared all the required processes that we continued with the trials,” the statement said in a reconciliatory tone.

Many public health experts have said that there was a lack of transparency in the way the Drug-Controller General of India dealt with the issue. They felt that the drug regulator should have stopped the trial till the time it was found out that the acute encephalopathy suffered by the 40-year-old healthy volunteer had nothing to do with the administration of the vaccine.

Not only that the drug regulator remained silent, it also refused to clear the air on the issue even 10 days after the volunteer informed it through a petition filed against the vaccine developer, sponsors of the trials and the centre where the vaccination took place in early October.

However, the ICMR chief sought to clarify that the regulator did not stop the trial because there was no ‘causal link’ between the adverse event and the vaccine and that the incident was properly followed up and evaluated.

On whether those recovered from the Covid-19 should be given vaccine, Bhargava, quoting the WHO, said there was no harm giving it to them. The government, however, is yet to take a call on whether to vaccinate those who have recovered from the infection, Bhushan said.

Covid cases dip in Nov

The Health Secretary also said that in November, the number of active cases had come down consistently and, in spite of an increase in the number of daily tests (10.55 lakh daily average), the cumulative positivity rate dipped to 6.69 per cent.

With inputs from PT Jyothi Datta in Mumbai

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Published on December 1, 2020