‘Adverse event’ won’t affect vaccine rollout plan: Govt

Sushmi.Dey

New Delhi: The initial causality assessment of the adverse event in the “Covishield” vaccine trials being conducted by Pune-based Serum Institute of India (SII) did not necessitate stoppage of the trial and has not impacted timelines for the vaccine’s rollout, the government said on Tuesday.

The Centre was responding to the claim of a Chennai-based man who has sought Rs 5 crore compensation from SII as his health worsened during clinical trials for the Covid-19 vaccine developed by the UK’s Oxford University and AstraZeneca. SII has said the event is not linked to the vaccine, which, it said, is safe and immunogenic. SII has warned of a retaliatory Rs 100-crore defamation suit.

No vaccine is absolutely risk-free, says expert Kang

Asked why the event was not disclosed by the government or SII until media reports came out, health secretary Rajesh Bhushan said there is no reason to conclude that processes and due diligence in dealing with such an incident were not followed. He listed the stages of scrutiny up to the final conclusion by DCGI that the ill-health and hospitalisation (a serious adverse event) were not linked to the vaccine.
Asked what the position of the ICMR was on the “intimidatory” move by SII to seek Rs 100-crore damages, Bhushan said ICMR has no view on a legal proceeding between two entities such as those in question. He pointed out that vaccines against Covid are being developed under extraordinary circumstances in a timeline of 12-18 months.

ICMR director general Balram Bhargava said adverse events occur with drugs, vaccines or any other health interventions. “It is the role of the regulator after collating all the data to ascertain or refute whether there is a causal link between the event and the intervention. This is done on scientific basis and the assessment is done with very objectively based criteria,” he said. In a statement on Tuesday, SII said the vaccine won’t be released for mass immunisation unless proven immunogenic and safe. In a more mellow tone, it said while the adverse event is not related to the vaccine, the company was “sympathetic”with the participant’s medical condition. The doctor in charge of the trial has said that the event was found unconnected with the vaccine and the patient’s hospitalisation was paid for.
Highlighting adverse events that have happened during previous trials for polio, measles or rotavirus, vaccine experts said some events are likely to happen when thousands of people are in trials though there is a need for thorough probe. Some illnesses are likely to happen to vaccinated people even if the vaccine is safe, said vaccine expert Gagandeep Kang in a series of tweets. “No vaccine (or drug from aspirin to zinc) is absolutely risk-free. But no vaccine is licensed where benefits don’t hugely outweigh any risk.”

The health ministry plans to come out with detailed norms that will address issues around vaccine safety and create awareness and dispel misinformation. Bhushan admitted there can be a case of “vaccine hesitancy”.

“When you have this context (Covid), then there is a potentiality that commercial interests would dictate certain strategic actions of commercial entities. Governments of the day have nothing to do with it. The responsibility of the government is that we must educate the people about safety, effectiveness of the vaccine and that all disinformation is countered promptly,” Bhushan said.