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‘Adverse event’ won’t affect vaccine rollout plan: Government | India News

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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.
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 the DCGI (Drug Controller General of India) that the ill-health and hospitalisation (a serious adverse event) were not linked to the vaccine.
Further asked what the position of the Indian Council for Medical Research 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.
“Due processes were followed in reporting the adverse event… We have been given to understand that there is a court case so we cannot comment on the specifics of the case,” he said. He pointed out that vaccines against Covid are being developed under extraordinary circumstances in a timeline of 12-18 months. “If a vaccine is developed in four years, it is seen as extraordinary,” he said while assuring that safety will not be lost sight of.
ICMR director general Dr 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 purely on scientific basis and the assessment is done with very objectively based criteria,” he said.
In 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 the event was found unconnected with the vaccine and the patient’s hospitalisation was paid for. The participant reported severe disorientation.
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 investigation. 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. To know risk is rare is no consolation when AEFIs (adverse event following immunisation) occur, but it is important as a society to understand risks exist & are measured,” Kang said, explaining how adverse events vary and are reported.
The health ministry plans to come out with detailed guidelines that will address issues around vaccine safety and create awareness and dispel misinformation. Bhushan admitted there can be a case of “vaccine hesitancy” and reiterated Prime Minister Narendra Modi’s appeal to experts and vaccine-makers to prevent doubts and fears from clouding the public mind.
Bharat Biotech, which is developing the Covid-19 vaccine Covaxin, also had an adverse event in August during the Phase 1 trial when a volunteer had to be hospitalised after being given the vaccine. The Hyderabad-based firm had found the incident as not vaccine-related.
“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. However, 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.
The government maintained that a subject is supposed to sign a prior infofrmed consent form about possible adverse events. Besides, the trials are multi-centric and there is an institutional ethics committee at each trial site that evaluates and reports such adverse events to the drug regulator. There are also data safety monitoring boards consisting of domain experts to monitor clinical trials on a day-to-day basis.
Both ethics committee and DSMB are independent of the vaccine developer and the government and report any adverse events, along with their assessment and recommendation on whether there is a need to halt the trials.

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