Compensation to be paid for serious adverse Covaxin events

Compensation to be paid for serious adverse Covaxin events

Sumitra.DebRoy@timesgroup.com

Mumbai:16.01.2021

Beneficiaries who receive Covaxin, a Bharat Biotech product, will be paid a compensation if they suffer a serious adverse event that is proven to be causally related to the vaccine.

The compensation was one of the points highlighted on top of the consent form shared with vaccination centres on Friday. Six centres in the state, including JJ Hospital in the city, will give Covaxin.

The form stated that the beneficiaries would be provided care in governmentdesignated and authorised centres or hospitals if they suffered serious after-effects.

3,006 session sites cover all states, UTs

Preparations for vaccine rollout were completed on Friday with the control room in Nirman Bhawan — which houses the health ministry — set to scrutinise implementation of the pan-India drive on a real-time basis. The PM will flag off the drive on Saturday at 10.30 am, activating 3,006 session sites covering all states and UTs.

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Govt says companies shall be liable for all adversities

The issue of liability has been a bone of contention between vaccinemakers and the government, with the former having made demands that it be indemnified against mishaps.

The vaccine purchase order of the government said the companies shall be liable for all adversities. State officials said that only the turnout on Saturday would tell whether a three-page consent form will allay concerns. The state is among 11to accept the vaccine, which is still undergoing phase III trials and has no large efficacy data. Unlike those getting Covishield, beneficiaries of Covaxin have to sign a consent form as it has been approved for restricted use in emergency situations and is supposed to be given in clinical trial mode. The recipients will also be handed over a fact-sheet and an adverse effect reporting form where they would have to note down any symptoms such as fever, pain and redness suffered within the first seven days. The consent form starts with the company saying that the vaccine has demonstrated the ability to produce antibodies against Covid-19 in phase 1and phase 2 clinical trials.

“However, the clinical efficacy of Covaxin is yet to be established and is still being studied in phase 3 clinical trial,” it said. For those listed to get this vaccine, though, it was Covaxin or no vaccine. “What if we don’t want to take an unproven vaccine? We will have to go without any vaccine at all and continue to work in Covid wards,” a physician from a medical college said.