Covaxin recipients sign consent form, to get compensation if vaccine causes adverse effect

People who are being given Bharat Biotech's Covaxin vaccine during the nationwide COVID-19 vaccination drive, which started today, will have to sign a 'consent form' and agree to certain terms and conditions before they are administered the dose. In the consent form for getting Covaxin vaccine, recipients have been promised that in case of any adverse situation following the administration of the vaccine and if it is determined that the vaccine was the cause then the recipients will be given compensation and medical.

"In case of any serious adverse events, vaccine recipients will be provided medically recognised standard of care in the government designated and authorised centres/hospitals. The compensation for serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to the vaccine. The compensation will be determined by ICMR's Central Ethics Committee, as appropriate," the consent form for Covaxin COVID-19 vaccine states.

Covaxin was the second vaccine that was approved by the country's drug regulators for emergency use in India. Bharat Biotech's Covaxin vaccine is the first indigenously developed vaccine. Covishield was the first vaccine which got approved in India for emergency use. The vaccine has been developed by Oxford University in collaboration with pharma giant AstraZeneca. The Covishield vaccine is being produced by Serum Institute of India (SII).

Recipients of Covishield are not being made to sign any consent form, unlike the people who are being administered the Covaxin vaccine.

Covaxin COVID-19 vaccine recipients will be handed over a fact-sheet and an adverse effect reporting form in which they have to jot down symptoms such as fever, pain and redness suffered within the seven days of receiving the vaccine dose.

Earlier, Prime Minister Narendra Modi launched the mass vaccination drive on Saturday. After the launch of the vaccination drive, AIIMS chief Dr Randeep Guleria, a sanitation worker, a healthcare worker were the first people who received the vaccine as part of the program.

Also Read: PM Modi launches COVID-19 vaccination drive; urges Indians to take both shots, follow protocols