‘Bharat Biotech will compensate if’: What Covaxin consent form says
The Covid-19 vaccine drive began on Saturday. The vaccine drive includes both the vaccines- Covishield that was made by the Serum Institute of India and the other one is Covaxin that was made by Bharat Biotech. The people who are getting the ‘Covaxin’ are asked to sign a separate consent form that says that the injection given to them is without the phase-3 trial.
The frontline and healthcare workers are taking the vaccine injection in the first phase after signing the form as the government has allowed it to be used in ‘clinical trial mode’. The form assured compensation if any adverse effect was found in the link to the vaccine.
“The Bharat Biotech COVID-19 Vaccine is a vaccine with approval for restricted use in an emergency situation that may prevent COVID-19. In phase 1 and phase 2 clinical trials, COVAXIN has demonstrated the ability to produce antibodies against COVID-19. However, the clinical efficacy of COVAXIN is yet to be established and it is still being studied in phase 3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covid-19 need not be followed,” the form says.
If any adverse effect happens from the vaccine, the compensation will be given by Bharat Biotech and care will be provided by the health center, the consent form says.
The compensation for the serious adverse event will be paid by sponsor BBIL if the SAE is proven to be causally related to the vaccine,” it said.
“The vaccine has demonstrated the ability to produce antibodies against Covid-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trials. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covid-19 need not be followed,” it said.
The vaccinator will have to give a declaration that he or she has reviewed the details of side effects with the vaccine recipient.