NEW DELHI: The consent forms, signing which has been made a must for people receiving Covaxin at vaccination centres makes it clear that Bharat Biotech will be liable for paying compensation in case of serious adverse events following immunisation but does not mention compensation amount. The form has been attached to the vaccine — still to prove its efficacy in protecting from SARS CoV 2- as it has been launched on a “clinical trial mode”, as mandated by the Drug Controller General of India.
The government has procured 55 million doses of Covaxin, apart from 110 million of Covishield by the Serum Institute of India, for the first phase of the nationwide Covid-19 vaccination drive but there are reports of concern among doctors, hesitant to go for a vaccine still under trial. In several states, like in Delhi, Covaxin is being offered only in Centrally run hospitals and healthcare workers are not being given a choice in opting for a vaccine they want.
Sources in the health ministry and the ICMR said that beneficiaries receiving Covaxin are required to sign a consent form, which assures medical care and compensation if any adverse effect was found linked to the vaccine. “In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against Covid-19,” says the form. “However, Covaxin ‘s clinical efficacy 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 need not be followed.” The form further says, “In case of any serious adverse events, vaccine recipients will be provided medically recognized standard of care in the government designated and authorized centers/hospitals. 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.”
Adding that the compensation will be determined by the ICMR Central Ethics Committee. Doctors, experts and bioethicists have questioned the restricted emergency use approval granted to Covaxin despite incomplete trial. Charges of unethical enrolment of participants for the phase 3 clinical trial of the vaccine in Bhopal—one of whom even died, even though it was ruled out that the event was related to Covaxin administration— has further eroded trust in the partially tested vaccine.