Consent Forms For Covaxin Jab, Compensation For "Serious Adverse Event": India Starts World's Largest Vaccination Drive

As India's vaccination drive started today, those receiving Bharat Biotech's Covaxin were asked to sign consent forms that assured compensation if any adverse effect was found related to the vaccine. Recipients of Covaxin also need to sign a consent form before being vaccinated as its use has been permitted by the centre in "clinical trial mode".

The form reads "COVAXINTM" is being offered under restricted use in an emergency situation and has been permitted in "public interest" as a precaution. It also mentions that the clinical efficacy of the vaccine is yet to be established and it is still in Phase 3 trials.

"The Bharat Biotech COVID-19 Vaccine (COVAXINTM) 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, COVAXINT 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 reads.

"In case of any adverse events or serious adverse events, you will be provided a medically recognized standard of care in the government designated and authorized centres/hospitals. The compensation for the serious adverse event will be paid by the sponsor (BBIL) if the (adverse effect) is proven to be causally related to the vaccine," it adds.

The declaration mentions: "I further emphasize that any information provided by me prior to taking the vaccine will be archived in the database maintained by the immunization program of the government and privacy as well as the confidentiality of the information provided by you will be maintained."

The recipients will also be given a factsheet and a form to report adverse effects, in which they have to mention symptoms like fever, pain within seven days.

The centre on January 12, said that states will not have the option to choose which vaccine to administer to its priority groups, citing limited doses of COVID vaccines available initially. The choice of vaccine to be administered remains with the government, even as COVID-19 vaccination remains voluntary in India, the centre said.

The two vaccines available are Pune-based Serum Institute of India's 'Covishield' and Hyderabad-based Bharat Biotech International Ltd's 'Covaxin'. Both vaccine candidates have got the approval from the Drugs Controller General of India (DGCI) although Covaxin is still in Phase 3 trials.

In Delhi, six central government hospitals will administer only Covaxin- AIIMS, Safdarjung, Ram Manohar Lohia hospital, Kalawati Saran Children Hospital, ESI Hospital Basaidarapur and ESI Hospital Rohini. The remaining 75 Sites, which include Delhi government and private hospitals, will receive Covishield shots.

the Indian Medical Association (IMA) on Friday said that it endorsed the safety and efficacy of both Covaxin and Covishield and added that the "misinformation around vaccines on social sites is unfortunate and more harmful than the disease itself."

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