Covaxin Consent Form Spells Out ‘Clinical Trial Mode’, Liability

The form assures medical care if “it is proven that the serious adverse event is caused by the vaccine”.

A consent form that those getting the Covaxin shot on Saturday, 16 January, are required to sign states that any adverse event will be compensated by Bharat Biotech, the manufacturer of the vaccine.

As a massive coronavirus vaccine roll-out gets underway, the first of many health care workers got their first shot of Covishield and Covaxin, the two vaccines approved for emergency use by the Drugs Controller General of India. Both vaccines have been approved under slightly different provisions.

Covaxin, jointly made by Bharat Biotech, in collaboration with Indian Council of Medical Research and National Institute of Virology, has been given restricted approval "in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.” This is because phase 3 trials of the indigenous vaccine are still ongoing.

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Covaxin and 'Clinical Trial Mode'

This is what the consent form for Covaxin states:

• In phase 1 & 2, the 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 vaccine does not mean that other precautions related to COVID-19 need not be followed.
• In case of adverse events, or serious adverse events, you 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 form also says:

"I further emphasis that any information provided by me prior to taking the vaccine will be archived in the database maintained by the immunisation programme of the government & privacy as well as confidentiality of the information provided by you will be maintained."

Interestingly, the same form is not being provided to those who receive Covishield. In fact, at most centres The Quint reporters were at, no documentation was shared at all for those receiving Covishield.

(This story was first published on FIT and has been republished here with permission.)