India launched its biggest vaccination drive on January 16. Drugs and Controller General of India (DCGI) gave approval to Covishield and Covaxin. However, the Phase-3 results of Covaxin are awaited. The DCGI gave "emergency approval for restricted use."
While Covaxin is an indigenous vaccine prepared by Hyderabad based Bharat Biotech, Covishield is prepared by Serum Institue of India that is an equivalent of Oxford-Astrazeneca vaccine.
Before anyone takes a shot of Covaxin, they are told to sign a consent form. The consent form have several details that if anything goes awry, the person who took the shot would be compensated.
The use of Covaxin has been allowed under "clinical trial mode." As per the consent letter, the "COVAXINTM" has been permitted in public interest for restricted use in emergency situations.
The consent letter clearly states that the efficacy of the vaccine is yet to be established considering the Phase-3 results are still awaited.
The form says, "The Bharat Biotech COVID-19 Vaccine (COVAXINTM) is a vaccine with approval for restricted use in 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."
Further, it has been mentioned in the consent form, "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."
"In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in the government designated and authorized centers/hospitals. The compensation for serious adverse event will be paid by sponsor (BBIL) if the (adverse effect) is proven to be causally related to the vaccine," the form says.
The declaration in the end states, "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 confidentiality of the information provided by you will be maintained."
The recipients of the vaccine have to note any adverse
side-effects within seven days of administering the vaccine in a fact sheet
provided to them.
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