India launched its biggest vaccination drive on January16. Drugs and Controller General of India (DCGI) gave approval to Covishieldand 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 byHyderabad based Bharat Biotech, Covishield is prepared by Serum Institue ofIndia that is an equivalent of Oxford-Astrazeneca vaccine.
Before anyone takes a shot of Covaxin, they are told tosign a consent form. The consent form have several details that if anythinggoes awry, the person who took the shot would be compensated.
The use of Covaxin has been allowed under "clinicaltrial mode." As per the consent letter, the "COVAXINTM" has been permitted in public interest forrestricted use in emergency situations.
The consent letter clearly states that the efficacy ofthe vaccine is yet to be established considering the Phase-3 results are stillawaited.
The form says, "The Bharat Biotech COVID-19 Vaccine(COVAXINTM) is a vaccine with approval for restricted use in emergencysituation that may prevent COVID-19. In phase 1 and phase 2 clinical trials,COVAXINT has demonstrated the ability to produce antibodies againstCOVID-19."
Further, it has been mentioned in the consent form,"However, the clinical efficacy of COVAXIN is yet to be established and itis still being studied in phase 3 clinical trial. Hence, it is important toappreciate that receiving the vaccine does not mean that other precautionsrelated to Covid-19 need not be followed."
"In case of any adverse events or serious adverseevents, you will be provided medically recognized standard of care in thegovernment designated and authorized centers/hospitals. The compensation forserious adverse event will be paid by sponsor (BBIL) if the (adverse effect) isproven to be causally related to the vaccine," the form says.
The declaration in the end states, "I further emphasizethat any information provided by me prior to taking the vaccine will bearchived in the database maintained by the immunization program of thegovernment and privacy as well as confidentiality of the information providedby you will be maintained."
The recipients of the vaccine have to note any adverseside-effects within seven days of administering the vaccine in a fact sheetprovided to them.