What Does ‘Clinical Trial Mode’ Mean and Why Does This Matter?
The vaccine was placed in ‘clinical trial mode’ when it was authorised for public use without having cleared all phases of the clinical trial.
This was done to monitor those who got Covaxin in a sort of ‘open-label’ trial.
Those given Covaxin during phase 1 of vaccination had to sign a form that spelt out what clinical trial mode meant. The form said:
• 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 centers/hospitals.
• The compensation…
