People who receive Bharat BioTech’s COVID-19 vaccine Covaxin during the vaccination drive will have to sign a consent form. The form assures that the beneficiaries will receive compensation if they suffer adverse effects related to the Covaxin.
What does the COVID-19 consent form say?
The consent form states that the Bharat Biotech Covaxin is approved for restricted use in an emergency situation that may prevent COVID-19. The people who receive Covaxin will be given medical care in the government designated and authorised hospitals if they suffer any serious adverse events.
How can people learn more about the COVID-19 consent form?
The recipients can ask the vaccinator or supervisor or they can visit the website https://www.mygov.in/covid-19/ for more information.
The Covaxin recipients will be given sufficient time to read the consent form. They will be given a fact-sheet about the vaccine and a side effect reporting form to write down symptoms like pain and fever that occur in the 7 days of getting the jab.
The Covaxin recipients will have to sign the consent form after understanding the benefits and risks of the Covaxin.
Who pays the compensation for the adverse events caused by Covaxin?
Bharat BioTech will pay the compensation if the adverse event is proven to be caused by the vaccine. The compensation amount will be decided by the ICMR Central Ethics Committee.
Can COVID-19 vaccine recipient choose their vaccine brand?
In the first round of the COVID-19 vaccination drive, two COVID-19 vaccines- Bharat Biotech’s Covaxin and the Serum Institute of India’s Covishield will be used to immunise three crore people across the country. For now, the recipients don’t have an option to choose their vaccine brand.
Why do only Covaxin recipients have to sign consent forms?
People receiving the Serum Institute of India’s Covishield don’t have to sign the consent form. But those receiving the Covaxin have to sign consent forms because the vaccine is still in trial mode.
The phase 1 and phase 2 clinical trials of the Covaxin have demonstrated that the vaccine is safe and triggers antibody production against the coronavirus. But the phase 3 human trials of the Covaxin to determine its efficacy is currently underway. So, it is very important to follow other precautions related to COVID-19.