'Bharat Biotech will compensate if...': What Covaxin consent form says
"The vaccine 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 trials," the form said.
All beneficiaries who were to be administered Bharat Biotech's Covaxin, the Covid-19 vaccine which was at the centre of several controversies in the last few days, have to sign a form which says that the beneficiary is aware of the vaccine and its probable side effects and has given his or her consent for the vaccination process.
But why Covaxin came with this consent form? When the Drug Controller General of India (DCGI) gave emergency-use authorisation to Covaxin, it was allowed in "clinical trial mode" where the consent of the beneficiaries is must before vaccination.
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"In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in government-designated and authorised centres or hospitals," the form said. If there is any serious adverse event which can be proved to be causally related to the vaccine, then Bharat Biotech will compensate, it says.
{{/usCountry}}"In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in government-designated and authorised centres or hospitals," the form said. If there is any serious adverse event which can be proved to be causally related to the vaccine, then Bharat Biotech will compensate, it says.
{{/usCountry}}"The vaccine 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 trials. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covid-19 need not be followed," it said.
{{/usCountry}}"The vaccine 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 trials. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covid-19 need not be followed," it said.
{{/usCountry}}The vaccinator too will have to give a declaration that he or she has reviewed the details of side effects with the vaccine recipient. The vaccinator will also have to confirm that the recipient was allowed to ask questions about the vaccination.
{{/usCountry}}The vaccinator too will have to give a declaration that he or she has reviewed the details of side effects with the vaccine recipient. The vaccinator will also have to confirm that the recipient was allowed to ask questions about the vaccination.
{{/usCountry}}The recipient will be asked nine questions, which are included in the consent form:
1. Are you feeling sick today?
2. Have you had a Covid-19 test in the last 14 days or been told by a healthcare provider to isolate or quarantine at home?
3. Have you been treated with antibody therapy in the past 90 days. Details if yes.
4. Have you ever had a serious allergic reaction?
5. Have you had any vaccines in the past 28 days? Details if yes
6. Are you pregnant or considering becoming pregnant?
7. Are you a nursing mother?
8. Are you on any medication for a long-standing disease?
9. Are you taking radiotherapy?
The Centre earlier instructed states to not vaccinate pregnant or lactating women or people below 18 years of age.
For the vaccination drive, the Centre procured 55 lakh doses of Covaxin of which 16.5 lakh doses have come at free of cost.
