COVID-19 Vaccination: All You Need To Know About the Consent Form

As the surge of nationwide coronavirus vaccination drive has begun this year, two approved vaccinations Serum Institute of India's Covishield- developed by Oxford -AstraZeneca and Bharat Biotech's Covaxin are set to cover over 3 lakh healthcare and frontline workers in the first phase of the vaccination.

People receiving these vaccination shots will have to sign a three-page informed consent form. The form states that the beneficiary has given his/her consent to the vaccine and is aware of the vaccine and its side-effects (if any).

"In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in government-designated and authorized centers or hospitals," the consent form said.

‘As the surge of nationwide coronavirus vaccination drive has begun this year, two approved vaccinations Serum Institute of India’s Covishield- developed by Oxford -AstraZeneca and Bharat Biotech’s Covaxin layout their three-page informed consent form. The form provides necessary details regarding the vaccination and its eligibility criteria.’

Any serious adverse side-effects/event that is proved to have occurred due to the vaccine will be paid as compensation by Bharat Biotech - the form stated.

The Vaccination Drive

"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. The Central Licensing Authority has granted permission for the sale or distribution of COVAXIN for restricted use in emergencies in the public interest as an abundant precaution, in clinical trial mode,'' note the form.

The production of antibodies against COVID-19 in phase 1 and phase 2 clinical trials is also very well stated in the consent form.

Any information provided to the recipient before taking the vaccine would be archived in the database that is maintained by the immunization program of the government. Also, the privacy and confidentiality of the information provided by the recipients are maintained as per the declaration of the consent form.

Meticulous attention is paid to include a factsheet that questions the recipients regarding any previous/present ailments or any serious allergic reactions, prior history of COVID-19 infection, or any treatment with antibody therapy.

Details of vaccinations in the past 28 days or pregnancy/nursing status in women, history of any medication for a long-standing disease or radiotherapy are also included in the factsheet.

The Ministry of Health and Family Welfare has earlier mandated the use of the COVID-19 vaccine only in a population above 18 years of age. Women who are breastfeeding or pregnant are not eligible for COVID-19 vaccination.

Interchange of the COVID-19 vaccine is also not entertained in all the states and union territories as per The Ministry of Health and Family Welfare.

Source: Medindia

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