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January 20, 2021

What is the Consent Form to be filled before getting the COVID-19 vaccine, Covaxin shot?

by CA Shivam Jaiswal in Compliance Law

What is the Consent Form to be filled before getting the COVID-19 vaccine, Covaxin shot?

The current COVID-19 pandemic has made the entire world sit up and realise that medical exigencies are unpredictable and can cause a financial upheaval that is tough to handle. With the commencement of 2020-21 financial year the effects of coronavirus have affected the stability of the economy of 150 countries – jeopardising their lifestyle, economy, impacting business and assumption of common wellbeing which we had taken for granted. The lockdown has adversely have affected service sector like banks, restaurants, food vendors, and food delivery providers.

The nationwide coronavirus vaccination drive began with two approved vaccinations of Serum Institute of India’s Covishield- developed by Oxford -AstraZeneca and Bharat Biotech’s Covaxin. The Covishield is approved for restricted use in emergency situation vaccine that may prevent COVID-19 disease in individuals 18 years of age and older. While, Covaxin is India’s indigenous COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

Bharat Biotech’s COVID-19 vaccine Covaxin was granted restricted emergency use approval under clinical trial mode. This meant that people who received the vaccine would have to sign a three-page informed consent form, and would also be monitored for any serious side effects. This was first such approval given to a vaccine in India.

What is the Covaxin Consent Form?

An informed consent is the process of getting permission from the recipient before administering a healthcare intervention, in this case the Covid-19 vaccine.

For the people getting Bharat Biotech’s COVID-19 vaccin, Covaxin shot will have to sign a three-page informed consent form, which states that the beneficiary has given his/her consent to the vaccine and is aware of the vaccine and its side-effects (if any). 

What does the consent form contain?

The informed consent collects information such as name, date of birth, gender, marital status, address, registration number and phone numbers.

It also contains name and address of clinic site where vaccine is administered and name and contact details of the vaccinator supervising your vaccination.

The consent form states that in phase 1 and phase 2 clinical trials, Covaxin has shown that it can 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 the vaccine does not mean that other precautions related to Covid-19 need not be followed.

There will also be questions like:

  • Are you feeling sick today?
  • 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?
  • Have you been treated with antibody therapy in the past 90 days? Details if yes.
  • Have you ever had a serious allergic reaction?
  • Have you had any vaccines in the past 28 days? Details if yes
  • Are you pregnant or considering becoming pregnant?
  • Are you a nursing mother?
  • Are you on any medication for a long-standing disease?
  • Are you taking radiotherapy?

The declaration reads: “I further emphasize that any information provided by me prior to taking the vaccine will be archived in the database maintained by the immunization program of the government and privacy as well as confidentiality of the information provided by you will be maintained.”

The form also states that in case of any serious adverse side-effects, vaccine recipients will be provided medically recognized standard of care in the government designated and authorized centres/hospitals. The compensation for the serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to the vaccine. The compensation will be determined by the ICMR Central Ethics Committee, as appropriate.

The vaccine recipient will be provided sufficient time to read, or have to be explained about the fact sheet about the vaccine. He will also be allowed ask questions which have to answered to his satisfaction. Following the understanding of the benefits and risks of the vaccination, the person will give his consent. If vaccine recipient is illiterate, consent should be taken in the presence of impartial witness. The witness will also have to sign the informed consent.

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