Consent form 'must' for Covaxin shot-Everything explained.

The consequences of 2020 Coronavirus have been so dramatic that it shattered the economy of 150 countries – jeopardizing their lifestyle, economy, impacting business and assumption of common wellbeing which we had taken for granted. It has thrown the whole world into a global recession.

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).

Why Covaxin is coming with a consent form?

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.

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

The form also states that in case of any serious adverse side-effects, Bharat Biotech will pay the compensation, if it is proved that event occurred due to the vaccine.

The recipients are also handed a factsheet in which they are asked nine questions, including:

  • 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?
Also read:  Asymptomatic pediatric dental patients as potential SARS-CoV-2 carriers in a dental setting.

The declaration read: “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 the confidentiality of the information provided by you will be maintained.”

The Ministry of Health and Family Welfare has informed all states and union territories that one cannot interchange the COVID-19 vaccine, and women who are breastfeeding or pregnant and youngsters of less than 18 years are not allowed to take the anti-coronavirus vaccine.

Reference: Faceless Compliance


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