The nationwide coronavirus vaccination drive began today with two approved vaccinations Serum Institute of India’s Covishield- developed by Oxford -AstraZeneca and Bharat Biotech’s Covaxin. The first phase of the vaccination drive will cover over 3 lakh healthcare and frontline workers. For the people getting Bharat Biotech’s COVID-19 vaccine, 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). Also Read - Death From Coronavirus: Why Overweight Adults Are At Higher Risk
“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 consent form said. Also Read - India's COVID-19 Vaccine Rollout 'Rescued The World’: Top US Scientist
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. Also Read - Maharashtra: Night Curfew, Weekend Lockdown in Aurangabad Till April 4; Ajanta, Ellora to be Shut on Saturdays And Sundays
Wondering why Covaxin is coming with a consent form?
The Covaxin vaccine was approved by the Drug Controller General of India (DCGI) for emergency use, it is still being studied in phase 3 clinical trials. “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 emergency situations in public interest as an abundant precaution, in clinical trial mode,’’ notes the form.
Covaxin can help in producing antibodies
The consent form, however, states that in phase 1 and phase 2 clinical trials, Covaxin has shown that it can produce antibodies against COVID-19.
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 confidentiality of the information provided by you will be maintained.”
As reported by Hindustan Times, 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?
Earlier, 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.