BENGALURU: The process of administering Bharat Biotech’s Covaxin, already mired in controversy and doubt, has not been without problems in Karnataka. Although the Centre has approved Covaxin for emergency use, phase 3 trials which measure efficacy are still under way. One centre each in six districts — Ballari, Shivamogga, Hassan, Chamarajanagar, Chikkamagaluru and Davanagere — have been given doses of Covaxin. The rest of the state has received doses of Oxford University’s Covishield.
Beneficiaries who receive a shot of Covaxin are to sign a consent form, and in case of an illiterate person, it has to be signed in the presence of an impartial witness. However, several people at centres where Covaxin is being used, have said that they either received no consent form, or were unaware that such a form existed. When they did receive the form, it was in English. Some health workers did not even know whether they were given Covishield or Covaxin.
“I was given Covaxin, but I was not asked to read or fill any consent form before taking it. The vaccinators only checked my blood pressure and asked for some personal and health information. If there is such a permission form, they should have taken my signature,” an Asha worker in Ballari district told TNIE, on condition of anonymity.A data entry operator in Sakleshpur, Hassan, who took Covaxin said, “I was not given any permission form. They only took my Aadhaar information before giving the vaccine.”
What the form says
The three-page consent form is crucial for many reasons. One, it states that “in case of any adverse events or serious adverse events, you will be provided medically recognised standard of care in government designated and authorised centres/hospitals. The compensation for serious adverse events will be paid by sponsor (BBIL) if the SAE is proven to be causally related to the vaccine”.
The details sought include recipient’s name, date of birth, age, gender, marital status, address, phone number, name and address of vaccination site, name and number of vaccinator or supervising officer. Questions on medical history include information about medication for a chronic illness, name of illness, whether they under radiotherapy, etc.
An excerpt of the consent form reads, “I have been provided and have read, or had been explained to me, the fact sheet about the Covid-19 vaccination. I understand that this vaccine requires two doses for it to be effective and two doses need to be administered. I have been allowed to ask questions which were answered to my satisfaction. I understand the benefits and risks of the vaccination as described. I request that the Covid-19 vaccination be given to me.”
A third Covaxin beneficiary who is a staff nurse and works with ASHA workers in Yelandur taluk, Chamarajanagar district, said, “I took Covaxin but was not given any consent form. They only checked my blood pressure and pulse rate and wrote down my details manually.”The consent form requires the vaccinator to confirm and sign that they have reviewed the details of side-effects with the vaccine recipient.
The form is not just about getting the signature as a purely mechanical process, but ensuring that the beneficiary is explained each section of the consent form and answering any questions they have, so that they understand it, said Dr Anant Bhan, researcher, Global Health, Bioethics and Health Policy.
“Consent has four factors -- information, understanding, ensuring it is voluntary and not coerced, as well as documentation for proof. Not giving the consent form to the Covaxin beneficiary is a clear violation of protocol, as the vaccine has been approved for restricted emergency use under the condition that the beneficiary receives this form. The vaccine is in clinical trial mode and is collecting data for study. People need to be told that the vaccine has been approved under special circumstances and that they will be tracked for any adverse effects following immunisation, if any, and whom to report if such things happen,” Dr Bhan said.
Forms in English
Some doctors and nurses who received Covaxin in Vijayanagar Institute of Medical Sciences, Hassan Institute of Medical Sciences and McGann District Hospital in Shivamogga, said they did receive the consent form and it was in English. Public Health Doctor Dr Sylvia Karpagam said, “Pourakarmikas, ASHA workers, Group D employees, are often Dalit women and men. They are at the lowest end of the hierarchy and may not be able to understand English. Healthcare workers who come under contractors may be vulnerable and may be forced to take the vaccine, under orders, without taking their consent.”
Dr Bhan added that the consent form must be printed in the languages of each state.