Health experts call for informed consent for COVID-19 vaccine

A dry run at the COVID vaccination centre at BKC

With the first phase of vaccination set to begin on January 16, healthcare experts have cautioned that frontline workers have every right to know the efficacy of vaccines, given emergency use approval, and that participation in the vaccination drive cannot be tagged as ‘voluntary', with consent being must. mid-day reported on January 11 about the concerns of frontline medical professionals, whose names were registered for the vaccine programme without their consent.

We must understand that the Drugs Controller General of India (DCGI) has given EUA for Covishield of Serum Institute of India and Covaxin of Bharat Biotech. Neither vaccine is registered or licensed for unrestricted mass usage. Hence, it is necessary to have ‘informed consent' of prospective recipients - whether healthcare workers or senior citizens. This is in the interest of the vaccine delivery personnel and supplier - so that it is clear that the individuals know that this is not a regular rollout and that the person accepts any risk and any level of vaccine efficacy," explained virologist Dr Jacob John.

Dr John added, "In case of an adverse reaction, the manufacturer and the facilitator (for example, civic body) should remain responsible/accountable as they are using an unlicensed vaccine."

A healthcare worker gets her temperature checked at the entrance of the COVID vaccination centre during a dry run at the BKC COVID Care Centre

"A large scale rollout without informed consent would be rather reckless and point to unmindfulness about adverse consequences. Large scale rollout should be postponed until the vaccine is fully registered, which is unlikely before January 16. Wide-scale use under EUA seems to contravene ethical principles of vaccination," Dr Jacob John said.

‘Educated consent must'

Dr Ketan Vagholkar, professor of surgery, D Y Patil Medical College, said, "A detailed vaccine information statement, containing details of the vaccine efficacy and adverse reactions has to be made public, before a mass vaccination program. An untoward or adverse vaccine reaction cannot be ruled out and a protective healthcare mechanism has to be in place. For example, the VICP program (National Vaccine Injury Compensation Program) introduced in the United States. Under this program, victims of side effects of vaccination are compensated," explained Dr Vagholkar.

"Since vaccinations were restricted to the paediatric population with established protocols, adverse effects were extremely less. Yet, there has been medico-legal litigation related to post adverse reaction in India. A few years ago, a Delhi court, awarded compensation to the parent of an infant who had an adverse reaction to the polio vaccine in 1999. The court ruled that healthcare authorities have to not only run public healthcare programmes but also protect people from side effects of vaccines. It is in the larger interest of vaccination volunteers to educate themselves about it and give valid consent," Dr Vagholkar said.

Dr Subhash Hira, professor of Global Health at the University of Washington-Seattle, said "It will be appropriate for healthcare workers to sign a written consent. The process includes providing the volunteer with detailed information on the contents of the vaccine, his/her free will participation for the two-shot course, likely adverse reactions and whom to contact in case of an emergency. It should also state that some individuals, such as pregnant and breast-feeding women, etc. should avoid the vaccine. It also shall authorise the government to use the person's his/her unlinked data for wider research for public good."

Dr Hira added, "Unfortunately, the Indian Ministry of Health and Family Welfare (MOHFW) website's FAQs on ‘COVID-19 vaccines-December 2020' appears to be outdated or is a draft. It does not mention written consent. When the DCGI eventually gives full approval for the vaccines to be used as preventive shots against COVID-19, it will be a good ethical practice to maintain a written consent form. It would spread knowledge about vaccines, builds confidence and quell rumours."

‘Exclude some populations'

Dr Wiqar Shaikh, senior allergy and asthma specialist and professor of medicine, Grant Medical College and Sir JJ Group of Hospitals, expressed concern that the document released on December 28, 2020, by the MOHFW regarding COVID-19 vaccine administration guidelines does not mention those who need to be excluded from the programme. Dr Shaikh said that based on the reading of guidelines in other countries and international reported data on adverse effects of the vaccine, the following groups should be excluded from the programme - anyone suffering from allergies, children aged under 16 years, people suffering from fever, patients with a bleeding disorder and patients receiving immunosuppressant medications (this includes organ receivers and those with autoimmune diseases such as rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), etc), and pregnant and breastfeeding women.

Dr Shaikh said that the MOHFW guidelines need to be updated accordingly and added that emergency medical treatment should be available for those who develop an allergic reaction. "This could be a challenge for India's rural and semi-rural areas, given our poor medical infrastructure. It would be extremely important that those in charge of vaccine administration centres be trained in obtaining the past history of patients, especially of allergies and other co-morbidities," Dr Shaikh said.
Dr Shaikh, too, emphasised on the importance of taking informed consent.

Dec
Month in 2020 the union health ministry uploaded guidelines for COVID vaccine but did not mention consent