prospective recipients of the Covid-19 vaccine as the jabs "are not licensed for unrestricted mass usage"." />
Wednesday, Jan 13 2021 | Time 21:03 Hrs(IST)
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States » EastPosted at: Jan 13 2021 8:20PM


Informed consent needed for Covid-19 vaccine: Expert

Kolkata, Jan 13 (UNI) A renowned physician today stressed on "informed consent" of
prospective recipients of the Covid-19 vaccine as the jabs "are not licensed for unrestricted mass usage".
'We must understand that the Drugs Controller General of India (DCGI) has given Emergency Use Authorisation (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,' Dr Naresh Purohit, Visiting Professor of Public Health at the West Bengal University of Health Sciences, Kolkata, told UNI here.
Dr Purohit, also Advisor for Universal Immunisation Programme (UIP) 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 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 Purohit cautioned.
He 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 have to be in place. For example like the VICP program (National Vaccine Injury Compensation Program) introduced in the United States. Under this program, victims of side effects of vaccination are compensated,' he explained.
'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 Purohit 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 breastfeeding women, should avoid the vaccine. It also shall authorise the government to use the person’s unlinked data for wider research for the public good,' the epidemiologist stated.
Dr Purohit added, 'Unfortunately, the Indian Ministry of Health document 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, build confidence and quell rumours.'
The renowned physician expressed concern that the recent document released by the Ministry of Health regarding COVID-19 vaccine administration guidelines does not mention those who need to be excluded from the programme.
Dr Purohit pointed out 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) ), and pregnant and breastfeeding women.
He observed that the Ministry of health and family welfare 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 history of patients, especially of allergies and other co-morbidities,' Dr Purohit said.
The arrival of vaccines for Covid-19 in India and the nation-wide drive to vaccinate people against this disease should not be misunderstood as a licence to start partying, he added.
'There may be an impression that taking the vaccine for Covid-19 is a passport to freedom but the safe and wise action is to continue with wearing masks and maintaining physical distance,' Dr Naresh Purohit.
This requires to be followed until we achieve 80 per cent herd immunity. Herd immunity refers to a majority of the population developing disease resistance,' he said.
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Tags: #Informed consent needed for Covid-19 vaccine: Expert
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