Would you be compensated for adverse reactions to the COVID-19 vaccines?
The Indian government and Big Pharma — such as Pfizer Inc and Moderna Inc — are still negotiating over the vaccines for the novel coronavirus disease (COVID-19) and the issue of indemnity around them.
The pharmaceutical industry wants the government to provide them immunity from legal liability arising due to adverse effects of the vaccines.
COVID-19 vaccines have been readied in record time. They have been given emergency-use licences and are being administered across the world.
Vaccines can cause adverse effects which can range from simple symptoms such as fever and body ache but sometimes, they can be serious and lead to permanent damage and even death. The pharma industry wants indemnity from any legal issues arising from such problems.
The fight over the indemnity issue indicates that both Indian government and the pharma industry are unwilling to compensate those who end up with serious adverse reactions to the vaccines.
This problem would not have arisen if countries had adhered to a system of accessing vaccines equitably via COVID-19 Vaccines Global Access (COVAX) coordinated by United Nations agencies like World Health Organization (WHO) and Unicef, along with non-profits such as Gavi, the Vaccine Alliance and Coalition for Epidemic Preparedness Innovations.
COVAX facility has a no-fault compensation system under which, the person who suffers from an adverse effect being vaccinated will be provided with a preset amount.
People who are vaccinated with the shots purchased directly from the manufacturers will need to go to court.
Failure to use COVAX as it was supposed to be has created a situation where it will be very difficult for a victim to be compensated, especially in poor and developing countries that do not have a robust system for monitoring adverse reactions.
Such systems are extremely poor in India. Historically too, very few people have received compensation for adverse effects in the country.
The situation in India is further complicated as the country is both providing vaccines to COVAX and is also eligible to receive vaccines from the facility. The same Covishield from Serum Institute of India will be provided via COVAX facility and will be purchased by the India government.
So, a person can be vaccinated with a vaccine from COVAX or directly purchased from a manufacturer. The general public has no idea which vaccine was administered to them. The government’s CoWin app does not provide this information either.
This problem exists with all other WHO-approved vaccines. Pfizer / BioNTech, Moderna, Johnson and Johnson, Sinopharm and Sinovac are selling to COVAX and directly to countries too.
India seems to have two choices as of now: Agree to COVAX’s supply terms (which includes indemnity) or provide indemnity directly to the manufacturer. Neither are good choices.
Murali Neelakantan, principal lawyer at amicus, Mumbai explained that COVAX is not likely to make any exception for India since every other country has signed up to the supply terms (including the indemnity). The industry, too, is not likely to budge as the market for COVID-19 vaccines is a seller’s market and if India continues to be picky about the terms of the contract, the companies will simply move on to the next prospective buyer.
What India needs to do is to learn from this situation. People who suffer from adverse reactions need to prove that their problems are related to the vaccine and this is difficult due to the lack of a robust system for assessing adverse reactions. For this, we need trained manpower. The aim should be to compensate fairly and quickly.
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