A look at how indemnity for the manufacturer remains a sticking point when it comes to the rollout of the US-made vaccine in India.
Seventy-five lakh doses of the Moderna vaccine are reportedly ready to be shipped to India under the COVAX programme. However, the supplies are stuck as discussions are still on to resolve issues related to the indemnity clause. Here’s what you need to know.
What is the indemnity clause?
When it comes to drugs or vaccines, there is a chance that despite rigorous tests, they may end up causing adverse events in rare cases. In a business-as-usual scenario, the World Health Organisation (WHO) says, “those involved in their manufacture, distribution and administration can normally get insurance to cover this risk”.
But given the unprecedented scale of the COVID-19 pandemic and the accelerated timelines under which vaccines against the novel coronavirus have been devised and deployed, WHO says that “normal insurance will not be available from the outset”. It further notes that the “lack of such coverage may limit or delay global access to life-saving vaccines as manufacturers are reluctant to deliver (those) if this risk is not addressed”.
This is what is meant by the indemnity clause. Basically, manufacturers are insisting that countries that are seeking their vaccines should “indemnify them against product liability claims”. WHO notes that it was a similar situation at the time of the H1N1 pandemic in 2009.
Indemnity would mean protection from lawsuits and waiver of any requirement to pay compensation in case any recipient suffers an adverse event following vaccination.
What is the centre’s stand?
According to news agency PTI, sources have said that “the talks are still on and a consensus on the indemnity issue is yet to be reached” with Moderna, whose mRNA vaccine has already received emergency use nod in India.
In early April 2021, the Centre had cleared the decks for vaccines okayed by the US, UK, European Union, Japan or the WHO to be rolled out in India. However, this move to encourage manufacturers like Pfizer and Moderna to supply to India hasn’t yielded results as the question of indemnity has not been resolved.
India has not granted indemnity to any of the three vaccines — Covishield, Covaxin, Sputnik V — that are currently being used as part of the country’s Covid-19 vaccination programme.
NITI Aayog member and chief of India’s Covid-19 taskforce, Dr VK Paul had last week said that the Centre is working actively with Moderna for the launch of its mRNA vaccine in the country. “…(T)o and fro (talks) are going on over the contractual specifics… We are now expecting to hear from them anytime. Currently, they have to respond to some of the points we have made and we will take it forward,” Paul had said.
Have Pfizer, Moderna got indemnity wherever they are being used?
Reports suggest that the Pfizer vaccine has been approved for emergency use in 96 countries while the Moderna shot has been rolled out in 63 jurisdictions. In all countries where these vaccines are being used, the makers are reported to have received indemnity from authorities.
No vaccines currently being used have received full approval from WHO and the emergency use listing procedure under which these have been rolled out require manufacturers to “commit to continue to generate data to enable full licensure”.
Having said that, the UN health agency says that the “EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan”.
The Moderna vaccines reportedly earmarked for India are being provided as part of the US’ contribution to the COVAX alliance, but the country has said that they will be made available subject to “pending legal and regulatory approvals”.
What is the COVAX stand on indemnity?
COVAX is an abbreviation for COVID-19 Vaccines Global Access, which is an international mechanism that was set up to ensure fair and necessary access to vaccines across the world. It is led jointly by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and WHO. The aim is to ensure that “all participating countries, regardless of income levels, will have equal access to these vaccines once they are developed”. Covax aims to have 2 billion doses available by the end of 2021.
WHO notes that “all vaccines made available or procured through the COVAX Facility will have received regulatory approval or an emergency use authorisation”. However, it adds that “each country receiving Covid-19 vaccines through the COVAX Facility… will be required to indemnify manufacturers, donors, distributors, and other stakeholders against any losses they incur from the deployment and use of those Vaccines”. What this essentially means is that each country “will be required to pay any legal awards… against the ‘Indemnified Entities'”.
However, there is scope for compensation under the COVAX scheme. WHO has said that for people who suffer serious adverse events after receiving an emergency Covid-19 jab, “a no-fault compensation mechanism will be established”. That is, people in any of the 92 countries that are part of the Advance Market Commitment (AMC) Group, who suffer an unexpected SAE “will receive a no-fault, lump-sum compensation for that event in full and final settlement of any claims”. India is listed as one of the 92 countries that is eligible to be supported by AMC.