Center wiped out Moderna, so why is Vax still stuck in the pipeline?


ndia has been offered 7.5 million doses of Moderna’s COVID-19 vaccine as part of the COVAX global vaccine-sharing program, but it’s not clear when the jabs will arrive in the country as a consensus on the indemnity clause has not yet been met.

An overview of how manufacturer compensation remains a sticking point when it comes to the rollout of the US-made vaccine in India

  • Last update: July 20, 2021, 12:54 IST

Seventy-five lakh doses of Moderna vaccine are said to be ready for shipment to India under the COVAX program. However, supplies are on hold as discussions are still ongoing to resolve the issues with the indemnity clause. Here’s what you need to know.

What is the indemnity clause?

When it comes to drugs or vaccines, it is possible that despite rigorous testing, they end up causing adverse events in rare cases. In a business-as-usual scenario, the World Health Organization (WHO) states that “those involved in their manufacture, distribution and administration can normally purchase insurance to cover this risk.”

But given the unprecedented scale of the Covid-19 pandemic and the accelerated timelines in which vaccines against the novel coronavirus have been designed and deployed, the WHO says “normal insurance will not be available as of departure”. He further notes that “the absence 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 taken into account.”

This is what is meant by the indemnity clause. Basically, the manufacturers insist that countries researching their vaccines should “indemnify them against product liability claims.” WHO notes that this was a similar situation at the time of the H1N1 pandemic in 2009.

Compensation would mean protection from legal action and waiving any obligation to pay compensation in the event that a recipient experiences an adverse event following vaccination.

What is the position of the Center?

According to the PTI news agency, sources said that “talks are still ongoing and a consensus on the issue of compensation has not yet been reached” with Moderna, whose mRNA vaccine has already is in emergency use in India.

In early April 2021, the Center had cleared the decks so that vaccines approved by the United States, United Kingdom, European Union, Japan or WHO could be deployed in India. However, this move to encourage manufacturers like Pfizer and Moderna to source from India has not yielded results as the issue of compensation has not been resolved.

India has not awarded compensation to any of the three vaccines – Covishield, Covaxin, Sputnik V – currently in use as part of the country’s vaccination program against Covid-19.

Member of NITI Aayog and head of the Indian Covid-19 working group, Dr VK Paul said last week that the Center was actively working with Moderna to launch its mRNA vaccine in the country. “… (T) comes and goes (discussions) take place on contractual details… We now expect to hear them at all times. Right now they have to respond to some of the points that we have raised and we will take them forward, ”Paul said.

Have Pfizer, Moderna been compensated wherever they are used?

Reports suggest that the Pfizer vaccine has been approved for emergency use in 96 countries while the Moderna vaccine has been rolled out in 63 jurisdictions. In all countries where these vaccines are used, manufacturers have reportedly received compensation from the authorities.

No vaccine currently in use has received full WHO approval and the emergency use list procedure under which they have been deployed requires manufacturers to “commit to continuing to generate data to enable full approval ”.

That said, the United Nations health agency says that “the path to EUL involves a rigorous evaluation late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan ”.

Moderna vaccines that are said to be destined for India are being supplied as part of the United States’ contribution to the COVAX alliance, but the country said they would be made available subject to “pending legal and regulatory approvals. “.

What is the COVAX position on compensation?

COVAX is an abbreviation for Covid-19 Vaccines Global Access, which is an international mechanism that has been put in place to ensure fair and necessary access to vaccines across the world. It is jointly led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and WHO. The aim is to ensure that “all participating countries, regardless of their income level, will have equal access to these vaccines once they are developed”. Covax aims to have 2 billion doses by the end of 2021.

WHO notes that “all vaccines made available or purchased through the COVAX facility will have received regulatory approval or emergency use authorization”. However, he adds that “each country receiving Covid-19 vaccines through the COVAX facility … will be required to compensate manufacturers, donors, distributors and other stakeholders against any loss they incur as a result of deployment and use. of these vaccines ”. What this essentially means is that each country “will be required to pay all legal rewards … against the” indemnified entities “.

However, there is a possibility of compensation under the COVAX scheme. The WHO has said that for people who experience serious adverse events after receiving an emergency Covid-19 vaccine, “a no-fault compensation mechanism will be in place.” That is, people in any of the 92 countries that are part of the Advance Market Commitment (AMC) group, who experience an unexpected SAE “will receive no-fault lump sum compensation for this event in full and final settlement of any claims. “India is listed as one of 92 countries eligible for AMC support.

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