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Vaccine Compensaton Claims Arrive(Source:Alamy)

Claim applications pertaining to COVID-19 vaccines have begun flowing in under the World Health Organization-backed COVAX facility no-fault compensation program, the global health agency has confirmed to Scrip.

The vaccine injury compensation mechanism was operationalized at the end of March this year and the “administrator has received a number of applications to date” the WHO said. But it underscored that claims relating to vaccine doses not distributed through COVAX, and claims from individuals outside the advance market commitment (AMC)-eligible economies, are not entitled for compensation. 

“Others are pending the receipt of supporting evidence and one is currently undergoing review. Monthly reports on anonymized applications and receivable claims activity are expected to be soon available on the program’s web portal,” the WHO explained.

ESIS Inc., part of the Chubb group, has been signed on as the independent administrator of the no-fault compensation program; Chubb is the world’s largest publicly traded property and casualty insurance company.

Details on which vaccines the claims pertain to, or the exact number of applications made, could not be immediately ascertained, though it will be interesting to see how many claims actually result in lump-sum compensation payouts.

The no-fault compensation program covers COVID-19 vaccines provided in any AMC-eligible economy via the COVAX Facility that either have received a WHO Emergency Use Listing (EUL) recommendation or prequalification (if applicable), following authorization from a “functional or stringent” national regulatory authority of reference for vaccines. Or under exceptional circumstances, the vaccine should have received either a standard or conditional marketing authorization, or emergency use authorization, from a stringent regulatory auth ority of reference for vaccines and also needs to be included in Schedule 1 of the program, among other requirements.

Currently, Schedule 1 (which is updated from time to time) to the program's protocol is believed to include vaccines from Pfizer Inc./BioNTech SE, AstraZeneca PLC-SK Biopharmaceuticals and Serum Institute of India Pvt. Ltd. (SII), though this could not be officially verified.

The WHO has already listed the Pfizer/BioNTech, AstraZeneca-SK Bio, SII, AstraZeneca EU, Janssen, Moderna, Inc., Sinopharm and Sinovac-CoronaVac COVID-19 vaccines for emergency use.

The broader COVAX facility portfolio comprises agreements related to vaccines and vaccine candidates from AstraZeneca/University of Oxford, Clover Biopharmaceuticals, Inc., J&J, Moderna, Novavax, Inc., Pfizer-BioNTech, SII (the Covishield and Covovax vaccines), and Sanofi/GlaxoSmithKline plc, Gavi, the Vaccine Alliance, said on 30 June, when the deal with Clover was firmed up.

This entails an advance purchase agreement up to 414 million doses of Clover’s protein-based adjuvanted vaccine candidate against COVID-19, pending an WHO EUL.

Compensation Program

On whether COVID-19 jabs donated by companies such as Moderna and Pfizer through COVAX to developing countries, including India, are covered by the compensation program, the WHO affirmed that donations to COVAX will be covered by the program, provided they are intended for AMC-eligible economies (which India is), and the per dose levy to finance the program capital is charged on the doses in question.

The compensation program is funded, at least initially, via Gavi COVAX AMC donor funding, determined as a levy charged on all doses of COVID-19 vaccines distributed through the COVAX facility to AMC-eligible economies until 30 June 2022. COVAX (COVID-19 Vaccines Global Access) is the vaccines pillar of the Access to COVID-19 Tools Accelerator and is co-lead by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.

But experts point to aspects that may require careful handling with respect to compensation programs in countries where there may be supplies made both via COVAX and outside of it.

Murali Neelakantan, principal lawyer at Amicus, told Scrip that it is to be seen how Indians who get vaccines under the COVAX program are entitled to compensation, but others who got the same vaccine outside the COVAX program aren’t entitled to similar compensation. “If India plans to have a similar compensation program, it will need to establish a similar procedure using the same insurer perhaps but it can’t just sign up to COVAX to get cover for all vaccination in India,” said Neelakantan, a former global general counsel at Indian pharma firms Cipla Limited and Glenmark Pharmaceuticals Limited.

Last year, things heated up in India when a trial participant sought compensation of INR50m ($670,000) after allegedly developing acute encephalopathy following the first dose of the SII/AZ/University of Oxford vaccine Covishield. Serum, in its counter argument at the time, asserted that the allegation was "malicious" and the claim was not linked to the vaccine trial. The Pune-based company said it would then seek INR1bn for reputational damage.

The Institutional Ethics Committee of the Covishield study, backed by the Data and Safety Monitoring Board, was reported to have subsequently stated that there was no indication that the event was caused by the vaccine, though the final position on the compensation issue could not immediately be ascertained.

COVAX Participants Must Have Indemnity Pacts

Meanwhile, claims-related activity under the COVAX no-fault compensation program comes amid back-and-forth in countries including India around vaccine procurement and the indemnity clause – essentially who bears the liability in the event of serious adverse reactions or death from the fast-tracked jabs.

The issue of indemnity has been a sticking point for US giant Pfizer, which has been in the advanced stages of finalizing an agreement with India for the supply of its BioNTech-partnered mRNA vaccine Comirnaty (tozinameran). All eyes are also on how the indemnity issue will be dealt with in the case of Moderna’s mRNA COVID-19 vaccine mRNA-1273, which has been cleared in India for restricted emergency use.

Front-line domestic company Cipla is “supporting” Moderna with the regulatory approval and importation of vaccines to be donated to India. (India Opens Gates To mRNA COVID19 Vaccines Moderna First Out)

Specifically on whether India is covered under the no-fault compensation program for COVID-19 vaccines, the WHO maintained that  “eligible individuals” in the country who suffer a serious adverse event resulting in permanent impairment or death following the administration of such a vaccine received through COVAX until 30 June 2022 can apply for compensation under the program.

Importantly, Gavi explained to Scrip that all COVAX facility participants “must have signed indemnity agreements with the manufacturers in question” in order to receive doses through COVAX – which would also hold true for doses received via bilateral deals.

“The facility is helping facilitate the process of getting these agreements in place for lower-income economies, as required. All doses delivered through COVAX to AMC-eligible economies, donated or procured, are covered by the COVAX No-Fault Compensation scheme,” Gavi said.

Whether this strictly means that Moderna’s donated vaccine doses for India can only be accessed once the indemnity issue is resolved, or there are other workaround options, isn’t very clear. Neither is it likely to be easy to reserve indemnity only for the foreign vaccine makers while excluding domestic firms such as SII and Bharat Biotech, as well as others in the wings.

Indemnity Scenarios

Interestingly, legal experts like Neelakantan have recently discussed various scenarios around indemnity for foreign firms, underscoring that it is a seller’s market for COVID-19 vaccines and it would be prudent for India to secure a supply of jabs as quickly as possible - if that means giving in to Pfizer’s request for granting indemnity, “so be it.”

Neelakantan, in a recent opinion piece in The Wire with Ashish Kulkarni, an assistant professor at the Gokhale Institute of Politics and Economics, Pune, also put forth that in the unlikely event of India deciding against providing indemnity to Pfizer, the US firm could either buy product liability insurance against claims in India and overseas, or self-insure (set aside a sum to pay for any compensation). In both instances though, these costs of taking on the risk will be built into the negotiated prices for its vaccines.

The duo also discussed another option around the Indian government “helping” private entities to buy vaccines from Pfizer. “The Indian government could purchase these vaccines from Pfizer after granting them indemnity" and sell them on to the private entities, it was suggested.

"These entities could in turn be required to undertake all liability for injury or death caused by the vaccine,” Neelakantan, who has held leadership positions at international law firms including Arnold & Porter and Ashurst LLP, and Kulkarni said in the piece.

How compensation, indemnity and COVID-19 vaccine supply issues in markets like India pan out will be closely followed – balancing the interests of pharma alongside securing the health of over a billion people is unlikely to be a breeze.

 


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