COVAX (WHO) Covid Vaccine NFCS

Summary

Introduction

COVAX is a multi-jurisdiction compensation scheme for COVID-19 vaccine injuries received through the COVAX Facility in the 92 low- and middle-income AMC Eligible Economies.

COVAX Countries: Afghanistan, Algeria, Angola, Bangladesh, Benin, Bhutan, Bolivia, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Congo Dem. Rep, Congo Rep., Côte d'Ivoire, Djibouti, Dominica, Egypt, El Salvador, Eritrea, Eswatini, Ethiopia, Fiji, Gambia, Ghana, Grenada, Guinea, The, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Kenya, Kiribati, Korea, Dem, People's Rep, Kosovo, Kyrgyz Republic, Lao DPR, Lesotho, Liberia, Madagascar, Malawi, Maldive Islands, Mali, Marshall Islands, Mauritania, Micronesia, Federated States of, Moldova, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papau New Guinea, Philippines, Rwanda, Samoa, São Tomé & Principe, Senegal, Sierra Leone, Soloman Islands, Somalia, South Sudan, Sri Lanka, St Lucia, St Vincent & the Grenadines, Sudan, Syrian Arab Republic, Tajikistan, Tanzania, Timor-Leste, Togo, Tongo, Tunisia, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank & Gaza, Yemen Rep., Zambia, Zimbabwe

This scheme is a non-statutory scheme, governed by a Program Protocol.

It is administered by ESIS, Inc., who are a private body (private provider of managed claim services).

The funding for the scheme comes from financial reserves established out of an ad-hoc fund based on a per dose levy charged on each covered vaccine procured or made available through the COVAX Facility for use in AMC Eligible Economies.

Vaccines Covered

This NFCS covers COVID-19 vaccines procured through COVAX facility to AMC eligible economies.

These are COVID-19 vaccines that ‘either (A) have received a WHO Emergency Use (EUL) recommendation or prequalification (if applicable), following authorization from a functional or stringent national regulatory authority of reference for vaccines, or under exceptional circumstances (B) have received either a standard or a conditional marketing authorization, or emergency use authorization, from a stringent regulatory authority of reference for vaccines)’ (see Program Protocol, 2.z.i).

The covered vaccines also have to be included in Schedule 1 to the Program Protocol and have been ‘earmarked for delivery through the COVAX Facility to the relevant AMC Eligible Economy, or to a Humanitarian Agency for use in the relevant AMC Eligible Economy, up to and inclusive of 30 June 2023’ (2.z.ii), have ‘received all required approvals and authorizations for importation, distribution and use in the relevant AMC Eligible Economy’ (2.z.iii) and have not reached its ‘Scope of Coverage Endpoint’ (2.z.iv), see ‘Time Limits’ section below).

Injuries Covered

This NFCS only covers permanent injuries.

Under this NFCS only eligible injuries are covered. Eligible injuries are serious bodily injuries or illness resulting in permanent total or partial impairment, congenital birth injury resulting in permanent total or partial impairment, or injuries/illness resulting in death.

Charges for making a claim

There is no charge for making a claim under this scheme.

Claimants

Under this scheme the following categories of individuals are permitted to make a claim:

Vaccine recipients (‘Patient’, see Program Protocol 2.f.i and 2.o):
Individuals who are duly authorized to represent the vaccine recipient if the vaccine recipient has died, is a child or otherwise lacks legal capacity (see 2.f.i).

The ‘Patient’ needs to have sustained an injury that ‘in the opinion of a Registered Health Professional is deemed to have resulted from a Vaccine or its administration’ (2.f.ii).

Under this scheme the claimant is allowed to nominate a legal representative to make their claim.

It is not known whether funding for legal representation is provided by the scheme.

Losses covered

This scheme pays the following:

Live vaccine recipient	Dependants of a vaccine recipient	Legal heir(s) of a deceased vaccine recipient
Compensation payments are for general categories and are not broken down into economic and non-economic losses.	No Compensation is provided specifically for Dependants	Compensation payments are for general categories and are not broken down into economic and non-economic losses.

Payments consist of a lump sum payment.

It is not specified in the Program Protocol whether funeral expenses are available under this NFCS.

Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification.

The amount that can be paid under this NFCS depends on the GDP per capita of the relevant country and the specific harm factor linked to the injury suffered by the vaccinee (GDP per capita of relevant country x 12 x harm factor) (see PP 9.a). Hospital payments of $100/day can also be awarded for a maximum of 60 days.

The following harm factors are specified in the Protocol:-

Harm Factor	Impairment following vaccination
1.0	Death
1.5	Impairment equal to or greater than 75%
1.0	Impairment equal to or greater than 50% but below 75%
0.5	Impairment equal to or greater than 25% but below 50%
0.25	Impairment equal to or greater than 10% but below 25%
0.1	Impairment below 10%
1.5	Congenital injury/illness causing Impairment equal to or greater than 75%
1.0	Congenital injury/illness causing Impairment equal to or greater than 50% but below 75%
0.5	Congenital injury/illness causing Impairment equal to or greater than 25% but below 50%
0.25	Congenital injury/illness causing Impairment equal to or greater than 10% but below 25%
0.1	Congenital injury/illness causing Impairment below 10%

Hospital payments of $100/day can also be awarded for a maximum of 60 days.

Time limits for claims

The scheme does not set a time limit between vaccination and the adverse event occurring. There is a minimum of 30 days between vaccination and making a claim, but no waiting time if the vaccinee is deceased.

Vaccine Administration. To be eligible for compensation the vaccine must have been administered before the ‘Scope of Coverage Endpoint’. The 'Scope of Coverage Endpoint' means, for each covered vaccine, the date which is 24 months following the date on which the vaccine was first put into circulation by the manufacturer in any country.

Reporting a Claim. To be eligible under the scheme a claim must also be brought within the ‘Reporting Period’ for that vaccine. The Reporting Period starts from the date on which the vaccine was first put into circulation by the manufacturer and terminates 36 to 24 calendar months after the 'Scope of Coverage Endpoint' for the vaccine considered (see COVAX Program Protocol, 2t and 2w, and also Schedule 1).

Schedule 6 provides a schematic of the time limits for making a claim.

The Reporting Period for any Patient can in no event extend beyond 30 June 2027.

Evaluating claims – standard of proof required

The standard of proof required by the scheme is the 'most probable cause': the most likely cause (based on the balance of probabilities) that a vaccine or its administration resulted in a claimed Injury.

Appeals and the right to litigate

Use of the scheme and litigation are mutually exclusive, and a claimant must choose which one they take.

There is an internal appeals process where the NFCS itself reviews the decision.

Useful information and links

It is not known whether the scheme produces an annual report including data on claims & financial performance (claim numbers, payments, claim processing timeframes, administrative costs, etc).

Link to NFCS website: covaxclaims.com

Program Protocol Link: https://covaxclaims.com/program-protocol/

Schedule 1 (List of vaccines): https://covaxclaims.com/wp-content/uploads/2021/03/COVAX-Compensation-Program-Vaccine-List.pdf

Schedule 6 (Reporting Period illustrative diagram): https://covaxclaims.com/wp-content/uploads/2021/03/COVAX-Compensation-Program-Illustrative-Diagram-of-the-Reporting-Period.pdf

AMC Eligible Economies list available here: COVAX_CA_COIP_List_COVAX_PR_V5.pdf (gavi.org)