COVAX Planning Per-Dose Vaccine Levy To Fund Compensation Scheme Medicines & Vaccines 26/01/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Without this fund, the world’s poorest countries would have to pay out legal claims made by people who might suffer serious side-effects after receiving their COVID-19 vaccination. The global COVID-19 vaccine access platform, COVAX, plans to impose a US 10-cent levy on each vaccine dose to fund a compensation scheme for people who suffer from severe adverse reactions to any of the vaccines it supplies. The “no-fault” compensation fund is crucial for countries who join COVAX, as one of the conditions of membership is that they agree to indemnify pharmaceutical manufacturers from any legal claims from people who might suffer serious side-effects. Without the fund, the world’s poorest countries – defined as COVAX’s advance market commitment (AMC) countries – would have to pay out citizens’ claims themselves. In the past two weeks, the US Centers for Disease Control and Prevention (CDC) reported several cases of people suffering from anaphylactic shock as a result of taking the Pfizer-BioNTech and Moderna vaccines. Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination, according to the CDC. In the case of the Pfizer-BioNTech vaccine in the US, by 23 December, some 4,393 adverse events had been reported out of 1,893,360 (0.2%). Of these, 21 cases were determined to be anaphylaxis (a rate of 11.1 per million doses administered), including 17 in persons with a history of allergies or allergic reactions. In Moderna’s case, by 19 December, 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the US, with 1,266 adverse events reported (0.03%). Of these, 10 cases were determined to be anaphylaxis, nine of whom had a history of allergies or allergic reactions. COVAX published an indemnification proposal in November, which states that “each country receiving COVID-19 Vaccines through the COVAX Facility, whether distributed under an emergency use authorization or recently licensed, will be required to indemnify manufacturers, donors, distributors, and other stakeholders against any losses they incur from the deployment and use of those vaccines”. A spokesperson for GAVI, the Vaccine Alliance, which manages COVAX, told Health Policy Watch that the facility had been working with all stakeholders to establish “a comprehensive solution addressing the need for indemnification and the financial obligations this may impose on middle- and low-income countries”. The compensation fund will be financed “from a $0.10 per dose levy charged by GAVI on the doses to be distributed to AMC countries through the COVAX Facility,” said the spokesperson. “We will be announcing more details, including specific terms around the principles governing indemnity, in the coming days.” COVAX has also facilitated a common template agreement for AMC-eligible economies, that has been negotiated with, and agreed upon by all manufacturers which will “greatly reduce the legal burden on AMC participants”. All Medicines Contain ‘Some Risk’ But Not An Excuse For Sub-Par Product, Experts Remind Professor Brook Baker, an access to medicines expert at Northeastern University in Boston, said that “there are credible arguments for some degree of indemnification, but it should not be a blanket indemnification for harms caused by manufacturer neglect”. “All medicines contain some risk of known and unanticipated adverse side effects or reduced efficacy. The risks of vaccines in particular are considered significant, not because vaccines don’t meet heightened safety requirements, but because they are given to large populations of otherwise healthy people,” explained Baker. “Some risks of vaccine administration are unavoidable. Most of them are rare and listed, but others may be truly rare and unexpected. It makes some sense for governments and payers to indemnify against these predictable and inevitable risks – otherwise vaccine manufacturers might charge much higher prices or avoid vaccine R&D and sales altogether,” added Baker. However, he said manufacturers should not have a “free pass” against adverse outcomes that they could have prevented, such as a sub-standard batch of vaccines or if the manufacturer failed to monitor and report significant side-effects adversely affected particular populations. COVAX is also proposing a “no-fault, lump-sum compensation” for an adverse event as a “full and final settlement of any claims”, but this won’t preclude a local claim. However, Baker cautioned that “a lot of people suffer health effects after vaccination that are not causally related to the vaccine – there is correlation but not causation”. For this reason, some no-fault schemes “get hung up on long, drawn-out investigations of causation”, making the compensation process slow. In addition, “no-fault compensation schemes can be overly bureaucratic and costly to maintain and administer”, warned Baker. “Resource poor countries with weak regulatory capacity would have particular difficulty setting up and running a no-fault compensation mechanism at the national level.” Image Credits: CIO Look/Flickr, Bret Bostock/Flickr. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.