A WHO co-sponsored partnership is laying the groundwork for a worldwide distribution plan of $US 6 billion worth of the most effective COVID-19 drugs, including cutting-edge monoclonal antibodies treatments if proven effective – so as to ensure that high-income countries do not snap up all available new therapies as they arrive on the market.

The proposed basket of medicines would be procured under the auspices of the World Health Organisation’s (WHO) co-sponsored ACT Accelerator: a collaboration with seven other UN and global health agencies and philanthropies, including Unitaid and The Wellcome Trust, to provide equitable access to COVID-19 drugs.

The scheme requires more than US$6 billion – $750 million of which is required by February 2021, according to the plan. Due to be released in the coming week, it is currently under review by the ACT Accelerator’s Facilitation Council, co-chaired by Norway and South Africa, represeneting both donor countries and as well as low- and middle-income countries (LMICs) that would benefit from reduced prices and drug reserves.

The new procurement scheme is being supported by Bill and Melinda Gates Foundation and Mastercard Impact Fund – which banded together with Wellcome in a COVID-19 Therapeutics Accelerator to provide funding and support for the drug procurement effort.

Procurement Plan Includes Monoclonal Antibodies, but Excludes Remdesivir – Due To Lack of Proven Benefit

More than half of this investment would go to procuring and distributing monoclonal antibodies, as part of what is referred to as the Therapeutics Pillar – 1 of 4 pillars of the Accelerator scheme, alongside vaccines, diagnostics and health systems.

Monoclonal antibodies appear to be a promising treatment: these artificial antibodies are manufactured copies of those created by the body to fight invading viruses. The emerging  treatment would join key approved treatments – like the steroid dexamethasone – in the medicine basket.

A Unitaid spokesperson, speaking on behalf of the ACT-A Therapeutics pillar, told Health Policy Watch that the procurement plan is being developed as part of the “investment case” for the ACT-Accelerator therapeutics pillar – which will then be shared with donors to recruit the needed $US billion in funding.

“What this investment case is doing is preparing the ground so that when a certain drug is proven to be effective and when it gets the go-ahead from the WHO, we are ready to go.”

The spokesperson added: “The ACT-Accelerator Therapeutics Pillar (co-convened by Unitaid and Wellcome) analysed the treatment pipeline to identify promising treatments with strong clinical safety and efficacy data that could be scaled up. Following this analysis, monoclonal antibodies (mAbs) and proven repurposed therapeutics like corticosteroids (dexamethasone and hydrocortisone) are the most promising options so far. The pillar is preparing different pathways to support access to mAbs as well as monitoring the pipeline and maintaining flexibility to invest in and support other promising therapeutics.”

She stressed that the plan would only be executed with drugs that are actually approved by regulators and the WHO. “Everything is evidence-based and the fundamental principle is to ensure that LMICs don’t lose out.”

Roche Also Confirms Contact With Act Acccelerator

Drugmakers Novartis and Roche are both developing monoclonal antibody treatments; Roche has collaborated with Regeneron to develop and manufacture an antibody treatment known as REGN-COV2.

A spokesperson for Roche told Health Policy Watch: “As part of our commitment to addressing the pandemic, we’ve had preliminary discussions with partners of the ACT-Accelerator about the access plan for REGN-COV2 antibodies.

“These discussions were in the context of development and production of COVID-19 therapeutics, which could eventually inform planning of the ACT-A Therapeutics Partnership,” the spokesperson added. “It is too early to speculate on future decisions, but we will continue working with them and other groups regarding REGN-COV2.”

On the other hand, Remdesivir, a drug approved by the United States Food and Drug Association (FDA), will not be included following a WHO study that found almost no evidence for reduced mortality. WHO announced it was issuing guidance on using remedesivir, but this information is yet to be published.

Cheaper Drugs for LMICs; Equitable Distribution Could Prevent 60% of Deaths

The aim is to ensure that LMICs receive access to these drugs, preventing pre-orders for supplies being locked-up by rich countries.

A recent model, created by researchers at the Northeastern University MOBS Lab, Massachusetts, found that distributing vaccines equitably based on population size could prevent up to 60% of deaths, highlighting the benefits of a scheme like the ACT Accelerator.

The scheme is intended to keep a consistent flow from research and development, to distribution and the administration of the vaccine. Drugmakers Novartis and Roche, both developing monoclonal antibodies, are confirmed to have had contact with WHO regarding the scheme.

Roche has collaborated with Regeneron to develop and manufacture REGN-COV2. A spokesperson from Roche told Health Policy Watch that approximately 2 million doses were projected to be supplied within the first half of 2021.

Image Credits: Roche.