A series of new COVID-19 drug and vaccine funding commitments worth just over US$300 million were announced on Thursday by the Gates Foundation, France and the European Commission – amidst a quickening pace of anticipation that at least one, if not two, COVID-19 vaccines may soon become available. 

Appearing at the Paris Peace Forum, Melinda Gates announced a new $US 70 million contribution by the Bill and Melinda Gates Foundation to vaccine research and the ACT Accelerator’s COVAX facility. The WHO co-sponsored ACT Accelerator aims to ensure the worldwide distribution of forthcoming COVID vaccines, along with drugs and tests, to countries that can least afford to purchase them. 

“In this pandemic there is no difference in helping yourself and helping others,” said Gates. “But its not enough to have the right values, we have to put enough money behind our values,” said Gates.

She spoke at the Paris Peace Forum shortly after WHO published an urgent appeal for US $4.579 in immediate financing to the Accelerator’s various arms of support – which aim to cover worldwide procurement of not only vaccines, but also COVID-19 tests, treatments – and required health systems capacity.  Some $US 28 billion will be needed over the course of 2021, WHO warned, in a detailed investment case, published just hours before the Paris Peace Forum event. 

Gates appeared at the Paris Peace Forum high-level event along with French President Emmanuel Macron, Norwegian Prime Minister Erna Solberg, European Commission President Ursula Von der Leyen, and Dr Tedros Adhanom Ghebreyesus, head of the World Health Organization.  Both the French President and the Von der Leyen also pledged another €100 million Euros each to the Act Accelerator vaccines, tests and treatments initiative. 

Macron also called upon global leaders to adopt an “Act-A Charter” to ensure that “regulatory and policies making COVID-19 products available for all people…if part of the planet is not safe, the entire planet will remain under threat,” he said.

Added von der Leyen, “If we have a COVID19 vaccine, we should have a common approach to give a fair share to everyone so the most vulnerable groups, the frontline workers and the healthcare workers are the ones that get it first.”

Macron’s proposal for a Charter was applauded by WHO’s Dr Tedros who said: “WHO welcomes the ACT-A Charter, which outlines the core principles of equity and fair allocation that align this landmark effort to ensure vaccines, diagnostics and therapeutics are allocated fairly as ‘global public goods’ and not private commodities.”

Meanwhile, however, Norway’s Solberg stressed that, “money talks” and what is needed is $US4.5 billion immediately – as well $US28 billion over the course of 2021 in order to fully fund all four pillars of the Act Accelerator’s activities.

She was referring to the new WHO “investment case” outlining “Urgent Priorities and Financing Requirements” for the ACT Accelerator initiative.  Solberg and other panelists pointed out that the monies, while significant, are small in comparison to the economic costs of a continuing pandemic.  

With the @ACTAccelerator, the world came together to work on a #COVID19 vaccine that would be our universal, common good.

How are we getting there? Watch my intervention at the @ParisPeaceForum 👇 pic.twitter.com/KrK7C2l9Q2

— Ursula von der Leyen (@vonderleyen) November 12, 2020

The Act Accelerator’s $US 28.3 billion ask includes: $US 5.3 billion for COVID tests;  $US 6.1 billion for drugs and other therapeutics; $US 7.8 billion for vaccines; and $US 9.1 billion for upgrading health systems to make it all happen, states the investment case.

The Access to COVID-19 (Act) Accelerator is a collaboration  between WHO and the GAVI Vaccine Alliance, the Global Fund, Gates Foundation, The Wellcome Trust, FIND diagnostics, Unitaid and the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI). It is acting on four pillars – that aim to ensure worldwide access to COVID drugs, vaccines, tests and health services.

“Our goal is to accelerate the development of COVID vaccines and ensure people in all countries get rapid and equitable access regardless of their ability to pay, said Seth Berkley, CEO of GAVI, also speaking about the Accelerator at the Paris Peace Forum.

Generic Drug Manufacturers Pledge To Collaborate With Medicines Patent Pool 

Meanwhile, a coalition of 18 of the world’s largest generic drug manufacturers pledged to work with the Geneva-based non-profit Medicines Patent Pool (MPP) to expedite delivery of the latest COVID-19 drug solutions, including monoclonal antibodies to low- and middle-income countries.  

“We strongly believe that collaboration is the only way we can make it past this pandemic. Each of us stands ready to contribute to the fight against COVID-19 through our technical expertise and longstanding experience in manufacturing and distribution of quality-assured medicines,” states the pledge, signed by the leading generics manufacturers such as Adcock Ingram, Celltrion, Sun Pharma, Natco and others. 

“This unprecedented cooperation from companies that are typically competitors represents a breakthrough in our efforts to level the playing field for access to drugs that will be crucial to controlling and defeating this pandemic,” said Charles Gore, Executive Director of MPP, in a press release. “These are companies with an excellent track record of working with originators to ensure generic versions of their innovations meet high standards for quality—while answering the need for more affordable, accessible therapies.”

Gore noted that collectively the 18 companies that have so far joined the  “open pledge”  have the capacity to deliver huge amounts of conventional drugs, technically known as “small molecules” in industry parlance.  They also have a growing capacity to produce cutting-edge “biologics,” or drugs based on the chemistry of living, biological compounds. Promising COVID-19 biologics include monoclonal antibodies targeting COVID-19 that are currently in clinical trials, and have shown potential for either treating or prevent viral infections such as COVID-10. However, their cost and manufacturing capacity pose substantial barriers to deploying them globally. 

Gore said he hopes the pledge by such a respected group of generic industry players to produce large volumes of high-quality COVID-19 treatments will encourage firms now developing either new or re-purposed therapies to negotiate agreements allowing rapid access to those in need. This can be either through licensing of their intellectual property, or where licences are not needed, facilitating ways to scale up manufacturing capacity to meet the high demands.

MPP was created in 2010 by the global health initiative Unitaid to negotiate license agreements for the generic manufacture of patented drug products of critical importance to health-care systems in low and middle income countries – vastly easing the process for generic drug manufacturers.  Beginning with HIV and Hepatitis C drugs, MPP’s mandate had recently expanded to include other treatments, most recently COVID-19 therapeutics. 

World Health Assembly Sees Debate on WTO Patent Waiver Proposals – Affirmation by Pharma of “Equitable Access”

In a separate statement, the International Federation of Pharmaceutical Manufacturers and Associations and the International Generic and Biosimilar Medicines Association, declared their “shared commitment to equitable acccess to COVID-19 medicines and vaccines” – adding that the pandemic has also highlighted the “importance of ensuring adequate resources are spent to build stronger, more resilient health systems that can cope with complex health challenges.”

The statement, coincided with this week’s World Health Assembly, which saw a wide-ranging discussion of the COVID-19 pandemic, including fears expressed by low- and middle-income WHO member states that their countries could be left out of the COVID-19 vaccine sweepstakes – as rich countries snap up huge pre-order supplies of those products most likely to come first to market.

To address those concerns, South Africa and India have already jointly proposed an IP “waiver” at the World Trade Organization on patents, copyrights and trade secrets for COVID-related health products – covering not only drugs, tests and vaccines, but also hospital supplies like respirator and protective gear.   The “waiver” proposal has, however, so far failed to make headway against rich countries’ objections. And the proposal was subject to considerable pushback again at this week’s WHA from high-income countries, including the United States and the United Kingdom.

Meanwhile, WHO has tried to promote a “third way” including a C-Tap initiative that would mimic the successful Medicines Patent Pool approach, but for a wider array of COVID-19 products, particularly vaccines.  So far, however, that WHO-led effort does not seem to have gained much ground. That appeared even more evident on Thursday in the news that MPP is now building an alliance with generic drug manufacturers to negotiate patent pooling deals over key COVID drugs – in a format that is more predictable and familiar to industry partners.

Overall, the trends have frustrated medicines access advocates who protest the notion that public monies will be spent to buy pharma products that were also financed, in part, by public “Lofty rhetoric on global public goods and solidarity in the COVID-19 response has not been matched by concrete action on the sharing of know-how and intellectual property rights to facilitate deep technology transfer,” said Knowledge Ecology International’s representative, Thiru Balasubramaniam, during the WHA debate. At the minimum, he said public funders of COVID-19 R&D, such as governments and philanthropies should “use their financial leverage to enable the sharing of know-how, cell lines and rights in data and patents, for COVID-19 related technologies.”

Along with tried-and-true MPP approaches, the mood at the Paris Peace Forum made it clear that European leaders are trying to cut a path forward in the marketplace to ensure universal access to whatever the world needs to recover from COVID-19.

Rather than upending the established legal order at WTO or anywhere else, the approach is to leverage huge loans and donations to buy cutting-edge vaccines, drugs and tests as they come to market – but in coordinated, large scale deals that would at least be more affordable.

And that, may be the other bottom line of the US$28 billion Ask.

Image Credits: Paris Peace Forum , WHO , WHO , WHOI , MPP.