In April, the WHO created the ACT-Accelerator with the overarching goal to deliver equitable access to diagnostics, treatments and vaccines for Covid-19. As part of the vaccines pillar of the accelerator, Gavi has developed a COVAX Facility and advanced market commitment (AMC) initiative that aims to de-risk Covid-19 vaccine development, as well as ensure fair allocation of vaccines based on need rather than economic might.

However, global health charity M茅dicins San Fronti猫res (MSF) has concerns about the ability of Gavi鈥檚 COVAX Facility and AMC mechanism to ensure equitable access to Covid-19 vaccines.

Avoiding business as usual

Central to MSF鈥檚 apprehensions is 鈥渢he transparency of the Covax facility itself,鈥 explains MSF access campaign senior vaccines policies advisor Kate Elder. She asks: 鈥淗ow is it being designed? Who is being invited to the table?鈥 as well as 鈥渨here is the transparency around the agreement [with AstraZeneca] they have announced so far?鈥

Part of the reason for concern about this is because MSF isn鈥檛 sure if Gavi should take the lead on this type of initiative. In a policy analysis, the charity stated: 鈥淕avi is a Swiss-based foundation with a mandate to finance vaccines听 for听 the听 world鈥檚 poorest听 countries听 鈥 currently听 58听 eligible听 countries (of听 an听 original听 73听 eligible听 countries).听 That Gavi听 would听 play听 a听 role听 in听 pooling听 procurement听 and听 negotiating听 prices听 for听 Gavi-eligible countries is logical, but the proposal that Gavi should be the host of a truly global 鈥渇acility鈥 for Covid-19 vaccines is beyond the organisation鈥檚 mandate and expertise.鈥

It adds: 鈥淕avi has no experience working with most middle-income countries nor any high-income countries on procuring for the countries鈥 vaccine needs. Gavi also does not have experience negotiating with pharmaceutical companies on behalf of these countries.鈥

This is linked to questions about whether Gavi is putting conditions on the public money being raised for the AMC. Since it is de-risking manufacturing costs for companies producing Covid-19 vaccines, Elder queries whether it is also 鈥渢rying to de-risk this for the public purse in the requirements they鈥檙e building into those agreements with industry?鈥

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Elder asks: 鈥淲hat are we requiring of the industry since we giving away a big envelope of taxpayers鈥 money to them? Are there conditions around the funding if the company doesn’t meet the volumes that are stipulated? What if they don’t meet the timeline? Are there any penalties?鈥

Elder adds that Gavi should build in a list of conditions and requirements for companies that is on 鈥減ar with a list of conditions that they put out for countries that they want to join the Covax facility. They鈥檙e explicit about what they expect of countries, but they are not so explicit about what they expect from companies.鈥

Need to learn lessons from Gavi鈥檚 PCV AMC

Central to MSF鈥檚 concerns about this Covid-19 AMC is that there were the perceived flaws of Gavi鈥檚 previous AMC for pneumococcal conjugate vaccines (PCVs). Although Gavi deems its PCV AMC to be a success, MSF notes 鈥渋ndependent evaluations of the AMC found it did not deliver on the first objective [of accelerating the development of PCVs for developing countries] in a timely way, and failed to fully accomplish the second objective [of increasing PCV availability for Gavi countries by supporting the scale up of manufacturing]鈥, as 鈥淧CV supply shortages occurred a few times throughout听 the听 AMC鈥.

In addition, evaluations suggest Gavi may have overpaid per dose of PCV. This is because it was in a 鈥渨eak negotiating position鈥 as it 鈥渄idn’t know the cost that existing manufacturers 鈥 Pfizer and GSK 鈥 were charging for those PCVs鈥, according to Elder. Also, because Gavi wanted to incentivise the participation of the pharmaceutical companies to the AMC, 鈥渢hey likely ended up setting the price higher than they would have possibly needed to get these manufacturers to participate鈥.

MSF summarises the lesson learned around an AMC鈥檚 limitations in 鈥渟timulating听 new听 vaccine听 development,听 stable听 supply听 and听 affordable听 prices [which] should听 be addressed in the design of the new COVAX Facility.鈥

MSF鈥檚 recommendations

Based on lessons from Gavi鈥檚 PCV AMC, MSF believes that to avoid 鈥榖usiness as usual鈥, 鈥渢he best thing would be to require that if a company has a successful vaccine, they need to transfer that technology to other companies that could make it. You could try and build that into the funding as a requirement 鈥 maybe to engage with the new WHO C-TAP [Covid-19 technology access pool]鈥, notes Elder.

The charity also calls for Gavi to use its COVAX Facility to negotiate an at-cost price for Covid-19 vaccines. It states in its analysis: 鈥淕avi has a responsibility to hold pharmaceutical corporations at their word and enforce no profiteering off a pandemic. The COVAX Facility should not be instrumentalised to advance industry鈥檚 longer-term pricing strategy goals.鈥

Elder is very adamant that the world cannot trust big pharma and its promises on price. 鈥溕绨 companies have such a very poor track record of honesty and integrity to maximise access鈥, she says, adding that it is 鈥渇oolish鈥 to take their word for it that they are operating at not-for-profit price. Instead we should require them to 鈥渟ubstantiate it with actual data鈥.

鈥淚n the science world, do we take a company鈥檚 word for it that their vaccine is good? No, we look at the data from their clinical trials,鈥 Elder says. 鈥淲hy don鈥檛 we do the same thing in the pricing world?鈥

More dialogue with civil society needed

To add to this, MSF calls for Gavi to engage better with civil society and non-governmental organisations. In its analysis it states: 鈥淥ftentimes these organisations are able to reach the most vulnerable people such as internally displaced and refugee populations鈥 and 鈥渢he right voices must be at the table to ensure the facility is听 appropriately designed to serve the needs of the most vulnerable populations鈥, which includes civil society.

However, Elder has been disappointed by Gavi鈥檚 lack of dialogue. 鈥淎t the beginning of their Covax facility, we were writing to them all the time trying to get information and asking for us, and other civil society, to be included,鈥 she says. 鈥淭hey just didn’t take it up so I would summarise it as disappointing. We couldn’t be clearer with our interest in participating and being at the table.

The response from a Gavi spokesperson states: 鈥淕avi partners including civil society have played an important role in the design of the Pillar and will continue to do so as we strive to end the pandemic as quickly as possible through global cooperation.鈥

Elder concludes: 鈥淟ots of people are saying 鈥榯his is not business as usual鈥欌 [and] that we鈥檙e seeing the best side of the industry. If this is the best of the industry, then the bar is devastatingly low for the world鈥檚 poorest, most vulnerable people.

鈥淐an we not dream bigger of doing things in the public interest by trying to deal with the age-old issue of monopolies?鈥