Is COVAX part of the problem or the solution?

As a plane carrying 600,000 doses of COVID-19 vaccines landed at the Kotoka International Airport in Accra, Ghana, in late February, world leaders celebrated the milestone — it was the first country to get a delivery through COVAX, a global vaccine distribution facility established in mid-2020.

Dr. Seth Berkley, CEO at Gavi, the Vaccine Alliance, called it “a historic moment” and said COVAX had to overcome “many hurdles” to reach it. But those hurdles are still standing: Countries that receive COVAX doses are often saddled with administrative costs, and questions remain about the mission and efficacy of the enterprise itself.

For months, COVAX — co-led by Gavi, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations — has struggled with its ambitious promise of providing global access to COVID-19 vaccines. Beset with delays and doubts over its ability to deliver on its goals, the initiative once heralded as the “only truly global solution” to the pandemic has found itself severely underfunded and hampered by vaccine hoarding in high-income countries.  

From the beginning, COVAX struggled to enter into firm purchase agreements with vaccine manufacturers. Companies’ slow or piecemeal submission of clinical trial data to WHO for emergency use listing posed delays, while individual governments secured vaccine doses via bilateral deals that ate up more and more of the global vaccine supply, limited by production capacity problems. To date, COVAX has only managed to purchase 1.1 billion doses of vaccine, compared to the 4.6 billion doses bought by high-income nations, according to data from Duke University.

But numbers don’t tell the whole story. Some have criticized COVAX’s seeming identity crisis: While it was set up to provide access to COVID-19 vaccines to people globally, COVAX is sometimes seen mainly as an aid project benefiting low- and middle-income countries, instead of a globally collaborative initiative that governments should support to get the pandemic under control.

And while COVAX is finally supplying vaccines, it’s been criticized for what it doesn’t do — namely, equip nations with the knowledge and infrastructure to produce their own. 

“It does raise the question of [whether] COVAX is part of the problem or the solution, because it doesn’t go to the fundamental problem,” said Sophie Harman, professor of international politics at the Queen Mary University of London.

“If your problem is you want to have affordable vaccines around the world to cover the majority of the world, then the solution would be free licensing or compulsory licensing. COVAX doesn’t do that,” she explained.

Waiving intellectual property and wider technology transfers to manufacturers in low-income countries could help scale up global vaccine supply, academic experts and public health professionals told Devex. But COVAX doesn't involve itself in addressing the issue of IP rights, although WHO has expressed support for such changes. Experts such as Harman also question whether COVAX has become an excuse to not discuss IP rights or if it is in fact the right vehicle to ensure equitable distribution of vaccines.

“It feels like it’s the kind of excuse saying, ‘Yes, we’re doing equitable vaccines. We’ve got COVAX. Look at it rolling out to Ghana. Isn’t this a great success?’” Harman said. “But no one’s actually thinking, ‘Is this the right way of making sure that vaccines are affordable to everybody and can reach the most people?’"

But as an ambitious initiative set up in the middle of a pandemic, COVAX has helped to set norms and principles in the global conversation about vaccination; underscoring the importance of high-risk groups such as health care workers getting vaccine priority, pushing the benefits of multilateralism, and playing a key role in getting vaccine access for lower-income countries.

Some of its shortcomings are part of a wider problem in global health policy and governance — one that existed before COVID-19 appeared.

The case for transparency

One long-standing criticism of COVAX is the lack of transparency in its contracts with pharmaceutical companies.

CEPI’s early funding helped secure vaccine deals with AstraZeneca and Novovax, and paved the way for partnerships between these firms and the Serum Institute of India to manufacture COVID-19 vaccines. But Moderna, which received up to $1 million in January 2020 in funding from CEPI to advance its mRNA vaccine candidate, has yet to commit doses to COVAX, although Gavi is “in active discussion” with the company, CEPI CEO Richard Hatchett told Devex.

What CEPI gave Moderna “was critical to get the project off the ground,” Hatchett said. However, the partnership predated the creation of the COVAX Facility and declaration of COVID-19 as a pandemic, and Moderna’s funding needs were eventually met by the U.S. government, he said.

But that’s drawn complaints from those who believe CEPI should be firmer with vaccine developers and more committed to transparency, especially when it comes to ensuring data and technology are shared with low-income country manufacturers.

“I don't think we can accept this mantra of trade secrets being sacrosanct in a pandemic where so much of the risk is taken by the public purse,” said Katerini Storeng, associate professor at the University of Oslo's Centre for Development and the Environment.

‘Political choices’

One of the biggest issues in meeting the current global demand for COVID-19 vaccines is limited manufacturing capacity, but some argue whether it is a matter of making conscious choices.

Nicole Lurie, strategic adviser to Hatchett, said there remains untapped, excess manufacturing capacity globally — but pharmaceutical firms are hesitant to partner with low-income country manufacturers. Their reasons range from lack of control over the supply chain to potential reputational risks, she said during a recent vaccine symposium hosted by Columbia University.

Vaccine developers have repeatedly said manufacturing capacity, not intellectual property, is what’s posing bottlenecks in scaling up vaccine supply, in response to aggressive calls for them to waive patent rights at the World Trade Organization. However, they also argue there’s limited expertise at the moment, and that the process of tech transfers will take years.

But Mark Eccleston-Turner, a lecturer in global health law at Keele University, calls this a mere excuse.

“All of those are political choices. We are choosing not to transfer the know-how, we're choosing not to build up capacity in low- and middle-income countries, we are choosing to not transfer the expertise there,” Eccleston-Turner told Devex.

These transfers could have been done while vaccines were still in clinical trials, he posits, at the same time investments were being made to ready and scale up vaccine manufacturing.

“We could have been doing this. We chose not to. And therein lies the problem,” he said.

But ultimately it’s likely governments — which provided billions of dollars in public funding for COVID-19 vaccine research and development — that will need to require companies to engage in tech transfers to scale up vaccine production globally. An international binding agreement could ensure that such issues are dealt with before the next pandemic, some experts suggested.

“COVAX, I would say, it’s not where we’re going to find solutions to these things. It’s governments and companies negotiating with each other, and disagreeing and fighting with each other,” said Suerie Moon, co-director at the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva.

“I think COVAX can do good things. But ... I don't think COVAX can persuade, or certainly twist the arm of any company to transfer technology. And it cannot change a government policy on IP,” she added.

Supply chain constraints

In recent months, COVAX has become concerned about potential shortages in the supply chain — including raw materials and vials in which to put the vaccine — and is now in discussion with industry about these constraints. Governments are also involved, in order to waive export controls on materials being manufactured in their territories, Hatchett said.

Supply constraints have an impact on the number of people and countries COVAX is able to reach. At the moment, COVAX aims to have enough vaccines to protect at least 20% of the population to cover high-risk groups. But experts argue this is not enough and doesn’t meet COVAX’s rhetoric on equity.

That is leading countries and political regional bodies such as the African Union to enter into their own bilateral agreements — which can undermine COVAX’s work, as global vaccine supplies are limited and the more are bought by countries directly, the more competition COVAX has to purchase their own.

A Gavi spokesperson told Devex that “as more doses are produced, COVID-19 vaccines will be made available to wider groups if appropriate. But such a phased approach will be important if we are to turn a corner with this crisis.”

Reaching the last mile

But COVAX’s challenges don’t end at securing supplies.

Before the vaccine shipments are made, a national deployment and vaccination plan as well as an indemnity and liability agreement with the vaccine manufacturer are needed. Countries also need to provide regulatory approval of the vaccine, or accept WHO’s emergency use listing.

Vaccines coming from India require an export authorization, and vaccine-receiving countries need to provide an importation license.

Only when these agreements and documentation are ready can UNICEF issue a procurement order for the vaccines. While not a co-convenor of COVAX, UNICEF is a partner and plays a key role in getting the vaccines under COVAX’s portfolio to countries.

“And once this was issued that meant the vaccines were kind of put on a pallet, wrapped up, and somebody put[s] a sticker on the outside like on your Amazon boxes ... and then the freight forwarder comes, picks it up, drives it … to the airplane. And then, off we go,” Benjamin Schreiber, UNICEF’s deputy chief for global immunization programme and COVAX coordinator, told Devex.

They had to make sure that syringes for the vaccines, which are coming from UNICEF’s warehouse in Dubai, also arrive in-country within the same time frame.

As of March 10, more than two weeks after the first shipment arrived in Ghana, 17.8 million vaccine doses have been shipped to countries through COVAX. As further shipments arrive in the coming weeks and months, Schreiber said they will be paying close attention to supplies, and in-country vaccine rollouts, though it’s not clear what the consequences will be if countries don’t follow their rollout plans.

There’s already confusion on who is prioritized to get the first jabs in Nigeria, and vaccine hesitancy is rife in the Philippines amid efficacy questions. Countries such as Tanzania, in denial of COVID-19, are eligible but refuse to take steps to receive vaccines.

A challenge for COVAX is how to ensure these rollouts continue, and that vulnerable populations don’t get left behind. The Gavi board has yet to approve a proposed 5% humanitarian buffer — a proposed allocation for vulnerable populations such as refugees — but the Gavi spokesperson said the organization is “working through the concept in collaboration with a broad range of stakeholders, and this will be put to the Gavi board for approval in the near future.”

In addition, there’s “very little operational funding” going to countries, Schreiber said, which includes the cost of delivery of vaccines, estimated at $2 billion for 2021. Countries are expected to shoulder the cost, although international financial institutions and some bilateral donors are offering assistance. While those costs are low at the moment, since few doses are being delivered, Schreiber expects that as volume ramps up, so will the need for more money.

“This shortage of funding could really become an important issue,” he said.

The next pandemic

COVAX was a hastily convened mechanism to address a pandemic that was already underway. But with many determined to be more prepared for the next disease that attacks humanity, its successes and failures can serve as a model for future initiatives — and even for equitable distribution for more pedestrian medical interventions.

An EU spokesperson meanwhile told Devex that a review will eventually determine which elements of COVAX “will be worth maintaining or evolving for improving global health.”

“A future role for COVAX beyond the current pandemic will depend on the lessons we will have learnt in pandemic preparedness and response as we are progressing to end it everywhere,” the spokesperson said.

“There's a lot of institutional interest in saying it was a huge success. It's a big step forward, we all started from scratch, and there are absolutely really, really valuable elements of success,” said Moon.

“But it's also clearly not enough, right? So how do we really frankly say, without everybody getting offended, and their egos being hurt, and the organizational mandates being in jeopardy … how can we honestly assess what it did well, what it didn't do well, [and] why would we need to change,” she added. “And I hope we can have a frank scrutiny of it.”