In the face of a pandemic rapidly claiming lives worldwide, governments, organisations and pharma companies mobilised to provide Covid-19 vaccine doses at a never-before-seen speed and scale. But while the novel coronavirus has become our most urgent public health threat, other infectious diseases still cause the illness and death they always have, and vaccines continue to be needed.
Covid-19 wreaked havoc on drug supply chains over the past two years, but these challenges have also provided opportunities. The lessons that vaccine companies and health organisations were forced to learn due to Covid-19 – from the value of strategic partnerships to the importance of localised manufacturing – have equipped them with new ideas and approaches to improving global access to other crucial vaccines, for the duration of the pandemic and beyond.
A strained supply chain
The interruptions to routine vaccination programmes worldwide due to the pandemic have been significant. According to a report by the World Health Organization (WHO) and UNICEF, almost 23 million children missed out on basic vaccinations as a result of the Covid-19 crisis in 2020 – the highest number since 2009.
From material shortages and insufficient manufacturing capacity to shipping and travel disruptions, the demands of the pandemic exposed existing vulnerabilities in the global vaccine production and supply chain, and highlighted the need to reassess how essential vaccines are made and distributed.
Margo Warren, head of policy at the Access to Medicine Foundation (AMF), says pharma companies had to “think outside the box” in response to Covid-19.
“All of a sudden, they needed to augment supply in a way that was quite unprecedented, and think of solutions for how to actually do this.”
At a forum recently organised by Access to Medicine, experts proposed shifting from a “just-in-time” to “just-in-case” manufacturing approach as a key step towards strengthening global medicine and vaccine supply.
“It’s about building inventory reserves – making sure that companies can develop plans for stockpiling – and expanding communication channels with a large network of suppliers,” Warren explains.
The forum’s speakers also noted that for drugmakers to respond quickly and adequately to future health emergencies, smart forecasting for supply and demand is crucial. In particular, a localised approach to demand planning would help companies to better anticipate need and reduce the risk of shortages, especially in LMICs.
Partnerships and collaboration
Every corner of the globe has been impacted by the pandemic, but limited access to Covid-19 jabs and disruptions to supplies of other vaccines disproportionately affect those living in low- and middle-income countries (LMICs), for whom the burden of disease is also higher. Of the 17 million children who didn’t receive a single basic vaccine dose in the first year of the pandemic, most live in Africa and areas affected by conflict, and lack access to health and other welfare services.
The work to ensure equitable vaccine and medicine supplies to poorer regions has historically been left largely to charitable organisations and humanitarian groups – and during the coronavirus crisis, as wealthy countries hoard coronavirus jab supplies and vaccine makers show no signs of considering patent waivers, this remains the case.
Gavi, the Vaccine Alliance was formed in 2000 to improve access to new and underused vaccines for children living in the world’s poorest nations. Six years ago, the private-public alliance launched STEP (the Strategic Training Executive Programme) with global transport company UPS, as a means of supporting supply chains in the Global South beyond ‘financial philanthropy’. Through STEP, leading immunisation programmes in Gavi-assisted regions receive training and mentorship on managing efficient supply chains from experts in the industry.
In the wake of the pandemic, STEP 2.0 came into being. The programme’s second iteration is jointly offered by Gavi, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the United States Agency for International Development, and coordinated by supply chain management organisation People that Deliver.
For Kevin Etter, who designed and developed STEP and now works on the project as a consultant, private-public partnerships like this are key to improving supply chains in LMICs and accelerating access to essential vaccines.
One of the key challenges associated with vaccine supply in LMICs is “last-mile delivery”, Etter says. The disruptions caused by Covid-19, such as widespread lockdowns, further complicated vaccine deliveries to these regions, and getting shipments back on track is one of STEP’s priorities.
“The next big thing to tackle is getting these routine immunisation programmes back to where they were before the pandemic,” Etter says. “It’s going to be the job of supply chain advocates everywhere to make sure that this is not forgotten.”
Warren at AMF says the pandemic has highlighted the value of industry partnerships and organisations leveraging their networks effectively to create a robust supply chain, and deliver large quantities of vaccine doses to countries in need. In her view, companies need to “recognise their own limitations”, and how much they can achieve alone when it comes to global vaccine distribution.
“Ideas around helping other manufacturers with a strong tech transfer component to develop these new vaccines have been a really important learning from the pandemic.”
Improving LMICs’ own vaccine making capabilities
Efforts to supply vaccines to poorer countries are all well and good, but the fact that 99% of Africa’s vaccines against all diseases are imported only highlights the fragility of supply chains to these regions. As long as LMICs are dependent on other countries or organisations for essential jabs, their access to them will always be precarious.
Oyewale Tomori is a professor of virology at Redeemer’s University in Nigeria, and a member of the African Vaccine Manufacturing Initiative. He says Africa’s reliance on humanitarian groups and donations has brought the continent’s need for better domestic manufacturing capabilities to the fore.
“Every initiative, every vaccine, is being dictated from outside; Africa has not been involved in finding solutions to its own problem,” Tomori explains. “We’re dependent on all those things, so whether we’re going to survive is based on the shifting interests of the of the people who brought [the vaccines] in.”
To ensure secure supplies of essential vaccines, African countries must build the ecosystems for life sciences innovation at home – but this, Tomori says, requires government investment.
“[In other countries] the government provided incentives, tax waivers and those kinds of things,” he says. “That’s why we have the Serum Institute and Bharat Biotech in India, because they have government support.”
“The talent is here, the human resources are here, but you need the right environment for them to function.”
Initiatives and innovation
While LMICs’ ability to produce vaccines independently is crucial, industry players and organisations are working to assist and empower countries in the Global South to reach this goal.
Last summer, WHO and its COVAX partners established a Covid-19 mRNA vaccine technology transfer hub in Africa, to boost the development and industrial-scale production of mRNA shots on the continent. Along with the vaccine technology, the facility provides local manufacturers with technical training, production expertise, and any licenses needed to make the shots.
South Africa was the first country to receive a hub; South African biotech Afrigen oversees vaccine development, while the country’s partly state-owned pharma company Biovac provides manufacturing capabilities.
In February, a Covid-19 vaccine made by Afrigen through the tech transfer project became the first mRNA vaccine designed, developed and produced at lab scale in Africa. WHO has since announced that Egypt, Kenya, Nigeria, Senegal and Tunisia will also be recipients of the technology transfer hubs, and Afrigen has agreed to begin training companies in Brazil and Argentina.
In the same month that Afrigen produced its first mRNA jabs, German vaccine maker BioNTech announced it would establish scalable, modular mRNA manufacturing facilities in Africa. The company’s drug substance and formulation modules, known as BioNTainers, would allow African countries to produce mRNA-based vaccines in bulk and according to their needs.
The BioNTainers, expected to be first installed in Rwanda and Senegal, are not limited to Covid-19 vaccines; BioNTech says its investigational malaria and tuberculosis vaccines could also be manufactured at scale using this technology, following their successful development and regulatory approval.
From investing in domestic manufacturing to building reliable partnerships, the key lesson pharma must learn from the past two years is to be prepared. Rather than mobilising at the start of a crisis, the industry should have in place the pre-emptive structures and coordinated systems needed to cope with the demands of a global health emergency, should one occur.
“Each time there is an epidemic or outbreak, there are a lot of lessons,” Tomori says. “But the question is, how long do we remember them?”
“In 2014, Nigeria had Ebola, and we were able to bring it under control in a very short time because a lot of structures were in place. As soon as we were declared Ebola-free, we dismantled all the structures we had – so when Covid-19 came, we had to start from scratch.”
Etter is optimistic about applying the lessons from the pandemic to routine immunisation programmes: “We’ll be advocating for and working towards shoring up those supply chains, and shifting funding into building on the lessons that we learned about the gaps in them.”
“There are other disease areas that require attention which could benefit from some of the lessons learned over the past two years,” Warren says. Specifically, companies need to focus on forecasting and making sure that last-mile distribution to LMICs is front-of-mind early in the process – and, she emphasises, ensuring supply to poorer countries is not an afterthought.
“In the context of Covid-19, we’ve seen some positive examples of companies thinking about this more strategically and earlier on,” she says. “And I’m hopeful that the issues that have been raised about health equity will translate to other disease areas.”