Better forecasting and management of raw materials and critical consumables and high-level political support – these were some of the suggestions that emerged from a meeting that saw the participation of big pharmaceutical companies – under the banner of International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and others, including the World Health Organisation (WHO).
The meeting comes against the backdrop of Covid-19-related global shortage of raw materials flagged by the WHO, caused by supply shortfalls and exacerbated by export bans by governments looking to keep vaccine stocks for their respective countries. The IFPMA represents pharmaceutical majors, including Pfizer, AstraZeneca, Johnson and Johnson, Gilead Sciences, among many others, who are at the centre of supplying vaccines and drugs being used to tackle SARS-CoV-2.
“The unprecedented scaling up of vaccine manufacturing, from zero to billions of doses in record time, has led to shortages that are impacting the entire vaccine supply chain,” said a note from the meeting held by Chatham House, in collaboration with the WHO-supported COVAX facility, IFPMA, Developing Countries Vaccine Manufacturers’ Network (DVCMN) and Biotechnology Innovation Organisation (BIO).
“Vaccine manufacturing processes (upstream, downstream, fill-and-finish) are highly complex and involve cutting-edge science and technologies. Effective manufacturing capacity expansion needs to overcome major challenges, including but not limited to the need for highly specialised equipment, qualified and trained personnel, difficult and time-consuming technology transfers and, not least, managing complex international supply chains frequently involving more than 100 components,”it added.
Towards improving supplies and addressing the shortages, the participants called for a free flow of goods and workforce; continued technology transfer and manufacturing partnerships between innovators and manufacturers to scale up and scale out Covid-19 vaccine capacity; better demand forecasting and inventory management of raw materials and critical consumables; political support at the highest level; regulatory harmonisation and streamlining to accelerate manufacturing capacity and supply; better production, demand and supply, forecast and visibility and a consideration to the potential impact of Covid-19 production on non-Covid products.
Putting the challenge ahead of them in perspective, Thomas Cueni, IFPMA Director General, said: “Pre-Covid, the global vaccine manufacturing capacity was 3.5 billion doses per year, 5 billion if you include seasonal flu shots. This year, for Covid-19 vaccines alone, manufacturers have scaled up new capacity from zero to 10 billion. Doubling world vaccine capacity of what is a very complex process in a matter of months, thanks to unprecedented industry commitment and collaboration.”
There will be bumps along the road, in the manufacturing process itself as well as strains on the whole supply chain, starting with hundreds of raw materials needed to make vaccines, he said. “It will inevitably lead to bottlenecks that will urgently need to be addressed,” he added.
Dr Soumya Swaminathan, WHO Chief Scientist, stressed the need to explore both short-term and medium-term solutions to address the problem of inequity in vaccine availability. “While removing roadblocks in supply chains can enable companies to ensure they can meet their commitments to supply doses now, a longer term more sustainable approach will be to enable technology transfer to manufacturing sites in low- and middle-income countries (LMICs) that have the capacity,” she said. Such measures would allow the strengthening of regional health security and enable the use of new platforms to develop vaccines for Covid and other infectious diseases, she added.