Not just Serum, shortage of vaccine raw material troubling global vaccine makers

When Adar Poonawalla, chief executive of Serum Institute of India recently stated that the US decision to block export of key raw materials is hampering vaccine production, especially Covid-19 vaccines, he was flagging a serious problem - shortage of key raw materials faced by vaccine makers all over the world. The unprecedented increase in demand for Covid-19 vaccines is creating global shortage of critical production inputs including raw and packaging materials, consumables and equipment, a meeting convened on March 9 by UK based think tank Chatham House, in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and other international stakeholders, suggests.

In a discussion paper that gave an overview of the current landscape of COVID-19 vaccine manufacturing and emerging supply chain challenges, Chatham House says that the signs of input supply challenges are being observed across all vaccine manufacturing steps which include bioreactor bags, single-use systems, cell culture media (upstream), filters, gamma sterilisation (upstream and downstream), vials (fill-and-finish), etc. These individual challenges are amplified as the absence of any single input can disturb the entire manufacturing process, it adds.

"It has become apparent that many COVID-19 vaccine input supplies of raw and packaging materials, consumables and equipment are in short supply which may result in several COVID-19 vaccine manufacturers not being able to meet their current vaccine manufacturing commitments. Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics. Mechanisms to ensure input supplies for current and increased manufacturing capacity intent need to be put in place with short, medium and long-term solutions," the discussion paper said.

According to a post-meeting statement issued by IFPMA, "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."

The products that are facing significant supply challenges are single-use bioreactor bags that are used for cell culture and fermentation, cell culture media which is essential to produce inactivated-virus, viral-vector, and protein-subunit-based COVID-19 vaccines, single-use filters, such as tangential flow filters (TFF), which are used in the downstream process of all four COVID-19 platforms and glass vials essential for vaccine distribution.

"Let's put the current challenge in perspective: pre-Covid-19 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. We should not be surprised if there are 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," Thomas Cueni, DG, IFPMA, said.

The Chatham House meeting agreed there is a need to expand capacity and in a way that promotes equitable access and leaves no one behind. The approaches that were discussed include 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, regulatory harmonisation, and better production, demand and supply, forecast and visibility.

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