Manufacturing vaccines is a challenge, Sanofi Pasteur’s head of global research Nicholas Jackson said last month, with long cycle times and complicated processes – sometimes involving several thousand steps in a GMP campaign – as well as ever-increasing regulatory complexities and unpredictable demands.
But the sector is also troubled with a dwindling workforce caused by “significant consolidation of vaccine companies,” he told delegates at last month’s BPI European Summit in Amsterdam.
“In the late 60s there were 26 manufacturers who provided an FDA licensed vaccine. Today there are only seven [companies] who produce one vaccine and only eight that have more than one vaccine.”
He added after years of mergers and acquisitions, on an international level “there are really only five players left: Sanofi Pasteur, GSK, Merck [& Co.], Pfizer and J&J.”
His claim of an oligopoly in the industry is supported by data from EvaluatePharma which found 86% of worldwide vaccine sales in 2015 were for products made by GSK, Sanofi, Merck & Co. and Pfizer.
“The issue we have as big international companies is it is incumbent on us to keep working on life-cycle management, because unlike small molecules vaccines can produce significant revenue for many decades after they are first launched,” Jackson said.
“That ties our hands when it comes to working on novel products because we are having to sustain the revenue generated from these long-term successful products.”
Lack of talent
And this has led to a significant decline in vaccinologists who both understand the translational process development from small to large-scale vaccine production, as well as analytical formulation development, and regulatory science and strategy.
“I can tell you from Sanofi Pasteur’s perspective it is extremely hard to recruit seasoned, up-and-coming, talented people in this area,” Jackson said.
“It’s a significant focus for our organisation to do our best to attract people in these particular disciplines as we realise in the future there is going to be a major issue for us.”
He did say new pipelines stemming from smaller vaccine development firms are beginning to bring new candidates forward, “but that end-to-end capability from an R&D perspective, from a process perspective, from a manufacturing perspective is extremely rare and unfortunately the talent behind that is shrinking.”