Tangle of global regulations adds to risk of vaccine shortages, Sanofi Pasteur executive says

Sanofi Pasteur
Sanofi Pasteur head of quality Anders Vinther said global regulatory considerations make it hard for companies to keep up with vaccine manufacturing demands.

Worried about emerging diseases, pharma has increasingly teamed with governments and nonprofits to work on vaccines to combat them. But in a new interview, Sanofi Pasteur’s chief quality officer, Anders Vinther, says drugmakers need help tackling another lurking challenge: global regulatory entanglements.

Anders Vinther

Speaking with The Pharma Letter (sub. req.), Vinther said a simple change to vaccine manufacturing lines can take up to five years to implement, thanks to the variety of different regulatory considerations in more than 100 countries. That fragmented regulatory system makes it difficult for drugmakers to quickly respond to changing vaccine needs around the world, he added.

Furthering the problem is that only a few large vaccinemakers operate globally, and that it takes about two years to produce some vaccine batches. Together, those factors can lead to shortages when unexpected demand crops up or if one company develops manufacturing problems, according to Vinther.

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Vinther’s statements come as Sanofi Pasteur struggles to keep up with yellow fever vaccine demand and a global shortage moves into the U.S. Late last month, the Centers for Disease Control and Prevention said supplies are set to run out this summer as the drugmaker shifts production to a new facility, expected to open next year.

Sanofi and a few other players around the world produce yellow fever vaccines, but they have had trouble meeting demand as recent outbreaks have spawned emergency vaccination campaigns.

Manufacturing complexities are just one challenge the highly consolidated vaccine industry faces. Obtaining funding for research on diseases that pose a future risk but aren’t certain to develop into a viable market for profit-driven drugmakers is also difficult. To address that hurdle, several pharma companies have partnered with the Gates Foundation and governments to finance early-stage R&D for vaccines against potential threats.

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Dubbed the Coalition for Epidemic Preparedness Innovations, the group formed in January with support from GlaxoSmithKline, Merck & Co., Johnson & Johnson, Pfizer, Sanofi and Takeda, plus $460 million in commitments from nonprofits and governments. First on the list for R&D work are the MERS-CoV, Lassa and Nipah viruses.

Seeking to contribute to the effort, GlaxoSmithKline established an R&D facility outside of Washington, D.C., where its scientists will conduct research against emerging diseases. The company wanted to “walk the talk” after years of discussions between stakeholders about emerging disease risks, former CEO Andrew Witty said at an opening ceremony.