Sector News

Tangle of global regs adds to risk of vaccine shortages, Sanofi says

May 10, 2017
Life sciences

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.

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.

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 concentrated 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.

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.

By Eric Sagonowsky

Source: Fierce Pharma

comments closed

Related News

February 4, 2023

MedTrace receives U.S. patent for diagnosing the human heart

Life sciences

The U.S. Patent and Trademark Office issued a patent to MedTrace for their method of diagnosing the human heart via 15O-water PET. The patented method is the foundation of the company’s software aQuant, currently under development. Hendrik “Hans” Harms, PhD and Senior Scientist at MedTrace, and Jens Soerensen, Professor and Clinical Advisor to MedTrace, are the originators of the method.

February 4, 2023

Roche taps insider Teresa Graham for top pharma job as setbacks prompt M&A questions

Life sciences

Teresa Graham, currently head of global product strategy for Roche pharma, will become the division’s new CEO next month, Roche said Thursday. Simultaneously, Roche is elevating Levi Garraway, chief medical officer, to the executive committee.

February 4, 2023

J&J’s pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Life sciences

Fierce Pharma has obtained internal documents and video of a town hall meeting conducted this week describing what J&J called a “comprehensive review” of its portfolio. Moving forward, J&J plans to operate its vaccines and infectious diseases outfits as one group, the executives explained.

How can we help you?

We're easy to reach