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

September 25, 2022

Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life sciences

Life sciences

Big Pharma has long seen the potential for AI and machine learning to accelerate drug development. But Novo Nordisk is going a step further by channeling $200 million toward the creation of a computer that will outrun anything in existence.

September 25, 2022

Mount Sinai AI uncovers new brain analysis method to predict dementia, Alzheimer’s disease

Life sciences

Current methods for diagnosing Alzheimer’s disease rely on a complex combination of self- and caregiver-reported symptoms, a physical examination and either a PET scan or a spinal tap to look for evidence of amyloid plaque build-ups in the brain. But a new artificial intelligence-based method may make the diagnostic process a much more objective one.

September 25, 2022

New AstraZeneca-backed report finds big money behind diverse owners and entrepreneurs in Europe

Life sciences

There is lots of talk about diversity and inclusion in business, including in pharma and medtech. A new report by the Open Political Economy Network (OPEN), a think tank focusing on migration and diversity, released its “Minority Businesses Matter: Europe” report highlighting the successes and challenges of ethnic minority-owned businesses in Europe.