Senate HELP Committee Issues Testimony From Seqirus
"Good morning
"Seqirus is a global leader in the development and manufacturing of influenza vaccines. With extensive research and production expertise and facilities in the
"Our long-established parent company,
"I would like to highlight Seqirus' state-of-the-art vaccine production facility in
"I would also like to highlight Seqirus' proprietary adjuvant MF59(R) which boosts response, and broadens vaccine match as well as enabling dose-sparing of vaccine antigen. MF59(R) is a cornerstone of broader access to pandemic influenza vaccines and part of BARDA's pandemic preparedness and response stockpiling strategy. We believe it is critical to manage MF59 as a long term asset within the pandemic preparedness enterprise which means that it needs a life cycle management strategy consistent with industry standards.
"We are currently working with BARDA to manufacture candidate vaccines against the H7N9 strain circulating in
"Seqirus believes it is critical that PAHPA be reauthorized in a timely manner to ensure BARDA has the resources it needs to continue its unique national security mission at the
"Similar to medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats, there is no commercial market for pandemic influenza vaccines. Seqirus relies on our partnership with the
"Seqirus also supports the PAHPA reauthorization priorities identified by the
"PAHPA has been a success since it was first passed by
"At the beginning of this process, industry partners with the
"Because there is no commercial market for MCMs, the procurement funding provided by the
"Of course, this process is not perfect and can certainly be improved. The overall structure created by PAHPA has enabled dynamic public-private partnerships to thrive, but these partnerships must be sustained over time through a demonstrated commitment by the federal government.
"Seqirus is just one example of how a partnership with BARDA could be successful in the pandemic influenza space. There are dozens of other companies - both large and small - that have committed to BARDA's mission and made significant new investments in MCM development. Reauthorization of PAHPA's authorities and a renewed commitment to MCM development funding will ensure these investments yield even more approved MCMs.
The Threat of Pandemic Influenza
"As members of this committee know well, one of the most urgent public health threats we face as a nation is pandemic influenza, a constantly changing global viral threat. It is often forgotten that the 2009 H1N1 pandemic, a relatively mild pandemic, killed more than 12,000 Americans and hospitalized 300,000 more. The cost to our citizens, our economy, and our security was incredibly high. It is not a matter of if, but when, the next pandemic strikes.
"Pandemic influenza is not just a public health threat; it is indeed a national security threat.
"Ensuring we are prepared to respond to an influenza pandemic is critical to our national and economic security.
"To be ready when a pandemic is declared, we have to invest in R&D for new and better influenza vaccines, to invest in, and sustain, the manufacturing surge capacity to rapidly produce more than 600 million doses of matched virus - two for every American, and we have to maintain stockpiles of vaccine against circulating pre-pandemic strains so we can protect first responders and essential personnel during the time it takes to manufacture matched vaccine.
"Pandemic influenza is related to seasonal influenza, but is also different in many significant ways. Most importantly, new pandemic influenza strains show up across the globe in real-time, emerging from animal to human transmission of strains new to our immune system. Because there is no commercial market to develop vaccines against these new pandemic strains, the
"Unfortunately, funding for preparedness against pandemic influenza threats has been episodic since 2009. The vast majority of funding provided to the
"In 2007, BARDA partnered with Seqirus (then Novartis) in the construction of a new influenza vaccine manufacturing facility in
"The
"The facility employs approximately 500 high-skilled workers to produce both pandemic and seasonal influenza vaccines using innovative cell culture-based manufacturing technologies. We believe
Seqirus is a Leader in the Development of Innovative, Cell-Based Vaccines Technologies
"How well flu vaccines work can vary from season to season. One of the main factors that impact flu vaccine effectiveness is the "match" between the viruses that the flu vaccine is designed to protect against, and the flu viruses spreading in the community.
"How closely the vaccine is "matched" to circulating strains can be impacted by changes in the circulating viruses between the time the influenza vaccine was manufactured and the public is vaccinated, as well as changes that can take place in the influenza vaccine production process.
"The majority of currently available influenza vaccines globally are manufactured using eggbased technology, and work reasonably well. However, the viruses used by manufacturers to start the production process can undergo changes when optimized for growth in eggs. When this occurs, the resulting vaccine may not be as closely matched to the circulating virus as would be preferred, which can reduce the level of protection against influenza infection.
"The influenza vaccine industry is pursuing several new technologies to improve vaccine effectiveness. One of the new technologies used by Seqirus is a cell-based influenza vaccine manufactured in
PAHPA reauthorization Must Include BARDA's Pandemic Influenza Program
"Over the last 13 years,
"For more than a decade, HHS has relied on and drawn down balances from supplemental appropriations bills to fund pandemic preparedness. These balances are now exhausted. Since the passage of these three emergency supplemental bills, sustained resources for HHS' pandemic flu readiness programs have dramatically declined. This has led to an aging stockpile that doesn't match currently circulating strains, critical adjuvants such as our MF59 that are expired, domestic manufacturing capabilities that must be sustained, and private sector partners who aren't sure if HHS is committed to this partnership that is so critical to the nation's readiness.
"In order to successfully prepare against a future influenza pandemic, Seqirus believes
"BARDA's most recent five-year budget outlined
Conclusion
"We believe tremendous progress has been made to ensure Americans are better protected against the threat of pandemic influenza, and Seqirus is excited about the future of our partnership with BARDA.
"I would like to thank members of this committee, and in particular
"I look forward to serving as a resource for this committee during the PAHPA reauthorization process, and I am happy to answer any questions you may have today. Thank you."
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