Last year, many of us paused to recognize the 100th anniversary of the 1918 influenza pandemic that infected approximately one third of the world’s population and killed at least 50 million people. Yet influenza outbreaks and pandemics are not just some footnote of history. In just the last decade, we have faced three serious influenza-related incidents: a severe flu season in 2017 claimed the lives of 79,000 people, most from H3N2 infections; the emergence of H7N9 in 2013 in China, which hit the elderly the hardest; and the 2009 H1N1 pandemic, which spread rapidly around the globe with an unexpectedly high rate of infection among pregnant women, young children, and other vulnerable populations.
Quite frankly, we need to become better prepared to face the next pandemic. Make no mistake, it’s not “if” there’s another pandemic; it’s “when” there’s another pandemic. According to a study on pandemic influenza by the White House’s Council of Economic Advisers, a future pandemic would likely incur costs ranging from $413 billion to $3.79 trillion and claim the lives of about half a million people in the United States alone.
Containing a pandemic will require layered end-to-end solutions: better diagnostics, closer to the patient; improved therapeutics, especially for hospitalized patients; and, perhaps most importantly, better vaccines that are produced in the United States using more modern, fast and flexible technologies. We cannot continue to rely on technologies that are old and too slow to save lives. We must continue to evolve mitigation strategies and technologies.
On September 19, 2019, the White House reaffirmed that we must take deliberate, decisive, and comprehensive action to combat the threat of both seasonal and pandemic influenza. On that day, President Trump issued his Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health to help safeguard the American people. At the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), we are proud to have a leadership role in the implementation of many key aspects of that plan.
ASPR oversees innovation, advanced research, development, manufacturing capacity improvements, and procurement of medical countermeasures. We also oversee the manufacturing, supply chain management, and stockpiling of countermeasures. Within the Biomedical Advanced Research and Development Authority (BARDA), ASPR has invested in the development and production of 23 new or improved influenza vaccines, antiviral drugs, diagnostics and devices.
But we aren’t just buying a bunch of different products – ASPR is working as a catalyst to spark change. We are partnering with the private sector to evolve from egg-based vaccines to cell-based and recombinant vaccines. One challenge with egg-based technologies is that you need eggs – in fact, you need both egg-specific vaccine strain selection and millions of eggs in advance. Also, the technology itself is slow to produce vaccine. In a pandemic, where early interventions save lives, that is a real vulnerability.
So, ASPR is investing in more flexible cell-based and recombinant technologies. ASPR has supported the development of six different cell-based manufacturing technologies since 2006, as well as four different recombinant manufacturing technologies starting in 2009. As a result of these investments, a cell-based influenza vaccine (Flucelvax®) was developed and can now be administered to individuals four years and older. In 2013, FDA licensed the first recombinant influenza vaccine (Flublok®), now available for people 18 years and older. This week, ASPR was pleased to announce that that we are partnering with Sanofi Pasteur to double its production of recombinant influenza vaccine.
To make these vaccines better – meaning vaccines that are more effective and require smaller amounts of antigen – we have partnered with a number of companies to develop and evaluate adjuvants. Adjuvants enhance the body’s immune response, reducing the amount of antigen needed. Some adjuvants can stretch a limited vaccine supply and ultimately allow more people to be protected during a pandemic.
ASPR supported the first adjuvanted pre-pandemic vaccine, which was approved by FDA in 2016. Through ASPR’s efforts, the domestic capacity for both seasonal and pandemic vaccine antigen production rose from approximately 60 million doses in 2006 to now over 600 million doses. Advances like this save lives while bolstering our domestic manufacturing capacity for seasonal vaccine. It is a win-win for domestic preparedness and our taxpayers.
Vaccination is the best protection against influenza, but vaccine alone will not be enough to save lives a pandemic. We must also be ready to treat people who have already become infected. ASPR is working to advance the development of antiviral drugs with novel mechanisms of action to reduce viral resistance, expand the timeframe for effective treatment, and allow for co-administration with other influenza antivirals.
ASPR has funded nine novel antiviral advanced development projects since 2007. One of the earliest projects supported development of intravenous (IV) peramivir, which received Emergency Use Authorization during the 2009 H1N1 pandemic. This product (Rapivab®) received FDA approval in 2014 as a single-dose influenza antiviral drug for treatment of uncomplicated influenza.
As part In 2015, ASPR awarded contracts to support the development of two influenza therapeutics that have novel mechanisms of action compared to existing approved antivirals. Novel antiviral drugs, especially when used in conjunction with early identification of infection through diagnostics, can strengthen preparedness and response levels in that the drugs enable health professionals to treat influenza disease effectively in patients, which in turn limits the spread of disease in communities.
We know diagnosing patients more quickly has a great ripple effect. The patient can get earlier treatment, leading to better health outcomes. The patient also is less likely to pass the infection to others. ASPR is supporting the development of in-home diagnostics to empower individuals with actionable information.
ASPR supported the development of a portable ventilator capable of providing mechanical respiratory support for critical care of newborn babies, adults and elderly patients. The Philips ventilator was cleared by FDA earlier this year for use in institutional, home, and field settings by minimally trained operators and is now stockpiled in the Strategic National Stockpile for immediate distribution when needed.
Through BARDA’s Division of Research, Innovation and Ventures (DRIVe), ASPR is supporting the development of wearable biometric sensors to inform and empower patients to seek earlier treatment. DRIVe is also investing in non-pharmaceutical approaches to reduce the severity of illness and spread of disease. So far, DRIVe has made six awards in support of these goals and the program continues to attract new partners from across the country to help drive innovation.
Several of the products that were developed with ASPR’s support, including cell and recombinant-based vaccines, new diagnostics, and therapeutics, are used every year to prevent, diagnose, or treat seasonal influenza. Those investments are helping to keep people healthy every day and can help save even more lives in a pandemic. Additional ASPR-supported vaccines have been licensed and, in some cases, stockpiled as pre-pandemic vaccines, ready to be rapidly formulated and distributed in a pandemic.
We must ensure that, on any given day, we are ready to respond to a new outbreak of pandemic influenza. Although we cannot predict when the next pandemic will emerge, we can expect it to come with little or no warning. ASPR is dedicated to enhancing our nation’s readiness by supporting next-generation medical countermeasures to address the threat of pandemic influenza and supporting domestic manufacturing of next-generation products. With sound investments, cutting-edge science, and strong partnerships, we are better able to protect Americans from the next influenza pandemic.