Although this is the first time Ebola has been diagnosed in the United States, it’s not the first infectious disease we’ve faced. From flu and SARS, to Lyme disease and West Nile Virus, we have had opportunities to learn from past outbreaks so we can prepare for the next. Here, we present lessons from a past outbreak, ways to prepare for infectious diseases, and a review of one option for potentially developing an Ebola vaccine: flexible manufacturing.
Excerpted from GAO-12-55
Lessons from an Outbreak: 2009 H1N1 Flu Pandemic
The 2009 H1N1 influenza pandemic was the first human pandemic in over 4 decades with as many as 89 million U.S. cases. Over $6 billion was made available for the response, most of which was spent on vaccines, and grants to states and selected local jurisdictions. The remaining $1.98 billion was meant for longer-term pandemic preparation efforts, such as speeding up vaccine development.
We identified several lessons from the government’s response to the H1N1 pandemic:
- prior pandemic planning efforts and federal funding paid off. For example, funding before the pandemic prepared vaccine manufacturers to produce more vaccines when they were needed.
- when fewer vaccines were available than expected, federal, state, and local government’s credibility was diminished.
- using a central distributor to get vaccines to state and local health providers and organizations was generally cited as an effective practice.
- CDC’s communication efforts were successful; however, they fell short in meeting the needs of some non-English-speaking populations.
- deployment of the Strategic National Stockpile—a supply of medicines and medical supplies for a national emergency—met its goals; however, there were gaps in planning, including the need for long-term storage plans for stockpiled materials.
Preparing for Outbreaks: The Need for a Biosurveillance Strategy
- timely detection and situational awareness is essential to confronting biological threats;
- multiple federal agencies have responsibility for different aspects of biosurveillance;
- federal efforts generally rely on resources that are owned by nonfederal entities—such as those in the state, local, tribal, and private sectors; and
- the systems and programs that make up the national biosurveillance capability were largely developed separately and are relatively uncoordinated.
We recommended a national biosurveillance strategy to provide a framework for building and maintaining national biosurveillance capability. In 2012, the White House released a strategy, but we found that it was not sufficient to address the issues raised in our reports. This recommendation remains open.
Responding to Outbreaks: Flexible Manufacturing
The Department of Health and Human Services recently announced accelerating the development of an Ebola vaccine. We previously reported on efforts to develop medical countermeasures, like vaccines, for new or reemerging infectious diseases.
Specifically, “flexible manufacturing” may help quickly produce countermeasures by allowing facilities to work on a number of products simultaneously or in quick succession. Some of the tools and techniques involved include
- disposable equipment, such as disposable plastic bag systems for growing cell cultures instead of stainless steel tanks that require more time to clean and sterilize before re-use;
- modular sterile rooms, which allow manufacturing of multiple products simultaneously in a single facility; and
- cell-based or recombinant technologies to make vaccines, rather than the traditional egg-based technology.
The use of flexible manufacturing has the potential to help increase the ability to produce the greater number of vaccines and other medical countermeasures needed during a public health emergency.