Public Health and Biosecurity

AAI monitors and responds to potential legislative, regulatory, or other policy changes that affect public health and biosecurity.  Key issues include responding to outbreaks and pandemics, including Ebola virus, Zika virus, and pandemic influenza; informing the public and policymakers about the safety and efficacy of vaccines; and monitoring regulations related to the use of select agents and toxins.  These issues are all within the jurisdiction of the Committee on Public Affairs Subcommittee on Public Health and Biosecurity, chaired by Jonathan Harton, Ph.D.

PUBLIC HEALTH

Vaccination

AAI strongly urges full adherence to recommended immunization schedules.  In March 2015, AAI issued a statement in strong support of routine and seasonal vaccinations.  Vaccination prevents disease and greatly improves individual and public health.

Outbreaks/Pandemics

AAI carefully monitors the preparation for, and the response to, disease outbreaks, like the recent outbreaks of the Zika and Ebola viruses.     

AAI is pleased that Congress appropriated $1.1 billion in emergency funding in September 2016 for Zika virus response activities.  Of the $1.1 billion, $397 million is designated for vaccines and diagnostic development.  Another $394 million will fund Centers for Disease Control and Prevention efforts to support vector control, technical assistance for states, and international response activities.  To see a full summary of the Zika funding provisions, click here.

AAI was also active during the 2014 Ebola epidemic. Then Committee on Public Affairs Chair Clifford Harding, M.D., Ph.D., issued a statement in September 2014 calling on Congress to institute a “two-prong strategy” to combat Ebola.  The AAI statement stressed that “in the long term, basic biomedical research, including research on the immune response, virology, disease pathology, and vaccine development, is necessary to develop efficacious and affordable therapies to prevent, treat, and potentially cure Ebola and other highly contagious, devastating infectious diseases.”  In the short term, AAI urged that policymakers heed the advice of public health experts such as isolating infected individuals and tracing the contacts of those who are infected.

Antibiotic Resistance

AAI supports efforts to address the rising threat of antibiotic resistance. AAI is a member of S-FAR, an organization that engages with non-government stakeholders to develop policy and exchange information about antibiotic resistance, and monitors activities of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria and implementation of the National Action Plan for Combating Antibiotic-Resistant Bacteria.

BIOSECURITY

Dual Use Research of Concern

The new Dual Use Research of Concern policy, which was announced in September 2014 and went into effect September 2015, sets up a system of checkpoints for investigators who are conducting research that could potentially be misused. The policy’s effectiveness depends on cooperation between the research institution, which assigns an Institutional Review Entity (IRE) and Institutional Contact for Dual use Research (ICDUR), and the investigator, who communicates with the institution about potential DURC, to evaluate the research and to potentially create a risk mitigation plan. In order for experimental research to be considered DURC, it must meet three criteria: the research must involve one of fifteen select agents or toxins, the research must fall into at least one of seven categories, and the IRE must determine that the research “can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security.”

Gain-of-Function (GOF) research

In October 2014, the White House Office of Science and Technology Policy (OSTP) implemented a “pause” on certain types of GOF research (i.e., experiments with influenza, SARS, and MERS viruses) and announced a plan to examine the risks and benefits associated with these types of research.  Since then, the National Science Advisory Board for Biosecurity (NSABB) has worked to determine appropriate regulations to govern this research.  Among other things, NIH (on behalf of NSABB) commissioned two studies, one to examine the risks and benefits of GOF research and one to analyze the ethical implications of such research.   In January 2016, the NSABB released to the public the draft recommendations, as well as the risk-benefit and ethical analyses.

In May 2016, NSABB released a set of recommendations, entitled “Recommendations for the Evaluation and Oversight of Proposed Gain-of-Function [GOF] Research.”  In this context, NSABB defines GOF research as “scientific research that increases the ability of … infectious agents … to cause disease by enhancing its pathogenicity or by increasing its transmissibility among mammals by respiratory droplets.” 

AAI submitted comments to NSABB in advance of its March meeting.   In its comments, AAI expressed general support for the draft recommendations, but noted that “the steps for implementation of these recommendations” had not been “clearly laid out…” and urged “that these recommendations be implemented very cautiously to avoid potential burdens.”  AAI also noted that “it may, in many cases, be more appropriate to apply current Dual Use Research of Concern (DURC) polices to these studies.”