Vaccines and Biodefense

BIO President and CEO Jim Greenwood wrote a letter in support of H.R. 6672, the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2012, sponsored and championed by Chairman Mike Rogers (R-MI).

  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Institute of Medicine’s (IOM’s) new report entitled,Ranking Vaccines: A Prioritization Framework, which was developed for the National Vaccine Program Office (NVPO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.  BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.  BIO membership includes both current and future vaccine developers and manufacturers who have worked closely with the public health community to support policies that help ensure access to innovative and life-saving vaccines for all individuals. BIO commends this worthy effort to improve the process for identifying and prioritizing new preventive vaccines for development.  The SMART Vaccines software has the potential to help governmental, non-governmental, and commercial enterprises reach consensus regarding mutually beneficial priorities and collaborations which will guide the future investment of resources.  Today, on average, a new vaccine takes 8 to10 years and over $1 billion to develop.  The advanced vaccines of today are even more challenging to make as they often require very complex technologies to address new diseases and indications that were not able to be conquered with more traditional vaccine methods.  Due to high development costs and lengthy processes, BIO believes that it is critical that limited resources are spent on vaccines that are considered priorities by many immunization stakeholders. Recommendations SMART Vaccines is a subjective, user-reliant model.  As such, it should be used in an appropriate and transparent manner to aid and clarify the vaccine prioritization process.  To help increase the utility of this tool for vaccine developers and manufacturers, BIO supports and recommends the following: 1.      BIO recommends users, including the U.S. government, make inputs and rankings transparent to industry to help companies understand how major purchasers, regulators, and policy makers perceive future markets and to inform private sector investment decisions; 2.      BIO recommends that the IOM Committee and NVPO carefully consider how frequently SMART Vaccines will be used to inform prioritization; 3.      BIO recommends that the SMART Vaccines model be modified to account for the quality of data used; 4.      BIO supports the use of a multi-attribute utility approach for the SMART Vaccines software and recommends the addition of several attributes, including “likelihood of a recommendation for routine use by the Centers for Disease Control and Prevention (CDC)”; and 5.      BIO supports the public release of SMART Vaccines 1.0 to allow companies and other users to test the software using various vaccine candidates.