Continued progress involves addressing difficult vaccine quality and safety issues, as discussed at the January 2013 WCBP
symposium in Washington, DC, sponsored by CASSS and FDA. Scientists noted the need to "solve the riddle" of how to make these
complex products at moderate cost using modern biotechnology. This progress involves defining the range of acceptable variability
in characterizing these inherently heterogeneous products, including release and stability data that reflect both process/analytical
capability and biological suitability of the final product. Participants in a WCBP vaccine workshop further explored issues
in achieving manufacturing control and in defining critical attributes for newer vaccines. There was discussion about strategies
for designing appropriate potency assays, for setting release and stability specifics, and for justifying a range of variability
with available clinical data. Concerns that some newer, highly purified vaccines may appear less efficacious than older, heterogeneous
products illustrate a need for clear potency assays.
The importance of harmonization in national vaccine regulatory policies was emphasized at the December 2012 PDA/FDA vaccine
conference in Bethesda, MD, which also examined issues related to expanding global access to effective vaccines. Leading vaccine
makers expressed frustration with frequently changing standards, data requirements, approval processes, and policy interpretations
by regulatory authorities around the world. Manufacturers would like to see a functional "mutual recognition" process for
vaccine market approvals, or perhaps a global body that reviews standardized data for all markets. The vaccine industry is
working closely with the world health community to greatly expand access to crucial vaccines for millions of children around
the world, a goal that would benefit from regulatory processes able to identify products that do and don't meet quality standards,
as well as an international process for identifying and monitoring vaccine safety problems.
Further research also is needed to address still prevalent "anti-vaccine" fears held by many parents and patients. A report
issued by the Institute of Medicine (IOM) in January 2013 confirmed the safety and benefits of the US childhood immunization
schedule and advised against moves by parents to stretch out or delay childhood vaccination (1). Even so, immunization rates
in most states fall below the desired 95% level and are even worse in Britain and many other countries. Manufacturers need
to join with the health community to support research on still-prevalent fears about vaccination and to bolster evidence on
the critical benefits of immunization.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, email@example.com
1. IOM, "The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies," (Jan.
http://www.nap.edu/, accessed Feb. 12, 2013.