Regulatory responses
The desire to develop more vaccines to meet global health needs has highlighted vaccine regulation in the US and abroad.
Although FDA streamlined its testing and data requirements for H1N1-vaccine candidates, manufacturers would like to see a
more coordinated international approval process. The WHO vaccine prequalification process takes approximately 18 months, in
addition to all the work involved in licensing a product with FDA or European authorities.
FDA is working closely with WHO to improve this process. One idea is to couple US or European Union licensure of a new vaccine
with WHO prequalification to spur world access to the new product, explained acting director of FDA's Center for Biologics
Evaluation and Research Karen Midthun at a November conference on global vaccine development sponsored by the Drug Information
Association. FDA is providing advice on clinical-trial issues for global vaccine development, helping to assess new technology
for vaccine manufacture, and working with WHO to help build regulatory capacity in developing countries.
"We are poised for a transformation in how we produce and use influenza vaccine," Goodman said, noting that these efforts
align with FDA's goal to strengthen the agency's scientific infrastructure, particularly for novel technologies and products
that can improve public health. FDA is, for example, looking to use molecular biology to improve the way the agency assesses
new influenza-virus strains and to test for potency, purity, and sterility in lot release.
A December 2009 report from the Institute of Medicine (IOM) urges a more coordinated US approach to vaccine development and
safety monitoring under a strengthened National Vaccine Program Office. The program would target support for vaccine R&D to
untreated diseases, focus more attention on vaccine safety issues, expand healthcare plan coverage for all recommended vaccines
and better address fears and misinformation about vaccine effectiveness and safety.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
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