When it comes to the development, licensure and manufacture of vaccines, the Food and Drug Administration (FDA) is engaged at every step to help ensure that a concept that works in animals eventually becomes a licensed product to help people. There is often a significant gap between advances in basic science and the availability of an approved manufactured vaccine. There are several reasons why that gap exists, including the difficulty in moving from research concept to a vaccine that is effective in people and can be reliably manufactured. Applied regulatory science, in collaboration with NIAID-funded researchers and academia, helps to bridge that gap and get vaccines into the marketplace.
For more information on how FDA is working to accelerate the testing of potentially viable vaccines, ensure quality, and evaluate safety, see Vaccines.
Last Updated January 14, 2011
Last Reviewed November 18, 2010