How FDA Works to Ensure Vaccine Safety
Abstract
The gasping for breath and desperate hacking of whooping cough. The iron lungs and braces of polio. Birth defects from rubella. For many people today, those signs of terrible diseases are the stuff of history books, thanks to vaccines. But the rare case of vaccine- associated polio or the death of an infant soon after receiving a dose of pertussis vaccine may make people wonder--are vaccines safe enough, or could they be safer? For the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER), vaccine safety, along with effectiveness, is central to regulation of these preparations. Clinical Trials The first step to licensing a new vaccine is safety testing in animals. If the laboratory animals immunized with the vaccine don't have serious reactions, FDA consults with the vaccine manufacturer or sponsor on further refining of the manufacturing process. Because the weakened viruses used for vaccines are grown in animal or human cells, "we spend a tremendous amount of time studying the safety of those cells," says M. Carolyn Hardegree, M.D., director of CBER'S office of vaccine research and review.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 1995
- Accession Number
- ADA395574
Entities
People
- Isadora B. Stehlin
Organizations
- Food and Drug Administration