Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies.

Vaccine safety is increasingly a focus for the general public, health care providers, and vaccine manufacturers, because the efficacy of licensed vaccines is accepted as a given. Commitment to ensuring safety of all vaccines, including childhood vaccines, is addressed by the federal government, academia, and industry. Safety activities conducted by the vaccine research, development, and manufacturing companies occur at all stages of product development, from selection and formulation of candidate vaccines through postlicensure studies and surveillance of adverse-event reports. The contributions of multiple interacting functional groups are required to execute these tasks through the life cycle of a product. We describe here the safeguards used by vaccine manufacturers, including specific examples drawn from recent experience, and highlight some of the current challenges. Vaccine-risk communication becomes a critical area for partnership of vaccine companies with government, professional associations, and nonprofit advocacy groups to provide information on both benefits and risks of vaccines. The crucial role of the vaccine companies in ensuring the optimal vaccine-safety profile, often overlooked, will continue to grow with this dynamic arena.

Confidence in vaccination: a parent model.

Although vaccination has been heralded as one of the 10 greatest public health achievements, how parents differ in their views about vaccination is not well understood. A deeper understanding of these attitudes and beliefs may improve the effectiveness of vaccine communications. In this mailed survey of U.S. parents in January 2001 (return response rate 49%), parental confidence in vaccination was very high, although there was significant variation among parents. Using multivariate analyses to group and profile parents, 90% of parents (n=1820) were classified into one of four distinct parent groups: (1) "Vaccine Believer" parents who were convinced of the benefit of vaccination; (2) "Cautious" parents noteworthy for a high emotional investment in their child; (3) "Relaxed" parents characterized by a less involved parenting style and some skepticism about vaccines; and (4) "Unconvinced" parents distinguished by their distrust of vaccinations and vaccination policy. These findings suggest that messages that are customized to parents' attitudes and beliefs may improve their understanding and acceptance of vaccination.