Vaccines have been extraordinarily effective in controlling dangerous childhood infections. The benefits of immunization are increasing many-fold as new technology is permitting vaccine invention to proceed at an unprecedented rate. Recombinant vaccines are already in the marketplace with many promising new products under development.
Several factors are influencing why there is a strong need for vaccine evaluation groups:
- The abundance of new vaccines with increasingly complex issues have made it essential for university investigators to participate in vaccine studies.
- Canadian vaccine consumers have high expectations of new vaccines requiring that evaluations be of higher quality than ever before. This requires input from all types of vaccine evaluators and scientists to improve study designs and enlarge the scale of testing. Social scientists are also required to help educate vaccine consumers to understand the complex schedule and the need for vaccines. The success of immunization programs in controlling the target infections means that parents today are unfamiliar with the diseases and their risks and tend to doubt the need to continue or worry excessively about vaccine safety. There is also an increasing tendency to blame diseases of unknown cause on prior immunization.
- Medical research has shown that vaccine evaluation must go beyond immunogenicity and reactogenicity studies to examine the long term effects of immunization particularly in the case of live viral vaccines. Such was the case with the Wyeth Lederle rotavirus vaccine that very quickly after routine use was found to cause a bowel problem in infants and was removed from the market.
- Assessing the quality of vaccines is vitally important. All new products must be meticulously evaluated for safety and effectiveness before they can be released for use by the general public. There are no short cuts: care, expertise and objectivity are essential. In the past, vaccine science progressed at a relatively slow rate of about one new vaccine per generation. With new technology, the 1990’s saw the introduction of acellular pertussis, varicella, Hib, Hepatitis A and rotavirus vaccines. As well, there was new combination of vaccines to decrease the need for multiple injections at a single visit. Not only was an acellular pertussis vaccine available but more than 10 different candidate vaccines had to be evaluated around the world. This was an evaluation process that was better done by the independent vaccine researchers than vaccine manufacturers. The VEC helped in evaluating several different Hib and pertussis vaccines and ensured that testing was relevant for Canadian children.
