Title : The need for separate regulations for prophylactic vaccines
Abstract:
Biological therapeutics, also referred to as Biologicals, are those diverse group of medicines that are grown and then purified from large-scale cell cultures of bacteria or yeast, or plant or animal cells. Biologicals include a wide range of products such as vaccines, allergenics, somatic cells, gene therapy, tissues, growth hormones, interleukins, immune modulators, growth factors, monoclonal antibodies, recombinant therapeutic proteins, blood and products derived from human blood and plasma. What distinguishes biologicals from other medicines is that these are generally large, complex molecules and can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues, whereas other medicines are considered as ‘small molecules’ and are either made synthetically or purified from plants.
Biologicals, including prophylactic vaccines, cell and gene therapy, and pharmaceuticals are all subject to the same regulations in terms of research and development, manufacture, pre-clinical and clinical studies, marketing authorisation, and post-licensing usage surveillance and monitoring. Designing a clinical trial for prophylactic vaccine is a challenge starting from validation process, selecting appropriate biomarkers, target population, defining inclusion criteria, laboratory investigations, out come measures in terms of antibody titres in a defined time period. These complexities make prophylactic vaccine stand apart from a pharmaceutical product.
The implementation of a strong regulatory system is critical for vaccines because they are inherently more difficult to develop, characterize, and manufacture than most drugs or biologicals. The regulatory documents for an intended prophylactic vaccine needs to be reviewed by a separate, trained and experienced agency, rather than by the central licencing agency that deals with pharmaceutical products, a process being followed in few advanced countries. Technical committees appointed by the regulatory agency has to include experienced immunologists in the panel. To keep in pace with the regulatory agency, Institutional Ethics Committees, scientific review boards must have expert immunologists, microbiologists and public health personnel in their team for comprehensive review. Hence, in view of their peculiarities and important differences, vaccines should be regulated differently and separately.
Audience Take Away:
- Peculiarities and important differences between drugs/ biologicals and vaccines
- Regulatory, scientific oversight and public oversight are not same, as they should be for vaccine
