Global Vaccine Production Examined by Kalorama Information08 Feb 2012 • by Natalie Aster
Generally speaking, vaccine clinical development in the world’s major markets follows a similar pathway as drugs and other biologics. A sponsor who wishes to begin clinical trials with a vaccine must first obtain permission to conduct clinical studies. In the U.S., this requires the submission of an Investigational New Drug (IND) application to the FDA. The IND describes the vaccine, its method of manufacture, and quality control tests for release. Also included is information about the vaccine’s safety and ability to elicit a protective immune response (immunogenicity) in animal testing as well as the proposed clinical protocol for studies in humans.
Vaccines are administered to large populations of adults and children with a low individual risk of contracting disease. This mandates extremely high standards for safety and tolerability. Clinical trials may involve 10,000 test subjects for a new vaccine during Phase III trials.
According to the report “Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)” by Kalorama Information, pre-marketing (pre-licensure) vaccine clinical trials are typically done in three phases, as is the case for any drug or biologic. Pre-clinical testing involves study of the candidate in animals to determine basic safety characteristics. Initial human studies, referred to as Phase I, are safety and immunogenicity studies performed in a small number of closely monitored subjects. Phase II studies are dose-ranging studies and may enroll hundreds of subjects. Finally, Phase III trials typically enroll thousands of individuals and provide the critical documentation of effectiveness and important additional safety data required for licensing. At any stage of the clinical or animal studies, if data raise significant concerns about either safety or effectiveness, the developer may discontinue testing of a product. This is a common occurrence, with a very small proportion of product candidates progressing from one stage of testing to the next.
Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)
Published: February, 2012
Price: US$ 2.500,00
Senior procurement staff and ministry officials normally participate in the assessment of potential nonmanufacturing vaccine suppliers. The business and management aspects of this second level prequalification are not appropriate areas of concern for NRA’s; however, they must be consulted on all technical matters Once a producer has been selected, this status remains so unless a particular reason arises for a review. However, it is also appropriate that reviews of producers and vaccines be undertaken every few years (3 to 5) to ensure that pre-qualification standards are maintained or earlier should an event trigger an earlier review.
Systems should be in place to monitor both the field performance of the vaccine and contractual performance of the supplier. In the case of an adverse event following immunization (AEFI), all documents relevant to the vaccine in question need to be reviewed, including history of temperature monitoring records.
These are produced by identifying and isolating components of the pathogen that elicit the immune response. The infectious agent is represented by a few characteristic molecules there is an immune response without risk of infection. Vaccination with a component of a pathogenic agent may result in a weakened antigenic response and the need for periodic booster shots.
More information can be found in the report “Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)” by Kalorama Information.
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