Marketing authorisation of vaccines
Most vaccines are prophylactic and administered to healthy subjects, who depending on their degree of exposure may carry only a small risk of infection. Consequently, there has to be a stringent emphasis on safety.
Modern vaccines undergo strictly controlled manufacturing processes and analytical testing, and are therefore well-tolerated and vaccine-related side-effects are very rare. Vaccines are classified as biologicals and their production differs from the production of conventional drugs in two key ways:
It is in the nature of the starting material (viruses, bacteria, cells) to have a degree of biological variability. The biological testing methods used in the assessment of interim- and final products are often pushed to the limit to detect minimal, yet crucial divergences. Vaccine manufacturers must therefore follow a clearly defined manufacturing process, which has to comply with international guidelines and the European Pharmacopoeia to ensure reproducibility (and consistency).
Furthermore, interim- and final products are continually tested using standardized, validated test methods, to ensure they comply with the specifications stipulated during marketing authorisation.
Application for marketing authorisation of vaccines
Vaccines may obtain a marketing authorisation either by centralised procedure or by MRP/DCP-procedure. Both types of licensing procedures follow strict rules and regulations and follow a set time framework.
Compared to older simpler licensing procedures, current marketing authorisation procedures provide a highly complex and integrated safety network across all areas of vaccine development and post-marketing use: clinical trials, scientific advice, marketing authorisation, official surveillance, batch testing and pharmacovigilance.
National batch release
Before a batch of vaccines is allowed to be marketed in Austria, it has to undergo tests by the Official Medicines Control Laboratory (OMCL) of e EU/EWR member state. The results of the tests must comply with the specifications stipulated during marketing authorisation.
The protocols for batch manufacturing and testing are checked for each batch. Additionally, test samples are submitted for analysis. It is common practice that vaccines are tested and cleared by the OMCL of the country where the vaccine was produced. Few vaccines are produced in Austria, and as a result the OMCL of the Austrian Federal Office for Safety in Health Care has specialized in testing FSME- (TBEV) and Flu-vaccines (including pandemic vaccines).
Created: 06.05.2009 | Page last modified: 27.07.2017