Thedevelopment and approval of COVID 19 vaccines has been accomplished much faster than expected due to the combined efforts of the European and national drug regulatory authorities. Nevertheless, there were no compromises in the quality, nature and scope of the regulatory review: The European approval process ensures this - even with an accelerated process - on the basis of independent scientific assessments by the medicines authority. Before an approved vaccine can actually be used in humans, one crucial step remains: The approval of each batch produced by a regulatory drug control laboratory to ensure a vaccine's consistently high quality.
In principle, the manufacturer of a vaccine decides which OMCL (= official medicinal product control laboratory) is commissioned to test and release the batches. Austria was chosen because of its high competence. The Austrian OMCL at AGES is part of the European OMCL network (EU and EEA). Testing by the laboratories is mutually recognized, and batch release by Austria is therefore valid for the entire EU/EEA area. A vaccine batch is tested for safety and efficacy based on the following criteria:
- Identity: is it actually the vaccine according to the submitted data
- Content: are the specifications of the vaccine met (mg active ingredient /ml)
- Appearance: Color, particles, damage, etc.
- Purity: test for potential impurities.
The certificate of release from BASG is issued after submission of all necessary documents by the manufacturer after approval by the European Commission and is recognized and valid in the whole EU/EEA area.