Ten-year study proves: Official batch testing of vaccines remains indispensible
Official batch testing of vaccines before marketing is compulsory by law in Germany. However, is it still required in view of modern vaccine production? Experts at the Paul-Ehrlich-Institute have performed a study on this matter with focus on batch testing in influenza (flu) vaccines in Europe over a period of ten years. In thirteen out of altogether 5800 batches tested, quality defects were found only when the batches were tested within official batch control. Thus, despite the very high quality standards in batch testing at the manufacturer, official batch testing continues to be essential from the experts’ point of view. Vaccine reports on the study in its online version of 23 March 2018.
Vaccines represent an essential contribution to maintaining public health. Legal and regulatory requirements for quality, safety and efficacy of vaccines, as well as their manufacture and monitoring are thus correspondingly high. Vaccine batches in Europe are tested by so-called Official Medicinal Control Laboratories (OMCLs), which, that way, contribute to the safety of the vaccines. The Paul-Ehrlich-Institut (PEI) is part of this OMCL network and tests around 470 batches annually, i.e. around 132 million single doses in the field of vaccines. The term batch refers to a production unit which, in the case of vaccines, can comprise up to 800,000 single doses.
Quality, efficacy, and safety of vaccines for Germany is one of the core duties of the PEI as the Federal Institute for Vaccines and Biomedicines. At the same time, PEI experts, jointly with their European colleagues, are committed to constantly reviewing regulatory processes and adapting them to technological developments. This serves to ensure that as many processes and controls as necessary and as few as possible are required.
Dr Evelyne Kretzschmar, Section 'Viral Vaccines' of Division 'Virology' of the PEI, and her colleagues examined whether, in view of the strictly regulated and controlled vaccine manufacture with a great number of quality checks by the manufacturers, an Official Medicinal Control Laboratory would still be necessary. They performed this study using influenza (flu) vaccines as an example. For this purpose, they evaluated the data from batch tests in Europe performed by the OMCL network between 2006 and 2016. Altogether 5,800 batches were examined. Out of these, defects were found in 32 batches (by so-called notifications). Most of these notifications referred to the manufacturing process. In most of the cases, the defects were already detected by checks performed by the manufacturer, and the batches were withdrawn before they were released for marketing. In 13 batches, however, the non-conforming quality was identified only during the tests at the OMCL. From the point of view of the PEI, this shows the necessity of official batch testing of vaccines which, as a rule, are administrated to very young individuals.
Kretzschmar E, Muckenfuss H, Pfleiderer M (2018): Official batch control of influenza vaccines: Is it still useful?
Vaccine 36: 2364-2370