Licensing and control authority batch release of influenza vaccine in Germany in accordance with EEC regulations.

The epidemiological situation calls for almost yearly changes in the antigenic composition of influenza vaccine, thus necessitating fresh licensing procedures. Since the time for bringing a new vaccine onto the market should be relatively short, the following work of all parties involved must be done expeditiously: 1) WHO recommendations on new virus strains and their subsequent adaptation by the EEC (February/March); 2) Distribution of the new virus strains to the International Reference Centers for Influenza in the UK and USA (February/March); the centers later issue reference materials for the determination of the haemagglutinin antigen concentration (April/May); 3) Production and testing of seed virus by manufacturers, as well as validation of the producer's inactivation process for the new virus strains (May/June); 4) Licensing of the vaccines by the National Control Authority (Paul-Ehrlich-Institute) (June/July); in the case of previously licensed products, the procedure is limited essentially to the approval of the detailed protocol of production and tests on the new virus strains, clinical studies not being required before licensing because of a lack of time; 5) Paul-Ehrlich-Institute's test for batch release, according to Directive 89/342/EEC, besides protocol approval, conducts material testing of the endotoxin and antigen content of each vaccine lot; the assay for the antigen quantification is especially laborious and sometimes must be repeated because of test invalidity.

[Neutralizing virus antibodies in human immunoglobulins for intravenous use]. / Neutralisierende Virusantikörper in humanen Immunglobulinen zur intravenösen Anwendung.

Neutralizing antibodies against measles, poliomyelitis, rubella, herpes simplex, influenza and vaccinia viruses were measured in batches of a representative selection of human immunoglobulins for intravenous use licensed in the Federal Republic of Germany. Rubella antibodies were also examined by haemagglutination-inhibition tests. Where available, reference preparations were used, and antibody levels expressed in I. U. All preparations contained significant amounts of the examined antibodies, with relatively low variation from one batch to the other. In most cases activity data specified by the manufacturers could be confirmed. However, differences between the various preparations were sometimes important, some of them relating mainly to individual antibodies, others more or less to the whole range. Some striking findings are emphasized with consideration of manufacturing and control problems.

Anti-ovalbumin sensitizing ability of influenza vaccines in guinea pigs.

The anti-ovalbumin sensitizing ability of four highly purified commercial influenza vaccines was tested in guinea pigs by means of passive cutaneous anaphylaxis. Aluminimum-adsorbed and fluid vaccines as well as pretreatments by one or two subcutaneous inoculations were compared. The two adsorbed vaccines induced significant sensitization after just one inoculation while the two fluid vaccines revealed their sensitizing ability almost exclusively after repeated administration.