News - Influenza Season 2022/23 – First Influenza Vaccine Batches Released (2024)

The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, is once again prepared for increased demand for influenza vaccinations this year, as it is known that double infection with influenza virus and the SARS coronavirus-2 can entail special risks. It has also been shown that it is possible to vaccinate against COVID-19 and influenza at the same time to build up immune protection against both viruses without reducing tolerability.

As of mid-August 2022 (end of calendar week 33), the Paul-Ehrlich-Institut had released nearly 17 million doses of influenza vaccine. This is almost twice as many doses as this time last year. The batch tests are carried out based on the master adjustments approved by the Paul-Ehrlich-Institut or by the EU Commission for the 2022/23 season. The Paul-Ehrlich-Institut publishes a weekly online account of the number of influenza vaccine doses that it has released for the German market after batch testing.

Master Adjustment Completed for 2022/23

Different influenza virus variants and potentially influenza virus subtypes circulate in the population during each influenza season. This means that influenza vaccines need to be adapted each year to the virus variants expected to circulate in order to ensure protection against influenza. The World Health Organization (WHO), supported in the EU by the CHMP at the EMA, makes annual recommendations on influenza vaccine adaptations. The WHO recommendations form the basis for the master adaptation of influenza vaccines for each season.

The Paul-Ehrlich-Institut has approved the master adaptations for all influenza vaccines that hold a national marketing authorisation and submitted an application for the 2022/23 season. The EU Commission has granted approval for the master adaptations of vaccines centrally authorised in the EU.

This year, a total of nine tetravalent influenza vaccine products containing four different antigen components are available for use in Germany.

Authorisation of Influenza Vaccine Products and Approval of the Master Adaptation

Seasonal influenza vaccine products for the annual influenza vaccination first receive an initial marketing authorisation with an exact specification of the amount and origin of the antigens contained in different influenza virus strains. For several years now, these vaccines have contained antigens of the globally circulating subtypes of influenza virus A-H1N1 and influenza virus A-H3N2, as well as of the influenza virus B lineages Victoria and/or Yamagata. The annual master adaptation specifies precisely which virus variants of the recommended subtypes and lineages collected in the laboratory during an influenza season (virus isolates) are to be used for the production of the influenza vaccines. It is important that the virus components (antigens) contained in the vaccine fit as well as possible to the virus strains and virus variants whose circulation is expected in the coming influenza season. This ensures the best possible immune protection.

For influenza vaccines that are to be placed on the market in Germany and the EU during a flu season, the marketing authorisation holder receives the approval for the seasonal master adaptation from the European Commission (for centrally authorised vaccine products) or the Paul-Ehrlich-Institut (for nationally authorised vaccine products). The master adaptation for the coming influenza season contains the antigenic components of the virus subtypes recommended by the World Health Organization (WHO) and the Committee for Human Medicinal Products (CHMP) at the European Medicines Agency (EMA) for the northern hemisphere. The list of seasonal influenza vaccines authorised in Germany posted on the Paul-Ehrlich-Institut (PEI) website indicates whether the master adaptation has been approved by including the adaptation year in the name of the vaccine product. This means 2022/2023 will be indicated in the name of the seasonal influenza vaccine products with approved master adaptations for the upcoming influenza season, which runs from the end of 2022 to the beginning of 2023. Influenza vaccine products included in the Paul-Ehrlich-Institut's list that do not have years indicated in their names are not authorised for the upcoming influenza season and cannot be placed on the market because there has been no master adaptation.

Variations in Age Indication

The initial marketing authorisation of influenza vaccine products is for adults, usually aged 18 years or over. After completion of clinical trials with other age groups, these vaccines may also receive marketing authorisation for those groups as a type 2 variation of the original marketing authorisation. However, certain vaccines are also developed specifically for certain age groups. Examples are the high-dose vaccine and the vaccine with adjuvant, both developed for the elderly, as well as the live attenuated vaccine for children and adolescents, which was developed as a nasal spray.

Tetravalent Seasonal Influenza Vaccines (with master adaptation for the influenza season late 2022/early 2023)

• Afluria Tetra 2022/2023 (18 years and older)
• Efluelda 2022/2023 (high-dose vaccine, adults 60 years and older)
• Fluad Tetra 2022/2023 (vaccine with adjuvant, adults 65 years and older)
• Flucelvax Tetra 2022/2023 (cell culture vaccine, two years and older)
• Fluenz Tetra 2022/2023 (nasal vaccine, live attenuated, from two years up to and including 17 years)
• Influsplit Tetra 2022/2023 (six months and older)
• Influvac Tetra 2022/2023 (six months and older)
• Vaxigrip Tetra 2022/2023 (six months and older)
• Xanaflu Tetra 2022/2023 (six months and older)

High Quality through Batch Testing

Federal batch testing of influenza vaccines before marketing is required by law in Germany. Randomly selected doses (test samples) of each batch (production unit) of each influenza vaccine product are tested by the Paul-Ehrlich-Institut before being placed on the market in Germany. If the specification has been complied with, the batch is released. Only then can it be placed on the market. Experts at the Institute check for compliance with the specification by reviewing the manufacturing documents and the results of the quality control examinations. In addition, the Paul-Ehrlich-Institut or an Official Medicines Control Laboratory (OMCL) in another European country evaluates the test samples of the batches produced in order to ensure a high quality of each batch of influenza vaccines. The Paul-Ehrlich-Institut will only grant batch release if the quality criteria laid down in the marketing authorisation of the vaccine have been met. Vaccinated individuals can rely on the fact that the vaccines administered in Germany are safe and effective in accordance with the marketing authorisation.