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Berlin – Yesterday, the Federal Ministry of Health (BMG) formally declared a shortage of supplies of the monoclonal antibody Nirsevimab (Beyfortus) in German packaging. The office of Federal Health Minister Karl Lauterbach (SPD) has thus laid the foundation for goods to be imported from outside of Europe.

The ministry had already announced the move last week and made a similar statement. Due to the high demand across Europe, Sanofi will only be able to provide a larger number of doses of Nirsevimab (Beyfortus) in a few weeks, a spokeswoman for the ministry told the German Medical Journal.

However, since Sanofi could make US goods of equivalent quality available to the German market at short notice, Federal Health Minister Karl Lauterbach (SPD) decided to announce a supply shortage and thus allow the countries to import the US goods for a limited period.

The background to this is that the German Standing Committee on Vaccination (STIKO) recently recommended passive immunization with Sanofi’s Nirsevimab for newborns and infants in their first season of exposure to respiratory syncytial virus (RSV) infections in Germany.

Sanofi could not confirm today whether the goods will ultimately come from the USA. The company told German Medical Journal However, Sanofi stated that it would provide “sufficient doses of Beyfortus during the RSV season to ensure that all infants are protected against RSV.” Sanofi did not want to disclose exact figures or calculation methods.

“It is our aim, in this extraordinary first RSV season, to work with all partners in the healthcare system and take a wide range of measures in accordance with STIKO recommendations to ensure that all infants in Germany can be protected against RSV,” said a Sanofi spokeswoman.

In order to meet the expected increased demand for Beyfortus in the wake of the STIKO recommendation, the company is already making the active ingredient available in French and Spanish packaging in addition to Beyfortus cans in German packaging. The Paul Ehrlich Institute had approved the manufacturer’s application for permission to sell medicines labelled in foreign languages ​​in Germany.

According to Sanofi, the prices for the immunization remain unaffected by the import. The contents are the same, only the packaging is different, it was said today.

On September 14, the Federal Ministry of Health issued a regulation on the right to specific prophylactic measures against respiratory syncytial viruses (RSV prophylaxis regulation). This means that all insured persons up to the age of one are entitled to a one-time supply of drugs containing Nirsevimab for general RSV prophylaxis.

The aim of the regulation is to reduce the frequency of severe RSV diseases in newborns and infants and to prevent RSV-related hospitalizations, intensive care treatments and RSV-related deaths as well as inpatient and outpatient care bottlenecks. © may/aerzteblatt.de