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On August 27, Jiemian News learned exclusively from Sanofi that due to potency issues, Sanofi decided to temporarily suspend the supply and sales of influenza vaccines in China.

According to Sanofi, during the ongoing stability study,It was observed that the potency of the influenza vaccines Valeline and Valeja (the relevant reference data for the expected biological effect of the vaccine) in the 2024-2025 influenza season showed a downward trendIt is expected that the effectiveness of the vaccine may be affected before the end of the product's shelf life.As a precautionary measure, Sanofi has decided to temporarily suspend the supply and sale of these vaccines in China.At the same time, Sanofi stated that it has actively communicated with relevant regulatory authorities and will continue to communicate.

Sanofi said that all vaccines in circulation and use meet the necessary quality standards for release, and no signs or evidence of product safety and effectiveness have been found. The decision to temporarily suspend the supply and sale of these vaccines in China is only a precautionary measure.

“Sanofi’s vaccine quality control process complies with the Good Manufacturing Practice (GMP) and the standards set by the Chinese Pharmacopoeia and Manufacturing Inspection Procedures. These standards cover various aspects such as identity, potency, impurity levels, safety, sterility, etc.To date, all influenza vaccines, including Valeant and Valjar, meet these criteria, and the decision to proactively stop sales and supply is a precautionary measure.To ensure that our vaccines continue to meet nationally approved quality standards throughout their shelf life, Sanofi conducts ongoing stability studies, which include potency testing at different time points. This process ensures that the vaccine maintains the appropriate and effective dose and continues to provide optimal protection.”

Sanofi is currently one of the world's largest suppliers of influenza vaccines., one in every 2.5 influenza vaccines in the world comes from Sanofi. In 2022 and 2023, the global sales of Sanofi influenza vaccines will be 2.977 billion euros and 2.669 billion euros respectively.

According to Sanofi's official website, it currently has two influenza vaccines on the market in China. In 1996, Sanofi introduced its first influenza vaccine product to China - the trivalent influenza virus split vaccine Vaxigrip®. On February 21, 2023, Sanofi's quadrivalent influenza virus split vaccine VaxigripTetra® was approved by the National Medical Products Administration for influenza vaccination for infants aged 6 to 35 months; in May of the same year, the vaccine was expanded to the entire population (6 months and above). In July 2023, Sanofi's quadrivalent influenza vaccine was officially supplied to the Chinese market.

The so-called vaccine potency refers to the ability of the vaccine to produce specific immunity in the human body, that is, the effectiveness of the vaccine. Potency is a reference indicator of vaccine effectiveness and a key quality control factor that determines whether a vaccine can enter the market. However, the potency and safety of vaccines are two different concepts, and a decrease in vaccine potency will not affect the safety of the vaccine.

It is also worth noting that according to Sanofi's response,At present, it has only been found that the vaccine potency shows a downward trend, and it is expected that the vaccine efficacy may be affected before the end of the product's shelf life.That is to say,At present, there is no situation where the vaccine potency does not meet the standards.

According to the China Food and Drug Administration Journal, in addition to the fact that vaccine production does not meet the standards, the factors that affect vaccine potency are mainly concentrated in the vaccine storage process, such as improper storage temperature. It is also mentioned that safety and potency are two characteristics of vaccines, and potency itself does not affect safety.