On August 27, The Paper exclusively learned from Sanofi that due to potency issues, Sanofi has decided to temporarily halt the supply and sales of its flu vaccine in China.
According to Sanofi, during the ongoing stability study, a declining trend in the potency (relevant reference data for the expected biological effect of vaccines) of the flu vaccines Vaxigrip and VaxigripTetra for the 2024-2025 flu season was observed. It is expected that the vaccine efficacy may be affected before the expiration date. As a preventive measure, Sanofi has decided to temporarily halt the supply and sales of these vaccines in China. Meanwhile, Sanofi stated that it has proactively communicated with relevant regulatory authorities and will continue to do so.
Sanofi stated that all distributed and used vaccines meet the necessary quality standards for release, and no signs or evidence have been found indicating that the safety and efficacy of the products have been affected. The decision to temporarily suspend the supply and sale of these vaccines in China is solely a precautionary measure.
"Sanofi's vaccine quality control process complies with the standards set by Good Manufacturing Practice (GMP), the Chinese Pharmacopoeia, and the manufacturing and inspection regulations. These standards cover various aspects such as identification, potency, impurity levels, safety, and sterility. To date, all influenza vaccines, including Vaxigrip and VaxigripTetra, meet these standards, and the decision to voluntarily halt sales and supply is a precautionary measure. To ensure that our vaccines consistently meet the 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 vaccines maintain appropriate and effective dosages and continue to provide optimal protection."
Sanofi is one of the largest influenza vaccine suppliers globally, with one out of every 2.5 influenza vaccines worldwide coming from Sanofi. In 2022 and 2023, the global sales of Sanofi's influenza vaccine were €2.977 billion and €2.669 billion, respectively.
According to the Sanofi official website, it currently has two influenza vaccines available in China. In 1996, Sanofi introduced its first influenza vaccine product to China – the trivalent inactivated influenza vaccine, Vaxigrip®. On February 21, 2023, Sanofi's quadrivalent inactivated influenza vaccine, VaxigripTetra®, was approved by the National Medical Products Administration for use in preventing influenza in infants and young children aged 6 to 35 months; in May of the same year, the vaccine's target population was expanded to include all age groups (6 months and above). In July 2023, Sanofi's quadrivalent influenza vaccine officially began supplying the Chinese market.
And the so-called vaccine potency refers to the ability of a vaccine to induce specific immunity in the human body, which is also the effectiveness of the vaccine. Potency is a reference index for the effectiveness of a vaccine and a key quality control factor that determines whether a vaccine can enter the market. However, the potency and safety of a vaccine are two different concepts, and a decrease in vaccine potency will not affect its safety.
Notably, according to Sanofi's response, a declining trend in vaccine potency has been observed so far. It is expected that the vaccine's efficacy might be affected before the product’s expiration date. However, currently, there has been no instance of the vaccine potency falling below standard.
According to the *China Food and Drug Administration Journal*, factors affecting vaccine potency include not only substandard vaccine production but also commonly involve issues in the vaccine storage process, such as improper storage temperature. It was also mentioned that safety and potency are two distinct characteristics of vaccines, and potency itself does not affect safety.
Interface News reporter |Tang Zhuoya
Interface News Editor |Xie Xin
On August 27, The Paper exclusively learned from Sanofi that due to potency issues, Sanofi has decided to temporarily halt the supply and sales of its flu vaccine in China.
According to Sanofi, during the ongoing stability study, Sanofi observed a declining trend in the potency (relevant reference data for the expected biological effect of the vaccine) of the flu vaccines Vaxigrip and VaxigripTetra for the 2024-2025 flu season. It is expected that the vaccine efficacy may be affected before the end of the product's shelf life. As a preventive measure, Sanofi has decided to temporarily halt the supply and sales of these vaccines in China. Meanwhile, Sanofi stated that it has actively communicated with relevant regulatory authorities and will continue to do so.
Sanofi stated that all distributed and administered vaccines meet the necessary quality standards for release, with no signs or evidence indicating any impact on the safety or efficacy of the products. The decision to temporarily suspend the supply and sale of these vaccines in China is purely a precautionary measure.
"Sanofi's vaccine quality control process complies with the standards set by Good Manufacturing Practice (GMP), the Chinese Pharmacopoeia, and the manufacturing and inspection regulations. These standards cover various aspects such as identification, potency, impurity levels, safety, and sterility. To date, all influenza vaccines, including Vaxigrip and VaxigripTetra, meet these standards, and the decision to voluntarily halt sales and supply is a precautionary measure. To ensure that our vaccines consistently meet the 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 vaccines maintain appropriate and effective dosages and continue to provide optimal protection."
Sanofi is one of the largest influenza vaccine suppliers globally, with one out of every 2.5 influenza vaccines worldwide coming from Sanofi. In 2022 and 2023, the global sales of Sanofi's influenza vaccine were €2.977 billion and €2.669 billion, respectively.
According to the Sanofi official website, it currently has two influenza vaccines available in China. In 1996, Sanofi introduced its first influenza vaccine product to China — the trivalent inactivated influenza vaccine, Vaxigrip®. On February 21, 2023, Sanofi's quadrivalent inactivated influenza vaccine, VaxigripTetra®, was approved by the National Medical Products Administration for use in preventing influenza in infants and young children aged 6 to 35 months; in May of the same year, the vaccine’s approved population was expanded to include all age groups (6 months and above). In July 2023, Sanofi's quadrivalent influenza vaccine officially began supplying the Chinese market.
And the so-called vaccine potency refers to the ability of a vaccine to induce specific immunity in the human body, which is also the effectiveness of the vaccine. Potency is a reference index for the effectiveness of a vaccine and a key quality control factor that determines whether a vaccine can enter the market. However, the potency and safety of a vaccine are two different concepts, and a decrease in vaccine potency will not affect its safety.
It is also worth noting that, according to Sanofi's response, a declining trend in vaccine potency has been observed so far, and it is expected that the vaccine's efficacy might be affected before the product’s expiration date. In other words, as of now, there has been no instance of the vaccine potency falling below standard.
According to the *China Food and Drug Administration Journal*, factors affecting vaccine potency include not only the failure to meet standards during vaccine production but also commonly involve issues in the vaccine storage process, such as improper storage temperature. It was also mentioned that safety and potency are two distinct characteristics of vaccines, and potency itself does not impact safety.
Source: Visual China
Interface News reporter |Tang Zhuoya
Interface News Editor |Xie Xin
On August 27, The Paper exclusively learned from Sanofi that due to potency issues, Sanofi has decided to temporarily halt the supply and sales of its flu vaccine in China.
According to Sanofi, during the ongoing stability examination, Sanofi observed a declining trend in the potency (relevant reference data for the expected biological effect of the vaccine) of the flu vaccines Vaxigrip and VaxigripTetra for the 2024-2025 flu season. It is expected that the vaccine efficacy might be affected before the end of the product's shelf life. As a preventive measure, Sanofi has decided to temporarily halt the supply and sales of these vaccines in China. Meanwhile, Sanofi stated that it has actively communicated with relevant regulatory authorities and will continue to do so.
Sanofi stated that all distributed and used vaccines meet the necessary quality standards for release, and no signs or evidence have been found indicating that the safety and efficacy of the products have been affected. The decision to temporarily halt the supply and sale of these vaccines in China is solely a precautionary measure.
"Sanofi's vaccine quality control process complies with the standards set by Good Manufacturing Practice (GMP), the Chinese Pharmacopoeia, and the manufacturing and inspection regulations. These standards cover various aspects such as identification, potency, impurity levels, safety, and sterility. To date, all influenza vaccines, including Vaxigrip and VaxigripTetra, meet these standards, and the decision to voluntarily halt sales and supply is a precautionary measure. To ensure that our vaccines consistently meet the 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 vaccines maintain appropriate and effective dosages and continue to provide optimal protection."
Sanofi is one of the largest influenza vaccine suppliers globally, with one out of every 2.5 influenza vaccines worldwide coming from Sanofi. In 2022 and 2023, the global sales of Sanofi's influenza vaccine were €2.977 billion and €2.669 billion, respectively.
According to the Sanofi official website, it currently has two influenza vaccines available in China. In 1996, Sanofi introduced its first influenza vaccine product to China – the trivalent inactivated influenza vaccine, Vaxigrip®. On February 21, 2023, Sanofi's quadrivalent inactivated influenza vaccine, VaxigripTetra®, was approved by the National Medical Products Administration for use in preventing influenza in infants and young children aged 6 to 35 months; in May of the same year, the vaccine's target population was expanded to include all age groups (6 months and above). In July 2023, Sanofi’s quadrivalent influenza vaccine officially began supplying the Chinese market.
And the so-called vaccine potency refers to the ability of a vaccine to induce specific immunity in the human body, which is also the effectiveness of the vaccine. Potency is a reference index for vaccine efficacy and a key quality control factor that determines whether a vaccine can enter the market. However, vaccine potency and safety are two different concepts; a decrease in vaccine potency does not affect the safety of the vaccine.
It is also worth noting that, according to Sanofi's response, a declining trend in vaccine potency has been observed so far, and it is expected that the vaccine's efficacy might be affected before the product’s expiration date. In other words, as of now, there has been no case of the vaccine’s potency falling below standard.
According to the *China Food and Drug Administration Journal*, factors affecting vaccine potency include not only vaccines that fail to meet standards during production, but also commonly involve issues in the storage process, such as improper storage temperatures. It was also mentioned that safety and potency are two distinct characteristics of vaccines, and potency itself does not impact safety.
Interface News reporter |Tang Zhuoya
Interface News Editor |Xie Xin
On August 27, The Paper exclusively learned from Sanofi that due to potency issues, Sanofi has decided to temporarily halt the supply and sales of its flu vaccine in China.
According to Sanofi, during the ongoing stability study, a declining trend in the potency (relevant reference data for the expected biological effect of vaccines) of the flu vaccines Vaxigrip and VaxigripTetra for the 2024-2025 flu season was observed. It is expected that the vaccine efficacy may be affected before the end of the product’s shelf life. As a preventive measure, Sanofi has decided to temporarily halt the supply and sales of these vaccines in China. Meanwhile, Sanofi stated that it has proactively communicated with relevant regulatory authorities and will continue to do so.
Sanofi stated that all distributed and used vaccines meet the necessary quality standards for release, and no signs or evidence have been found indicating that the safety and efficacy of the products have been affected. The decision to temporarily suspend the supply and sale of these vaccines in China is solely a precautionary measure.
"Sanofi's vaccine quality control process complies with the standards set by Good Manufacturing Practice (GMP), the Chinese Pharmacopoeia, and the Manufacturing and Inspection Regulations. These standards cover various aspects such as identification, potency, impurity levels, safety, and sterility. To date, all influenza vaccines, including Vaxigrip and VaxigripTetra, meet these standards, and the decision to voluntarily halt sales and supply is a precautionary measure. To ensure that our vaccines consistently meet the 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 vaccines maintain appropriate and effective dosages and continue to provide optimal protection."
Sanofi is one of the largest influenza vaccine suppliers globally, with one out of every 2.5 influenza vaccines worldwide coming from Sanofi. In 2022 and 2023, the global sales of Sanofi's influenza vaccine were €2.977 billion and €2.669 billion, respectively.
According to the Sanofi official website, it currently has two influenza vaccines available in China. In 1996, Sanofi introduced its first influenza vaccine product to China – the trivalent inactivated influenza vaccine, Vaxigrip®. On February 21, 2023, Sanofi’s quadrivalent inactivated influenza vaccine, VaxigripTetra®, was approved by the National Medical Products Administration for use in preventing influenza in infants and young children aged 6 to 35 months; in May of the same year, the vaccine's approved population was expanded to include all age groups (6 months and above). In July 2023, Sanofi's quadrivalent influenza vaccine officially began supplying the Chinese market.
And the so-called vaccine potency refers to the ability of a vaccine to induce specific immunity in the human body, which is also the effectiveness of the vaccine. Potency is a reference index for the effectiveness of a vaccine and a key quality control factor that determines whether a vaccine can enter the market. However, the potency and safety of a vaccine are two different concepts; a decrease in vaccine potency will not affect the safety of the vaccine.
It is also worth noting that, according to Sanofi's response, a declining trend in vaccine potency has been observed so far, and it is expected that the vaccine's efficacy may be affected before the end of its shelf life. This means that, as of now, there has been no instance of the vaccine's potency falling below standard.
According to the *China Food and Drug Administration Journal*, factors affecting vaccine potency include not only vaccines that fail to meet standards during production, but also commonly involve issues in the vaccine storage process, such as improper storage temperatures. It was also mentioned that safety and potency are two distinct characteristics of vaccines, and potency itself does not impact safety.
