Red Star Capital Bureau reported on August 27th that on the night of August 26th, major WeChat groups reported that the Pasteur influenza vaccine (trivalent and quadrivalent) under Sanofi had been suspended from vaccination.
On August 27th, Sanofi responded by stating that they have observed a downward trend in the efficacy of the influenza vaccines Valin and Valga during the 2024-2025 flu season (relevant reference data for the expected biological effects of the vaccines). It also stated that all circulating and used vaccines meet the necessary quality standards for release, and no signs or evidence of product safety and efficacy being affected have been found. The decision to temporarily suspend the supply and sale of these vaccines in China is only a preventive measure.
It is reported that Sanofi currently has two flu vaccines on the market in China, namely Flu Ling (trivalent) and Flu Jia (quadrivalent).
It is worth noting that there have been previous recalls of the Pasteur flu vaccine.
Sanofi response:
[align center] Suspending supply is only a preventive measure
Last night, various WeChat groups suddenly reported: "Dear Jiahui guests, we have received an urgent notice from the CDC to suspend all Pasteur influenza vaccine (trivalent and quadrivalent) vaccinations from August 27th. You can cancel your appointment and refund through the Jiahui Health APP Vaccine Center
On August 27th, Jiahui Medical Customer Service stated that the hospital had received a notice from the Shanghai Center for Disease Control and Prevention that all hospitals in Shanghai have temporarily suspended the vaccination of Pasteur influenza vaccine.
Subsequently, Sanofi responded by stating that the flu vaccine products themselves are highly complex. During the ongoing stability assessment by Sanofi, it was observed that the potency of the influenza vaccines Valin and Valga (relevant reference data for expected biological effects of vaccines) during the 2024-2025 influenza season showed a decreasing trend. It is expected that the efficacy of the vaccine may be affected before the end of the product's shelf life. As a preventive measure, Sanofi has decided to temporarily suspend the supply and sale of these vaccines in China.
Sanofi stated that the influenza vaccines Valin and Valga, which have been launched and circulated this year, have been approved for marketing and strictly comply with various laws and regulations, national drug standards, and legal requirements, meeting the release standards. No signs or evidence have been found to affect the safety and effectiveness of the product. The decision to temporarily suspend the supply and sale of these vaccines in China is only a preventive measure.
On the secondary market, Red Star Capital noticed that due to the news of Sanofi's suspension of vaccination, flu concept stocks Hualan Vaccine (301207. SZ) and Jindike (688670. SH) hit the daily limit up, while Baike Biotechnology (688276. SH) rose more than 4% at one point.
[align center] There has been a recall precedent
It is worth noting that there have been previous recalls of the Pasteur flu vaccine.
In April 2018, Shenzhen Sanofi Pasteur Biological Products Co., Ltd. reported that the company had found a decreasing trend in the efficacy of some batches of influenza virus split vaccines during routine monitoring, and actively recalled the relevant batches of influenza virus split vaccines, with a recall level of level three.
According to the recall brief at the time, Sanofi Pasteur observed a decreasing trend in the potency of specific batches of influenza virus split vaccines (Valin I) produced in 2017 during routine quality tracking inspections. The relevant batches of Flu R influenza vaccine are safe and effective, and will not affect the immunization effect and safety of vaccinated consumers. As a preventive measure, it has been decided to proactively recall the relevant batches of Valin R influenza vaccine. According to the "Drug Recall Management Measures", with the cooperation of relevant disease control centers and vaccination sites, the company has completed the proactive recall of all relevant batches of products.
According to statistics from Everbright Securities, as of the end of December 2023, there were 260 batches of quadrivalent influenza vaccines issued in China throughout the year. Among them, Hualan Biotechnology and the three major institutions ranked first with 88 batches of issuance, while Sinovac Biotech and Sanofi Pasteur ranked second and third with 41 and 25 batches of issuance, respectively.
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