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Sanofi suddenly dominated the screen!

Late at night on August 26, news spread in various WeChat groups that the Pasteur influenza vaccine under Sanofi was suspended. On the morning of August 27, the China Business Network reported that a hospital had received a notice from the Shanghai Municipal Center for Disease Control and Prevention, but the specific reason was unknown and the hospital was still waiting for further notice from the Shanghai Municipal Center for Disease Control and Prevention. Currently, all hospitals in Shanghai have suspended all Pasteur influenza vaccines. For customers who have already received the vaccine, they need to wait for official news.

Later, we learned from Sanofi that due to the potency issue, Sanofi decided to temporarily suspend the supply and sale of influenza vaccines in China. Sanofi said that all vaccines in circulation and use meet the necessary quality standards for release, and no signs and 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.

So, what exactly happened?

Pasteur Breakout

Late last night, a message suddenly came out in the WeChat group: "Dear Jiahui guests, according to the emergency notice from the Centers for Disease Control, all Pasteur influenza vaccines (trivalent and quadrivalent) will be suspended from August 27. You can cancel your appointment and get a refund through the Jiahui Health APP-Vaccine Center."

Soon after, news came out that Sanofi's Pasteur influenza vaccine was suspended.

On the morning of August 27, the China Business Network reported that a hospital had received a notice from the Shanghai Municipal Center for Disease Control and Prevention, but the specific reason was unknown and the hospital was still waiting for further notice from the Shanghai Municipal Center for Disease Control and Prevention. At present, all hospitals in Shanghai have suspended all Pasteur influenza vaccines. For customers who have already received the vaccine, they need to wait for official news. China Business Network also made a similar report. Many netizens are asking: Is there something wrong with Pasteur? What should I do if I have already received Pasteur?

According to The Paper, on August 27, Sanofi responded that influenza vaccine products themselves are highly complex. During the ongoing stability study, Sanofi observed that the potency (reference data for the expected biological effects of the vaccine) of the influenza vaccines Valeline and Valeja for the 2024-2025 influenza season showed a downward trend. We expect that the efficacy of the vaccine may be affected before the end of the product's validity period. As a precautionary measure, Sanofi decided to temporarily suspend the supply and sale of these vaccines in China.

Sanofi said that the influenza vaccines Valeline and Valga, which have been launched and circulated this year, have been approved for marketing, strictly abide by various laws and regulations, national drug standards and various statutory requirements, and meet the release standards. No signs and 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.

There have been recalls before

It is worth noting that there has been a precedent of recall of Pasteur influenza vaccine.

In April 2018, Shenzhen Sanofi Pasteur Biological Products Co., Ltd. reported that during routine monitoring, the company found that the potency of some batches of influenza virus split vaccines showed a downward trend, and proactively recalled the relevant batches of influenza virus split vaccines with a recall level of three.

According to the recall summary at the time, Sanofi Pasteur observed a downward trend in the potency of specific batches of vaccines during routine quality follow-up inspections of the influenza virus split vaccine (Valenza I) produced in 2017. The relevant batches of Valenza R influenza vaccine are safe and effective and will not affect the immune effect and safety of vaccinated consumers. As a preventive measure, it was decided to proactively recall the relevant batches of Valenza R influenza vaccine. In accordance with the provisions of the "Drug Recall Management Measures", with the active cooperation of relevant CDCs and vaccination sites, the company has completed the proactive recall of all relevant batches of products.

Influenza vaccines have been approved for marketing in China, and the competition landscape is becoming increasingly fierce. According to statistics from Everbright Securities, as of the end of December 2023, 260 batches of quadrivalent influenza vaccines were issued in China throughout the year. Among them, Hualan Bio and the three major institutes ranked first with 88 batches issued, and Sinovac Biotech and Sanofi Pasteur ranked second and third with 41 batches and 25 batches issued, respectively.

According to the Drug Review Center of the National Medical Products Administration, since 2024, my country has added three entities that have applied for the marketing of quadrivalent influenza vaccines, namely Chengdu Sinomin/Olin Biotech/Lanzhou Bailing, Jiangsu Kangrun Biotech, and Shenzhen Kangtai Biotech.

In the morning trading today, after the above incident was exposed, Hualan Biological's stock price performed quite well.