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"In order for my baby to produce antibodies as soon as possible, I want to get the vaccine in the first batch in August. I just received news that the first batch of influenza Pasteur quadrivalent vaccine antibodies did not meet the standards and were recalled. They are no longer allowed to be used, or you can make an appointment for other influenza vaccines." "I received a call and was told not to get the Pasteur influenza vaccine scheduled for tomorrow." ...

On the evening of August 26, news that Sanofi's Pasteur influenza vaccine was suspended or urgently recalled circulated on the Internet. An unnamed hospital official told the 21st Century Business Herald reporter, "The suspension of Sanofi influenza vaccine is not unique to one hospital. All medical institutions in Shanghai should have received the notice.Many netizens also expressed their concerns, "What should I do if I have already received the Pasteur influenza vaccine?"

Sanofi told the 21st Century Business Herald reporter that "influenza vaccine products themselves are highly complex. During its ongoing stability studies, 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 shelf life. As a precautionary measure, Sanofi has decided to temporarily suspend the supply and sale of these vaccines in China.”

"The influenza vaccines Valeline® and Valeja® that have been launched and circulated this year have been approved for marketing, strictly abide by various laws and regulations, national drug standards and statutory requirements, and meet the release standards. No signs or evidence of product safety and effectiveness being affected were found.The decision to temporarily suspend the supply and sale of these vaccines in China is merely a precautionary measure."Sanofi emphasized.

“Safety is not a problem.Antigen content is reduced

Sanofi is currently one of the world's largest suppliers of influenza vaccines. According to its official website, in order to meet China's needs for responding to a possible large-scale influenza outbreak, Sanofi Pasteur established a seasonal influenza vaccine production plant in Shenzhen in 2007. Currently, two influenza vaccines are on the market in China.

Specifically, 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.

Regarding the temporary suspension of the supply and sale of influenza vaccines in China due to the drop in potency, an insider explained to 21st Century Business Herald:“Combining Sanofi's official response and offline verification, the safety of (Pasteur influenza vaccine) is definitely not a problem. The effectiveness can be simply understood as a reduction in antigen content, but it is currently unclear whether it is the duration or protective power. There may be several situations in which "potency reduction" occurs, such as the vaccine's protective power in the real world is lower than that in the clinic, and the vaccination effect is significantly reduced.”

As we all know, influenza vaccination is an effective means of preventing influenza, which can significantly reduce the risk of influenza and serious complications. The influenza season in the northern hemisphere is mainly from September to May of the following year. Studies have shown that influenza vaccination will take effect within 2-4 weeks after vaccination, and the protection period can reach 6-8 months.Therefore, the corresponding sales cycle of the seasonal influenza vaccine is from August to June of the following year, and the peak sales season is mainly concentrated in September to December. This emergency may have an impact on Sanofi's influenza vaccine sales in China.

According to preliminary statistics from the Chinese Institute of Inspection and Quarantine Scientific Research Institute's biological product batch release data, as of August 18, 2024, 272 batches of influenza vaccines have been approved for domestic release this year, including 19 batches of quadrivalent influenza virus split vaccines produced by Shenzhen Sanofi Pasteur Biological Products.

At present, domestic influenza vaccines include trivalent/quadrivalent influenza virus split vaccine, trivalent/quadrivalent influenza virus subunit vaccine and freeze-dried nasal spray influenza vaccine. Among them, quadrivalent influenza vaccine is the main force of influenza vaccine in my country. According to the batch release data of biological products of China Institute of Inspection and Quarantine, the market share of quadrivalent influenza vaccine has risen to 75% in 2023.

Possibly affected by the news that Sanofi has suspended the supply and sales of influenza vaccines in China, according to Flush, as of the midday break on August 27, the vaccine sector rose 3.58%, among which Jindik's share price led the increase by 20%, Hualan Vaccine rose 19.97%, and the share prices of CanSino, Kanghua Biological, Beike Biopharmaceuticals, Hualan Biological, and Kangtai Biological all rose to varying degrees.

According to public information, in September 2018, Hualan Vaccine's first batch of quadrivalent influenza virus split vaccines were approved for marketing, making it the first company in China approved to produce quadrivalent influenza vaccines.Its quadrivalent influenza vaccine has ranked first in the domestic market share for six consecutive yearsIn addition, Sinopharm Group, Sinovac Biotech, Jindik and many other companies are also developing quadrivalent influenza vaccines, and many products have been launched on the market, creating fierce market competition.

According to relevant reports, regarding whether the company's influenza vaccine production capacity and batch release will be accelerated after Sanofi suspended influenza vaccination, relevant staff of Hualan Vaccine said that these are all preliminary work. Now the company has approved many batches of influenza vaccines and has begun to supply the market. Some markets can be vaccinated, and the company's production volume can meet market demand. 

The relevant person in charge of Jindik also said that the company's influenza vaccine production plan was set at the beginning of the year, and the production cycle, including batch release, takes a long time. According to the current news, Sanofi Pasteur's influenza vaccine is suspended. "I don't know if it will not be available later this year, or it is just temporarily unavailable."If you completely withdraw from this market, other companies will occupy and fill this market. The specific impact will depend on the specific circumstances.

In addition, Clover Biopharmaceuticals also stated that currently, the influenza vaccine of Guoguang Biopharmaceuticals can be administered in community health service centers in most provinces, including Zhejiang, Shanghai, Jiangsu, Anhui, Shandong, Henan, Sichuan, Shaanxi, and Hunan. We hope to provide better protection for more "susceptible people" before the flu season arrives. In 2024, we will continue to improve the commercialization strategy layout, expand the accessibility of Guoguang Biopharmaceuticals influenza vaccination, and strive to bring internationally processed, safe and high-quality vaccines to more people.

In fact, since the beginning of this year, many domestic influenza vaccines have been accelerating their search for market growth. In the first half of the year, the Changchun Institute, Wuhan Institute, and Shanghai Institute of Sinopharm Group first reduced the price of quadrivalent influenza vaccine to 88 yuan per dose, and the quadrivalent influenza vaccine fell below 100 yuan; then private enterprises such as Hualan Vaccine and Beijing Kexing followed suit and also reduced the price of some quadrivalent influenza vaccines to around 80 yuan per dose, and the "price war" began. In early June, Hualan Vaccine and Beijing Kexing also joined the "price war".

On May 20, the Jiangsu Provincial Public Resources Trading Center issued the "Notice on Adjusting the Supply Prices of Some Vaccines", among which the winning bid price of the quadrivalent influenza virus split vaccine of the Changchun Institute, Wuhan Institute and Shanghai Institute under Sinopharm Group was reduced from 128 yuan/dose to 88 yuan/dose, a price reduction of 31.25%.

On the evening of June 4, Hualan Vaccine issued an announcement stating that starting from June 5 this year, the prices of its quadrivalent influenza vaccine products will be adjusted downwards: quadrivalent influenza virus split vaccine (adult dosage, prefilled 0.5 ml/vial) will be reduced to 88 yuan/vial; quadrivalent influenza virus split vaccine (adult dosage, vial 0.5 ml/bottle) will be reduced to 85 yuan/vial; quadrivalent influenza virus split vaccine (children's dosage, prefilled 0.25 ml/vial) will be reduced to 128 yuan/vial.

This is also in line with the market strategy. If latecomers want to catch up, price reduction becomes an option. Zhao Heng, founder of Latitude Health, a medical strategy consulting company, previously told a reporter from 21st Century Business Herald that“In fact, the logic behind the price reduction is very simple, which is to seize the market. From the perspective of market supply and demand, the overall production capacity of the quadrivalent influenza vaccine is large, and it is difficult to successfully seize the market without reducing the price.”

Zhao Heng believes that after companies seize the market by cutting prices, their profits will definitely decline first. What needs to be paid attention to is whether the company's revenue growth can be driven in the future. If it can be driven, it will be a positive result. But in the long run, companies need to develop higher-level vaccines and create uniqueness, because relying solely on "price wars" may end up making no money.

Will price reduction increase vaccination rates?

According to the World Health Organization (WHO), influenza causes 3 million to 5 million severe cases and 290,000 to 650,000 respiratory disease-related deaths each year worldwide. People are generally susceptible to influenza viruses, and the incidence rate among children is higher than that among adults. WHO recommends that the influenza vaccination rate for key groups such as children, the elderly, and patients with chronic diseases should reach 75%.

But the reality is that data from the Chinese Center for Disease Control and Prevention show that the vaccination rate for the 2022-2023 influenza season in my country is 3.84%.The vaccination rate for key populations is not high, far lower than the WHO recommended vaccination rate, and also far lower than the levels in Europe, America and East Asia.。

Taking the United States as an example, in the 2022-2023 flu season, 57.4% of children aged 6 months to 17 years in the United States received at least one dose of influenza vaccine, the vaccination coverage rate for adults aged 18 and above reached 46.9%, and the influenza vaccination rate for people over 65 years old was as high as 69.7%.

"The public and professionals have misunderstandings about the severity of influenza and lack confidence in the protective effects of influenza vaccines. Hesitation over influenza vaccination is still relatively common. In addition, vaccination costs are also closely related to influenza vaccination rates," an industry insider analyzed to 21st Century Business Herald.

Specifically, there needs to be sufficient willingness to consume at the individual level, which includes the improvement of health awareness and consumption capacity. To make consumers "have the money and are willing to get vaccinated", it is necessary to increase consumer income and supplement it with large-scale health education activities and professional science popularization; the market level needs to lower product prices and formulate differentiation strategies; the government level needs to provide financial subsidies or free vaccination services to reduce vaccination costs, provide special support for high-risk groups, and increase vaccination contact points to facilitate the public to get vaccinated nearby.

In the "price war", if enterprises want to dominate the market, Deng Yong believes that "they must analyze whether their product positioning is high-end, mid-range or low-end, and how the cost compares to the price, and on this basis, choose to adopt a low-price competition or stable price differentiation strategy. And determine whether the product positioning is 'recovering cash flow' or 'occupying strategic territory', and make appropriate sacrifices to adapt to this wave of price cuts from a long-term perspective and cater to the company's long-term development strategy."