Sanofi is halting distribution of its two approved flu shots in China due to low potency, and says it won’t meet supply expectations for the products there this flu season.
After what it called a routine check of its facility in Shenzhen, China, Sanofi found that two of its flu vaccines, Vaxigrip and Vaxigrip Tetra, had decreased in potency, a Sanofi spokesperson told Endpoints News. The French pharma company believes that one of the antigens used in the vaccines could be past its shelf life.
The company won’t be able to meet supply for the flu season this year and into 2025, but it is working with partners to make sure its flu vaccines will be available for the next influenza season, the spokesperson said.
Vaxigrip and Vaxigrip Tetra are Sanofi’s only flu vaccines approved in China, but the company believes this will not have a “major impact” on China’s overall flu protection, the spokesperson said. Vaxigrip protects against three strains of influenza, and Vaxigrip Tetra protects against four.
Vaccines already distributed from the Shenzhen facility met the required potency, and the decision to halt production is a “preventative measure,” the spokesperson said.
The manufacturing facility in Shenzhen only produces vaccines for China and no other market is affected, the spokesperson said. The Shenzhen site also manufactures other vaccines such as Pentaxim, used to prevent polio, tetanus and whooping cough. Sanofi has another manufacturing and R&D site in Shanghai and two other factories in Beijing.
The decision to halt distribution comes as China is cracking down on healthcare corruption, causing overall vaccination sales to decrease and large pharmas like Merck to see dwindling use of its HPV vaccine Gardasil.
Separately, during the second quarter of 2024, Sanofi faced a decline in overall vaccine sales and in the last quarter of 2023, its sales for its booster and flu vaccines also dipped, with the company citing lower vaccination rates as well as an increase in competition.