Sanofi's Quadrivalent Influenza Vaccine VaxigripTetra® Gains NMPA Approval for Infants and Toddlers Aged 6–35 Months in China

Recently, Sanofi announced that its quadrivalent influenza virus split vaccine -- VaxigripTetra -- has received marketing authorization approval from the National Medical Products Administration (NMPA) for use in children aged 6 to 35 months, offering a new, high-quality international option for influenza prevention and control in Chinese children.

Influenza is an acute respiratory infectious disease caused by the influenza virus, which is highly variable in antigenicity and spreads rapidly. Each year, seasonal influenza epidemics result in 3 to 5 million severe cases globally, and on average, one person dies from influenza infection every 49 seconds worldwide, posing a serious threat to public health.

Children are a high-risk group for influenza, with an annual influenza incidence rate of 20% to 30% during flu seasons, and this rate can reach as high as around 50% during peak epidemic seasons. Notably, after children are infected with influenza, it may lead to severe complications such as severe pneumonia, necrotizing encephalitis, and fulminant myocarditis, and could even result in death. Vaccination against influenza is the most cost-effective preventive measure, but currently, there are limited options for full-dose (15μg HA/strain) quadrivalent influenza vaccines available in China for children aged 6 to 35 months, necessitating more potent and reassuring vaccine choices.

Inactivated Quadrivalent Influenza Vaccine – VaxigripTetra@ (VaxigripTetra) has demonstrated in large-scale Phase III clinical trials conducted in China that it provides a seroprotection rate of up to 97.4% against four influenza virus subtypes among infants and young children aged 6-35 months. With few contraindications and precautions for vaccination, it is a reassuring choice for infant influenza vaccines. Similar products from other countries have been launched in over 100 countries globally* and have been the subject of up to 35 clinical studies on immunogenicity, efficacy, and safety worldwide.

Adopting a globally unified production process and high-quality raw materials, 70% of production time is dedicated to quality testing, ensuring consistent global quality*.

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