French pharmaceutical major Sanofi (NASDAQ: SNY) has announced receiving market approval from the National Medical Products Administration (NMPA) for its VaxigripTetra, a tetravalent influenza virus split vaccine, for use in children aged 6 to 35 months. This approval is significant as children are a primary susceptible population to influenza, with high infection rates during epidemic seasons.
Influenza in Children
The incidence rate of influenza in children during the epidemic season can reach 20%-30% each year, and the annual infection rate in high epidemic seasons can reach about 50%. Despite these high rates, the overall influenza vaccination rate in China remains relatively low, at 2.46% in 2022, which is significantly lower than the 75% target vaccination rate recommended by the World Health Organization (WHO).
VaxigripTetra: Clinical Study Results
A large Phase III clinical study for VaxigripTetra in China demonstrated that the serum protection rate of the four subtypes of influenza virus in infants aged 6 to 35 months is up to 97.4%, with few contraindications for vaccination. The study also found that compared to the half dose (7.5 μg HA/strain), the full amount (15 μg HA/strain) of the tetravalent influenza vaccine can improve the immunogenicity of the vaccine, while the incidence of adverse reactions remains similar.
Strategic Implications
The approval of VaxigripTetra by the NMPA represents a significant step forward in improving influenza vaccination rates among young children in China. By offering a highly effective and well-tolerated vaccine, Sanofi aims to address the significant unmet need for influenza prevention in this vulnerable population. This development is expected to enhance Sanofi’s position in the Chinese vaccine market and contribute to the global effort to reduce the burden of influenza in children.-Fineline Info & Tech
