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A clear or slightly whitish opaque suspension.
This vaccine contains purified influenza virus HA antigen.
One dose of 0.5 mL of vaccine contains A/Sydney/5/2021 (H1N1)pdm09-like virus: A/Victoria/4897/2022 (IVR-238) 15 μg HA*.
A/Darwin/9/2021 (H3N2)-like virus: A/Darwin/9/2021 (SAN-010) 15 μg HA*.
B/Austria/1359417/2021-like virus: B/Austria/1359417/2021 (BVR-26) 15 μg HA*.
B/Phuket/3073/2013-like virus: B/Phuket/3073/2013 (BVR-1B) 15 μg HA*.
*Hemagglutinin.
This vaccine preparation has a pH of 6.8-8.0 and an osmolarity ratio to normal saline of approximately 1. The influenza virus strain is inoculated into the allantoic cavity of developing embryonated chicken egg. After incubation, the virus-containing allantoic fluid is collected and sucrose density gradient centrifugation is performed to isolate and concentrate the virus particles. Ether is added to lyse the virus particles and the resulting hemagglutinin (HA) fraction is recovered, inactivated by formalin, and diluted with a phosphate buffered solution to formulate a final suspension containing the required amount of HA of the virus strain.
The previously mentioned virus strain follows the WHO-recommended composition of influenza virus vaccines for use in the 2023/2024 influenza season in the northern hemisphere. The vaccine may contain traces of formaldehyde and polysorbate 80, which are added during the vaccine manufacturing process.
Excipients/Inactive Ingredients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate and water for injection.
