sounds like sva has their hands full!
Pipeline
Anflu Home
About Anflu
About Influenza
FAQs
About Anflu
Loosely translated into English, Anflu means, “If you live in safe, you are very lucky.” It is Sinovac’s wish that those who chose an Anflu? vaccine will have the chance to live in safe.
Comparison of live attenuated influenza vaccines (LAIV) with Inactivated Influenza Vaccines – both inactivated influenza vaccine and LAIV are available to reduce the risk of influenza infection and illness. However, the vaccines also differ in key ways.
Major Similarities
LAIV and inactivated influenza vaccines contain strains of influenza viruses that are antigenically equivalent to the annually recommended strains: one influenza A (H3N2) virus, one A (H1N1) virus, and one B virus. Each year, one or more virus strains might be changed on the basis of global surveillance for influenza viruses and the emergence and spread of new strains. Viruses for both vaccines are grown in eggs. Both vaccines are administered annually to provide optimal protection against influenza infection.
Major Differences
Inactivated influenza vaccine contains killed viruses, whereas LAIV contains attenuated viruses still capable of replication. The user administers LAIV with an intranasal sprayer, whereas inactivated influenza vaccine is administered intramuscularly by injection. LAIV is more expensive than inactivated influenza vaccine. LAIV is approved for use only among healthy persons aged 5–49 years; inactivated influenza vaccine is approved for use among persons aged >6 months, including those who are healthy and those with chronic medical conditions.
Sinovac began split flu influenza vaccine research and development in 2001, completed clinical trials in early 2004, and filed its New Drug Application with the SFDA in June 2004. Quite significantly, the total time to market for Sinovac’s products have been consistently reduced, from ten years for HealiveTM, to just over four years for BiliveTM, to just under four years for AnfluTM.
The Company received a New Drug Certificate from the SFDA for its split flu vaccine (AnfluTM) on February 25, 2005. The AnfluTM production line is located in Beijing and nearing completion. The Company believes the SFDA will grant GMP certification for the production line in time to begin sales during the 2005-2006 flu season. AnfluTM is safe for children and the elderly.
The Company expects to produce 500,000 doses of split flu vaccine in the first year after completing construction of production facilities and 2 million doses per year thereafter.
Demand is expected to exceed Sinovac’s production capability as demand in China for flu vaccines largely exceeds total supply. As such, the Company intends to build another, much larger AnfluTM vaccine production facility if financing is obtained.
