Sanofi Pasteur announced its first doses of the Fluzone (Influenza Vaccine) portfolio for the 2017-2018 influenza season have been released by the U.S. Food and Drug Administration (FDA). Sanofi Pasteur has begun distributing initial shipments, representing the first of nearly 70 million total doses of seasonal influenza vaccine manufactured by the company for this upcoming influenza season. Widespread shipment of Fluzone Quadrivalent, Fluzone High-Dose and Fluzone Intradermal Quadrivalent vaccine to health care provider offices, pharmacies and other immunizers will begin in early August to support fall immunization campaigns.
"As we enter the Swiftwater site's 120th year, it reminds us of our innovation and growth as we came to understand the science of influenza and its impact on human health," said David P. Greenberg, M.D., Associate Vice President and Regional Medical Head North America, Sanofi Pasteur. "Influenza can be especially severe for the most vulnerable populations, including the elderly, young children and those with compromised immune systems; however, it can also have a serious health impact on otherwise healthy individuals. Sanofi Pasteur is and always has been deeply committed to improving public health by continuously striving to develop new vaccines and on improving existing ones."
According to the U.S. Centers for Disease Control and Prevention (CDC), the single best way to prevent the flu is to get an annual flu vaccination, which is recommended for everyone six months of age and older, with rare exception. The CDC recommends receiving the vaccine as soon as it is available to help with prevention even before the season begins.
As the single largest provider of influenza vaccine to the United States, Sanofi Pasteur provides a wide range of influenza vaccines. The Fluzone vaccine portfolio meets immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older, and includes the following products:
Fluzone High-Dose vaccine, the first influenza vaccine designed specifically for people 65 years of age and older, is the only influenza vaccine approved by the U.S. Food and Drug Administration (FDA) that has been shown in clinical trials to have superior efficacy compared to Fluzone vaccine, its standard-dose comparator, in helping to protect against the flu. During the 2016-2017 season, about 60 percent of adults 65 years of age and older who were vaccinated in the United States received Fluzone High-Dose vaccine, helping to protect this vulnerable population. Since its introduction in 2010, more than 70 million doses of Fluzone High-Dose vaccine have been distributed in the United States.
In two observational, comparative effectiveness studies conducted by the CDC, Centers for Medicare and Medicaid Services (CMS) and the FDA of 6 million seniors, Fluzone High-Dose vaccine reduced influenza-associated medical visits and hospitalizations by 22 percent and, during an H3N2-predominated season (2012-2013), reduced post-influenza death by 36 percent compared to standard-dose influenza vaccines. During an H1N1-predominated season (2013-2014), there was a 13 percent reduction in influenza hospitalizations and no significant reduction (2.5 percent) in death.
Fluzone Quadrivalent vaccine helps protect against four influenza strains (two A strains and two B strains) and is the first four-strain influenza vaccine licensed for use in people six months of age and older.
There is also a 0.25-mL prefilled syringe (pediatric dose), that has been available for influenza immunization of children six months through 35 months of age since its launch in 2004 and maintains a record of safety and immunogenicity.
Fluzone Intradermal Quadrivalent vaccine, the first intradermal influenza vaccine for adults 18-64 years of age, offers four-strain protection using a 90 percent smaller, 1.5 mm microneedle.