Novartis announced that it started shipments of its Fluvirin Influenza Virus Vaccine to US health care facilities and practitioners for the 2008/2009 influenza season.
The company is producing up to 40 million doses of Fluvirin, with the World Health Organization recommended change in all three virus strains included in the influenza vaccine composition.
Fluvirin Influenza Virus Vaccine is indicated for immunization against the influenza virus strains contained in the vaccine for use in the United States (only) for persons of four years of age and older. Fluvirin vaccine may not protect 100% of individuals who are susceptible to influenza. Before administering Fluvirin vaccine, please see full prescribing information.
This year's influenza vaccine contains three strains of the influenza virus, i.e. A/Brisbane/59/2007 (H1N1)-like virus (A/Brisbane/59/2007 IVR-148); A/Brisbane/10/2007 (H3N2)-like virus (A/Uruguay/716/2007 NYMC X-175C) and B/Florida/4/2006-like virus (B/Florida/4/2006).
Novartis expects to deliver at least 20 million doses by the end of September, when widespread vaccination campaigns usually begin, and strives to ship the remainder by October 31.
"As one of the largest US suppliers of influenza vaccine, providing large quantities of Fluvirin early in the season supports public health efforts to vaccinate as many people as early as possible this upcoming influenza season," said Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostics. "Novartis is committed to delivering high quality influenza vaccine to help protect more people against this potentially serious and contagious disease."
Influenza prevention is critical since an estimated 36,000 deaths in the US every year are blamed on influenza. This is similar to the more than 40,000 people in the US estimated to die from breast cancer every year and about half the estimated 70,000 people who die annually of diabetes and its complications. During last influenza season, 83 children were reported to have died of influenza-related causes. Of the 63 whose vaccination status was known , 58 (92 per cent) were not vaccinated according to recommendations.
To help address these potentially avoidable fatalites, new recommendations from the Advisory Committee on Immunization Practices (ACIP) increase the number of individuals advised to receive an annual influenza vaccination to include nearly all children from six months through 18 years of age. Whereas previous recommendations included children from six months through 59 months of age this new recommendation aims to help protect approximately 30 million additional Americans. In addition, the ACIP recommends vaccination for other people who are at high risk of having serious influenza complications or who live with or care for people. In general, anyone over 6 months old who wants to reduce their chances of getting influenza should get vaccinated. Fluvirin Influenza Virus Vaccine is not indicated for use in children under four years of age.
To help meet demand for influenza vaccine earlier in the season, Novartis now has a second manufacturing facility in Rosia, Italy, in addition to its Liverpool, England facility. The FDA recently granted approval to the Rosia facility to fill Fluvirin in pre-filled syringes.
"Novartis has made a concerted effort to manufacture and deliver a vaccine that includes these three new strains in the most efficient manner," said Rajiv De Silva, President of Novartis Vaccines in the US. "Despite the new composition, Novartis made sure we were able to deliver a timely and robust supply of influenza vaccine this year."
According to a Novartis press release, Fluvirin is available for ordering for the US 2008-2009 influenza season via the company's influenza vaccine online ordering portal, www.NovartisVaccinesDirect.com.