Flu vaccine for elderly on track to approval

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NVS Influenza Vaccines said Tuesday its candidate vaccine for those 65 and older to protect against seasonal influenza is currently under review by the U.S. Food and Drug Administration (FDA).

NVS Influenza Vaccines, which is owned and operated by the CSL Limited, said licensure of the vaccine has been recommended by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA. The recommendation was for accelerated approval.

If approved, the inactivated influenza candiate vaccine would be the first adjuvanted seasonal influenza vaccine licensed for use in adults age 65 and older in the United States. It is indicated for active immunization and protects against influenza caused by influenza virus subtypes A and B contained in the vaccine.

"NVS Influenza Vaccines is committed to delivering clinically proven vaccines to help protect everyone from seasonal influenza and its potentially debilitating consequences," NVS Influenza Vaccines Global Head Brent MacGregor said. "While it's important to vaccinate people against the flu throughout their lives, we are proud to have developed an alternative solution to help meet a major public health need of adults age 65 and older, one of the populations at greatest risk for seasonal influenza."

The elderly can be more susceptible to complications related to influenza and to reduced effectiveness of influenza vaccines compared to younger, healthier people.

"There is a critical need for a seasonal flu vaccine that can help provide an enhanced immune response in the elderly population," Vanderbilt University Assistant Professor of Medicine H. Keipp Talbot said. "According to the Centers for Disease Control and Prevention, high-risk groups, including people 65 years old and older who are at risk of developing serious complications should ensure that they are vaccinated each year."

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CSL Limited U.S. Food and Drug Administration (FDA)

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