FDA Advisory Panel Recommends Licensure of NVS Influenza Candidate Vaccine for Protection Against Seasonal Influenza in the Elderly

CAMBRIDGE, Mass., Sept. 15, 2015 /PRNewswire/ -- NVS Influenza Vaccines, now owned and operated by the CSL Limited, announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted to recommend licensure of a candidate vaccine to help protect against seasonal influenza in those aged 65 years and older via accelerated approval. Currently under review by the FDA and if approved, the candidate vaccine would become the first adjuvanted seasonal influenza vaccine licensed for use in adults aged 65 and older in the US.¹

The candidate vaccine is an inactivated influenza vaccine indicated for active immunization of adults aged 65 and older against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.³ It contains the World Health Organization (WHO) recommended antigens and the Novartis proprietary adjuvant MF59^® designed to help elicit an immune response to vaccine antigens.^4,5

"NVS Influenza Vaccines is committed to delivering clinically proven vaccines to help protect everyone from seasonal influenza and its potentially debilitating consequences," said Brent MacGregor, Global Head of the NVS Influenza Vaccines. "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 aged 65 and older, one of the populations at greatest risk for seasonal influenza."

Due to distinct characteristics of the immune system, which typically weakens with age, the elderly can be more susceptible to complications related to influenza and to reduced effectiveness of influenza vaccines compared to younger, healthier people.⁶ Adults 65 years and older account for more than half of all influenza-related hospitalizations and approximately 90 percent of influenza-associated deaths in the US.⁷

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

As the FDA has solicited the feedback of the Committee as part of the review of the adjuvanted influenza vaccine, the agency will include this opinion as part of the body of evidence used to determine whether to license a vaccine for marketing.

In making its recommendation, the Committee examined the results of a pivotal Phase III study comparing the immunogenicity and safety of the candidate vaccine with a US licensed, non-adjuvanted trivalent influenza vaccine in people over 65 years of age. The candidate vaccine demonstrated non-inferiority in relation to the comparator vaccine for all three vaccine strains on the basis of both seroconversion rates and geometric mean titers (GMTs).³ Furthermore, the candidate vaccine demonstrated significantly higher antibody titers versus the comparator vaccine.³

The candidate vaccine was assessed in the pivotal study in more than 7,000 participants and the safety profile was generally similar to the non-adjuvant comparator.³ While higher rates of solicited adverse reactions were noted, they were typically mild to moderate in severity.³ The most common solicited local adverse reactions in elderly adults aged 65 years were pain and tenderness.³ The most common solicited systemic adverse reactions observed were myalgia, headache, and fatigue.³ Importantly, there was no imbalance in unsolicited adverse events, serious adverse events, adverse events leading to study withdrawal, adverse events of immune-mediated disease or death.³

The candidate vaccine is currently licensed in more than 30 countries, and approximately 76 million doses have been distributed since first approved.¹

About Seasonal Influenza

Seasonal influenza is a highly communicable, acute viral infection that predominantly attacks the respiratory tract.⁸ Transmission to others may occur one day before symptoms develop and up to five to seven days after becoming sick.⁸ Because transmission prior to onset of symptoms can occur, the disease can easily be transmitted to others. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and death.⁸

The CDC estimates that from the 1976-1977 season to the 2006-2007 influenza season, influenza-associated deaths in the US ranged from a low of about 3,000 to a high of about 49,000 people.⁸ Influenza seasons are unpredictable; they can begin as early as October and substantial activity can occur as late as April.^8,9 The CDC encourages annual vaccination for everyone 6 months of age and older who have no contraindications and recommends that people get vaccinated against influenza as long as the viruses are circulating.⁸

About NVS Influenza Vaccines

On July 31, 2015 the CSL Limited acquired the influenza vaccines business of Novartis AG in the U.S.  The influenza vaccines business previously owned by Novartis is for an interim period referred to as NVS Influenza Vaccines.  NVS Influenza Vaccines is among the world's largest producers of influenza vaccines. The company is committed to improving public health by assuring the quality, safety, efficacy and supply of our influenza vaccines. NVS Influenza Vaccines is a leader in research, development, manufacturing, and distribution of seasonal influenza vaccines worldwide and is a global partner of choice for governments and institutions in pandemic preparedness, emergency response and the prevention and control of influenza.

SOURCE NVS Influenza Vaccines