Novartis receives approval in Canada for Fluad Pediatric™, the first vaccine designed to help better protect infants from seasonal flu

• Children are most at risk in the first 2 years of life for severe complications from flu that can lead to hospitalization and even death^2,4
  
  
• Studies have shown that compared to adults the effectiveness of non-adjuvanted flu vaccines is limited in young children, particularly under 2 years of age^1,2
  
  
• Fluad Pediatric^™, approved for use from 6 months to 2 years of age, demonstrated a more robust and persistent immune response versus conventional flu vaccines¹

DORVAL, QC, Jan. 7, 2015 /CNW/ - Novartis announced today that Health Canada has approved Fluad Pediatric^™ (MF59^® adjuvanted seasonal trivalent influenza vaccine) for use in children 6 months to less than 2 years of age. Fluad Pediatric^™ is the first vaccine developed specifically for infants to help elicit a robust immune response against seasonal influenza (also commonly known as flu) ¹.

Due to their immature immune systems and lack of prior exposure to the seasonal flu virus, children may need to achieve a higher immune response (HI titres) than adults in order to attain protective antibody levels². Fluad Pediatric^™ contains MF59^®, a Novartis proprietary adjuvant, to help boost the immune response^1,3. In clinical trials, Fluad Pediatric^™ elicited a higher immune response in children that was sustained over 6 months when compared to non-adjuvanted inactivated seasonal flu vaccines¹. Fluad Pediatric^™ also demonstrated a robust safety profile¹.

"I am delighted that we are now able to offer parents and pediatricians in Canada a vaccine with the potential to better protect infants from seasonal flu," said Andrin Oswald, Division Head, Novartis Vaccines. "Addressing this need, which affects not only the very young at a critical juncture in their development but also families and communities, has been a key priority for our scientists and associates."

In Canada, rates of serious illness and death associated with the seasonal flu are among the highest in children less than two years of age and the elderly (age 65+)⁴. The National Advisory Committee on Immunization (NACI) in Canada recommends annual seasonal influenza vaccination for all children 6 to 59 months of age⁴. Until now, non-adjuvanted traditional seasonal influenza vaccines were the only option for children in Canada⁴.

"During the winter months, seasonal influenza is a major public health concern as it can impact any child. Seasonal flu can have serious consequences including hospitalization and even death. This is especially concerning in babies and young children because of their under-developed immune systems and high rates of influenza infection," said Dr. David Scheifele, Professor, Pediatrics, University of British Columbia and Director, Vaccine Evaluation Center, Child and Family Research Institute. "A vaccine that is capable of stimulating a higher level of antibodies for children is a very welcome development and is likely to help protect more young children."

Fluad^® was the first adjuvanted seasonal flu vaccine approved for use in older adults aged 65 years and older in 1997 in Europe^3,6. It remains a demonstrated improvement in the prevention of influenza in the elderly population, including demonstration of a 25% reduction in hospitalization due to influenza or pneumonia in those 65 years and older compared to a non-adjuvanted flu vaccine⁵. A recently published clinical trial showed significant further reduction of influenza cases in children 6 months to less than 6 years of age who received doses of Fluad^® versus non-adjuvanted vaccines¹.

About Fluad Pediatric^™
This approval is based on data from a randomized, controlled, observer blinded, multicenter trial involving 6,100 children¹. In the study, Fluad Pediatric^™ demonstrated increased immunogenicity compared to non-adjuvanted, inactivated seasonal influenza vaccines¹.  Fluad Pediatric^™ is intended for use in the pediatric population of 6 months to less than 2 years of age¹. It is administered as a 0.25 mL injection in children 6 months to less than 2 years of age¹. The National Advisory Committee on Immunization (NACI) encourages annual vaccination for all Canadians who have no contraindication⁴. Influenza vaccines should be offered to the pediatric and elderly populations up to and even after seasonal influenza virus activity is documented in a community⁴.

About Novartis

Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2012, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

Novartis Pharmaceuticals Canada Inc. is a subsidiary of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

References

1. Nolan, T. et al. "Higher antibody titres in response to MF59®-adjuvanted seasonal influenza vaccine compared with nonadjuvanted vaccines in children under six years of age." Vaccine. 2014; 6146-6156. Accessed November 2014.
2. Lee B., Shah M. "Prevention of influenza in healthy children." Expert Reviews of Anti-infective Therapy. 2012; 10:1139 -1152. Accessed November 2014.
3. Canadian Product Monograph.
4. Canada Communicable Disease Report. Statement on Seasonal Influenza Vaccine for 2013–2014. Available at: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/13vol39/acs-dcc-4/assets/pdf/13vol39-acs-dcc4-eng.pdf.
5. Mannino S., et al. "Effectiveness of adjuvanted influenza vaccination in elderly subjects in northern Italy." American Journal of Epidemiology. 2012; 176:527- 533. Accessed November 2014.
6. Novartis data on file.  

SOURCE Novartis Pharmaceuticals Canada Inc.