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Novartis Receives FDA Approval for Flucelvax®, the First Cell-Culture Vaccine in US to Help Protect Against Seasonal Influenza
-Cell-culture technology, an alternative to traditional egg-based production, is the most significant advancement in influenza vaccine manufacturing in more than 40 years1
By: PR Newswire
Nov. 20, 2012 05:35 PM
CAMBRIDGE, Mass., Nov. 20, 2012 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) approved the use of Flucelvax® (Influenza Virus Vaccine), the first cell-culture-derived vaccine, for individuals 18 years of age and older3.
Flucelvax utilizes full-scale cell-culture manufacturing technology, an alternative production method to traditional egg-based production1. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains2. The production occurs in a closed, sterile, controlled environment, which significantly reduces the risk of potential impurities. Flucelvax does not contain any preservatives, such as thimerosal, or antibiotics2.
Cell-culture technology enables rapid response to urgent public health needs such as a pandemic within weeks1. Traditional influenza vaccine production depends on a large number of fertilized chicken eggs to grow virus strains and requires many months for organization of egg supplies, virus incubation and actual production before the vaccine is delivered to physicians or pharmacies4. Cell-culture technology is successfully used to manufacture other vaccines, including those distributed during the H1N1 pandemic, as well as vaccines for polio, rubella and hepatitis A5,6.
"The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the US," said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. "Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way."
Novartis has partnered with the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA) for the development of the cell-culture manufacturing technology, as well as for construction of the state-of-the-art facility in Holly Springs, N.C. Total public/private investment in the technology development and facility is more than $1 billion1. Flucelvax will be produced in Holly Springs once the facility is ready for full-scale commercial production. The facility is the first of its kind in the US and also allows for enhanced domestic pandemic preparedness1.
"The availability of a cell-culture vaccine is an important step to ensuring our readiness for seasonal influenza, as well as a potential pandemic," said Dr. William Schaffner, professor of medicine and chairman of preventive medicine at Vanderbilt University, Nashville, Tennessee. "Annual influenza vaccination is an important public health measure that helps protect thousands of people from illness and death each year."
Solicited adverse reactions are similar to those observed with administration of other seasonal influenza vaccines. Overall, in clinical studies, the most common (greater than or equal to 10 %) solicited adverse reactions occurring in adults 18 to 64 years within seven days of vaccination with Flucelvax were pain at the injection site, erythema (redness) at the injection site, headache, fatigue, myalgia and malaise. The most common (greater than or equal to 10 %) solicited adverse reactions occurring in adults 65 years of age or older within 7 days of vaccination were erythema at the injection site, fatigue, headache and malaise3.
Novartis Vaccines partnership with US Department of Health and Human Services
Construction of the Holly Springs facility was funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200900101C.
Indication and Important Safety Information
Do not administer FLUCELVAX to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX should be based on careful consideration of the potential benefits and risks.
The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
After vaccination with FLUCELVAX, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
Vaccination with FLUCELVAX may not protect all vaccine recipients against influenza disease.
Please see full Prescribing Information for Flucelvax.
Novartis 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 and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group's continuing operations achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 127,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
To view the multimedia assets associated with this release, please visit: http://www.multivu.com/mnr/58937-novartis-receives-fda-approval-for-flucelvax-influenza-vaccine
Novartis Media Relations
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