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Wednesday, November 28, 2012

FDA approves first cell-culture vaccine for seasonal influenza

FDA approved Influenza Virus Vaccine (Flucelvax, Novartis Vaccines), the first cell-culture-derived vaccine, for individuals aged 18 years of age and older.
Influenza Virus Vaccine uses full-scale cell-culture manufacturing technology, an alternative production method to traditional egg-based production. Cell-culture technology uses a well-characterized mammalian cell line rather than chicken eggs to grow virus strains. The production occurs in a closed, sterile, controlled environment, which significantly reduces the risk of potential impurities. Influenza Virus Vaccine does not contain any preservatives, such as thimerosal, or antibiotics.
Cell-culture technology enables rapid response to urgent public health needs such as a pandemic within weeks. 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 pharmacies. 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 A.
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 billion. Influenza Virus Vaccine 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 United States and also allows for enhanced domestic pandemic preparedness.
"The availability of a cell-culture vaccine is an important step to ensuring our readiness for seasonal influenza, as well as a potential pandemic," Dr. William Schaffner, professor of medicine and chairman of preventive medicine at Vanderbilt University, Nashville, Tenn., said in a company press release. "Annual influenza vaccination is an important public health measure that helps protect thousands of people from illness and death each year."
The basis for approval included data from clinical trials that found Flucelvax to be well tolerated, with an efficacy of 83.8% against antigenically-matched strains compared to placebo. A multinational, randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Flucelvax during the 2007-2008 influenza season in adults aged 18 to 49 years in the United States, Finland, and Poland. A total of 11,404 subjects received Flucelvax (N=3,828), seasonal influenza vaccine Agriflu (N=3,676), or placebo (N=3,900) in a 1:1:1 ratio. In a separate study in adults aged 65 years and older, Flucelvax demonstrated comparable immunogenicity to Agriflu for all three strains post-vaccination.
Influenza is a highly infectious and potentially deadly disease of the respiratory tract, which spreads easily through transfer of respiratory droplets typically by coughing or sneezing. In any given season, influenza may cause between 3,000 and 49,000 deaths and can hospitalize more than 200,000 people in the United States alone. The CDC recommends that everyone 6 months of age and older get vaccinated for seasonal influenza every year.
Solicited adverse reactions are similar to those observed with administration of other seasonal influenza vaccines. Overall, in clinical studies, the most common (≥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 (≥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.



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