|By PR Newswire||
|November 20, 2012 05:35 PM EST||
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."
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 sneezing7. In any given season, influenza may cause between 3,000 and 49,000 deaths and can hospitalize more than 200,000 people in the US alone7,8. The Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months of age and older get vaccinated for seasonal influenza every year7.
The basis for approval included data from clinical trials that found Flucelvax to be well tolerated, with an efficacy of 83.8 percent against antigenically-matched strains compared to placebo3. 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 US, Finland and Poland3. A total of 11,404 subjects received Flucelvax (N=3828), seasonal influenza vaccine Agriflu® (N=3676) or placebo (N=3900) in a 1:1:1 ratio3. In a separate study in adults aged 65 years and older Flucelvax demonstrated comparable immunogenicity to Agriflu for all three strains post-vaccination3.
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
Development of cell-culture technology has been funded in part with Federal funds from the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200600012C.
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
FLUCELVAX® is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUCELVAX is approved for use in persons 18 years of age and older.
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.
The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "potential," "potentially," or similar expressions, or by express or implied discussions regarding potential future revenues from Flucelvax. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Flucelvax to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Flucelvax will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Flucelvax could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Vaccines and Diagnostics is a division of Novartis, focused on the development of preventive treatments. The division has two businesses: Novartis Vaccines and Novartis Diagnostics. Novartis Vaccines is the world's fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the US. The division's products also include meningococcal, pediatric and travel vaccines. Novartis Diagnostics, the blood testing business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world's blood supply.
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
- U.S. Department of Health and Human Services. "HHS Awards Contracts Totaling More Than $1 Billion to Develop Cell-Based Influenza Vaccine." 2006. Available at: http://archive.hhs.gov/news/press/2006pres/20060504.html.
- Ambrozaitis, Arvydas et al. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. Vol 27. Issue 43. October 9, 2009: 6022–6029. Available at: http://www.sciencedirect.com/science/article/pii/S0264410X09011177. Accessed on October 3, 2012.
- Flucelvax Package Insert. 2012.
- Gerdil, Catherine. "The Annual Production Cycle for Influenza Vaccine." Vaccine 21 (2003): 1776-1779.
- World Health Organization. "Production and Availability of Pandemic (H1N1) 2009 Vaccines." 2009. Available at: http://www.who.int/csr/disease/swineflu/frequently_asked_questions/vaccine_preparedness/production_availability/en/index.html. Accessed October 2012.
- U.S. Food and Drug Administration. "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications." 2010. Available at: http://www.fda.gov/downloads/biologicsbloodvaccines/ guidancecomplianceregulatoryinformation/guidances/vaccines/ucm202439.pdf. Accessed October 2, 2012.
- Centers for Disease Control and Prevention. "Key Facts About Influenza and Flu Vaccine." 2012. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed July 2012.
- Centers for Disease Control and Prevention. "Seasonal Influenza-Associated Hospitalizations in the United States." 2011. Available at: http://www.cdc.gov/flu/about/qa/hospital.htm.
Novartis Media Relations
Novartis Vaccines and Diagnostics
+1 212 830 2465 (direct)
+1 617 871 7985 (direct)
+1 862 579 8456 (mobile)
+1 617 583 3015 (mobile)
e-mail: [email protected]
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Jan. 26, 2015 05:00 PM EST Reads: 9,814
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, addressed the big issues involving these technologies and, more important, the results they will achieve. Rodney Rogers, chairman and CEO of Virtustream; Brendan O'Brien, co-founder of Aria Systems, Bart Copeland, president and CEO of ActiveState Software; Jim Cowie, chief scientist at Dyn; Dave Wagstaff, VP and chief architect at BSQUARE Corporation; Seth Proctor, CTO of NuoDB, Inc.; and Andris Gailitis, C...
Jan. 26, 2015 05:00 PM EST Reads: 3,860
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 26, 2015 02:30 PM EST Reads: 3,944
Performance is the intersection of power, agility, control, and choice. If you value performance, and more specifically consistent performance, you need to look beyond simple virtualized compute. Many factors need to be considered to create a truly performant environment. In his General Session at 15th Cloud Expo, Harold Hannon, Sr. Software Architect at SoftLayer, discussed how to take advantage of a multitude of compute options and platform features to make cloud the cornerstone of your online presence.
Jan. 26, 2015 02:15 PM EST Reads: 4,782
SYS-CON Media announced that Splunk, a provider of the leading software platform for real-time Operational Intelligence, has launched an ad campaign on Big Data Journal. Splunk software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. The ads focus on delivering ROI - how improved uptime delivered $6M in annual ROI, improving customer operations by mining large volumes of unstructured data, and how data tracking delivers uptime when it matters most.
Jan. 26, 2015 02:00 PM EST Reads: 5,334
In this Women in Technology Power Panel at 15th Cloud Expo, moderated by Anne Plese, Senior Consultant, Cloud Product Marketing at Verizon Enterprise, Esmeralda Swartz, CMO at MetraTech; Evelyn de Souza, Data Privacy and Compliance Strategy Leader at Cisco Systems; Seema Jethani, Director of Product Management at Basho Technologies; Victoria Livschitz, CEO of Qubell Inc.; Anne Hungate, Senior Director of Software Quality at DIRECTV, discussed what path they took to find their spot within the technology industry and how do they see opportunities for other women in their area of expertise.
Jan. 26, 2015 01:45 PM EST Reads: 3,368
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete at launch. DevOps may be disruptive, but it is essential.
Jan. 26, 2015 01:15 PM EST Reads: 3,776
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
Jan. 26, 2015 01:00 PM EST Reads: 5,633
SYS-CON Media announced that Cisco, a worldwide leader in IT that helps companies seize the opportunities of tomorrow, has launched a new ad campaign in Cloud Computing Journal. The ad campaign, a webcast titled 'Is Your Data Center Ready for the Application Economy?', focuses on the latest data center networking technologies, including SDN or ACI, and how customers are using SDN and ACI in their organizations to achieve business agility. The Cisco webcast is available on-demand.
Jan. 26, 2015 12:00 PM EST Reads: 2,110
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 26, 2015 11:30 AM EST Reads: 3,411
Advanced Persistent Threats (APTs) are increasing at an unprecedented rate. The threat landscape of today is drastically different than just a few years ago. Attacks are much more organized and sophisticated. They are harder to detect and even harder to anticipate. In the foreseeable future it's going to get a whole lot harder. Everything you know today will change. Keeping up with this changing landscape is already a daunting task. Your organization needs to use the latest tools, methods and expertise to guard against those threats. But will that be enough? In the foreseeable future attacks w...
Jan. 26, 2015 11:00 AM EST Reads: 4,501
As enterprises move to all-IP networks and cloud-based applications, communications service providers (CSPs) – facing increased competition from over-the-top providers delivering content via the Internet and independently of CSPs – must be able to offer seamless cloud-based communication and collaboration solutions that can scale for small, midsize, and large enterprises, as well as public sector organizations, in order to keep and grow market share. The latest version of Oracle Communications Unified Communications Suite gives CSPs the capability to do just that. In addition, its integration ...
Jan. 26, 2015 11:00 AM EST Reads: 4,355
Building low-cost wearable devices can enhance the quality of our lives. In his session at Internet of @ThingsExpo, Sai Yamanoor, Embedded Software Engineer at Altschool, provided an example of putting together a small keychain within a $50 budget that educates the user about the air quality in their surroundings. He also provided examples such as building a wearable device that provides transit or recreational information. He then reviewed the resources available to build wearable devices at home including open source hardware, the raw materials required and the options available to power s...
Jan. 26, 2015 11:00 AM EST Reads: 3,280
“The age of the Internet of Things is upon us,” stated Thomas Svensson, senior vice-president and general manager EMEA, ThingWorx, “and working with forward-thinking companies, such as Elisa, enables us to deploy our leading technology so that customers can profit from complete, end-to-end solutions.” ThingWorx, a PTC® (Nasdaq: PTC) business and Internet of Things (IoT) platform provider, announced on Monday that Elisa, Finnish provider of mobile and fixed broadband subscriptions, will deploy ThingWorx® platform technology to enable a new Elisa IoT service in Finland and Estonia.
Jan. 26, 2015 11:00 AM EST Reads: 2,298
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile devices as well as laptops and desktops using a visual drag-and-drop application – and eForms-buildi...
Jan. 26, 2015 10:45 AM EST Reads: 3,920
From telemedicine to smart cars, digital homes and industrial monitoring, the explosive growth of IoT has created exciting new business opportunities for real time calls and messaging. In his session at @ThingsExpo, Ivelin Ivanov, CEO and Co-Founder of Telestax, shared some of the new revenue sources that IoT created for Restcomm – the open source telephony platform from Telestax. Ivelin Ivanov is a technology entrepreneur who founded Mobicents, an Open Source VoIP Platform, to help create, deploy, and manage applications integrating voice, video and data. He is the co-founder of TeleStax, a...
Jan. 26, 2015 10:45 AM EST Reads: 4,779
ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ -- IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's platform-as-a-service. The new platform enables developers to build ap...
Jan. 26, 2015 10:30 AM EST Reads: 4,340
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
Jan. 26, 2015 10:30 AM EST Reads: 3,724
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tracker. The mesh of things that we manage must be segmented into zones of trust for sensing data, transmitting data, receiving command and control administrative changes, and peer-to-peer mesh messaging. In his session at @ThingsExpo, Ryan Bagnulo, Solution Architect / Software Engineer at SOA Software, focused on desi...
Jan. 26, 2015 10:00 AM EST Reads: 3,552
Disruptive macro trends in technology are impacting and dramatically changing the "art of the possible" relative to supply chain management practices through the innovative use of IoT, cloud, machine learning and Big Data to enable connected ecosystems of engagement. Enterprise informatics can now move beyond point solutions that merely monitor the past and implement integrated enterprise fabrics that enable end-to-end supply chain visibility to improve customer service delivery and optimize supplier management. Learn about enterprise architecture strategies for designing connected systems tha...
Jan. 26, 2015 10:00 AM EST Reads: 4,626