Welcome!

Microsoft Cloud Authors: Stackify Blog, Liz McMillan, David H Deans, Automic Blog, Pat Romanski

News Feed Item

Novartis Bexsero®▼ Meningitis B Vaccine Receives Clinical Recommendation for Use in Infants and Adolescents in Australia

FRIMLEY, England, March 13, 2014 /PRNewswire/ --



  • Australian recommendation adds to clinical recommendations in the Czech Republic, Poland and funding decisions in regions of Germany and Italy
  • Recommendations highlight support for inclusion of Bexsero on routine childhood immunisation schedules to help protect against this devastating disease
  • Bexsero is licensed in the EU, Canada and Australia and has been available privately since 2013, with more than 500,000 doses shipped to date[1],[2],[3],[4],[5]

Novartis has announced that Australia has joined the growing number of countries where following licensure, Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) has received a clinical recommendation for the vaccine's routine use to help protect against meningitis B. These recommendations follow recent access milestones for Bexsero in multiple regions across Europe, including some regions of Italy and Germany. Bexsero is the only broad coverage vaccine to help protect against meningitis B, a potentially deadly disease that disproportionately affects infants and adolescents[6],[7].

Australia's advisory body on immunisation matters, the Australian Technical Advisory Group on Immunisation (ATAGI), has recommended Bexsero for all young Australians, with an emphasis on infants and children under 2 years of age and adolescents 15-19 years of age[8]. Inclusion in the National Immunisation Program is under consideration.

In Europe, Bexsero continues to gain endorsements from health authorities and experts:

  • In Italy, the Basilicata region recommends Bexsero for the routine vaccination of infants and will have an active call to parents that includes providing the vaccine free of charge. The Board of Calendario per la Vita, comprised of the country's foremost scientific societies, has recommended Bexsero for all infants with three doses in the first year of life and one dose at 13 months of age[9].
  • In Germany, more than 35 statutory sickness funds (semi-public health insurance providers) have chosen to voluntarily reimburse Bexsero for all children (ages 2 months to 18 years). Bexsero is also recommended by the German Academy of Child and Adolescent Medicine (DAKJ), a leading paediatric association[10],[11].
  • Poland has a clinical recommendation for routine vaccination with Bexsero for infants, children and adolescents (starting at 2 months of age)[12].
  • In addition, the Czech Vaccinology Society has recommended vaccination with Bexsero for infants, toddlers and children (aged 2 months to 10 years), adolescents (ages 13-15 years) and other high-risk individuals[13].

"For a vaccine-preventable disease, every child lost or disabled is one too many," said Andrin Oswald, Division Head, Novartis Vaccines. "These regional milestones are a testament to the public health benefits of Bexsero and we are hopeful that governments around the world will continue to act with a sense of urgency to help protect those most vulnerable from the devastation of meningitis B."

Meningitis B is a rare but aggressive and often deadly disease; it is the leading cause of meningococcal disease and septicaemia in the developed world[6],[14]. Meningitis B can kill or cause serious life-long disabilities within 24 hours of onset, leaving little time for intervention[14]. Vaccination is therefore the best defence against this aggressive disease.

Bexsero is the only licensed broad coverage vaccine approved in the European Union, Canada and Australia to help protect against meningitis B[1],[2],[3],[4], and has been available privately since 2013 in an ever-increasing number of countries with more than 500,000 doses shipped to date[5]. Bexsero was also recently provided to students at Princeton University and the University of California Santa Barbara (UCSB) in the United States (US) under an Investigational New Drug (IND) designation from the US Food and Drug Administration (FDA) which was issued in response to meningitis B outbreaks on these campuses[15],[16]. To date, over 30,000 doses of Bexsero have been distributed in the US[17].

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "recommendation," "recommendations," "potentially," "recommended," "under consideration," "continues," "recommends," "will," "call," "hopeful," "continue," "can," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for Bexsero, or regarding potential future revenues from Bexsero. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Bexsero will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that Bexsero will be commercially successful in the future. In particular, management's expectations regarding Bexsero could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; global trends toward health care cost containment, including ongoing pricing pressures; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. 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.

About Novartis

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 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 amortisation charges). Novartis Group companies employ approximately 136,000 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.

References

  1. EMA. Authorization Details for Bexsero. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp& mid=WC0b01ac058001d124. Accessed March 2014.
  2. EMA. EU Member States. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000219.jsp&mid=WC0b01ac058003174e. Accessed March 2014.
  3. Health Canada. Bexsero. Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_bexsero_147275-eng.php. Accessed March 2014.
  4. Australian Government: Department of Health: Therapeutic Goods Administration. Available at: http://www.tga.gov.au/pdf/auspar/auspar-meningococcal-131031.pdf. Accessed March 2014.
  5. Novartis Data on File.
  6. World Health Organization. Meningococcal Meningitis. Fact sheet 141. November 2012. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/index.html. Accessed March 2014.
  7. Cohn, A. et al. Changes in Neisseria meningitides Disease Epidemiology in the United States, 1998-2007: Implications for Prevention of Meningococcal Disease. Clinical Infectious Diseases 2010:50. Accessed March 2014.
  8. Australian Technical Advisory Group on Immunisation. Advice for immunisation providers regarding the use of Bexsero. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/85A6879534C02B4DCA257B640002F38E/$File/ATAGI-advice-bexsero.pdf. Accessed March 2014.
  9. Proposta del Board del 'Calendario per la Vita' (Sltl, SIP, FIMP e FIMMG) sull'inserimento del vaccine anti-meningococco B nel calendario delle vaccinazioni dell'infanzia. Available at: http://www.panoramasanita.it/docs/documentocongiuntositifimpsipfimmg.pdf. Accessed on March 2014.
  10. Novartis Data on File.
  11. Deutsche Akademie fur Kinder - und Jugendmedizin E.V. Impfprophylaxe invasiver Erkrankungen mit Meningokokken der Serogruppe B. Available at: http://dakj.de/media/stellungnahmen/infektionskrankheiten-impffragen/2013-meningokokkenB-impfprophylaxe.pdf. Accessed March 2014.
  12. Poland Ministry of Health. W sprawie Programu Szczepień Ochronnych na rok 2014. http://www.gis.gov.pl/ckfinder/userfiles/files/EP/informacje%20dla%20podr%C3%B3%C5%BCuj%C4%85cych/PSO%202014.pdf. Accessed March 2014.
  13. Novartis Data on File.
  14. World Health Organization. Bacterial Meningitis. Available at: http://apps.who.int/nuvi/meningitis/en/. Accessed March 2014.  
  15. Centers for Disease Control and Prevention. Princeton University Meningococcal Disease Outbreak. December 2013. Available at: http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed March 2014.
  16. Centers for Disease Control and Prevention. University of California, Santa Barbara Meningococcal Disease Outbreak. January 2014. Available at: http://www.cdc.gov/meningococcal/outbreaks/ucsb.html. Accessed March 2014.
  17. Novartis Data on File.

 

UK/BEX/14-0018    
Date of preparation: March 2014

 

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Analytic. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at Dell EMC, introduced a methodology for capturing, enriching and sharing data (and analytics) across the organization...
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software in the hope of capturing value in IoT. Although IoT is relatively new in the market, it has already gone through many promotional terms such as IoE, IoX, SDX, Edge/Fog, Mist Compute, etc. Ultimately, irrespective of the name, it is about deriving value from independent software assets participating in an ecosystem as one comprehensive solution.
The explosion of new web/cloud/IoT-based applications and the data they generate are transforming our world right before our eyes. In this rush to adopt these new technologies, organizations are often ignoring fundamental questions concerning who owns the data and failing to ask for permission to conduct invasive surveillance of their customers. Organizations that are not transparent about how their systems gather data telemetry without offering shared data ownership risk product rejection, regu...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in compute, storage and networking technologies, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/...
Judith Hurwitz is president and CEO of Hurwitz & Associates, a Needham, Mass., research and consulting firm focused on emerging technology, including big data, cognitive computing and governance. She is co-author of the book Cognitive Computing and Big Data Analytics, published in 2015. Her Cloud Expo session, "What Is the Business Imperative for Cognitive Computing?" is scheduled for Wednesday, June 8, at 8:40 a.m. In it, she puts cognitive computing into perspective with its value to the busin...
NHK, Japan Broadcasting, will feature the upcoming @ThingsExpo Silicon Valley in a special 'Internet of Things' and smart technology documentary that will be filmed on the expo floor between November 3 to 5, 2015, in Santa Clara. NHK is the sole public TV network in Japan equivalent to the BBC in the UK and the largest in Asia with many award-winning science and technology programs. Japanese TV is producing a documentary about IoT and Smart technology and will be covering @ThingsExpo Silicon Val...