NVS Influenza Vaccines Welcomes North Carolina Congresswoman Renee Ellmers On Tour Of Holly Springs Manufacturing Facility

October 13, 2015 |

9 min read

HOLLY SPRINGS, N.C., Oct. 13, 2015 /PRNewswire/ -- Yesterday Congresswoman Renee Ellmers (R-NC-02) visited the award-winning NVS Influenza Vaccines Holly Springs manufacturing site located in Holly Springs, NC.⁴ Since 2014, the facility has produced Flucelvax^® (Influenza Vaccine) using cell-culture technology, a state-of-the-art production method that has the potential for faster start-up and is not reliant on chicken eggs.^1,2 On July 31, 2015 CSL Limited acquired the influenza vaccines business of Novartis AG in the US, which for an interim period is referred to as NVS Influenza Vaccines.¹

Brent MacGregor, Global Head of NVS Influenza Vaccines, and Chris MacDonald, NVS Influenza Vaccines, Holly Springs Site Head, provide Congresswoman Renee Ellmers, RN, a first-hand look at the complex process behind influenza vaccine production during a visit to the NVS Influenza Vaccines Holly Springs manufacturing facility. Vaccination is the single most important way to help protect against the flu, according to the Centers for Disease Control and Prevention.

"I am thrilled to tour the Holly Springs site again and get a first-hand look at influenza vaccine production and the progress that has been made in increasing supply capabilities for seasonal and pandemic influenza. Holly Springs represents an important public-private partnership with the US government to support the national strategy for pandemic and seasonal influenza," said Congresswoman Ellmers, who currently sits on the Energy and Commerce Committee, the oldest standing legislative committee in the US House of Representatives, with responsibility for the nation's drug safety, public health research, and national health security. "As a registered nurse, I know the value of a flu vaccine, the single most important way to help protect against the flu."

Flucelvax, 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, is the only seasonal influenza vaccine of its kind in the US.^1,5 Produced using modern cell-based influenza vaccine manufacturing, Flucelvax has the potential to relieve some of the issues of egg-based manufacturing, allowing for rapid initiation of vaccine production within sterile, closed-system bioreactors without the use of antibiotics.⁶

"We are proud to have the Holly Springs manufacturing facility in our community as it provides an invaluable contribution to addressing a major public health and health security issue," said Dick Sears, mayor of Holly Springs, MC. "We are fast-approaching peak influenza season and getting vaccinated can help reduce the chance of contracting the flu and spreading it to others."

Both Congresswoman Ellmers and Mayor Sears visited the NVS Influenza Vaccines Holly Springs site in September, 2014, to mark the first shipments of Flucelvax to the US market following FDA licensure.¹ The event also commemorated the partnership with the US Government department of Health and Human Services (HHS) to help protect the public against seasonal and pandemic influenza.⁷

On July 31, 2015, CSL Limited acquired the influenza vaccines business of Novartis AG in the US. In joining forces, the two companies form the second largest public health and health security partner in the prevention of influenza and pandemic threats around the globe.¹ The combined business will operate under the new name Seqirus later this year.

NVS Influenza Vaccines remains committed to maintaining high standards for customers and patients, and ensuring continuity of seasonal influenza vaccines supply and pandemic preparedness in the US.

About Flucelvax
For the 2015-2016 season, Flucelvax contains antigens that target three influenza virus strains identified by World Health Organization (WHO) experts as likely to dominate circulation this winter.

For Flucelvax, these include:

A/California/7/2009 (H1N1) (a pdm09-like virus)
A/Switzerland/9715293/2013 (a H3N2-like virus)
B/Phuket/3073/2013-like virus

Flucelvax^®
Flucelvax (Influenza Vaccine) 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.

Flucelvax is contraindicated for individuals with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

The safety and efficacy profile of Flucelvax is comparable to other seasonal influenza vaccines.

Overall, the most common (10 %) solicited adverse reactions occurring in adults 18 to 64 years of age within 7 days of vaccination with FLUCELVAX were pain at the injection site (28%), erythema at the injection site (13%), headache (16%), fatigue (12%), myalgia (11%) and malaise (10%). The most common (10%) solicited adverse reactions occurring in adults 65 years of age and older within 7 days of vaccination were erythema at the injection site (10%), fatigue (11%), headache (10%) and malaise (10%).

Overall, the most common (10%) solicited adverse events occurring in children 4 through 8 years of age within 7 days of any vaccination with FLUCELVAX were pain at the injection site (49%), erythema at the injection site (21%), myalgia (15%), headache (14%), fatigue (13%), induration at the injection site (12%), malaise (12%), and swelling (10%). The most common (10%) solicited adverse events occurring in children and adolescents 9 through 17 years of age within 7 days of any vaccination with FLUCELVAX were pain at the injection site (45%), myalgia (17%), headache (17%), erythema at the injection site (13%), fatigue (12%), and malaise (12%).For more information about Flucelvax, please visit Flucelvax.com.

Important Safety Information: FLUCELVAX
Important Safety Information 2015

Contraindication

Do not administer FLUCELVAX^® (Influenza Vaccine) to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.

Warnings & Precautions

Guillain-BarréSyndrome (GBS): The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. 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.
Latex: The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Altered Immunocompetence: After vaccination with FLUCELVAX, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX may not protect all vaccine recipients against influenza disease.

Please see accompanying US Full Prescribing Information for FLUCELVAX.

About Seasonal Influenza
Seasonal influenza is a highly communicable, acute viral infection that predominantly attacks the respiratory tract. Transmission to others may occur one day before symptoms develop and up to five to seven days after becoming sick. Because transmission prior to onset of symptoms can occur, the disease can easily be transmitted to others. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and death.

The CDC estimates that from the 1976-1977 season to the 2006-2007 influenza season, influenza-associated deaths in the US ranged from a low of about 3,000 to a high of about 49,000 people. Influenza seasons are unpredictable; they can begin as early as October and substantial activity can occur as late as April. The CDC encourages annual vaccination for everyone 6 months of age and older who have no contraindications and recommends that people get vaccinated against influenza as long as the viruses are circulating.

About NVS Influenza Vaccines
On July 31, 2015 the CSL Limited acquired the influenza vaccines business of Novartis AG in the U.S. The influenza vaccines business previously owned by Novartis is for an interim period referred to as NVS Influenza Vaccines. NVS Influenza Vaccines is among the world's largest producers of influenza vaccines. The company is committed to improving public health by assuring the quality, safety, efficacy and supply of our influenza vaccines. NVS Influenza Vaccines is a leader in research, development, manufacturing, and distribution of seasonal influenza vaccines worldwide and is a global partner of choice for governments and institutions in pandemic preparedness, emergency response and the prevention and control of influenza.

About CSL Limited
CSL Limited (ASX: CSL) is a global biopharmaceutical company that develops, manufactures and markets biotherapies to prevent and treat rare and serious human diseases. CSL owns major facilities in Australia, Germany, Switzerland, the UK and the US, and employs over 14,000 people in more than 30 countries. For more information, please visit www.csl.com.au.

References

Novartis data on file.
Center for Disease Control and Prevention (CDC). "Cell-based flu vaccines." Seasonal influenza (flu). Available at: http://www.cdc.gov/flu/protect/vaccine/cell-based.htm.
Centers for Disease Control and Prevention (CDC). "Key Facts about Influenza (Flu) & Flu Vaccine." Seasonal Influenza (Flu) 2015. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed October 2015.
ISPE. "2012 ISPE Facility of the Year Awards Program Names Novartis' United States Flu Cell Culture Facility as Overall Winner." November 4, 2013. Available at: http://www.ispe.org/news/2013/2013-foya-overall-winner. Accessed October 2015.
Flucelvax package insert.
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: 60226029. Accessed October 2015.
US Department of Health & Human Services. HHS creates new centers to develop manufacture medical countermeasures. June 18, 2012. Available at: http://www.hhs.gov/news/press/2014pres/06/20140617a.html. Accessed October 2015.