Seqirus, a leading innovator in influenza vaccines and pandemic preparedness, applauds the Administration for recognizing the urgency of ensuring Americans are better protected against seasonal and pandemic influenza threats by releasing the Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health. The Executive Order represents a significant step towards accelerating access to more effective technologies, such as cell-based platforms, immunity-enhancing adjuvants, and other innovative approaches.
“We are encouraged by the intent of the White House Executive Order to enable and accelerate broad access to cell-based influenza vaccine technology in the United States,” said Anjana Narain, Executive Vice President of Seqirus. “While egg-based vaccines are widely used today and continue to play a critical role in the fight against influenza, Seqirus is committed to innovative approaches to influenza vaccine development, implementation and access. We look forward to partnering with the recently announced Influenza Taskforce to further accelerate this vision.”
Seqirus, the world's largest cell-based influenza vaccine manufacturer, produces FLUCELVAX® at its Holly Springs facility in North Carolina. The facility was purpose-built in partnership with the Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA) to combat pandemic threats and harness cell-based technology as a modern, efficient and highly-scalable alternative to traditional egg-based manufacturing.[1] The technology also offers the potential to avoid possible mismatch scenarios in influenza seasons characterized by egg-adaptation.[2],[3],[4]
As a result of this partnership, the Seqirus cell-based technology, during the 2017/18 influenza season in the U.S., was found to be 36% more effective than standard egg-based quadrivalent vaccines in preventing influenza-like illness.[5] This study took place in a season when H3N2 was the predominant strain.5Ongoing process innovation is enabling Seqirus to manufacture the vaccine at increasingly large volumes each season and may further reduce pandemic vaccine production timelines.[6]
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About Seqirus
Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 22,000 people with operations in more than 60 countries.
Seqirus was established on 31 July 2015 following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Seqirus operates state-of-the-art production facilities in the U.S., the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries. For more information about Seqirus, visit www.seqirus.com.
About CSL
CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus - provides life-saving products to more than 60 countries and employs more than 22,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL Limited, visit www.csl.com.
Intended Audience
This press release is issued from Seqirus USA Inc. in Summit New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.
Forward-Looking Statements
This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
MEDIA CONTACT
Polina Miklush
+1 (908) 608-7170
polina.miklush@seqirus.com
FLUCELVAX® QUADRIVALENT (Influenza Vaccine) Important Safety Information
Indication and Usage
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older.
Contraindications
- Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
Warnings and precautions
- Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
Most Common Adverse Reactions
- The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%), headache (18.7%), fatigue (17.8%), myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).
- The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%) and injection site erythema (11.9%).
- The most common (≥10%) local and systemic reactions in children 4 to <6 years of age were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%), and change in eating habits (10%).
- The most common (≥10%) local and systemic reactions in children 6 through 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and myalgia (12%).
- The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%), myalgia (16%), and injection site induration (15%).
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please see the accompanying US full prescribing information for FLUCELVAX QUADRIVALENT.
FLUCELVAX QUADRIVALENT® is a registered trademark of Seqirus UK Limited or its affiliates.
[1] This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C and HHSO100200900101C.
[2] Milián E., Kamen A.A. (2015). Current and emerging cell culture manufacturing technologies for influenza vaccines. Biomed Res Int. 2015:504831. doi:10.1155/2015/504831
[3] CDC. (2018). How influenza (flu) vaccines are made. Retrieved from: http://www.cdc.gov/flu/protect/vaccine/how-fluvaccine-made.html. Accessed September 2019.
[4] CDC. (2018). Cell-based flu vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.html. Accessed September 2019.
[5] Boikos T. (2018). Effectiveness of the cell culture- and egg-derived, seasonal influenza vaccine during the 2017-2018 northern hemisphere influenza season. Presented at NFID Clinical Vaccinology Course, November 2018.
[6] Data on file. (2019). Seqirus USA Inc.
[3] CDC. (2018). How influenza (flu) vaccines are made. Retrieved from: http://www.cdc.gov/flu/protect/vaccine/how-fluvaccine-made.html. Accessed September 2019.
[4] CDC. (2018). Cell-based flu vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.html. Accessed September 2019.
[5] Boikos T. (2018). Effectiveness of the cell culture- and egg-derived, seasonal influenza vaccine during the 2017-2018 northern hemisphere influenza season. Presented at NFID Clinical Vaccinology Course, November 2018.
[6] Data on file. (2019). Seqirus USA Inc.