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Seqirus is First-to-Market with U.S. 2019/20 Influenza Vaccines


SUMMIT, N.J., July 15, 2019 /PRNewswire/ --

Seqirus, a global leader in influenza prevention, announced today it is first-to-market with shipping its portfolio of seasonal influenza vaccines to customers in the United States for the 2019/20 influenza season. Seqirus expects to distribute over 50 million doses to the U.S. market this year, with the majority of doses coming from its adjuvanted and cell-based technology platforms.

The company will provide FLUAD® (Influenza Vaccine, Adjuvanted), the first-and-only adjuvanted seasonal influenza vaccine developed for people aged 65 and older2,3,4; and FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the most widely available cell-based influenza vaccine in the country, available for those aged four and older.5

FLUCELVAX® QUADRIVALENT was manufactured for the 2019/20 influenza season using cell-based candidate vaccine virus (CVV) for all four influenza strains recommended by the World Health Organization (WHO).6,7

Seqirus, the world's largest cell-based influenza vaccine manufacturer, produces influenza vaccines across its global manufacturing network of three manufacturing facilities, all of which are fully dedicated to producing influenza vaccines. The Seqirus manufacturing network includes a state-of-the-art facility in Holly Springs, North Carolina. This facility utilizes cell-based technology and was built in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support pandemic preparedness.8

"As the only global vaccine company solely dedicated to the prevention of influenza, Seqirus is proud to bring our broad portfolio of innovative vaccines to customers as part of our leading role on the front line of influenza prevention," said Brent MacGregor, Senior Vice President, Commercial Operations at Seqirus. "We work closely with partners all year long to build on our track record of reliable supply, and we're proud to be the first influenza vaccine manufacturer to ship product to the U.S. market during this influenza season."

The Seqirus 2019/20 influenza vaccine portfolio also includes AFLURIA® QUADRIVALENT (Influenza Vaccine), an egg-based quadrivalent influenza vaccine. The complete portfolio of influenza vaccines provides a range of options for people six months of age and older, four years of age and older, and 65 years of age and older, presented in pre-filled syringes as well as multi-dose vials.2,5,9

Seqirus also distributes Rapivab® (peramivir injection), the only one-dose intravenous antiviral treatment for acute uncomplicated influenza for people two years of age and older.10-12

"Vaccination can save millions of people," said Gregg Sylvester, M.D., Vice President of Medical Affairs at Seqirus.1 "In recent years, we have introduced vaccine technology designed to deliver on our commitment to protect people and communities from seasonal influenza."

About Seasonal Influenza 
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. To reduce the risk of more serious outcomes, such as hospitalization and death, resulting from influenza, the CDC encourages annual vaccination for all individuals aged 6 months and older. Because transmission to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death. The CDC estimates that 959,000 people in the United States were hospitalized due to influenza-related complications during the 2017-2018 influenza season. Since it takes about 2 weeks after vaccination for antibodies to develop in the body that protect against influenza virus infection, it is best that people get vaccinated to help protect them before influenza begins spreading in their community.

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 visit www.seqirus.com and www.csl.com.

SEQIRUS, FLUAD, FLUCELVAX, AFLURIA, and RAPIVAB are trademarks of Seqirus UK Limited or its affiliates.

All other trademarks referenced herein are property of their respective owners.

MEDIA CONTACT
Polina Miklush 
+1 (908) 608-7170
[email protected] 

FLUAD® (Influenza Vaccines, Adjuvanted) Important Safety Information

Indication

FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older.

Contraindications

Warnings and precautions

Adverse reactions

Please see the accompanying important safety information and the full prescribing information for FLUAD.

FLUAD is a registered trademark of Seqirus UK Limited or its affiliates.

FLUCELVAX® QUADRIVALENT (Influenza Vaccine) Important Safety Information

Indication

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

Warnings & Precautions

Most Common Adverse Reactions

Please see accompanying important safety information and the full prescribing information for FLUCELVAX QUADRIVALENT.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

AFLURIA® QUADRIVALENT (Influenza Vaccine) Important Safety Information

Indication

AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older.

Contraindications

Warnings and precautions

Adverse reactions

The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions:

Please see the accompanying important safety information and the full prescribing information for AFLURIA QUADRIVALENT.

AFLURIA is a registered trademark of Seqirus UK Limited or its affiliates.

RAPIVAB® (Peramivir Injection) Important Safety Information

Indication

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.

Limitations of Use

Contraindications

RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome.

Warnings and Precautions

Adverse Reactions

The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% RAPIVAB vs 7% placebo). Lab abnormalities (incidence ?2%) occurring more commonly with RAPIVAB than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%), and neutrophils <1.0 x 109/L (8% vs 6%). In a subset of subjects with serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy (N=101), the following adverse reactions were also reported more frequently with RAPIVAB as compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased (3% versus 2%), and hypertension (2% versus 0%).

The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to that observed in adults. Specific adverse reactions reported in pediatric subjects treated with RAPIVAB (occurring in ?2% of subjects) and not reported in adults included vomiting (3% versus 9% for oseltamivir), fever and tympanic membrane erythema (2% versus 0%, respectively, for each of these events). The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in ?2% of pediatric subjects treated with RAPIVAB was proteinuria by dipstick analysis (3% versus 0% for oseltamivir).

Concurrent Use With Live Attenuated Influenza Vaccine

Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and thus may reduce vaccine efficacy). The concurrent use of RAPIVAB with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of RAPIVAB within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.

Please see the accompanying important safety information and the full prescribing information for RAPIVAB.

US/CORP/0719/0151

References

1.  CDC. "Key Facts About Seasonal Flu Vaccine." Retrieved from: https://www.cdc.gov/flu/prevent/keyfacts.htm. Accessed July 2019.
2.  FLUAD [package insert]. (2018) Summit, NJ. Seqirus USA Inc.
3.  CDC. "Flu Vaccine with Adjuvant." Retrieved from: https://www.cdc.gov/flu/prevent/adjuvant.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fflu%2Fprotect%2Fvaccine%2Fadjuvant.htm. Accessed July 2019.
4.  Tsai, T. Fluad®-MF59®-Adjuvanted Influenza Vaccine in Older Adults. Infection & Chemotherapy. 2013;45(2): 159-174.
5.  FLUCELVAX QUADRIVALENT [package insert]. (2018) Holly Springs, NC. Seqirus USA Inc.
6.  WHO. (2019). Addendum to the recommended composition of influenza virus vaccines for use in the 2019?2020 northern hemisphere influenza season. Retrieved from: https://www.who.int/influenza/vaccines/virus/recommendations/201902_recommendation_addendum.pdf?ua=1. Accessed March 2019.
7.  Data on file. (2019). Seqirus USA Inc.
8.  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, HHSO100200900101C and HHSO100201200003I.
9.  AFLURIA QUADRIVALENT [prescribing information]. Parkville, AU: Seqirus, Inc. 2018.
10.  RAPIVAB (Peramivir Injection) [prescribing information]. Durham, NC: BioCryst Pharmaceuticals, Inc. 2018.
11.  Kohno S, Kida H, Mizuguchi M, Shimada J; S-021812 Clinical Study Group. Efficacy and safety of intravenous peramivir for treatment of seasonal influenza virus infection. Antimicrob Agents Chemother. 2010;54(11):4568-4574.
12.  CDC. "What You Should Know About Flu Antiviral Drugs." Retrieved from: https://www.cdc.gov/flu/antivirals/whatyoushould.htm. Accessed July 2019.

SOURCE Seqirus


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