FDA Approves Audenz For Influenza A Virus H5N1 Subtype
HPAI H5N1 virus is one of the most deadly flu strains known
Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted), developed by Seqirus, has been approved by the FDA. The product is indicated for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. It is administered via intramuscular injection and requires two doses (0.5 mL each) spaced at 21 days apart.
Audenz is a welcome addition to the global vaccine family. Of the few avian influenza A viruses hurdling the species barrier to infect humans, Asian HPAI H5N1 virus has caused the largest number of detected cases of severe disease and death in humans. The virus attacks respiratory systems in people creating significant stress on breathing functions including respiratory failure and pneumonia.
The majority of human infections with Asian HPAI H5N1 are children and adults younger than 40 years old. Mortality has been highest in people aged 10–19 years old and in young adults. HPAI Asian H5N1 virus is considered endemic in poultry in six countries (Bangladesh, China, Egypt, India, Indonesia, and Vietnam), although other nations and regions have experienced outbreaks.
Seqirus on a roll with 2 vaccines approved in 2020
Seqirus, based in Maidenhead, UK is a business unit of CSL Limited which is headquartered in Melbourne, Australia. CSL acquired the flu vaccine business of Novartis in 2014 for about $275 million and made it a core element of Seqirus. With a U.S. main office in Cambridge, Massachusetts, the company has had a robust 2020, in addition to Audenz, Seqirus had its Fluad Quadrivalent (Influenza Vaccine, Adjuvanted) for adults 65 years and older approved recently.
Seqirus has proven vaccine expertise and an extensive portfolio of flu vaccines and other products
The parent company of Seqirus, CSL (originally known as Commonwealth Serum Laboratories) has a rich history in vaccines and medicines dating back to 1916. Seqirus has 3 flu manufacturing facilities (Australia, United States and the UK); the capacity of its U.S. plant, located in Holly Springs, North Carolina has a 6-month capacity of 150 million doses. In addition to antivenoms and Q Fever vaccines, Seqirus produces these flu immunization products:
- Afluria Quadrivalent (also marketed as Afluria Quad and Afluria Tetra)
- Afluria (also marketed as Enzira, Fluvax or Nilgrip)
- Agrippal (also marketed as Begripal, Fluazur, Sandovac, Agriflu, Chiroflu)
- Fluad (also marketed as Chiromas)
- Fluad Pediatric
- Flucelvax Quadrivalent
- Rapivab
Seqirus is engaged in the battle against COVID-19
Being a global leader in the development and manufacturing of immunizations, Seqirus is involved in the exploration of a vaccine for COVID-19. One of their initiatives concerning COVID-19 involves their collaboration with the University of Queensland (AUS) which includes donating their proprietary adjuvant technology (MF59) to the university’s pre-clinical development program.
As a business unit of CSL, Seqirus is a growing company in an expansive organization
CSL (ASX: CSL) focuses on developing new biopharmaceutical agents especially those for rare diseases. Its product portfolio and pipeline encompass:
- Cardiovascular
- Hematology
- Immunology
- Metabolic
- Neurology
- Respiratory
- Thrombosis
- Transplant
- Vaccines
CSL and Seqirus enrich the spectrum of innovation in healthcare and the development of new advanced medications. Generating almost $9 billion in annual sales, CSL employs over 20,000 associates worldwide. The company has all the essential attributes in place to develop more breakthrough therapies in the future.
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