2020-02-05| R&DTrials & Approvals

Seqirus’ AUDENZTM, a Vaccine against Potential Flu Epidemic Gets FDA Approval

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Seqirus’ AUDENZTM, a vaccine for a potential pandemic associated with the H5N1 flu virus commonly known as “bird flu” was approved by FDA on Monday. AUDENZ is designed to be rapidly deployed to protect the U.S. population and can be stocked for the first responders in case of a pandemic.

What is the Need for an H5N1 Pandemic Vaccine?

History has taught us many lessons. In 1918, 500 million people got infected and 50-100 million people died of Spanish flu. Even now, every year, 10000 or more people die and hundreds of thousands get hospitalized due to seasonal influenza. If an outbreak of the scale of Spanish flu were to happen today, it will result in a catastrophe that will be difficult to recover from both socially and economically. As stated by the WHO global Influenza strategy for 2019-2030, a severe flu pandemic would result in a loss of national economic productivity as well as severe economic burdens on affected citizens and communities.

But the question is, can the H5N1 virus cause pandemic? The answer is yes. The H5N1 virus is avian borne but it can spread to humans on rare occasions. It is well known that viruses are rapidly evolving organisms. Therefore, bird flu can become easily transmissible from person to person and cause bird flu pandemic.

What is AUDENZ?

Designed to protect from influenza A (H5N1), AUDENZ is the first cell-based influenza vaccine, which is made by combining Seqirus’ MF59 adjuvant and cell-based antigen manufacturing. The advantage of adjuvant-based vaccine is two-fold. Firstly, it enhances antibody production against mutated virus strains and secondly, it reduces the amount of antigen required to produce an immune response. An adjuvant-based vaccine even when given in small amounts can create a big impact on the body. This advantage is particularly useful when it comes to manufacturing vaccines. Since the amount of vaccine needed is small, a large number of doses of the vaccine can be developed helping a large number of people at the same time during the pandemic.

Who Developed AUDENZ?

AUDENZ is developed by Seqirus in collaboration with Biomedical Advanced Research and Development Authority (BARDA), which is a part of the U.S. Department of Health and Human Services. In this multi-year public-private partnership, Seqirus plans to stockpile the vaccine by using the facilities built and developed through the collaboration with BARDA. Director of BARDA, Rick Bright proudly mentions that the approval of AUDENZ would help the country achieve the security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine.

What is in the Future for Seqirus?

Seqirus is one of the largest providers of flu vaccines in the world, which was formed in 2015 after Australia based CSL limited acquired Novartis’ influenza vaccine business. The company has production facilities in the U.S., the U.K., and Australia. Besides, AUDENZ, the company is also working on the development of Fluad, an adjuvanted trivalent influenza vaccine. Seqirus’ partnership with BARDA gives it a unique position to manufacture cell-based vaccines on a large scale.

In the words of Russel Basser, chief scientist and head of research and development at Seqirus. “AUDENZ is a key advance for the company and the nation in preparation for an influenza pandemic. This is part of our commitment to protect the U.S. community at large from flu pandemic”.




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