A Vaccine for Probable Flu Pandemic Gets Approval from FDA

The world is currently suffering from a coronavirus outbreak and US health officials are preparing for a potential flu pandemic. The U.S. Food and Drug Administration (FDA) has recently approved Seqirus’ Audenz, which is a vaccine against a potential pandemic caused by the flu virus (H5N1).

Audenz is one of its kind, cell-based flu vaccine which is designed to provide complete protection from influenza (H5N1). This vaccine uses a combination of Seqirus’ MF59 adjuvant and an antigen, based on cell.

This vaccine is specially designed to protect US citizens from a flu pandemic.

Russel Basser, the chief scientist and head of R&D at Seqirus, shared an interview with BioSpace that the Audenz approval would be an advanced step from the company’s end to prepare for the possible flu pandemic.

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Audenz would be different from the standard flu vaccines available that are injected every year before the flu season hits. A typical influenza virus may cause extreme distress and lead to 10,000 deaths and leaves thousands of people in hospitals. A flu pandemic would be a huge problem because people might not consider a common thing like flu virus to cause a pandemic.

If true, this flu pandemic would be catastrophic and killing millions leading to the social and economic crises. The World Health Organization has issued a “Global Influence Strategy” during the 2019-2030 influenza pandemic, which if happened would cause a massive economic loss and productivity.

Basser mentioned the Spanish flu outbreak of the year 1918 which was caused by the H1N1 influenza virus. This virus affected nearly 500 million people around the globe. This HIN1 virus is different from H5N1 which is why Audenz vaccine was designed and developed.

The common name of the H5N1 flu virus is “bird flu” which is due to its high incidence in class avian. Usually, these types of viruses don’t affect humans but it is possible for them to infect them rarely. Even if this H5N1 virus was transmitted from person to person, this transmission could lead to a severe disease outbreak. About which the public health officials are concerned and ready.

This vaccine is developed with an MF59 adjuvant that is an immunity enhancer for humans. It is even helpful against viruses that have mutated themselves like a flu virus that is much likely to change every time. The addition of adjuvant limits the antigen amount which is typically required to initiate an immune response. By increasing the vaccine doses, more and more people can b protected from a flu pandemic.

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Audenz is developed by a joint venture of “Biomedical Advanced Research” and “Development Authority (BARDA)” which is a part of the “U.S. Department of Health and Human Services”.

Not many know that, Audenz is not the first product of Seqirus. Last year in December, the company published data which said that the adjuvanted trivalent flu vaccine is better than the standard non-adjuvanted trivalent flu vaccine.

Established in 2015, Seqirus is one of the biggest flu vaccine producers in the world. It has its production units in the United States., the United Kingdom. and Australia.