CSL (ASX:CSL) share price higher on US FDA flu vaccine news

CSL’s shares are on form on Wednesday…

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The CSL Limited (ASX: CSL) share price is pushing higher on Wednesday morning.

At the time of writing, the biotherapeutics company’s shares are up 1% to $319.78.

Why is the CSL share price rising?

The catalyst for the rise in the CSL share price this morning appears to have been the release of an announcement relating to its Seqirus business.

According to the release, the US Food and Drug Administration (FDA) has granted supplemental approval of a multi-dose vial (MDV) formulation of Audenz. This is the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.

Audenz was originally approved by the FDA in a single dose, prefilled syringe (PFS) presentation in 2020.

Management notes that FDA approval of the MDV presentation of Audenz marks an important milestone in Seqirus’ pandemic preparedness efforts in partnership with Biomedical Advanced Research and Development Authority (BARDA).

BARDA is a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS).

Under the terms of the public-private partnership, which was established in 2009, Seqirus would position itself to deliver 150 million influenza vaccine doses to the U.S. government to support an influenza pandemic response within six months.

Seqirus executive director Marc Lacey commented:

Producing AUDENZ in multi-dose vials allows for increased speed and efficiency, which is absolutely critical to help protect public health in the case of an influenza pandemic.

According to the CDC, the influenza A(H5N1) virus is highly pathogenic and has high pandemic potential, so it’s critical to be prepared. Seqirus is committed to partnering with key stakeholders to develop adequate and effective influenza pandemic preparedness plans.

What is pandemic influenza?

While similar to seasonal influenza, pandemic influenza is a contagious airborne respiratory disease which is unpredictable in timing and severity and has a higher risk of morbidity and mortality.

This is because there is likely to be little or no pre-existing immunity to the virus in the human population.

CSL notes that four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history and estimated to have killed up to 50 million people worldwide. As such, this makes the work Seqirus is doing extremely important for the global population.

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