$34 Million Funds Sixth Avian Influenza Pandemic Preparedness Award

As the United States continues reporting avian influenza cases in animals and people, the U.S. government is making another investment in pandemic prevention vaccines.

The emergence of highly pathogenic avian influenza (HPAI) H5N1 clade 2.3.4.4b viruses and their transmission to animals and humans poses a significant global public health threat. 

CSL Seqirus recently announced it had been selected by the Biomedical Advanced Research and Development Authority (BARDA) to fill and finish additional pre-pandemic vaccine doses as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS).

The NPIVS utilizes the HHS Influenza Risk Assessment Tool to identify and evaluate potential pandemic influenza virus threats.

Under the terms of the $34 million award, CSL Seqirus will deliver approximately three million finished doses of MF59®-adjuvanted H5N1 pre-pandemic vaccine and manufacture an additional lot of H5N8 antigen.

Recent evidence produced by the U.S. CDC indicates both the H5N1 strain and the H5N8 strain are similar to A(H5N1) strains circulating among U.S. dairy cattle. It suggests that both strains could induce protection in vaccinated people.

Avian influenza viruses do not usually infect humans; however, humans have been infected with them in rare cases.

The U.S. latest acquisition of a pre-pandemic vaccine will further supplement BARDA's stockpile of vaccines to support the U.S. government's pre-pandemic response to avian influenza. 

"Although the risk to Americans from influenza A(H5) virus infection remains low, we're leaning forward with our preparedness efforts," said BARDA Director and Deputy Assistant Secretary for Preparedness and Response Gary Disbrow, Ph.D, in a press release.

CSL Seqirus' manufacturing facility utilizes a highly scalable production method. It is positioned to deliver 150 million influenza vaccine doses within six months of a pandemic declaration to support an influenza pandemic response. 
  
"As a global leader in pandemic preparedness, this new award from BARDA emphasizes the value of collaboration in tackling global health threats as they emerge," said Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic, in a press release on October 4, 2024.

"We're proud to be a pandemic partner to over thirty governments globally and to do our part to help safeguard and protect public health." 

According to a Brief Communication published in July 2024 by Nature Medicine, the stockpiled US-licensed adjuvanted H5N1 vaccines generate cross-neutralizing antibodies against circulating HPAI H5N1 clade 2.3.4.4b in humans and may be helpful as bridging vaccines until updated H5N1 vaccines become available.

As of October 6, 2024, U.S. FDA-approved avian influenza vaccines, such as Audenz™, are not commercially available. Furthermore, the FDA says annual flu shots are unlikely to protect people during avian influenza (bird flu) pandemics.