CSL Seqirus announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), selected CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study that is anticipated to begin in Q2 2023.
This agreement is the third award that CSL Seqirus has received from BARDA in the last twelve months, following an April 2022 award to produce an H5N8 A/Astrakhan cell-based synthetic influenza Working Seed lot, as well as a separate October 2021 award to develop one influenza A(H2Nx) vaccine virus candidate utilizing its cell-based and adjuvant technologies, and clinically assessing both the cell-based as well as its next-generation self-amplifying mRNA platform, further underscoring the importance of public-private partnerships in bolstering pandemic preparedness.
Over the past year, outbreaks of highly pathogenic avian influenza (HPAI) A(H5) viruses among wild and farmed birds, as well as commercial poultry, have been reported in the U.S.1 and other parts of North America, as well as across Africa, Asia and Europe.2 BARDA has requested the manufacture and clinical assessment of the H5N8 vaccine candidate to support its pandemic preparedness program.
"Certain influenza strains such as avian flu present a serious pandemic risk, and governments, regulatory agencies, and vaccine manufacturers must take measures to ensure proper and rapid response," said Jonathan Edelman, MD, Vice President, Vaccines Clinical Development, Interim Head, CSL R&D Seqirus Vaccines Innovation Unit. "For influenza, this preparation begins with clinical trials to test that a vaccine candidate provides a sufficient level of immunogenicity against the strain of interest, and partnerships with governments guide our decision making as we progress these candidates through the research and development phase."
Under the terms of the $30.1 million agreement, CSL Seqirus will deliver an H5N8 A/Astrakhan virus vaccine candidate and will then sponsor a subsequent Phase 2 clinical trial to evaluate the candidate along with CSL Seqirus' proprietary adjuvant MF59®. MF59 has been successfully combined with other influenza strains in vaccines to boost immune response, as well as to accelerate manufacturing output.3 The Phase 2 trial will assess the safety and immunogenicity of this vaccine. Additionally, the study will examine homologous and heterologous boosting after six months, as well as the use of heterologous priming pairs (H5N8 A/Astrakhan and H5N6 A/Guangdong).
CSL Seqirus will harness its cell-based influenza technology, building on the platform technology used by FDA-approved AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), at the company's Holly Springs, North Carolina, facility, which was built in partnership with BARDA, to manufacture the required bulk vaccine. The H5N8 vaccine will then be filled into pre-filled syringes (PFS) to support the Phase 2 clinical study.
"When faced with a public health threat like highly pathogenic avian influenza, governments make plans to protect the population, which takes both time and a substantial collaborative effort with industry," said Marc Lacey, Executive Director, Pandemic Response Solutions, CSL Seqirus. "For more than a decade, CSL Seqirus has demonstrated its ability to come to the aid of government partners to prepare for and rapidly respond to emerging pathogens of concern, and we are able and ready to do so again for avian influenza."
CSL Seqirus has been working together with BARDA in a longstanding partnership for more than a decade, which has included numerous R&D and manufacturing activities in support of BARDA's pandemic preparedness objectives:
- In 2006, in partnership with BARDA, facilities currently owned by CSL began developing candidate vaccine viruses against different pre-pandemic strains.
- In 2013, when a novel influenza H7N9 strain emerged, synthetic seed processes developed in partnership with BARDA were used to initiate the production of CSL Seqirus' cell-based candidate vaccine.
- In October 2021, BARDA selected CSL Seqirus to develop one cell-based influenza vaccine candidate and clinically evaluate two influenza A(H2N3) virus vaccine candidates.
- In February 2022, CSL Seqirus was awarded the renewal of a five-year agreement with BARDA to provide pre-pandemic and pandemic goods and services, including influenza vaccines and adjuvants for stockpiling or clinical assessment, to ensure proper preparedness for an influenza pandemic or other public health emergency.
- Most recently, in 2022, the Holly Springs facility was recognized by BARDA as having successfully achieved all criteria required to establish domestic manufacturing capability for innovative cell-based seasonal and pandemic influenza vaccines.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122D00004.
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