HOLLY SPRINGS – Seqirus, a manufacturer and provider of influenza protections including vaccinations with a Holly Springs facility, announced it had renewed a five-year partnership with the Biomedical Advanced Research and Development Authority (BARDA).

Seqirus, a is part of CSL Limited (ASX: CSL), received a nearly $35 million federal contract in 2021, and noted in a statement that renewing the contract agreement “further strengthens the U.S. Government’s pandemic readiness in the event of an influenza pandemic, the most likely future pandemic.”

According to the company, the agreement will also allow the company to scale up the cell-based manufacturing capabilities at its Holly Springs plant, which Seqirus is in the process of expanding.

Flu fight: Huge Holly Springs plant to house Seqirus’ big vaccine efforts

Preparing for future influenza pandemics

Under the terms of the agreement, BARDA will be able to request that Seqirus provide influenza vaccines and adjuvants “for pre-pandemic stockpiling or for manufacture to support rapid response to an influenza pandemic or other public health emergency,” during the contracted period.  According to a statement, Seqirus and BARDA have held similar agreements since 2006.

The company will be able to provide a supply of the AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), which it described as “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.”

That vaccine uses the company’s technology and its cell-based manufacturing platform, which is an alternative to traditional egg-based manufacturing, according to the company.

Seqirus noted that AUDENZ™ was approved in 2020 and received a supplemental FDA approval in 2021.

The company has developed other products as well.

Vaccine giant Seqirus plans $9M expansion at massive Holly Springs plant

Holly Springs Site Lead on Plant Expansion, BARDA deal

WRAL TechWire connected with Dave Sehgal, Seqirus vice president manufacturing and the site head for the Holly Springs facility, to discuss the renewal of the BARDA agreement and the current state of the company’s expansion in Holly Springs.  A lightly edited transcript follows.

WRAL TechWire (TW): What does the extension of the BARDA agreement mean for the company and for communities in the United States?

Dave Sehgal (Sehgal): Seqirus has a longstanding public-private partnership with BARDA which is the first in the world to establish cell-based technology as a highly scalable method of production. Seqirus is committed to partnerships with key stakeholders like BARDA to prepare for the significant risk of pandemic influenza.

The renewal of this multi-year contract with BARDA approves the offering of vaccines for the U.S. population in the event of an influenza pandemic, the most likely future pandemic. The agreement will allow BARDA access to pre-pandemic vaccines using either cell- or egg-based manufacturing technologies from Seqirus’ global network of production facilities, including Holly Springs, N.C.; Liverpool, United Kingdom; and Parkville, Australia.

TW: What’s the current understanding of the existing COVID pandemic and its variants – and this year’s influenza strains?

Sehgal: A continued focus on influenza vaccination is critically important, because the flu season is still upon us. Based on data we have seen from the 21/22 season, there was a shortage of immunizers as they were redirected from flu to COVID immunization. We are partnering with stakeholders across the influenza ecosystem to leverage best practices to continue to grow immunization rates in the 2022/23 season and maintain for future seasons, potentially alongside concurrent COVID-19 vaccination programs.

On February 25, the World Health Organization (WHO) announced the recommended influenza A and B strains for the 22/23 Northern Hemisphere season, which manufacturers will include in vaccines for next season.

TW: How has consumer behavior changed during the COVID pandemic and will these changes stay? Are such changes “good” or “bad” – how do we know? 

Sehgal: In preparation for the 2022/23 season, we need to work with our partners in flu protection to ensure we’re prepared for another concurrent flu and COVID-19 vaccination effort in the fall. During the 2021/22 season, the concurrent COVID-19 booster campaign caused a shortage of immunizers as they were redirected from flu to COVID immunization. Significant attention on COVID-19 contributed to flu vaccination apathy. We need to work with our partners at the CDC to align on one clear and specific immunization goal for flu to ensure we are moving closer to the Healthy People 2030 target of 70%.

TW: What’s the value to public health for a flu-vaccinated population?

Sehgal: Seasonal influenza preparedness directly supports pandemic influenza preparedness, and it is critical that the public understands the overall importance and benefits of seasonal influenza vaccination. If seasonal vaccination rates are high across a population, there will likely be a comparable uptake in pandemic vaccination. The best way to prevent the spread of seasonal influenza is by getting your annual flu vaccine – anyone ages 6 months and above is eligible for vaccination.

TW: Can you explain how the vaccine boosts the immune system, and why it works?

Sehgal: Vaccines are designed to help develop immunity by imitating an infection. This type of infection, however, rarely causes illness, but rather produces antibodies. The imitation causes a supply of “memory” cells to be left within the body, which then remembers how to fight that disease in the future.

The influenza vaccines manufactured each year are selected based on the WHO-recommended A and B strains using a cell- and egg-based process. In the cell-based manufacturing process, these viruses are grown in mammalian cells, which is designed to avoid the egg-based adaptation that may occur during the egg-based manufacturing process.

It is important to note that the risk of an influenza pandemic is ever-present, but it is difficult to predict so it’s critical to be prepared. A pandemic occurs when a new influenza virus emerges, which was not previously circulating among humans, infects humans and is spread from person to person across the globe. Seqirus is committed to partnerships with key stakeholders like BARDA to prepare for the significant risk of pandemic illness. In the event of a pandemic, BARDA would source vaccines from the Seqirus Holly Springs facility in North Carolina.

TW: What’s the latest with the company’s facility expansion, and how is hiring progressing?  

Sehgal: We are continuing to make progress on the expansion of our Holly Springs site, that will enable us to increase capacity for formulation, fill and finish manufacturing of cell-based and adjuvanted influenza vaccines for global markets.

We broke ground on this project in 2018 and expect it to be operational in time for the 2022/2023 Northern Hemisphere season.  The Holly Springs site currently has 700+ employees.

The Triangle is a competitive market for talent, particularly in the life sciences industry.

Overall, we are doing well in terms of attracting the talent that we need, but it is something we are continuously looking at.

People are key to our success and enable us to achieve our mission to improve public health.