If you live in Holly Springs, you may have heard of Seqirus. If you’ve lived in Holly Springs for more than a few years, you may have also heard of Novartis. If you haven’t heard either of those names, maybe you’re familiar with “that place in the industrial park that makes flu shots or something”.
As a Holly Springs resident, I was just as curious about the facility as many of my neighbors. I reached out to the good people at Seqirus, and they were kind enough to invite me to the facility to answer some of my questions, and to learn more about what they do.
For those of you that have no idea what I’m talking about, back in 2006, a facility was built in the Holly Springs Industrial Park that became, and still is, the largest facility and employer in Holly Springs. The Holly Springs facility features 475,000+ square feet of manufacturing space on a 185-acre site and employs approximately 550 full-time associates and another 140 contractors.
The Holly Springs site was selected in July of 2006, with a groundbreaking taking place in 2007. The facility was a jointly-funded project with the Human Health and Services Department (HHS) of the US Government. The project required an investment of over $600 million to become fully operational. In January of 2009, a $486 million contract was signed with the HHS.
Although Novartis was the company that started the process. in 2015, the parent company of Seqirus, CSL, acquired the business. Seqirus quickly won over the employees when they announced that there would be no layoffs, and that their compensation package would remain intact since the new company didn’t want to break up the team. The employees I spoke with are happy with the new owners. “I like that they listen to us to make changes. They keep us in the loop as to what’s going on ‘upstairs’. They also listen to our suggestions. A recent survey went out, and once they were collected, the company started to make adjustments almost immediately to address concerns that were brought up in the surveys,” said 8- year employee LaToya McDuffie.
Seqirus is not only the top tax payer for Holly Springs, but they do a lot for the community. Since about half the people that work at Seqirus live in Holly Springs, there are strong ties to the community, and staff is encouraged to give back to the community. They have organized food drives for the Holly Springs Food Cupboard, helped volunteer at the Kraft YMCA, and have taken part in volunteering all over Holly Springs. The campus holds an annual “Benefits Fair” where they invite local businesses to come and increase their exposure to the 700+ people working at the campus.
Seqirus has recently made an announcement that you may have seen in the last issue of the magazine. The company has announced a $9 million expansion in order to increase output of the vaccine. They hope to eventually triple current production. According to Dr. John Anderson, the Site Head for the Holly Springs facility, they plan to hire local contractors for the expansion whenever possible. The expansion will also allow the company to hire more employees as well as bring more business to the local economy during the construction process. Dr. Anderson prefers to hire employees from the area whenever possible. His logic is simple. If you hire locally, the chance they will stay at the company increases dramatically. The increased production will enable Seqirus to not only serve the US better, but even help markets outside the US, and eventually the Southern Hemisphere. Since their peak flu season is the 6 months that ours isn’t, it will keep the facility busy all 12 months.
I spoke to David Minella, Communications Manager for Seqirus, about the widespread flu season this year, and the company capitalizes when the flu is worse. “Unlike Big Pharmacy, we’re not in it for the money. It’s a labor of love. Our staff has great pride in knowing that they are helping people stay healthy, and helping to prevent the spread of this sometimes-deadly virus. If you’re looking to make money in pharmaceuticals, you don’t go into making the flu vaccine. You can get a flu shot without insurance for about $31.”
Although my goal within this article isn’t to make Holly Springs the most knowledgable community in the country about the flu vaccine, I do want to share some of the details in order to help you understand why the Holly Springs facility is so important not just to our community, but the country, and ultimately the world.
Seqirus’ state-of-the-art vaccine producing facility in Holly Springs uses a novel cell culture-based process as an alternative to traditional egg-based influenza vaccine production, and gives Seqirus vital additional capacity, particularly in the event of a pandemic. Should there be a pandemic of the flu, the Holly Springs facility will respond by manufacturing 200 million doses in a 6-month timeframe. The expansion will help them to be able to achieve that target should a flu pandemic break out.
‘Cell-based’ refers to how the flu vaccine is made. A cell-based flu vaccine is made by growing viruses in animal cells, which is a different manufacturing process than the traditional egg-based manufacturing process that is used to produce most flu vaccines. While the production processes are similar, a significant difference is that the influenza viruses used in the cell-based vaccine are isolated and grown in cultured cells of mammalian origin instead of in hens’ eggs.
A cell-based flu vaccine was developed as an alternative to the egg-based manufacturing process. Cell culture technology is potentially more flexible than the traditional technology, which relies upon adequate supply of eggs. In addition, the cell-based flu vaccine that uses cell-based candidate vaccine viruses (CVVs) has the potential to offer better protection than traditional, egg-based flu vaccines as a result of being more similar to flu viruses in circulation.
The cell-based vaccine manufacturing process is different than the traditional egg-based manufacturing process. In place of fertilized chicken eggs, the cell-based vaccine manufacturing process uses animal cells in liquid culture as a host for the growing influenza virus. In the past, the FDA required that egg-isolated candidate vaccine viruses be used in the production of flu vaccine. However, on August 31, 2016, the FDA approved the use of cell-isolated candidate vaccine viruses in the production of Flucelvax, the only licensed cell-based flu vaccine in the United States.
What is the significance of the FDA approving cell-based candidate vaccine viruses for use in the Flucelvax cell-based flu vaccines? Growing influenza viruses in eggs can introduce changes (i.e., egg-adapted changes) that can have important implications for the body’s immune response to vaccination. For example, these egg-adapted changes could cause the body’s immune system to produce antibodies that are less effective at preventing disease caused by the specific flu viruses in circulation. FDA approval of cell-grown CVVs will reduce egg-adapted changes and may result in vaccines containing virus that is more “like” wild-type circulating viruses. Therefore, the FDA’s approval of cell-based candidate vaccine viruses has the potential to improve the effectiveness of cell-based flu vaccines.
A major advantage of cell culture technology includes the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic. The cells used to manufacture Flucelvax are kept frozen and “banked.” Cell banking assures an adequate supply of cells is readily available for vaccine production. Growing the influenza viruses in cell culture for the manufacture of Flucelvax is not dependent on an egg supply. Also, as described above, cell-based flu vaccines that are produced using cell-based candidate vaccine viruses have the potential to improve the effectiveness of cell-based flu vaccines (compared to egg-based flu vaccines) by eliminating the kinds of egg adaptations that occur in egg-manufactured flu vaccines. (Information from the CDC website)
Cell-based influenza technology requires the use of what’s known as MDCK cells. These cells come from a common cell line used in biomedical research and manufacturing. The cell line was first isolated in 1958 and identified as a suitable influenza virus host in the 1970s. The cell line has lived on and been able to propagate in culture since its initial isolation, so, while the cells are animal in nature, animals have not been involved in the cell acquisition for over half a century.
The Holly Springs site is the largest cell culture-derived flu vaccine facility in the world, including antigen production and pre-filled syringe capacity. Last year the facility was able to output over 25 million doses of the vaccine.
The Holly Springs site also houses Seqirus’ advanced research and development facility, exploring the connection between antigens, their combinations and the vaccine formulations and ensuring the safety and efficacy of vaccines in development.
Seqirus partners with the North Carolina Biotechnology Center to transform North Carolina’s life science opportunities into economic prosperity through innovation, commercialization, education and business growth.
Seqirus is also a partner with North Carolina State University’s Biotechnology Education Center (BTEC) program, BioNetwork’s community college program and other university programs across the country to build a source of talent for future positions.
Q & A
Q. Do the vaccines contain the live virus?
A. Although some vaccines carry trace amounts of the live virus within the formula, Influenza (The Flu) vaccine is not one of them. In the process at Seqirus, not only does the vaccine not carry a deactivated version of the virus, it breaks it down at the cell level, and only uses the proteins from the outside layer of the deactivated virus. The bottom line is that it is biologically impossible to get the flu from the vaccine.
Q. Why is it being reported that the vaccine is as little as 10% effective?
A. The vaccine protects against more than one strain of the virus. The vaccine protects against all four strains. From the four strains, there are four different vaccines, which are blended into one vial for your flu shot.
Every February, the World Health Organization (WHO) and the Center for Disease Control (CDC) release their list of which four strains pose the highest risk to the public. The list comes from data that has been gathered from all over the world, analyzed, and then released to Seqirus, as well as the other vaccine manufacturers throughout the world. The manufacturers take that data, and the viruses, and use that to create the vaccines. With that said, don’t blame Seqirus if the shot is less effective one year as opposed to another. They are following the very specific instructions from the CDC as to what they need to manufacture.
The virus does have the ability to mutate over time, and that can cause the vaccine to be less effective. It’s important to know that the vaccine, which you could go get today, was manufactured mid-2017. The last vial leaves the facility in August for the upcoming season.
Although the vaccine is sometimes not 100% effective at fighting the flu, it will curb even the most aggressive attack. With the vaccine, you may be sick for 2-3 days, as opposed to the same exposure without the vaccine, could put you down for 2-3 weeks….or worse.
Q. How long does the shot defend against the flu virus?
It takes about two weeks before the vaccine can build the full resistance to the virus. If you get the shot, then get the flu within a few days, you were most likely sick when you got the shot, but were not yet showing the symptoms.
Q. Is there any scenario where the live virus can leave the facility?
The short answer is no. The virus is cultivated in a 100% contained environment, and there are multiple fail-safes in place to make sure the virus stays where it belongs. The HHS closely monitors these facilities, and there are strict guidelines that have to be followed. There are also quarterly visits from the governing body to ensure that the facility is adhering to the guidelines.
Q. When is the best time to get the flu shot?
September and October are the best months to get vaccinated.
It’s best to get it before the height of flu season for obvious reasons.
Q. How long once vaccinated does the immune system protect against the virus?
Once the vaccine is in your system, it should protect you for at least 6 months. Strong immune systems will allow the vaccine to last for a longer period – even up to a year. The reason that you should get a flu shot annually is because it does wear off, and the virus can mutate from year to year.
Q. Why is there a shortage of the vaccine?
A. Roughly the same amount of the vaccine is created and shipped every year. The shortage is a simple case of supply and demand. Since the flu is more prevalent this year, more people are going to get vaccinated. The supply that was sufficient when ordered last year by the pharmacists, is insufficient this year due to demand. It is NOT that the facilities can’t keep up. Remember that the vaccines that you’re getting now, were all shipped last August.
Q. How does the facility affect the environment and the air quality in Holly Springs?
A. The facility has no effect on the local environment and no more air-pollution than any other building of the same size. Biohazard byproducts are shipped offsite as they are with a hospital or other facility following strict guidelines.
The visit was an eye opener for me, and hopefully I’ve taken most of the mystery out of the facility for you. If you have not yet gotten a flu shot, go get one. Although it’s late in season, it’s still the season for another three months. Most insurance companies cover the shot 100%. Make the time to get vaccinated. It’s a lot better than being down for weeks.
