How SC companies played a key role in testing and implanting the COVID-19 vaccine

As the distribution of COVID-19 vaccines has increased in recent weeks, life sciences companies in South Carolina have endeavored to play a role in the vaccination campaign.

After weeks of just 60,000 doses allocated in January, that number has doubled with more than 130,000 first doses expected to arrive in South Carolina this week.

The brands are well-known – Pfizer, Moderna, Johnson & Johnson – but lesser-known companies have played a role in clinical trials and auxiliary supplies essential for the vaccine’s launch and some are found in the state of Palmetto.

Governor Henry McMaster celebrated SCBIO, a nonprofit life sciences organization, and the industry in February for its big year. Part of that success was in response to COVID-19.

“While 2020 will forever be remembered as the year of a ruthless global pandemic, our stakeholders heroically took up the challenge,” wrote Sam Konduros, SCBIO’s president and CEO, in the 2020 nonprofit’s report.

SCBIO and more than 100 companies in the sector supported pandemic efforts, such as the distribution of personal protective equipment – which includes the creation of an online PPE exchange portal – the creation of a job portal, testing and promoting the proper use of masks on the social networks.

That list now includes research and packaging for COVID-19 vaccines and, potentially, their production.

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Clinical trials vital to vaccine development

The Modern vaccine was authorized for emergency use on December 18, after clinical trials have proven its efficacy and safety. VitaLink, a research firm based in Greenville, played an important role in Moderna’s phase 3 tests.

South Carolina had four Modern Phase 3 clinical trial sites among nearly 100 sites across the country. Three test sites – Anderson, Greenville and Spartanburg – were conducted by VitaLink Research, a South Carolina-based research firm specializing in respiratory medicine.

“It was really a natural fit for us,” said Steve Clemons, CEO and President of VitaLink.

Clemons expected about 400 participants at the three locations, but Upstate had about 1,200 of the 30,000 participants registered across the country.

“There should be a lot of pride in Upstate because, frankly, we, like VitaLink, couldn’t have done it without the volunteers,” said Clemons.

Participants were enrolled in the summer and received the drug or a placebo.

One such participant was George Acker, who has since heard from The News in November that he received the placebo – much to his surprise.

The studies were not blinded in January and those who received the placebo were able to obtain the real vaccine.

Acker has received both shots since then.

VitaLink continues to conduct monthly follow-ups with participants for two years to track the side effects, safety and efficacy of the vaccine.

Nearly 400,000 doses of the Moderna COVID-19 vaccine have been administered in South Carolina in the past three months.

The Moderna product played a vital role in vaccinating residents and employees of long-term care facilities, since the initial allocations were given to these populations.

Clemons is proud that VitaLink has played a role in solving the pandemic, but also in its work in general.

“I can treat people every day using, like, tomorrow’s therapies,” said Clemons. “And I get paid to do that and patients are never charged.”

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Pfizer vaccine packaging

The Pfizer-BioNTech vaccine requires deep-frozen storage, around minus 70 degrees Celsius. This makes shipping a little more challenging, but a local packaging company had the solution.

Softbox Systems, a British company based in North America in Greenville, has more than two decades of experience in thermal shipments.

They provide ultra-cold temperature senders that keep vaccines between -90 and -60 degrees Celsius for at least ten days closed with the use of dry ice and isolation. If well administered, these reusable containers can store vaccines for about a month, freezing the dry ice.

“[Softbox] immediately understood the unprecedented task that faced us with the distribution of the vaccine, “said Tanya Alcorn, vice president of global biopharma supply chain at Pfizer, in a March 10 press release.” And he quickly started working with us to develop a unique packaging system that won’t waste any precious vaccines and create a perfect customer experience. “

One of the two manufacturing centers to support the distribution of the vaccine is located in Greenville, the other is in the Netherlands.

“Our Americas headquarters in Greenville has a complete qualification test lab, product engineering resources and a world-class team,” said John Hammes, general manager of Softbox for the Americas. “All of this helped us to support Pfizer in the fight against COVID and to develop a way to successfully distribute a vaccine to support the global community.”

Vaccines may be filled soon at Lowcountry

Lou Kennedy did not expect his company to fill vaccines, but she also did not plan the pandemic – no one did.

In addition to helping with COVID-19’s testing efforts, she thought Nephron Pharmaceuticals could go a step further and help with vaccinations.

“We already have the type of equipment in our possession, we are going to have it refurbished,” said Kennedy. “We are going to build a ward and it is our sincere desire to find a vaccine partner – like Moderna, Pfizer or Johnson & Johnson – and to say, we are going to fill some of the capacity that the American patient needs.”

The Lexington County-based company is currently undergoing a $ 215 million expansion that includes a 110,000 square foot vaccine production space. Kennedy expects at least 380 new jobs with the expansion.

About 300 of them could be focused on vaccine production and she hopes to partner with a vaccine manufacturer COVID-19 to fill vaccines and help increase vaccine supplies.

Nephron is currently working to find a vaccine partner. It could be Moderna, Pfizer, Johnson & Johnson or it could be another brand that receives authorization in the United States, Kennedy said.

“Between now and the moment we move there, there may be ten new ones, so we are keeping our eyes and ears open,” said Kennedy.

They have already hired about half the people they need. The building is still being renovated, but once it is completed, Kennedy believes the production lines may be operational in the summer.

The expansion, originally announced in July, will also include a new office, a new warehouse, expanded secondary packaging operations and a 20,000-square-foot machine shop.

In the meantime, Nephron Pharmaceuticals has already partnered with Dominion Energy to create a drive-thru vaccination site in Lexington County in February.

“I came up with this idea because we can’t help with vaccination,” said Kennedy. “We have nurses on the team and we have [doctors of pharmacy]. “

Dominion Energy provided the space and set up a temporary power pole for Nephron’s nurses and staff. They also enlisted the help of Rick Lee, a member of the board of the Rock Hill Department of Environmental Control, on how best to set up a drive-thru clinic.

Like healthcare systems across the state, Nephron is running this clinic from its own pocket. Vaccines and ancillary supplies are provided by the government, but personnel and other costs are not.

“We are not being reimbursed for any of this,” said Kennedy. “We are doing this from the bottom of our hearts.”

The drive-thru site increased from about 30 vaccinations a day when it opened to about 150 vaccinations a day in March. Kennedy expects to get up to 300 a day.

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