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  • sam patrick posted an article
    SCBIO, 3 life sciences companies highlighted in media reports see more

    Courtesy Greenville News/Gannett

    As the distribution of COVID-19 vaccines have ramped up in recent weeks, life science firms in South Carolina have pivoted to play a role in the vaccination campaign.

    After weeks of only 60,000 dose allocations in January, that figure has doubled with over 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 the clinical trials and ancillary supplies critical to the rollout of the vaccine and some are found in the Palmetto State.

    Gov. Henry McMaster celebrated SCBIO, a life sciences non-profit, and the industry in February for their great year. Part of that success was in response to COVID-19.

    "While 2020 will forever be remembered as the year of an unmerciful global pandemic, our stakeholders heroically rose to the challenge," Sam Konduros, SCBIO's president and CEO, wrote in the non-profit's 2020 report.

    SCBIO and over 100 industry firms supported pandemic efforts such as distribution of personal protective equipment — which includes creating an online PPE exchange portal — creation of a jobs portal, testing and promoted proper mask use on social media.

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

     

    Clinical trials vital to vaccine development

    The Moderna vaccine was authorized for emergency use on Dec. 18 after clinical trials proved its effectiveness and safety. VitaLink, a Greenville based research company, played an important role in Moderna's phase 3 trials.

    South Carolina had four Moderna phase 3 clinical trial locations out of the nearly 100 locations around the country. Three trial locations — Anderson, Greenville and Spartanburg — were conducted by VitaLink Research, a South Carolina based research company which specializes in respiratory medicine.

    "It really was just a natural fit for us," Steve Clemons, VitaLink's CEO and president, said.

    Clemons expected roughly 400 participants through the three sites but the Upstate had roughly 1,200 of the 30,000 enrolled participants nationwide.

    "There should be an awful lot of pride to the Upstate because, frankly, we as VitaLink couldn't have done this without the volunteers," Clemons said.

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

    One of these participants was George Acker who has learned since talking with The News in November that he got the placebo — to his surprise.

    The studies were unblinded in January and those who received the placebo were able to get the real vaccine.

    Acker has received both shots since then.

    VitaLink continues to conduct monthly follow-ups with participants for two years to track 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 last three months.

    The Moderna product has played a vital role in vaccinating long-term care facility residents and staff as initial allocations were given to these populations.

    Clemons is proud that VitaLink has played a part in the solution to the pandemic but also in their work in general.

    "I get to treat people every day using, kind of, tomorrow's therapies," Clemons said. "And I get paid to do it and patients never get billed."

     

    Packaging of Pfizer vaccines

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

    Softbox Systems, a British company with North America headquarters in Greenville, has over two decades of thermal shipping experience.

    They supply ultra-cold temperature shippers which keep vaccines between minus 90 and minus 60 degrees Celsius for at least ten days unopened with the use of dry ice and insulation. If managed well, these reusable containers can store vaccines for about a month by re-icing the dry ice.

    "[Softbox] immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine," Tanya Alcorn, Pfizer's vice president for biopharma global supply chain, said in a March 10 press release. "And quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.”

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

    "Our Americas headquarters in Greenville features a full qualification testing lab, product engineering capabilities, and a world-class team," John Hammes, Softbox's general manager of the Americas, said. "All of which helped us support Pfizer in the fight against COVID and develop a way to successfully distribute a vaccine to support the global community."

     

    Vaccines could soon be filled in the Lowcountry

    Lou Kennedy didn't expect on her company would be filling vaccines, but she also didn't plan on the pandemic — no one did.

    In addition to helping with COVID-19 testing efforts, she thought Nephron Pharmaceuticals could take it a step further and help with the vaccinations.

    "We have the type of equipment already in our possession, we will have it retooled," Kennedy said. "We'll build a wing and it is our sincere desire to find a vaccine partner — like Moderna, Pfizer or Johnson & Johnson — and say, let us fill some of the capacity that the American patient needs."

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

    About 300 of those could be centered around the vaccine production and she hopes to partner with a COVID-19 vaccine manufacturer to fill vaccines and help ramp up vaccine supply.

    Nephron is currently working to find a vaccine partner. It could be Moderna, Pfizer, Johnson & Johnson, or it could be another brand who could receive authorization in the U.S., Kennedy said.

    "Between now and the time we move in there, there could be 10 new ones, so we're keeping our eyes and ears open," Kennedy said.

    They've already hired about half the people they need. The building is still being worked on but once it's completed, Kennedy believes the production lines could be operational by 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 already partnered with Dominion Energy to set up a drive-thru vaccination site in Lexington County in February.

    "I had this idea that why can't we help the vaccination," Kennedy said. "We have nurses on staff 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 Department of Environmental Control board member from Rock Hill, on how to best setup a drive-thru clinic.

    Like health systems across the state, Nephron is running this clinic out of their own pocket. Vaccines and ancillary supplies are supplied by the government, but staff and other costs are not.

    "We're not getting reimbursed for any of this," Kennedy said. "We're doing this out of the bottom of our heart."

    The drive-thru site has ramped up from about 30 vaccinations per day when it first opened to about 150 vaccinations per day by March. Kennedy hopes to get this up to 300 per day.

  • sam patrick posted an article
    Softbox a key player in battle to beat COVID see more

    Softbox, a leading global innovator and provider of passive temperature control packaging solutions for the pharmaceutical, life science and cold chain logistics industries, is proud to support Pfizer in the distribution of Covid-19 vaccines through the supply of a high-performance temperature-controlled parcel shipper developed specifically for ultra-low temperature applications.

    Softbox supported Pfizer with the development of the highly specialised and reusable ultra-low temperature (ULT) shipper to help them on the distribution of ultra-low temperature vaccines and storing them at Point of Use (POU) sites.  

    Ultra-Low Temperature vaccines, such as that developed by Pfizer – BioNTech, uses mRNA (messenger RNA) technology and must be stored at temperatures between -90°C to -60°C to ensure that the vaccine’s quality and efficacy is maintained. The ULT shipper is capable of maintaining the required temperature during shipping of Covid-19 vaccines between -90°C to -60°C for at least 10 days unopened.

    The highly innovative shipper utilises high performance insulation materials, incorporated in a robust and reusable construction, in conjunction with dry ice, to ensure long term ultra-low temperature control. Based on current guidelines, the Softbox ULT Shipper can be opened twice a day, for up to three minutes at a time. This allows clinicians at Point of Use (POU) sites to access the vaccine vials required for each day’s immunisation clinics without exposing the remaining vaccine stored within the shipper to ambient temperatures, thus ensuring integrity of the vaccine is maintained.

    When correctly managed, the ULT Shipper can be used to store vaccines for in excess of 30 days. Through a process called “Re-Icing” the dry ice in the Softbox ULT Shipper can be topped up ensuring maximum thermal protection of the highly temperature sensitive mRNA vaccines.

    “Softbox’s extensive knowledge and experience in temperature control packaging solutions and the cold chain industry was the right choice for us. They immediately understood the unprecedented task at hand that was in front of us with the distribution of the vaccine, and quickly started to work with us to develop a unique packaging system that does not waste any precious vaccine and creates a seamless experience for customers.” said Tanya Alcorn, Vice President, Biopharma Global Supply Chain for Pfizer. “Their technical capabilities and innovative approach helped us achieve an excellent result in a very short period of time.”

    Kevin Valentine, CEO of Softbox, said: “We are immensely proud to be playing such an important role in the fight against Covid-19. We worked extremely hard during 2020 to help Pfizer develop this highly innovative ULT shipper; establishing one of the world’s largest fleets of reusable temperature-controlled parcel shippers in the process and setting up two world-class service centres to support ULT shipper refurbishment.”

    “It’s a huge honour to have the opportunity to support the distribution of these vital vaccines at the right temperature, maintain their integrity and help save millions of lives.” 

    For more information about Softbox visit: www.softboxsystems.com

    About Softbox
    Softbox is an award-winning temperature control packaging innovator that has been designing and producing high performance passive temperature control packaging solutions for over 20 years. We offer consistent quality to our clients from our strategically located global manufacturing sites throughout Europe, North America, Latin America, India and Asia Pacific.

    We have formed long standing partnerships with the world’s leading pharmaceutical, clinical research, biotech and logistics companies, and apply innovative thinking to overcome the challenges that our clients face in managing the Cold Chain when shipping temperature sensitive clinical trial and commercialised products.

    For more information about Softbox visit: www.softboxsystems.com

  • sam patrick posted an article
    Shipping vaccine immediately, delivering more than 20 million doses to U.S. in March see more

    Johnson & Johnson (NYSE: JNJ) (the Company) has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.  

    This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.  

    The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.  

    “This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.” 

    Read on for complete details here.

  • sam patrick posted an article
    $30.2 million investment will create 425 new jobs see more

    Pall Corporation (Pall), a global leader in filtration, separation and purification, today announced plans to establish operations in Spartanburg County. The company is creating 425 new jobs and investing $30.2 million into a new facility that will support the rapid development and production of vaccines and therapeutics, including a COVID-19 vaccine.

    Pall serves the needs of customers across the broad spectrum of life sciences and industry and works with clients around the world to advance health, safety and environmentally responsible technologies.

    Located at 816 Berry Shoals Road in Duncan, Pall's new facility will focus primarily on single-use technology such as the Allegro™single-use platform.

    The facility is expected to be operational in May 2021. Individuals interested in joining the Pall team should visit the company's careers webpage.

    The Coordinating Council for Economic Development has approved job development credits related to the project.

    QUOTES

    "Spartanburg County provides Pall with the diverse workforce we need to manufacture life-saving therapeutics and vaccines. We look forward to building our presence in this county." -Pall Life Sciences President Joseph Repp

    "Pall Corporation's decision to invest into South Carolina comes at a time when our life sciences sector has evolved into one of our fastest-growing industries. The continued development of life sciences will create high-paying jobs that will ensure wellness and prosperity in South Carolina for years to come." -Gov. Henry McMaster

    "We could not be happier with Pall Corporation's decision to invest in Spartanburg County. We welcome this globally recognized company to South Carolina, and we look forward to partnering with them going forward." -Secretary of Commerce Bobby Hitt

    "The decision by Pall Corporation to come to Spartanburg is a win for our county, and a win for our budding life sciences sector. The variety of investments coming into our county, and the diversity of the industries that now call Spartanburg home, is a sign that our future is bright in the years to come." -Spartanburg County Councilman and Chairman of the Economic Development Committee David Britt

  • sam patrick posted an article
    Single shot may be enough for AZ vaccine see more

    Britain’s health chief says a new study showing that a single dose of the COVID-19 vaccine developed by Oxford University and AstraZeneca provides a high level of protection for 12 weeks supports the government’s strategy of delaying the second shot so more doses can be delivered to more people.

    Health Secretary Matt Hancock’s comments came after Oxford released a study showing the vaccine cut transmission of the virus by two-thirds and prevented severe disease. The study has not been peer-reviewed yet, but it was greeted with excitement by U.K. officials under pressure to justify their decision to delay the second dose. 

    “That reduction in transmission, as well as the fact there is no hospitalizations, the combination of that is very good news. And it categorically supports the strategy we’ve been taking on having a 12-week gap between the doses,” Hancock told Sky News on Wednesday. 

    One of the lead researchers on the project, Dr. Andrew Pollard of Oxford University, said Oxford scientists believe the vaccine will continue to offer protection against new variants of COVID-19, although they are still waiting for data on this.

    Even if the virus adapts, “that doesn’t mean that we won’t still have protection against severe disease.’’

    “If we do need to update the vaccines, then it is actually a relatively straightforward process it only takes a matter of months, rather than the huge efforts that everyone went through last year to get the very large-scale trials run,” he told the BBC.

  • sam patrick posted an article
    Softbox Systems the partner of choice for Pfizer vaccine see more

    Compliments of GSA Business Report and SCBIZ News

    Frontline workers at Prisma Health received the first shipment of Pfizer’s COVID-19 vaccine last week, but to some extent, the shipment was simply returning home to the Upstate.

    Greenville is the North American headquarters for Softbox, the British manufacturer of the insulated containers critical to the stability of the Pfizer vaccine.

    “I consider this the start to the finish as we move into this process of trying to get enough immunity into the community,” Dr. Steve Shelton said as the dry ice-laden Softbox made a triumphant arrival at Prisma Health-Midlands, complete with pom-poms and cheering health care workers. Shelton is an emergency room physician with Prisma Health who spearheaded COVID-19 treatment efforts in the Midlands.

    “I know there is a lot of anxiety about this, but I am confident in the FDA in making sure that they have approved an effective vaccine,” he said. “I feel like I am honored to be here to receive this and am doing my part to combat this disease.”

    To remain effective, the vaccine must be shipped at temperatures colder than most of Antarctica, in a box with more layers than a Russian doll. The Softbox includes a top layer or “pod” of dry ice housed on top of five trays of the vaccine, which in turn, nests in a carrying box with a foam lid and temperature gauge. All this is fitted in a cardboard shipping container, according to a Dec. 3 manual from Pfizer.

    Read the entire story here...

  • sam patrick posted an article
    EUA means help is on the way to millions worldwide as the first vaccine for COVID-19 is rolled out see more

    The Food and Drug Administration on Friday granted emergency authorization to Pfizer and BioNTech's coronavirus vaccine, clearing its use after a historic 10-month research sprint and a rapid review that culminated Thursday with the endorsement of an independent advisory committee.

    With the vaccine's authorization, millions of vulnerable U.S. residents could soon have a shot at protection from a resurgent COVID-19 pandemic that has claimed hundreds of thousands of lives and sickened millions. Daily case counts and deaths have hit new highs in the weeks following Thanksgiving and more than 100,000 people are currently hospitalized.

    Initial supplies, however, are extremely limited, forcing public health officials to prioritize which groups should receive the vaccine first. Healthcare workers and nursing home residents, who have fallen ill and died from COVID-19 in disproportionate numbers, are expected to begin receiving the vaccine within days, as Pfizer began manufacturing while clinical trials were still underway.

    Some 2.9 million doses are expected to be available initially, with the U.S. holding some in reserve to ensure people receive the second of two doses that vaccination requires.

    "While not an FDA approval, today's emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine holds the promise to alter the course of this pandemic in the United States," said Peter Marks, director of the FDA division that reviews vaccines, in a statement.

    Authorization of a vaccine within a year of scientists identifying the new coronavirus is a scientific milestone that, at the pandemic's outset, looked unattainable.

    "In my wildest dreams, I thought it would be fast. But fast means, if it [typically] takes seven years, maybe you can get it down to a couple of years," said Anthony Fauci, in a Dec. 11 interview with the editor of JAMA. "Now it's our challenge to convince people that this wasn't rushed in a reckless way."

    Yet the FDA has been under immense pressure to speed an approval and, on Friday, the Trump administration reportedly told agency head Stephen Hahn to submit his resignation if Pfizer and BioNTech's vaccine was not cleared by the end of the day. The vaccine was cleared by regulators in the U.K., Bahrain, Canada, Saudi Arabia and Mexico earlier this month.

    The emergency use authorization, a special type of approval used in public health crises, came one day after a panel of FDA advisers voted 17-4 to recommend use of the shot.

    Two of the four "no" votes came from committee members who wanted to recommend the vaccine only for people aged 18 or older, rather than include 16- and 17-year olds as the FDA had advocated. The FDA's final decision authorized its use for people as young as 16.

    The regulator, along with its advisers, was persuaded by a massive trial that enrolled 44,000 people and randomly assigned them to receive either Pfizer and BioNTech's vaccine or a placebo.

    Trial results announced Nov. 18 showed the vaccine to be 95% effective in preventing COVID-19, easily surpassing the 50% threshold set by the FDA earlier this year. Vaccination was similarly protective in older adults and in individuals of different races or ethnicities, according to detailed data presented at Thursday's meeting.

    "The data are pretty clear cut so it's a very straightforward decision," said Philip Grant, an infectious disease doctor at Stanford University Medical Center.

    Importantly, Pfizer and BioNTech also proved their vaccine is safe, with no unexpected or serious adverse reactions observed in the study. Many participants did experience injection site pain, fever, headache and fatigue, generally mild or moderate in nature.

    While the companies first reported positive results from their Phase 3 study on Nov. 9, they waited 11 more days before submitting an application in order to collect at least two months' of safety follow-up on half of trial participants. Most side effects to vaccines emerge within 40 to 60 days, which motivated the FDA to set the two-month requirement.

    Four cases of Bell's palsy — temporary weakness or paralysis in one side of the face — were reported among trial volunteers who received the vaccine, three of which had resolved. FDA reviewers, however, noted the frequency was no greater than what would be expected in the general population.

    Regulators in the U.S. and elsewhere are also on now watch for signs of allergic reactions to vaccination among individuals with a history of severe allergies, after two people in the U.K. had reactions after receiving their first shot. The authorization from the FDA instructs medical personnel not to give the vaccine to people who have a history of severe allergic reaction to any of its ingredients.

    The emergency clearance for Pfizer and BioNTech's shot is expected to be followed quickly by one for a similar type of vaccine developed by Moderna. An advisory committee is scheduled to meet and vote on the company's application on Dec. 17.

    Study results showed Moderna's vaccine, which was developed in collaboration with U.S. government scientists, to be similarly effective against COVID-19.

    The shots' high efficacy could help convince skeptical portions of the public who have indicated in polls they'd be cautious or unlikely to get a vaccine.

    "There will be less vaccine hesitancy in March than there will be in January, and then a lot less in May than in March," said Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and co-leader of a vaccine trial network.

    It's still unclear, however, whether either vaccine can protect against infection and transmission, as well as disease. Data from Pfizer could come soon, however, Kathrin Jansen, the company's head of vaccine research and development, told the FDA's advisers Thursday.

    Both companies have worked feverishly to scale up manufacturing in preparation for an approval, but both will only have limited supplies to offer the U.S. and other countries in which their vaccines are approved.

    Pfizer and BioNTech, which make their vaccine at sites in Michigan and in Puurs, Belgium, expect to make 50 million doses by the end of 2020, only some of which is reserved for use in the U.S. Production should ramp up considerably in 2021, when the two companies expect to manufacture up to 1.3 billion doses.

    Moderna has said it can produce 20 million doses for the U.S. this month, and another 85 million to 100 million by the end of March.

    The U.S. initially preordered 100 million doses of each vaccine, an amount that would cover less than a third of the U.S. population. According to The New York Times, the U.S. passed up its chance to order more doses from Pfizer under an option it had negotiated, although officials dispute the Times' account.

    On Friday, Moderna announced the U.S. had agreed to purchase another 100 million doses for delivery in the second quarter of 2021. The U.S. also appears to be counting on approvals for several vaccines still in testing by AstraZeneca, Johnson & Johnson and Novavax. Deals with the three companies reserve some 500 million doses for the U.S.

    Moncef Slaoui, the scientific leader of the U.S.'s "Operation Warp Speed" vaccine program, recently predicted 100 million U.S. residents will get a vaccine by the end of February — an ambitious target even if two shots are approved.

    Further complicating roll-out plans are the temperature requirements for Pfizer and BioNTech's vaccine, which must be shipped and stored at minus 70 degrees Celsius. Pfizer built shipping containers that will use dry ice to keep doses cold, and is handling distribution on its own.

    Dry ice has been in short supply this year, requiring logistics companies to beef up production to meet the demand of transporting vaccines.

    Moderna's vaccine must also be kept cold, but at a more moderate minus 20 degrees Celsius.

  • sam patrick posted an article
    SC company to play role in vaccine distribution see more

    Courtesy of WIS-TV News

    A South Carolina pharmaceutical company will play a huge role in getting a COVID-19 vaccine to the American people.

    Columbia-based Ritedose Corporation announced Thursday it’s been named a partner in Operation Warp Speed and will be responsible for filling and packaging millions of vaccines.

    ApiJect, a medical technology company that received $138 million from the federal government to produce the first 100 million COVID-19 vaccines, patented the vial in which the vaccine will be distributed. They needed Ritedose to produce and manufacture those vials with their blow-fill-seal technology.

    Ritedose CEO Jody Chastain says more COVID-19 vaccines will be packaged and filled in Columbia than any other place in the country.

    “It’s tremendously rewarding,” Chastain explained.

    He and his employees did the near impossible, getting two 150,000 square-foot warehouses ready to package and fill the vaccines in only a few months.

    “Typically, that would take anywhere from 18-24 months, but within five months, we were able to outfit the facility to be able to handle the vaccine,” said Chastain.

    Ritedose has upped its staff by more than 10% to help handle the demand.

    “The potential for the workforce here in Columbia is huge, as well as putting Columbia on the map in the response to COVID,” Chastain noted.

    The company’s nearly 400 employees also learned Thursday the role they will play in distributing the vaccine.

    “It’s been hush-hush around the facility,” said Chastain. “People know that we’ve been doing work around the facility to be able to handle a new product, but they were unaware of what the new product is. Making this announcement to the employees today was very exciting because they’ve been able to see a tremendous amount of pride that’s been able to go into the workforce to be able to handle the vaccine.”

    As soon as a vaccine candidate receives FDA approval, Ritedose will work with the company to make sure the vaccine is compatible with their plastic packaging.

    “We’re much more efficient,” said Chastain. “We can produce a higher volume in a shorter time period.”

    Once the vaccine is rolled out, front line workers, like Prisma Health Baptist Parkridge doctor Jennifer Risinger, will be the first in line.

    “I’m very encouraged that we’re looking at months instead of years,” said Risinger.

    She says she and her colleagues are eager to get the vaccine.

    “It does give us a sense of relief and confidence that we’ll be able to deliver the care that people here in the Midlands deserve,” she noted. “I think we should all be very proud that we have a local company who is this involved in bringing this to the national spotlight as soon as possible.”

    Ritedose says it’s likely the first vaccines distributed in South Carolina will have been packaged and filled in Columbia.

    Operation Warp Speed has a goal to produce and deliver 300 million safe and effective doses of the COVID-19 vaccines, with the first doses expected to be ready by January 2021.

  • sam patrick posted an article
    Nephron prepping to fill COVID vaccines in state see more

    Courtesy of WSPA-TV

    VIDEO: https://www.wspa.com/news/sc-pharmaceuticals-company-says-theyll-be-ready-to-fill-covid-19-vaccines-in-2021/

     

    LEXINGTON COUNTY, SC (WSPA) — With a potential COVID-19 vaccine looming, one South Carolina company said they’ll be able to fill vaccines next year.

    According to Nephron Pharmaceuticals CEO and Founder Lou Kennedy, the company is in the midst of a $215 million expansion. They are adding new office and new warehouse space. The investment will also create more than 380 jobs the company said.

    The expansion also includes vaccine production space. Kennedy said once completed, they’ll be able to fill COVID-19 vaccines at their facility.

    “We’re actively looking for the right partner that will produce and we’ll fill the vaccine. We’re speaking with people throughout the federal government and Department of Defense to find the right partner,” Kennedy said.

    Tuesday, the company held a beam raising ceremony to celebrate their expansion. Kennedy said she expects to have the vaccine production space completed by March 2021.

    As of Tuesday afternoon, the FDA has not approved a COVID-19 vaccine for distribution. However, preliminary reports on vaccines from Moderna Inc. and Pfizer Inc. show their vaccines have at least a 90% effectiveness rate.

    Kennedy said they are anticipating a medical grade glass shortage because of the high demand for the vaccine. She said they have the ability to work around that. “Our option will be to put the vaccine in plastic. We have the technology and the capability.”

    Under the South Carolina Department of Health and Environmental Control’s (SCDHEC) statewide vaccine plan, front line medical personnel and nursing home residents will be some of the first South Carolinians to get doses of an approved vaccine. They anticipate vaccine supply will be limited to start off, but Kennedy hopes they can help alleviate that.

    She said, “We’re right in tandem with the research work and the clinical trials that are going on. We’re trying to time that perfectly for the vaccine filling side of it.”

  • sam patrick posted an article
    Cold storage for vaccines could be an issue see more

    Courtesy of The Post and Courier

    News last week that a COVID-19 vaccine has shown a 90 percent success rate in testing has buoyed hopes that the coronavirus pandemic might soon be under control, but getting that vaccine to patients promises to be a logistics challenge.

    The vaccine, developed by Pfizer Inc., has to be stored at temperatures of at least minus-94 degrees Fahrenheit. That’s approaching the lowest temperatures at the South Pole.

    It’s also much lower than the temperatures experienced in typical cold-storage logistics. The refrigerated cargo containers that move through the Port of Charleston can achieve temperatures of below-30 Fahrenheit, but that fluctuates during summer months when outside temperatures are climbing. The coldest refrigerated container built by industry leader Thermo King can reach minus-76 Fahrenheit, but that’s still not cold enough for vaccine storage.

    Read the PandC's full story here.

  • sam patrick posted an article
    Moderna vaccine results looking very good early see more

    The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.

    Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.

    Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.

    Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.

    Read the entire story here.