COVID variant surging in SC see more
When associate professor Julie Hirschhorn, Ph.D., saw the latest results of the Medical University of South Carolina’s sequencing run for COVID variants, she was struck by the absolute dominance of the Delta variant.
“Literally 100%,” the director of MUSC’s Molecular Pathology Lab said. “It kind of boggles my mind. We’re waiting to see what's going to come next. The possibility is that we have hit a branching point where from now on, anything that we see is going to be an offspring of Delta.”
Delta is already a prolific parent variant, spawning a growing number of “sublineages,” or variants with slightly different mutations. Hirschhorn’s colleague, Bailey Glen, Ph.D., is tracking their progress.“They went from there being no Delta sublineages to three to 12. Now we're up to 33, I think,” he said.
“I have never seen that many new lineages pop up quickly,” Hirschhorn said.
What does all of that mean for the public? First of all, the threat to unvaccinated people is clear.“We want them to know that Delta's still very much out there and still very transmissible,” Hirschhorn said.
Second, Glen said, Delta’s mutations serve as a reminder of how important it is to slow the virus’ spread. “The more it spreads the more chance there is for it to mutate, and clearly it can change pretty dramatically and how effectively. We've definitely seen that already. What’s the ceiling on this? How bad can it get? I don't know, but there's no reason to think it can't get worse.”
As for why Delta has been able to vanquish the variant competition so completely, Hirschhorn pointed to its characteristics. “It has mutations in the spike protein that help it get into cells easier. And then some of the other mutations assist in making more copies of the virus itself. So it gets in better and it makes more copies of itself,” she said.
“If you think about virus transmissibility, when we had the original version of the virus, every infected person would infect on average one or two people. And then with the Alpha variant we first saw in the U.K., every person infected would transmit it, on average, to four people. And then with Delta, it transmits on average to seven or eight people.”
Part of the problem may be that Delta causes people to carry higher viral loads, Hirschhorn said. “And so if somebody coughs or you're sitting in a room together and no one's masked, it's going take a shorter period of time to transmit to you.”
The good news is that for now, indications are that the current COVID surge in South Carolina may be easing. In the Charleston Tri-county area, case numbers are still high, but down from the surge’s peak of a couple of weeks ago.
But that doesn’t mean the virus is going away. “One of the things that I do get concerned about when coming off of a curve like this is where we end up, as far as a steady state,” Hirschhorn said, referring to the level where case numbers settle.
“So before Delta hit, we had gotten down to only 1% — it was so low. It's the lowest I'd seen it. My biggest concern is that steady state level of COVID might get stuck at like 5% or 7% or even 10% positivity. And that really doesn't bode well for the next mutated version, because the next wave could result in even higher positivity rates. And if the next variant strain transmits faster, we would start out in a rough spot.”
Her lab is working with the South Carolina Department of Health and Environmental Control to get that message out. “It has been a really positive experience so far. I've had multiple people from DHEC reach out and say, ‘Thank you for sharing your data. This is great. We're so excited.’ I hope that our contribution will help the DHEC website give a clear picture of what's going on,” Hirschhorn said.
She also hopes people use the information to make good decisions. “I guess that's part of this thought process — how do we keep each other safe while still trying to have a life? My best advice is to be kind and think about others. There are ways to get together safely, such as being outside. There are ways to see each other and keep in touch and try to keep that human connection.”
Op-Ed: As a doctor in a COVID unit, I’m running out of compassion for the unvaccinated. Get the shotInfectious disease physician calls for vaccinations see more
My patient sat at the edge of his bed gasping for air while he tried to tell me his story, pausing to catch his breath after each word. The plastic tubes delivering oxygen through his nose hardly seemed adequate to stop his chest from heaving. He looked exhausted.
He had tested positive for the coronavirus 10 days ago. He was under 50, mildly hypertensive but otherwise in good health. Eight days earlier he started coughing and having severe fatigue. His doctor started him on antibiotics. It did not work.
Fearing his symptoms were worsening, he started taking some hydroxychloroquine he had found on the internet. It did not work.
He was now experiencing shortness of breath while doing routine daily activities such as walking from his bedroom to the bathroom or putting on his shoes. He was a shell of his former self. He eventually made his way to a facility where he could receive monoclonal antibodies, a lab-produced transfusion that substitutes for the body’s own antibodies. It did not work.
He finally ended up in the ER with dangerously low oxygen levels, exceedingly high inflammatory markers and patchy areas of infection all over his lungs. Nothing had helped. He was getting worse. He could not breathe. His wife and two young children were at home, all infected with the virus. He and his wife had decided not to get vaccinated.
Last year, a case like this would have flattened me. I would have wrestled with the sadness and how unfair life was. Battled with the angst of how unlucky he was. This year, I struggled to find sympathy. It was August 2021, not 2020. The vaccine had been widely available for months in the U.S., free to anyone who wanted it, even offered in drugstores and supermarkets. Cutting-edge, revolutionary, mind-blowing, lifesaving vaccines were available where people shopped for groceries, and they still didn’t want them.
Outside his hospital door, I took a deep breath — battening down my anger and frustration — and went in. I had been working the COVID-19 units for 17 months straight, all day, every day. I had cared for hundreds of COVID patients. We all had, without being able to take breaks long enough to help us recover from this unending ordeal. Compassion fatigue was setting in. For those of us who hadn’t left after the hardest year of our professional lives, even hope was now in short supply.
Shouting through my N95 mask and the noise of the HEPA filter, I introduced myself. I calmly asked him why he decided not to get vaccinated.
“Well, I’m not an anti-vaxxer or anything. I was just waiting for the FDA to approve the vaccine first. I didn’t want to take anything experimental. I didn’t want to be the government’s guinea pig, and I don’t trust that it’s safe,” he said.
“Well,” I said, “I can pretty much guarantee we would have never met had you gotten vaccinated, because you would have never been hospitalized. All of our COVID units are full and every single patient in them is unvaccinated. Numbers don’t lie. The vaccines work.”
This was a common excuse people gave for not getting vaccinated, fearing the vaccine because the Food and Drug Administration had granted it only emergency use authorization so far, not permanent approval. Yet the treatments he had turned to — antibiotics, monoclonal antibodies and hydroxychloroquine — were considered experimental, with mixed evidence to support their use.
The only proven lifesaver we’ve had in this pandemic is a vaccine that many people don’t want. A vaccine we give away to other countries because supply overwhelms demand in the U.S. A vaccine people in other countries stand in line for hours to receive, if they can get it at all.
“Well,” I said, “I am going to treat you with remdesivir, which only recently received FDA approval.” I explained that it had been under an EUA for most of last year and had not been studied or administered as widely as COVID-19 vaccines. That more than 353 million doses of COVID-19 vaccine had been administered in the U.S. along with more than 4.7 billion doses worldwide without any overwhelming, catastrophic side effects. “Not nearly as many doses of remdesivir have been given or studied in people and its long-term side effects are still unknown,” I said. “Do you still want me to give it to you?”
“Yes” he responded, “Whatever it takes to save my life.”
It did not work.
My patient died nine days later of a stroke. We, the care team, reconciled this loss by telling ourselves: He made a personal choice not to get vaccinated, not to protect himself or his family. We did everything we could with what we had to save him. This year, this tragedy, this unnecessary, entirely preventable loss, was on him.
The burden of this pandemic now rests on the shoulders of the unvaccinated. On those who are eligible to get vaccinated but choose not to, a decision they defend by declaring, “Vaccination is a deeply personal choice.” But perhaps never in history has anyone’s personal choice affected the world as a whole as it does right now. When hundreds and thousands of people continue to die — when the most vulnerable members of society, our children, cannot be vaccinated — the luxury of choice ceases to exist.
If you believe the pandemic is almost over and I can ride it out, without getting vaccinated, you could not be more wrong. This virus will find you.
If you believe I’ll just wait until the FDA approves the vaccine first, you may not live to see the day.
If you believe if I get infected I’ll just go to the hospital and get treated, there is no guarantee we can save your life, nor even a promise we’ll have a bed for you.
If you believe I’m pregnant and I don’t want the vaccine to affect me, my baby or my future fertility, it matters little if you’re not alive to see your newborn.
If you believe I won’t get my children vaccinated because I don’t know what the long-term effects will be, it matters little if they don’t live long enough for you to find out.
If you believe I’ll just let everyone else get vaccinated around me so I don’t have to, there are 93 million eligible, unvaccinated people in the “herd” who think the same way you do and are getting in the way of ending this pandemic.
If you believe vaccinated people are getting infected anyway, so what’s the point?, the vaccine was built to prevent hospitalizations and deaths from severe illness. Instead of fatal pneumonia, those with breakthrough infections have a short, bad cold, so the vaccine has already proved itself. The vaccinated are not dying of COVID-19.
SARS-CoV-2, the virus that causes COVID-19, has mutated countless times during this pandemic, adapting to survive. Stacked up against a human race that has resisted change every step of the way — including wearing masks, social distancing, quarantining and now refusing lifesaving vaccines — it is easy to see who will win this war if human behavior fails to change quickly.
The most effective thing you can do to protect yourself, your loved ones and the world is to GET VACCINATED.
And it will work.
Anita Sircar is an infectious-disease physician and clinical instructor of health sciences at the UCLA School of Medicine.
Once again, Lou Kennedy and Nephron step up for South Carolina see more
A South Carolina-based pharmaceutical manufacturer that has offered coronavirus vaccines to the public and run thousands of COVID-19 tests throughout the pandemic will now require all of its employees to get inoculated.
Nephron Pharmaceuticals Corp. is mandating that all of the company’s nearly 2,000 workers be fully vaccinated or have started a two-dose vaccine series by Aug. 27, unless the employee has “an exemption or reasonable accommodation,” according to CEO Lou Kennedy.
The company is one of the first major businesses in South Carolina, other than hospitals, to publicly declare such a directive. Details of the requirement were shared with The Associated Press ahead of an official announcement Monday.
“As COVID-19 cases, driven by the deadly serious Delta variant, continue to impact communities and businesses alike, we can be one of the first businesses of our size to have a fully-vaccinated workforce,” Kennedy wrote in a company-wide letter.
Kennedy told reporters that employees who are not vaccinated by the deadline and can’t provide a medical or religious exemption will be fired, and she isn’t worried about lawsuits.
“I’ll be very sad if we lose even the first person,” Kennedy said. “I hate that, but we’ve got to do what is right, to keep us healthy so we can keep others healthy.”
Nephron, which makes a number of drugs used to treat COVID-19 patients, is also mandating all visitors, vendors and guests be fully vaccinated. Those who need the shots can get them from Nephron itself, which has run a vaccine site in West Columbia since February.
The company is still compiling data on how many of its workers are vaccinated.
A growing number of hospitals around the state, including the Medical University of South Carolina and Tidelands, have made vaccination a requirement for health care employees. Prisma Health, South Carolina’s largest hospital system, has offered incentives to staffers instead, news outlets have reported.
The Nephron announcement comes as vaccine rates continue to lag. Less than half of eligible South Carolinians were fully vaccinated as of last week, according to data from the South Carolina Department of Health and Environmental Control.
Although most businesses in the state have yet to implement such requirements, the resurgence of the virus with the highly contagious delta variant has prompted many to consider a mandate, S.C. Chamber of Commerce President and CEO Bob Morgan told The Associated Press on Monday.
More and more businesses will likely require employees to be vaccinated, following Nephron’s lead and the expected full approval of the vaccine by the Food and Drug Administration later this fall, Morgan said: “Momentum is growing.”
Lawmakers in the South Carolina Senate did approve a proposal that would prevent employers from requiring COVID-19 vaccines for workers earlier this year. That measure still awaits House action.
USC College of Pharmacy hosts special event for minorities see more
The University of South Carolina’s College of Pharmacy held a COVID-19 vaccine education event at the Juneteenth Freedom Fest. Instructors and students from the college offered science-based information to passersby who had not been vaccinated yet.
DHEC data suggests that minorities make up approximately 43% of South Carolinians who have received at least one COVID-19 shot. Data from DHEC also shows that Black South Carolinians make up just 19.5% of people with at least one dose.
“We feel like we can do better,” said clinical associate instructor and infectious diseases pharmacy specialist Dr. Julie Ann Justo. “We want to protect individuals and their loved ones from contracting COVID-19.”
The college hosts similar community education events regarding various public health issues such as penicillin allergies and flu shots at events like Soda City Market. The program chose to host the COVID-19 vaccination information booth at the Juneteenth event to target specific groups that may be hesitant to get their shot.
“Juneteenth is the place to be this weekend; there’s a lot of joy here, a lot of celebration and remembrance and respect for history,” said Justo. “We’re really excited to be here with the community and listen to their concerns as they relate to COVID-19 vaccination, and hopefully give a little bit of helpful information as well.”
Dr. Justo says the pharmacy students that talked to community members are vaccine experts. She says they have been studying all vaccines for at least four years and they also have extensive knowledge about the COVID-19 vaccines.
Dr. Jordan Cooler, clinical assistant professor of pharmacy and psychiatric pharmacist, says she hopes the event helped the community understand both the vaccine and the role of pharmacists better. She says pharmacists are among the most accessible medical professionals as they typically don’t require appointments for consultations.
“This is an opportunity for our students to get out into the community and hone those skills, as far as educating individuals and interacting,” said Cooler. “We’re coming and we’re meeting them where they’re at.”
Cooler says the event served to boost vaccine confidence in the community and if people felt more confident getting their shot after speaking to the students, they were able to go get their shot at a vaccine tent that was also at the festival.
The college plans to continue educating the public in the coming weeks about the COVID-19 vaccine to help increase vaccination rates across the state.
Sen. Tim Scott Introduces Bill to Stop Administration from Releasing American COVID-19 Vaccine Intellectual PropertySenator steps up to protect American IP see more
United States Senators Pat Toomey (R-Pa.) and Tim Scott (R-S.C.) introduced the Preventing Foreign Attempts to Erode Healthcare Innovation Act to prevent the Biden administration from relinquishing intellectual property (IP) protections on COVID-19 vaccines, a move that would undermine American innovation while doing nothing to actually increase the amount of vaccines reaching developing nations.
“The Biden Administration should protect the intellectual property of American companies, especially those that produced COVID vaccines in record time,” said Senator Toomey. “Instead, the administration is advocating foreign countries expropriate these precious American assets. Our bill would limit the administration from pursuing this misguided policy, ensuring American companies can continue their vaccine distribution efforts without fear of losing their intellectual property.”
“The United States has already pledged more money than any other country toward global vaccine efforts,” said Senator Tim Scott. “President Biden’s willingness to cave to the World Trade Organization instead of guarding one of our most valuable assets from getting into the hands of bad actors is concerning. The president needs to draw a clear line in dealing with Beijing, and releasing our data ensures that China will benefit off the hard work and innovation of American workers, and will also ensure our next vaccine takes longer to develop.”
The House companion bill was introduced last week by United States Representative Byron Donalds (R-Fla.).
“It deeply concerns me to hear of the Biden Administration’s plan to forgo IP protections on COVID-19 vaccines. This plan is a direct infringement upon American ingenuity and innovation and hands over our nation’s intellectual prowess for the world’s taking,” said Rep. Byron Donalds. “This Administration has made it a point to put America last, and this is just another glaring example of this sad reality. I appreciate my Senate colleagues Sen. Tim Scott and Sen. Pat Toomey, for championing my bill in the United States Senate and joining my efforts to prevent the Biden Administration from senselessly giving away America’s intellectual property to countries like China.”
Senators Chuck Grassley (R-Iowa) and Richard Burr (R-N.C.) are also cosponsors of the Preventing Foreign Attempts to Erode Healthcare Innovation Act.
- The bill bars the Office of the U.S. Trade Representative (USTR) from supporting the waiver of certain World Trade Organization (WTO) intellectual property protections for COVID-19 vaccines, as the Biden Administration announced it would.
- The bill accomplishes this by “prohibiting the authorization of appropriations to USTR for supporting a measure at the WTO waiving certain intellectual property rights.”
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.
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.
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
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
Johnson & Johnson COVID-19 Vaccine Authorized by FDA; First Single-Shot Vaccine in Fight Against Global PandemicShipping 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.”
$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.
"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
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.
Softbox Systems the partner of choice for Pfizer vaccine see more
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.
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.
SC company to play role in vaccine distribution see more
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.
Nephron prepping to fill COVID vaccines in state see more
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.”
Cold storage for vaccines could be an issue see more
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.