South Carolina and National executive address what's next for South Carolina as we battle COVID. see more
On September 9, 2021 SCBIO hosted a statewide webinar program entitled "COVID-19 and South Carolina: What's Next?". The program was attended by a large audience across South Carolina, including business leaders, healthcare executives, elected officials, and regional media.
BIO’s Phyllis Arthur, Nephron Pharmaceutical’s Lou Kennedy and VCOM’s Matt Cannon shared their views on what obstacles we have to overcome to get through this latest surge, using science as the foundation. This discussion also addressed the science, data and real life experiences confronting us all as we manage our response to the Delta Variant of COVID-19. It’s a conversation you won’t want to miss if you aren’t sure about vaccines, antibodies, masks and more.
Top executives opine on what's next for SC as Covid surges see more
After attending a Chamber of Commerce breakfast where a hospital CEO ticked off statistics about the number of unvaccinated patients suffering from Covid – many in their 20s and 30s – Nephron Pharmaceuticals CEO Lou Kennedy decided something had to be done.
So she mandated vaccination at her company and today, everyone at the West Columbia business, which manufactures generic respiratory products, has had the shot, she said. And she lost just 30 out of 2,000 employees over the decision.
“It was the right thing to do, and I encourage my fellow business leaders to follow suit,” Kennedy said. “Somebody had to be the first to do it, and why not make it us.”
In addition, Kennedy said, the company spent $2.5 million last year on people being out of work and overtime to cover them – money that could have been spent on innovation, such as the mask the company introduced for patients getting nebulizer treatments that protects the health care provider from respiratory droplets.
Kennedy spoke at an online event hosted by SC BIO, the Palmetto State’s life sciences group, to discuss what comes next in the pandemic.
South Carolina is still lagging in vaccinations, said SC BIO interim CEO Erin Ford, with Covid deaths on the rise.
By Sept. 7, just 49 percent of residents had been fully vaccinated, and 58 percent had had at least one shot, according to the state Department of Health and Environmental Control.
Meanwhile, nearly 780,000 cases had been confirmed by that date and 11,050 South Carolinians had died, DHEC reports.
But the number of vaccinations is slowly rising, Ford said, offering some hope that things will turn around.
The full FDA approval of the Pfizer vaccine pushed some people to get vaccinated in recent weeks, said Phyllis Arthur, vice president of infectious diseases and diagnostic policy at BIO Global, the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions.
But many are rolling up their sleeves after seeing how the Delta variant left loved ones sick and dying, she said.
“Delta is nearly twice as contagious as the previous variants,” she said. “And … (it) moved so quickly and spread so fast we saw a giant spike in cases and deaths. When immunization numbers go up, we will see cases come down.”
The speakers agreed that the greatest obstacle to making progress in the fight against the virus is the politicization of the pandemic and misinformation.
“There’s no R or D in the word science. It has nothing to do with your favorite politician,” said Kennedy. “This is science.”
Arthur said people should beware of misinformation and trust the scientists who’ve done the work on the virus.
“One of the things I ask people to do is look at the source of what you’re reading and hearing,” she said. “Look at the data yourself. It’s all publicly available and it’s very transparent.
And Dr. Matthew Cannon, dean of the Carolinas Campus of the Edward Via College of Osteopathic Medicine, agreed.
“(It’s) being politicized, in my opinion, and I just hope people would look at it objectively, not through partisanship,” he said. “This is a public health crisis.”
Cannon said that as of Sept. 7, one Upstate hospital had 278 Covid patients and all but 25 were unvaccinated. Another had 566 Covid patients and all but 41 were unvaccinated. The average age of the vaccinated patients was 75 to 78, he said, and they were immunocompromised. The average age of the unvaccinated patients was 50, he said.
Though breakthrough cases occasionally occur among the vaccinated, Arthur said they typically are milder and of shorter duration.
She said she expects FDA approval of the Pfizer vaccine for children younger than 12 in the next month or so and the Moderna vaccine in the next few months.
Kennedy said her antibody level dropped from 6,900 to 3,800 in recent weeks and is watching to see when the booster is approved.
There are still two steps to go before a booster is approved for the general population, but that it could come in a matter of weeks, Arthur said.
And Cannon said the college is working on research to determine when boosters should be given, noting the mRNA technology used in the Pfizer and Moderna vaccines has been around for years.
Arthur added that the mRNA technology will be able to be used for many vaccines and even disease treatments.
“You can speed the next product, and that can allow us to have many more innovations from the treatment perspective and the vaccine perspective,” she said. “It’s the same for monoclonal antibodies. And that will ripple through the industry for years to come.”
Cannon said he’s proud of the health care workers who are surrounded by contagious Covid patients putting them and their families at risk, but continue to step up every day for the greater good of the community.
Nonetheless, he said, he worries about the stress they endure, seeing so much loss and knowing it could be prevented.
Meanwhile, he said, although medical residents got the experience of learning how to work in the midst of a pandemic - something their predecessors never had - they are missing out on some hands-on training because hospitals are canceling elective procedures.
Kennedy said the employees who refused vaccination weren’t willing to listen to the science. And while she got lots of phone calls asking whether there were protests in the street about her mandate, it all went smoothly.
“There were a couple people grumbling in the plant,” she said, “but it amounted to much ado about nothing.”
All the speakers encouraged everyone to be vaccinated and wear masks.
“It will prevent you from giving the virus to someone else,” said Cannon, “or from them giving it to you.”
“We’re in this together,” said Arthur, “and we can get out of it together.”
Another hospital system mandates vaccines for workers see more
Another hospital system in the Lowcountry will soon mandate that workers get a COVID-19 vaccine as a condition of employment.
Roper St. Francis alerted its approximately 6,000 employees of the impending requirement on Aug. 24. The announcement comes a day after the federal Food and Drug Administration granted full approval to the Pfizer vaccine for people 16 and older and comes amid a new surge of COVID patients flooding hospitals and intensive care units across South Carolina.
“We are proceeding with this requirement because we care about you and our patients,” Roper St. Francis wrote in an email to employees. “This mandate is unanimously supported by the RSFH Board of Directors, senior leadership and our medical staff.”
Roper St. Francis staff who are not fully vaccinated must get their first dose by Oct. 1 and their second dose by Nov. 1. Employees who intend to file medical or religious exemptions to the mandate must do so by Sept. 17. Roper St. Francis spokesman Andy Lyons said the details of those exemption forms are still being finalized and he did not yet know if employees who developed natural immunity through a previous COVID-19 infection would qualify for a medical exemption.
Lyons said approximately 1,500 of the system’s 6,000 employees have not been vaccinated yet.
The Medical University of South Carolina and the Ralph H. Johnson VA Medical Center in Charleston already require employees to be vaccinated. In July, MUSC fired five employees who declined to be vaccinated. Vaccines for Trident Health employees remain optional, but encouraged.
In the letter to employees, Roper St. Francis leaders said more than 3,600 health care workers across the country died during the first year of the pandemic and explained that unvaccinated hospital and health care employees create more risks for patients.
According to the latest hospital census, across all four Roper St. Francis hospitals, all but 14 of the 107 COVID-19 inpatients are unvaccinated. None of the vaccinated patients who are hospitalized are on ventilators.
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
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.
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.