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.
MUSC has multi-billion-dollar impact on South Carolina... see more
A new report shows the Medical University of South Carolina has an annual economic impact on the state of about $5.6 billion. MUSC Health CEO Patrick Cawley, M.D., knows where a big part of the credit lies. “MUSC Health has grown significantly in the past 18 months and this report details the growing economic impact across the entire state of South Carolina.”
In early 2019, MUSC bought four hospitals in Lancaster, Florence, Marion and Chester, creating a regional hospital network and establishing itself as a health care organization that reaches well beyond Charleston.
Joseph Von Nessen, Ph.D., a research economist at the Darla Moore School of Business at the University of South Carolina in Columbia, led the six-month economic impact study. “MUSC maintains a unique and sizeable statewide economic footprint. Its impact in Charleston may already be well known, but it’s also important to recognize that MUSC’s economic benefits extend well beyond the borders of the Tri-county region.”
For example: “About 38,000 people in South Carolina can attribute their jobs either directly or indirectly to the activities that are going on at MUSC every day. It really shows how significant MUSC’s impact is,” Von Nessen said.
South Carolina life sciences is booming, with new organizations growing and moving here see more
Comprised of 650 life sciences firms, with wages nearly double state averages and an annual economic impact over $12 billion, South Carolina life sciences employs 43,000 professionals in research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. It’s a powerful force in today’s Palmetto State economy.
The fastest growing segment of the state’s innovation economy, life sciences shows no signs of slowing — despite a global pandemic that has advanced public awareness of the vital sector.
Life sciences’ 6 major segments include pharmaceuticals/biotech (including such state organizations as Nephron Pharmaceuticals, Thorne and Thermo Fisher Scientific), medical devices/medtech (Abbott, Arthrex and AVX), Health IT/digital health (ChartSpan), research-testing-diagnostics-labs (Greenwood Genetics Center, Precision Genetics and Vikor Scientific), bioscience distribution (SoftBox Systems), and Bio-Ag. Every sector is well-represented across South Carolina, with life sciences active in at least 43 of our 46 counties.
What makes the industry even more compelling is that it averages triple the R&D spend of all other industries and is highly recession resistant due to its connectivity with healthcare. An $8 trillion annual global healthcare spend is supported by a $1.5 trillion global life sciences industry – with the United States responsible for almost half of the world’s innovations.
To help the Palmetto State become a significant player in life sciences, SCBIO was refocused 3 years ago – with economic development as the focal point. Providing support for existing industry, working with economic development organizations to recruit global life sciences companies, and developing strategies to grow our own companies has had a seismic impact on SCBIO and its stakeholders — and ushered in a new era ripe with opportunity.
Aligning with the SC Department of Commerce in 2017 helped SCBIO to triple revenue in 3 years, more than quintuple membership, develop a full-time multi-disciplinary team, and cultivate an extraordinary board of directors from industry, academia, healthcare, core service providers, and economic development partners.
SCBIO has become a catalyst for and voice of South Carolina life sciences. From offices in Greenville, Columbia, and Charleston, SCBIO represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members and allies include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
Working with allies and partners, SCBIO created the state’s first ever SC Life Sciences Strategic Plan – now in its third iteration — to build a nationally competitive and sustainable ecosystem focused on building, advancing, innovating and growing the industry.
And innovation is the lifeblood of progress. For the state to become an innovation destination for life sciences, the effort requires relentless pursuit – of talent, of transformational ideas, of organizations bringing operations and R&D to our state, and of an enhanced ecosystem that supports existing industry while growing our own companies.
Life sciences innovation has a rich legacy in South Carolina, drawing on the notable talents and creativity of the research universities of Clemson, University of South Carolina, and MUSC… a Top 25 national health system in Prisma Health… plus South Carolina Research Authority, Greenwood Genetics Center and others whose ground-breaking work has earned South Carolina a deserved reputation as a life sciences up-and-comer.
From pioneering medical grade electrolytic capacitors that made thoracic implantable defibrillators possible at St. Jude Medical (now Abbott)… to the recent invention and introduction by MUSC, ZIAN and Rhythmlink of a novel safety electrode that has the potential to reduce needle sticks in surgical settings around the globe, South Carolina life sciences innovation is on the move.
Even facing a global pandemic, SC’s life science companies are on the front lines and performing at a high level. Entrepreneurs and academic institutions have deftly shifted focus or pivoted production to address needs resulting from the crisis. Providing everything from COVID-19 PCR test kits to antibody tests, from respiratory therapies to face shields, and from developing specialty garments for frontline workers to being selected to conduct Phase III vaccine trials in the hunt for a COVID cure, South Carolina is now a part of the global solution team.
A prime example is Columbia’s ZVerse, a digital manufacturer. Seeing desperate need for protective shields for healthcare workers, the early-stage company quickly pivoted to become one of America’s largest manufacturers of reusable face shields. ZVerse then devised a new, proprietary shield that is more comfortable to wear over long periods of time. Sales have soared.
The booming ecosystem includes technology incubators and accelerators across the state, providing entrepreneurs with guidance and opportunity to collaborate with peers. A recent SCRA initiative—the creation of the South Carolina Business Incubator Association — is an important step in helping organizations share best practices and stimulate innovation.
Along with Southeastern partners Global Center for Medical Innovation and Health Connect South, SCBIO is championing a unique innovation partnership: The Southeast HealthTech Collaboration. Leveraging complementary strengths, resources and networks, the group will identify pressing health needs in our region without requiring major new investment in infrastructure or capital.
Now a finalist for a major grant in the EDA 2020 Build to Scale Venture Challenge, the Southeast HealthTech Collaboration will launch a three-year program to:
- Convene healthcare leaders to identify top healthcare challenges and innovators working on technology-based solutions to address them;
- Accelerate best solutions through development and into commercialization; and
- Scale startups and networks to drive investment and job creation across South Carolina and Georgia.
With a focus on minority and underserved populations, the initiative will accelerate development and commercialization of technological solutions to address unmet clinical and health needs, leading to scaling of startup growth and a sustainable economic engine.
As American poet Robert Frost penned:
“The woods are lovely, dark and deep, but I have promises to keep,
And miles to go before I sleep.”
Despite miles to go, there is plentiful evidence that our state is “punching above our weight class”, given our relative size and resources. With innovation blossoming and a surging passion for improving prosperity, the promise of South Carolina and its future has never been brighter.
Healthcare leaders address good, not so good in COVID-19 response see more
Four thought leaders from South Carolina healthcare’s executive ranks will address how SC health systems have responded to the impacts of COVID-19, compelling lessons learned, and what they see as the path forward for healthcare in the Palmetto State and beyond, in a free, public webinar to be held Tuesday, May 19 at 10 a.m. EST, officials have announced.
Featured panelists include Dr. Danielle Scheurer, Chief Quality Officer of MUSC Health; Dr. Alain Litwin, Health Sciences Center Rapid Innovation Task Force leader of Prisma Health; Thornton Kirby, CEO of the South Carolina Hospital Association; and Matthew Roberts, Chair of Healthcare Practice of the Nexsen Pruet Law Firm. The webinar will be hosted and moderated by Sam Konduros, CEO and President of SCBIO. Participation is free and interested parties can register to participate at https://www.scbio.org/events/next-up-how-sc-healthcare-is-taking-on-covid-19.
The 60-minute program is meant to provide business leaders, elected officials and key stakeholders of South Carolina’s life sciences industry with a real-time status of the state’s healthcare climate two-plus months into the global COVID-19 pandemic, unique responses to this modern day plague, and how the public healthcare crisis has impacted both current and future delivery of healthcare. The panelists will also address a realistic path forward as South Carolina begins the move to return to normalcy while still navigating a virus with no clear endpoint.
“Our goal is to identify and discuss what South Carolina healthcare has done well, such as widespread implementation of telehealth, advances in equipment and testing, and partnering with other players and states to make a difference, while also addressing the state’s and nation’s challenges including limitations in our rural health systems, and a surprising level of dependence on drugs and equipment from foreign countries,” noted SCBIO CEO Sam Konduros.
“The panelists will also share their thoughts on important lessons learned, innovation opportunities and strategies for the future – identifying ways for organizations and the healthcare industry in SC to come together to collectively solve problems and improve treatment and quality of life for all South Carolinians,” he added.
SCBIO is South Carolina’s investor-driven public/private economic development organization exclusively focused on building, advancing, and growing the life sciences industry in the state. The industry has an $11.4 billion annual economic impact in the Palmetto State, with more than 600 firms directly involved and 43,000 professionals employed directly or indirectly in the research, development and commercialization of innovative healthcare, medical device, industrial, environmental and agricultural biotech and products. The state-wide nonprofit has offices in Greenville, Columbia, and Charleston, and represents companies in the advanced medicines, medical devices, equipment, diagnostics, IT, and healthcare outcome industries. As the official state affiliate of BIO, PhRMA and AdvaMed, SCBIO members include hundreds of academic institutions, biotech companies, medtech companies, entrepreneurial organizations, service providers, thought leaders, economic development organizations and related groups.
For additional information on SCBIO, visit www.SCBIO.org.
MUSC Shawn Jenkins Children’s Hospital and Pearl Tourville Women’s Pavilion open see more
The long-awaited MUSC Shawn Jenkins Children’s Hospital and Pearl Tourville Women’s Pavilion opened Saturday, bringing a dedicated space for women’s and children’s health care to the Lowcountry.
In just under 12 hours, Medical University of South Carolina staff and partners transported almost 200 patients from the former MUSC Children’s Hospital on Ashley Avenue to the new building on the corner of Courtenay Drive and Calhoun Street.
“We saw an incredible amount of teamwork and a very professional approach to the whole thing, but also just a whole lot of joy,” said Mark Scheurer, MUSC Children’s Hospital chief medical officer and project leader. “It was really fun just watching the little things happen that you talked about in the planning period when they were just hypothetical.”
The 11-story hospital includes the state’s only level-one pediatric trauma and burn unit and the state’s largest level-four NICU.
Starting with patients in the neonatal intensive care unit, teams simultaneously transported patients along four routes with the use of 36 ambulances, Scheurer said.
The 11-story, 625,000-square-foot hospital includes a 20% increase in capacity. It has the state’s only level-one pediatric trauma and burn unit and the state’s largest level-four NICU. There also is an advanced fetal care center and a dedicated elevator for transporting mothers in labor from the hospital’s entrance directly to the fourth-floor maternity pavilion.
“This new hospital is so important for the community because it will offer a different experience for women and children and their families because they (the team) will be able to deliver care using new technology,” said Carolyn Donohue, MUSC’s executive director of nursing for children’s and women’s health. “It also involves our patients to be able to use that technology to improve their ability to communicate with the health care team and their family during the acute care of their hospitalization.”
This $389 million project was expected to open in October and then December. Neither opening took place delayed after setbacks from Hurricane Dorian and because the hospital didn’t pass safety and regulatory inspections.
The hospital began its operating room and outpatient services Monday. Staff members will continue to move in any remaining supplies and equipment and to monitor operations to make sure they work as smoothly as planned.
Clemson, Prisma health professionals working to develop early cancer screening test see more
When her younger brother was diagnosed with cancer, Clemson bioengineering professor Terri Bruce re solved to tap her knowledge of human cells to find a way to help others suffering from the dis ease. After devouring all the scientific literature she could, she chose to focus on developing a screening test to detect the disease in its earliest stages when it has a better chance of being cured.
“It was a time in my life when I felt helpless,” she told The Greenville News.
“And I felt there’s got to be something I can do — even if I can’t help Greg — to help other people.”
Because he suffered from brain cancer, she looked to another form of the disease that wasn’t as emotionally entangled but had no early screening tests. She decided on ovarian cancer.
Now Bruce and her research team are on the brink of a test that they believe could be a screening tool — not only for ovarian cancer, but other cancers too.
“The hope,” she said, “is to ... catch this deadly cancer much earlier and give women a fighting chance.”
Ovarian cancer will strike 22,530 women this year, according to the American Cancer Society, and about 14,000 will die of the disease.
But only about one in five cases is discovered early because there are no reliable screening tests, the society reports.
A late diagnosis reduces survival. And because the symptoms are so vague, about three quarters of all women are diagnosed at a late stage, said Dr. Larry Puls, the director of gynecologic oncology at Prisma Health Cancer Institute.
Only 10% to 15% of them will survive long-term. And overall survival numbers haven’t changed much in 40 years, he said.
Though blood work can test for a protein that can identify some ovarian cancers, only half of stage 1 patients test positive for it, Puls said.
“One of the things that has eluded us in ovarian cancer is that we have no screening for it,” he said. “But if you can find it when it’s confined to just the ovary alone, 90% of patients beat their cancer.
“If we could shift women out of stage 3 and into stage 1,” he added, “we can make a huge impact on this disease.”
For some time, Bruce has been studying exosomes, which are microscopic droplets found in body fluids that were traditionally regarded as a way for cells to rid themselves of debris.
But further research revealed that they contain parts of the cell they are from as well as proteins that can serve as biomarkers of what’s going on in that cell, she said.
Cancer often develops because something goes awry in the DNA, leading to aberrant proteins and tumor growth, she said. So she theorized that finding those protein signatures in exosomes could be a way to diagnose cancer.
“If we can find those aberrant protein signatures and see them on the cells and exosomes,” she said, “ ... it potentially could be used for any type of cancer, as long as you find the biomarker.”
The process has the potential to be used as a diagnostic tool for other diseases as well, she said.
So Bruce approached Clemson chemistry professor Ken Marcus, who’d been separating whole human cells for years using fiber strips, and asked if he could separate exosomes.
“I said, ‘I don’t even know what they are,’ ” he recalls with a chuckle.
“But she got us some samples and in pretty short order ... we made some really good educated guesses and it worked.”
Marcus and his “very talented students” were not only able to separate the exosomes, but reduced the time needed to do it from 2 1 / 2 hours to 8 min utes using a test strip made of a polymer that is grooved much like the top of a zip lock bag.
When fluid is added, it flows down the channels where it interacts with different antibodies that in turn isolate the exosomes, he said, much the way a pregnancy test works.
Catching it early
Bruce and Marcus were then introduced to Puls, who joined the research team.
He’s collecting samples of cervical fluid containing exosomes and proteins obtained at the same time as a pap test. So far, 49 women have been tested with the strip, Puls said, and two who had no symptoms and normal blood tests were revealed to have stage 1 ovarian cancer.
“That’s the patient we covet the most because we cure 90% of those patients,” he said.
Puls also hopes the test will one day detect precancerous changes, enabling doctors to surgically remove the tissue — like they do when a pap test reveals a precancerous change — and prevent the development of cancer in the first place.
While the initial data will be crunched in the next few weeks, Puls said he’s optimistic that the test could be a promising new tool in the battle against ovarian cancer.
He hopes the test could be used to screen for uterine cancer as well, which strikes another 63,000 women a year.
The Holy Grail for the process, Marcus said, would be a urine test because it can show what’s going on inside the whole body. But the first step is testing cervical fluid in the doctor’s office.
“And even that is an infinite step up from where we are today,” he said.
Because tumors can be caused by a variety of proteins, the test will look for a bank of markers in an effort to capture more cancers, said Bruce, who is also director of Clemson’s Light Imaging Facility.
“I think we’re close on getting some kind of screening tool,” she said. “And we’re in the process now of (getting) all the patents.”
So far, the research has been privately funded, but the team plans to use their initial data to apply for federal grants to continue their work.
They estimate a test could be ready for market in about five years.
Carmen Brotherton hopes the test will be routine in her daughter and grand-daughters’ lifetimes.
The Easley woman’s ovarian cancer was discovered in 2009, making her one of the few to be diagnosed in stage 1.
“I’ve lost some good friends ... who weren’t caught in time,” said Brotherton, who volunteers with the South Carolina Ovarian Cancer Foundation.
“It’s always been one of my prayers that some day they would come up with something that would catch it,” she said.
“This is just a small place compared to the U.S. or the rest of the world. Imagine how many women this could catch. And it might save their lives.”
When Bruce’s brother was diagnosed in 2012, little could be done to stop the progress of the cancer, she said. He died in January, leaving his two sons fatherless.
Now she hopes the test will one day mean that fewer people will be left without a parent like her nephews.
“In conjunction with the discovery of distinct biomarkers, the fibers could lead to finding diseases such as ovarian cancer — and brain cancer — much earlier,” she said.
“Early enough, I hope, to save many lives in the future.”