Mount Sinai Creates COVID-19 Vaccine for Low- and Middle-lncome Countries

An effective COVID-19 vaccine developed by scientists, from left, Florian Krammer, PhD; Adolfo García-Sastre, PhD; and Peter Palese, PhD, could help ease the shortage of vaccines available to low-and-middle-income countries.

The development of a safe, effective, and inexpensive COVID-19 vaccine that can easily be produced and distributed in low- and middle-income countries is underway at the Icahn School of Medicine at Mount Sinai, where early phase 1 clinical testing in Vietnam and Thailand has shown positive results.

The vaccine is the brainchild of three renowned scientists at Mount Sinai—Peter Palese, PhD, Horace W. Goldsmith Professor and Chair of the Department of Microbiology; Adolfo García-Sastre, PhD, Irene and Dr. Arthur M. Fishberg Professor of Medicine and Director of the Global Health and Emerging Pathogens Institute; and Florian Krammer, PhD, Mount Sinai Professor in Vaccinology. By combining their expertise, the scientists—who previously developed a universal influenza vaccine—hope to bring closure to this deadly pandemic by providing less affluent countries with an accessible and cost-effective COVID-19 vaccine they can manufacture themselves.

To date, the World Health Organization has distributed only 90 million vaccine doses to 131 countries, far short of the number needed to stop the spread of SARS-CoV-2, the virus that leads to COVID-19. More contagious variants of the virus will continue to evolve and plague countries around the world as long as their populations remain unvaccinated. “When we protect other countries we protect ourselves, as well,” says Dr. Palese.

Dr. Krammer says, “In North America and Europe many people are getting vaccinated and the virus circulation is going down. But that is not the case in countries in Asia or Latin America, for example. Their COVID-19 case numbers are going up quickly. They need a vaccine and they don’t have access.”

Anticipating this need, Dr. Palese and his colleagues designed Mount Sinai’s COVID-19 vaccine to use the avian Newcastle virus (NDV), and constructed it similarly to an influenza virus vaccine, which can be manufactured in embryonated or fertilized chicken eggs.

Mount Sinai’s COVID-19 vaccine, which would require two doses, could be made using the same influenza vaccine production facilities that many countries already have in place.

The NDV-based vaccine is engineered to express the spike protein of SARS-CoV-2. The construct is injected into an embryonated egg, the virus replicates, and the amplified vaccine virus is then collected, purified, and inactivated. According to Dr. Palese, the resulting vaccine is stable, extraordinarily immunogenic, and induces highly protective immune responses against SARS-CoV-2. Immunogenicity is a measure of the type of immune responses that a vaccine generates and their magnitude over time.

“The beauty of this vaccine is that it can be made using the same influenza vaccine production facilities that many countries already have” in place, Dr. Krammer says. Approximately three billion doses of flu vaccine are produced each year using embryonated eggs.

There are other advantages, as well. Mount Sinai’s Newcastle vector vaccine does not appear to cause any side effects, such as the low-grade fevers, headaches, or pain and swelling at the injection site that are associated with the Moderna and Pfizer-BioNTech mRNA vaccines. The vaccine can also be stored at the same temperature as a home refrigerator, whereas both mRNA vaccines require extra-cold temperatures found only in commercial-grade freezers.

Mount Sinai’s vaccine, says Dr. Palese, can “probably be produced for under one dollar per dose,” and will require two doses spread over 21 days. By comparison, the mRNA vaccines, which also require two doses spread over three to four weeks, cost roughly $50 per dose. To keep costs down, Mount Sinai has agreed to grant licenses for its intellectual property to low- and middle-income countries that produce the vaccine and forgo any royalties on its use.

Dr. Garcia-Sastre says, “Prior to COVID-19, we realized the potential of NDV-based vaccines and for several years optimized this vaccine vector to achieve optimal immunogenicity of the delivered antigen (or toxin). NDV-based vaccines not only have the potential to stop COVID-19 in countries that have no access to the existing SARS-CoV-2 vaccines, but  could be easily tailored to stop future pandemics caused by novel pathogens.”

As phase 2 testing for the vaccine ramps up in Thailand and Vietnam, accelerated phase 1 trials are ongoing in Mexico and Brazil. The trial designs used in these countries should lead to rapid phase 3 results. So far, the scientists say they have been pleased with their phase 1 results and with the tests that have been conducted in animal models.

“You can say that in animals, the vaccine protects beautifully,” says Dr. Krammer. “There is preliminary immunogenicity data that suggests the vaccine induces very good neutralizing titers.”

It is not yet clear whether the current vaccine will need to be updated to protect against aggressive new variants, according to Dr. Krammer. “But if it’s needed, we can change and move quickly to a variant vaccine. It would not be complicated.”

With regard to safety, which is top priority in a phase 1 trial, Dr. Palese says, “We are passing with flying colors.”

 

Tracy Layne, PhD, MPH, Receives the Schneider-Lesser Foundation Fellowship for Junior Faculty

Tracy Layne, PhD, MPH

The Blavatnik Family Women’s Health Research Institute (BFWHRI) congratulates Tracy Layne, PhD, MPH, who was recently awarded the Schneider-Lesser Foundation Fellowship for Junior Faculty. The fellowship is intended to advance the chances of long-term success for promising junior faculty in the Investigator or Clinician-Educator Tracks at the Icahn School of Medicine at Mount Sinai.

Dr. Layne is an Assistant Professor in the Departments of Population Health Science and Policy and Obstetrics, Gynecology and Reproductive Science as well as a faculty member of the Blavatnik Family of Women’s Health Research Institute.

Since joining the BFWHRI in December 2018, Dr. Layne has had the opportunity to join multiple projects, including a study examining whether there are treatment differences among Black and White women with advanced endometrial cancer. A cancer epidemiologist with a background and interest in the multifactorial and often interrelated drivers of racial and ethnic cancer disparities across the cancer continuum, Dr. Layne focuses on the etiology of disparities in endometrial and ovarian cancer risk and mortality. Her research centers on endometrial cancer and is aimed at understanding the elevated risk of aggressive disease among Black women and the contributors that make it the largest Black-White disparity in gynecologic mortality. A critical component of her work is collaborating with faculty across multiple disciplines and institutions on a range of clinical, epidemiological, and socioeconomic issues relevant to narrowing gaps in women’s health disparities research.

In 2020, five fellowships of $20,000 each were awarded to recipients that have demonstrated high impact research accomplishments and have strong potential for an independent scientific career. Dr. Layne will use her support from the Schneider-Lesser Foundation Fellowship for Junior Faculty to develop preliminary data that examines the relationship between vitamin D metabolism and endometrial cancer disparities between Black and White women.

“Black women are virtually missing from the preclinical and observational research examining the relationship between vitamin D activity and endometrial cancer,” says Dr. Layne. “This despite preclinical research suggesting that vitamin D metabolism is altered in endometrial cancer tissue and may be associated with aggressive disease.  It is also notable given that Black women have well-established higher rates of both aggressive endometrial cancer and chronically lower circulating vitamin D concentrations compared to their White counterparts. With these factors in mind, this project will use next-generation sequencing to evaluate whether patterns of vitamin D activity, as measured by gene expression and genomic interaction, differs in bio-banked tissue from non-Hispanic Black and non-Hispanic White women with endometrial cancer.”

We look forward to highlighting Dr. Layne’s research findings from this prestigious award in the coming months. Congratulations and well done, Dr. Layne!

Mount Sinai’s Master’s Commencement—A Time for Reflection and Recognition

The Graduate School of Biomedical Sciences at the Icahn School of Medicine at Mount Sinai conferred 201 master’s degrees during a ceremony that was held virtually on Friday, June 26, as New York City continued to observe masking and social distance protocols in the midst of the COVID-19 pandemic. The Graduate School now has eight master’s degree-granting programs, including its newest, Biomedical Data Science, which graduated its first student.

“Class of 2020, I applaud your passion, your dedication, and your commitment to hard work,” said Marta Filizola, PhD, in greeting the graduates. Dr. Filizola is Dean of the Graduate School of Biomedical Sciences and the Sharon & Frederick A. Klingenstein/Nathan G. Kase, MD Professor of Pharmacological Sciences, and Neuroscience.

Marta Filizola, PhD

“This has, of course, been an academic year with an unusual conclusion. But even in these times, there is much to be grateful for. In a year when the world is filled with uncertainty, I also feel hope because of all of you,” she continued. “You have seen your studies through, and now, when they are greatly needed, you will be applying your new skills in biomedical sciences, in data science and statistics, in genetic counseling and clinical research, in public health and health care leadership, to meet some of the greatest challenges these fields have ever faced. Whether you continue in academia; pursue careers in biotechnology, pharmaceuticals, or other industries; or even start your own companies and show the world what it has been missing, I hope you will do it with drive, with discipline, with integrity, and with empathy. The world can use your help.”

Presiding over the ceremony was Eric J. Nestler, MD, PhD, Director of The Friedman Brain Institute, Dean for Academic and Scientific Affairs, and Nash Family Professor of Neuroscience. In addressing the graduates, he said: “We were caught flat-footed by COVID-19 and should have responded much better early on, but public health and modern medicine have saved the lives of innumerable people—through medical support, antiviral agents, and mitigation efforts—who otherwise would have died. And how impressive and heartening it has been to see the leadership role played by Mount Sinai and our health care heroes on the front lines in these efforts.”

Eric J. Nestler, MD, PhD

Still, Dr. Nestler cautioned, “As we continue to focus on containment and treatment, we must also now heed warnings on the impact of contagion on our humanity. We have already seen a dramatic increase in depression, post-traumatic stress, suicide, and drug overdoses, and we all expect that this is the tip of the iceberg of people who are hurting emotionally from the stress and fear of themselves or loved ones getting sick, in addition to the toll of social isolation and severe unemployment. We should also keep the toll of COVID-19 in perspective. Before the pandemic, 70,000 Americans died each year of drug overdoses, and 50,000 from suicides; one might argue that addiction, depression, and suicide have been pandemics for years to which our society has not paid nearly enough attention.”

Dr. Nestler introduced Helena Hansen, MD, PhD, Associate Professor of Anthropology and Psychiatry at the Grossman School of Medicine at New York University, who gave the Commencement address. Dr. Hansen also was awarded an honorary Doctor of Science degree for dedicating her “wide-ranging career to studying the intersections of social forces and medicine, identifying opportunities for improving health, and greatly improving access to care for all.”

Helena Hansen, MD, PhD

Dr. Hansen, who began her training at the peak of AIDS activism, challenged the graduates to seek wisdom in new places. “Our turbulent times have placed health inequalities and climate as centerpieces of social justice, at the very center of our society’s future. You, as highly trained scholars and practitioners of public health, are in the eye of the storm,” she said, as she provided the graduates with three principles for positive action. “Look for expertise and leadership from ‘below.’ The power structure of our society will continually belittle the knowledge of those who never had access to college or graduate education. Your job is to go against the grain and redefine knowledge, expertise, and power.”

She continued: “Look up to larger systems for fundamental causes of syndemics and health inequalities—their roots are almost always in policies and institutions. The predictable patterns of overlapping epidemics signal that they are biosocial in nature, that they represent the biological end points of social environmental assaults. Your job will be to continually redefine health problems from problems of individual behaviors to problems of pathological systems. Build communities of practice wherever you go: you will need the affirmation and power of many like-minded people.” Dr. Hansen concluded, “I congratulate you on choosing the eye of the storm for your career, and I look forward to meeting you there.”

Charles Sanky, MPH

Charles Sanky, a dual MD/MPH degree candidate who received a Master of Public Health degree and intends to complete his MD degree in 2021, was the student speaker. “I’d like to talk about muting ourselves,” he began. “It’s something we tend to do out of courtesy on Zoom calls, but we do this in real life, too—stopping ourselves from speaking our truth, taking action, and sharing what we have to offer. Some of us have felt powerless and incapable of meaningfully effecting change without more education, more skills, more experience. ‘If only I get my master’s, then I’ll be able to tackle the big questions. Then, I’ll be able to contribute. Then, I will be heard.’ We muted ourselves instead of realizing that we had a powerful voice all along.”

Mr. Sanky urged the Class of 2020 to not be silent. “Our graduation, this moment, celebrates our ability to raise our voices, to continue in that fight for serving humanity through health care,” he said. “We have the privilege, ability, and the duty to do something more, to push boundaries to reimagine solutions. In this moment, let’s promise ourselves that we will speak up, take action, be creative, and think beyond the structures handed to us. Class of 2020, let’s live our lives off mute.”

Why a Master’s Degree? New Graduates Share Their Perspective and Aspirations

“Mount Sinai has been the perfect academic community for me for the past two years, growing my love of research while at the same time challenging me and developing my skills. I’m excited to keep chasing my aspirations as I continue on to complete my PhD at Mount Sinai and further my research goals.” —Kimberly Okoli, MSCR

I’m the first one in my family to attain my master’s; therefore, while this is an academic achievement, it also feels like a hugely personal one. In retrospect, Mount Sinai provided the perfect environment and opportunity for me to pursue my graduate education. The rigor and wisdom of the professors really helped spark the curiosity and interest to learn. And, while my last semester here wasn’t exactly as I envisioned (due to COVID-19), Mount Sinai adapted really well and still opened new doors for me and my future.” —Aaron Sunil, MSCR

“The Master of Science in Clinical Research Program at the Icahn School of Medicine at Mount Sinai has the most comprehensive curriculum and exceptional faculty from a diverse clinical background, which provided me with the perfect intellectual and social milieu to extend my research skills and actively participate in this field. The knowledge and the experience I gained here will help me to pursue a career as a clinical researcher in the field of neurology.” —Dhaivat Shah, MBBS, MSCR

“My time in the Master of Public Health program gave me the opportunity to discover passions for health disparities research, environmental health, and preventive medicine that I never knew existed. Before coming here, I didn’t know that being a physician and research scientist was possible to balance. Having physicians as professors, and forming bonds with these mentors and becoming a part of their research endeavors created a very unique experience that I’m truly thankful for.” —Acacia Smash, MPH

Upon graduating the Health Care Delivery Leadership Master’s program, I find both the world and myself transformed. The knowledge and expertise that I gained from the program have been invaluable in successfully leading my clinic through the pandemic. Armed with a renewed sense of determination and skills, I’m taking this opportunity to expand into various areas by both building on the clinic redesign I have started and taking the Addiction Medicine boards this fall.”  — Jameela Yusuff, MD, MPH, Medical Director and Associate Professor of Medicine (Infectious Diseases), STAR Program, SUNY Downstate Medical Center

A Passion for Community Wellness Drives New Graduate Gavriella Hecht, MPH

Gavriella Hecht, MPH, was one of 201 students receiving a master’s degree from Mount Sinai.

At a time when the world is focused on public health, the students in the Master of Public Health (MPH) program at the Graduate School of Biomedical Sciences at the Icahn School of Medicine at Mount Sinai are as committed as ever to preventing disease, protecting the environment, and promoting good health at the local level and in populations around the globe.

Gavriella Hecht, who graduated from Mount Sinai’s MPH program on Friday, June 26, pursued the epidemiology track, taking on a variety of projects to gain knowledge and experience. She served as a research assistant on data management for the Integrated Care at Mount Sinai study on substance use among HIV patients. The study was conducted at outpatient HIV clinics within the Mount Sinai Health System.

In 2019, she presented research on opioids and HIV at the annual conference of the American Public Health Association. Earlier, Ms. Hecht had the opportunity to participate in county-level New York State projects that included lab work with mosquitoes and research on how certain species impact the West Nile virus.

“One of the great things about the Mount Sinai MPH program is that students have the opportunity to do significant work and really make a difference,” she says. “It allowed me to pursue my passions and to feel valued for my work. The faculty and staff are very committed to the success of their students.”

Today, Ms. Hecht is continuing her training through a two-year Centers for Disease Control and Prevention / Council of State and Territorial Epidemiologists Applied Epidemiology Fellowship at the Arizona Department of Health Services. She is assigned to its Public Health Preparedness/Epidemiology and Disease Control Office of Infectious Diseases, working primarily on projects involving data management related to COVID-19, including the evaluation of electronic laboratory reporting and contact tracing.

At the Master’s Achievement Ceremony that preceded Commencement, Ms. Hecht was recognized for her accomplishments with the Excellence in Public Health Leadership and Service Award. She is also a member of the Delta Omega Honorary Society.

Ms. Hecht plans to continue her focus on epidemiology, studying patterns of zoonotic and vector-borne diseases, an emerging field she became interested in after taking a class on the topic at Mount Sinai. “My biggest passion,” she says, “is understanding how human, animal, and environmental health all impact each other.”

How a Small Force of Mount Sinai Nursing Students Played Key Support Roles at the Height of COVID-19

Nursing student volunteers, from left, Pearl Scalzo, Sylvie Jean Baptiste, and Jacky Lee stocked emergency trays for the Mount Sinai Beth Israel Pharmacy.

Twenty-two students at the Phillips School of Nursing at Mount Sinai Beth Israel have logged more than 1,000 volunteer hours since early April, taking on key support roles in pharmacy and research to help overburdened Mount Sinai Health System staff at the height of the COVID-19 pandemic. The effort was launched by two student leaders, Shayna LaSala, President of Student Government at the School of Nursing, and Frances “Frankie” Burney, chapter president of its National Student Nurse Association. They say they were inspired by the several hundred medical and graduate students and postdoctoral fellows from the Icahn School of Medicine at Mount Sinai who had been volunteering through the newly created Sinai Student Workforce.

With the help of Dean Todd F. Ambrosia, DNP, MSN, APRN, FNP-BC, FNAP, Ms. LaSala and Ms. Burney created the Nursing Student Workforce, giving nursing students the opportunity to volunteer in the pharmacy at Mount Sinai Beth Israel and at Mount Sinai Morningside, and to play vital roles in a significant COVID-19 research project at the Icahn School of Medicine.

As part of their efforts, the nursing students assembled crash carts and emergency kits, prepared medications, and performed whatever tasks were requested by pharmacy technicians. One student who was particularly skilled in phlebotomy trained registered nurses and personal care assistants on the latest venipuncture techniques. They also joined a cadre of staff and other volunteers on the Mount Sinai COVID-19 Tissue Collection Taskforce, where they helped to create a biobank of specimens from COVID-19 patients that later would be analyzed in research laboratories as part of a study by Mount Sinai scientists. The students were assigned to help assemble test tubes, deliver them to unit nurses, and then collect the full ones hours later, working in day or evening shifts.

Nursing student volunteers, from left, Dominique Falci, Rebecca Dornfeld, and Gurpawan “Gia” Kang helped to create a biobank of specimens from COVID-19 patients as part of a research study.

“Our nursing students were determined to help during this crisis,” says Dr. Ambrosia. “Their actions demonstrated that nursing truly is a calling—one that attracts those who strive to help humankind. I am extremely proud to stand with them and the nursing profession as we continue to care for our patients and one another.”

“It was inspiring to be part of a team where everyone—doctors, nurses, volunteers—came together to get through this,” says Dominique Falci, a nursing student who was involved in both research and pharmacy tasks. “There were so many extremely sick patients and so much bad news, but staff and volunteers were so warm and supportive of each other. It was very uplifting, especially as a student,” she says.

The students believe they got a unique perspective that will influence how they perceive hospital relationships. “Everyone brings a different skill set into a situation,” says Ms. Burney. “This experience has, for me, highlighted the special relationship between doctors and nurses and how much they can achieve by working together closely as a team across all disciplines.”

The students volunteered between semesters, launching the project in April after completing their final exams. However, now that classes have resumed, most are unable to continue volunteering, though Ms. Falci intends to make it part of her schedule. Fortunately, as new COVID-19 admissions have been declining, there is less need for volunteers. The student volunteers, who are in the Accelerated Bachelor of Science in Nursing Program, will graduate in August.

“It really has been a privilege to ease some of the burden on front-line workers,” says Ms. LaSala. “And, seeing our student body come together and work seamlessly as an interdisciplinary team with the medical students and Mount Sinai staff during such a stressful time is a learning experience we’ll never forget.”

Nursing student volunteer Gurpawan “Gia” Kang, left, helped Nicole Simons, MA, Team Leader of the COVID-19 biobank research study, collect biospecimens at an inpatient unit in Guggenheim Pavilion.

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