Montefiore & Einstein Open COVID-19 Vaccine Unit to Ensure Underrepresented Included in COVID-19 Vaccine Trials

Montefiore & Einstein Open COVID-19 Vaccine Unit to Ensure Underrepresented Included in COVID-19 Vaccine Trials

Preeminent New York City healthcare institutions, ones with global brand recognition and influence, introduce a new COVID-19 vaccine unit, established to support the enrollment of participants in clinical trials to test efficacy of the vaccines against SARS-CoV-2, the virus behind COVID-19. The effort is timely: Montefiore Health System and Albert Einstein College of Medicine opened the new COVID-19 vaccine unit as the next wave of this pandemic grows, with almost 200,000 reported cases daily in the United States. Led by Dr. Barry Zingman, MD, professor of medicine at Einstein and clinical director, infectious diseases, at the Moses division of Montefiore Health System, this mission-critical unit will serve this most dynamic, diverse, and densely populated part of the United States in a bid to ensure over half of all trial participants are adults most affected by COVID-19. That is, the unit will work to diversify COVID-19 vaccine trial participation, ensuring that important underrepresented groups participate in the research, from the elderly to communities of color. These groups have been heavily impacted by the pandemic. This new vaccine unit builds on established leadership of both Montefiore and Einstein in conducting COVID-19 trials and providing lifesaving clinical care to thousands of people in the community. The group has already commenced volunteer enrollment for the AstraZeneca-Oxford vaccine trial, for example. Sponsors involved with the clinical development of COVID-19- focused vaccines and therapies should consider involvement with this unit.

A Dynamic, Diverse and Densely Populated Place: Hit Hard

Both Montefiore Health System  and Albert Einstein College of Medicine are based in New York City’s Bronx Borough. New York City (NYC), the most populated city in the United States, has approximately 8.7 million residents and represents one of the most diverse cities in the world. The city is approximately 29% Hispanic, 24.3% Black and 13.9% Asian. With a population of about 1.4 million, the Bronx is 48.4% Hispanic, 35.6% Black and 3% Asian.  With about 20 million residents, the New York City metropolitan area is classified as one of the top ten “mega cities” in the world.

As it turned out, during the first major pandemic wave, NYC as a whole was hit hard by the new pathogen’s wave of infection. But if matters in NYC were bad enough, in the Bronx they were twice as bad. Why so much worse in the Bronx? More than likely the social determinants of health (SDoE) play a major role in shaping the impact of this disease.

For example, Manhattan’s large concentrations of wealth, education, and privilege enable many of that Borough’s residents to access the time, space and other factors needed to protect one’s self from COVID-19. With growing gentrification in this northern Borough, the Bronx is transforming. Yes, the uniquely New York City-based collection of diverse communities has come a long way since the late 1970s, when parts of the South Bronx resembled some war-time cities in Germany.  

But pockets of severe poverty persist here in the Bronx, where large often dilapidated public housing projects often combine with a lack of access to nutritious food (so-called food deserts) severe income inequality and at times health care access challenges.  Many poor people may not have what is called a “medical home” for example as well. The Montefiore and Einstein COVID-19 vaccine unit comes just at the right time. Too much painful loss has afflicted poor communities across the Bronx because of this virus. Perhaps the vaccine center can be a catalyst for the emerging clinical research as a care option movement, helping to offer a medical home to those that don’t have one, via research. 

Enter the COVID-19 Vaccine Unit

Now two long-standing Bronx medical institutions’ investment in the new COVID-19 vaccine unit will bring a concentrated effort to this front on the war on COVID-19. Since March, physician-scientists at Montefiore and Einstein have studied COVID-19’s impact on almost every major health condition, ranging from asthma to cancer; examined health inequities in local communities; and helped determine which treatments work best against COVID-19.

The new vaccine unit builds on Montefiore and Einstein’s leadership conducting COVID-19 trials and providing lifesaving clinical care to thousands of people in the community and has already started enrolling people in the AstraZeneca-Oxford vaccine AZD1222 trial. Dr. Zingman is the principal investigator at Montefiore for the vaccine, which is one of 13 COVID-19 vaccines in phase III trials and the first to be evaluated at Montefiore and Einstein. He was also the principal investigator at Montefiore and Einstein for the ACTT-1 and ACTT-2 National Institutes of Health trials, which evaluated remdesivir (now FDA-approved as a treatment for people hospitalized with COVID-19) and remdesivir plus baricitinib.

Notable Research Rivals the Best Worldwide

The physician-scientists and research teams have been intensely busy since the onset of the pandemic. Teams at Montefiore and Einstein operated, heroically, at the epicenter of the world pandemic during the Spring and into part of the summer. Consequently, the accumulated experience, research expertise, capacity and know-how associated with COVID-19 rivals any healthcare group worldwide.

Recent examples of research were included in a recent press release, including the following:

  • The first New York City medical center to enroll participants in the ACTT-1 remdesivir trial and the second highest enrolling site worldwide
  • Published the first major U.S. study on the use of steroids, which confirmed the findings of the large-scale British RECOVERY trial showing that steroids are effective in treating COVID-19; the study also revealed which patients can be harmed by steroids
  • Led the first-ever study comparing the immune responses of adults and children with COVID-19 and detected key differences that may explain why children have milder disease than adults
  • Led the development of a monoclonal antibody therapy to neutralize COVID-19—and potentially other emerging coronaviruses—clinical trials will begin in December
  • Created a blood test for detecting COVID-19 antibodies, used clinically and for research
  • Launched the first randomized, placebo-controlled, double-blind trial of convalescent plasma with NYU Langone Medicine Center, which has expanded to include the University of Miami and the University of Texas-Houston, among other locations across the country
  • Will offer the first randomized controlled trial of dexamethasone versus baricitinib (NIAID ACTT-4 study) for the hyperinflammatory state in COVID-19

Andrew D. Racine, MD, PhD, system senior vice president and chief medical officer at Montefiore and professor of pediatrics at Einstein recently shared “Montefiore and Einstein have a legacy of providing inclusive access to cutting edge care.”  Dr. Racine continued, “By ensuring that historically underrepresented patients are included in COVID-19 vaccination research, this effort will help ensure the efficacy and safety of vaccines for these underrepresented patient groups.”

Director’s Point of View

Dr. Barry Zingman emphasized in the recent press release the gratitude, strength and directed drive of New Yorkers to not only take the pandemic head on but as New York residents will always in the end do, overcome any challenge.  “Words cannot express my appreciation for the many people who worked so hard to establish the new COVID-19 vaccine unit, making sure underrepresented communities will have access to the most promising protection from COVID-19” declared Dr. Zingman who also profusely thanked all involved in this major effort.

About Montefiore Health System

Montefiore Health System is one of New York’s premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester, and the Hudson Valley. It is comprised of 10 hospitals, including the Children’s Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. For more information please visit www.montefiore.org. Follow us on Twitter and view us on Facebook and YouTube.

About Albert Einstein College of Medicine

Albert Einstein College of Medicine is one of the nation’s premier centers for research, medical education, and clinical investigation. During the 2019-20 academic year, Einstein is home to 724 M.D. students, 158 Ph.D. students, 106 students in the combined M.D./Ph.D. program, and 265 postdoctoral research fellows. The College of Medicine has more than 1,800 full-time faculty members located on the main campus and at its clinical affiliates. In 2019, Einstein received more than $178 million in awards from the National Institutes of Health (NIH). This includes the funding of major research centers at Einstein in aging, intellectual development disorders, diabetes, cancer, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States through Montefiore and an affiliation network involving hospitals and medical centers in the Bronx, Brooklyn and on Long Island. For more information, please visit www.einstein.yu.edu, read our blog, follow us on Twitter, like us on Facebook, and view us on YouTube.

Call to Action: Check out the new COVID-19 vaccine unit. Barry Zingman leads the effort.