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Montefiore News Releases

November 23, 2020

The Majority of Vaccine Trial Participants will be People of Color & Individuals Older Than 65

(BRONX, NY)—Today, Montefiore Health System and Albert Einstein College of Medicine opened the doors to its new COVID-19 vaccine unit, which will enroll people in clinical trials that will test the efficacy of vaccines against the novel coronavirus. The unit is led by Barry Zingman, MD, professor of medicine at Einstein and clinical director, infectious diseases, at the Moses division of Montefiore Health System.

The vaccine unit opening comes as global coronavirus infections are rising sharply, with nearly 200,000 cases reported daily in the United States. Montefiore’s goal is to ensure more than half of all trial participants are adults most affected by COVID-19 with a focus on people older than 65. Across the country, older individuals and communities of color have been disproportionately impacted by the pandemic.

“Montefiore and Einstein have a legacy of providing inclusive access to cutting edge care,” said Andrew D. Racine, M.D., Ph.D., system senior vice president and chief medical officer at Montefiore and professor of pediatrics at Einstein. “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.”

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, respectively.

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.

Among its notable research, Montefiore and Einstein faculty:

  • 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
  • Was the first New York City medical center to enroll participants in the ACTT-1 remdesivir trial and the second highest enrolling site worldwide
  • Will offer the first randomized controlled trial of dexamethasone versus baricitinib (NIAID ACTT-4 study) for the hyperinflammatory state in COVID-19

“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,” said Dr. Zingman. “To the healthcare providers and investigators who enthusiastically joined the effort and to the people who are coming in to participate in these critically important trials, we thank you for your role in helping the world end this pandemic.”

The AstraZeneca/University of Oxford vaccine is a randomized, placebo-controlled, double-blinded trial in which two people will get the vaccine for each person who receives a placebo injection. Two injections will be given during the first 29 days.

An independent analysis of the AstraZeneca-Oxford vaccine found it successfully provoked a powerful immune response against COVID-19. The study will not include people previously diagnosed with COVID-19, people whose immune systems are suppressed due to disease or medications, people with cancer, people who are pregnant or nursing, and anyone under age 18.

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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.