Majority of candidates for vaccine trial will be people of color, people over 65
A new vaccine unit at Montefiore Hospital in the central Bronx has opened, with the goal of enrolling people in clinical trials to test the efficacy of vaccines against COVID-19.
The opening comes as coronavirus infection rates are spiking sharply around the world. The unit will focus on people older than 65, an age bracket that has been hardest hit by the pandemic.
“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,” said Dr. Andrew D. Racine, chief medical officer at Montefiore and a professor of pediatrics at Einstein.
The new vaccine unit has started enrolling people in the AstraZeneca-Oxford vaccine, one of 13 COVID-19 vaccines in phase III trials and the first to be evaluated at Montefiore. Previously Dr. Racine was Montefiore’s worked on studies to evaluate remdesivir, which was later approved by the FDA as a treatment for people hospitalized with COVID-19.
Physician-scientists at Montefiore have studied COVID-19’s impact on people with major health conditions, ranging from asthma to cancer, with a focus on examining health inequities in the Bronx.
Montefiore and Einstein faculty have:
- Published the first major U.S. study on the use of steroids in treating COVID-19, and revealed which patients can be harmed by steroids
- Led a 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, now being conducted at other locations nationally
- Was the first New York City medical center to enroll participants in the remdesivir trial
- Will offer the first randomized controlled trial of dexamethasone versus baricitinib, a medication for the hyperinflammatory state in COVID-19
The unit will help ensure that “underrepresented communities will have access to the most promising protection from COVID-19,” according to Dr. Zingman.
The AstraZeneca-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. Participants will receive two injections during the first 29 days.
An independent analysis of the vaccine found it worked to set off 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.