Antibodies to COVID-19 in Human Breast Milk Being Tested as a Potential Therapy

Rebecca Powell, PhD, right, with lab technician Alisa Fox

Could the dominant antibodies found in milk produced by women who have recovered from COVID-19 serve as a potent treatment for individuals—both adults and children—who now have the disease? Rebecca L. Powell, PhD, Assistant Professor of Medicine (Infectious Diseases), at the Icahn School of Medicine at Mount Sinai, is pursuing research to answer that question. An HIV researcher, Dr. Powell has also studied human breast milk extensively for its significant role in human health.

In early April, Dr. Powell began a large recruitment effort in New York City, collecting breast milk from 1,600 lactating women, 600 of whom had recovered after testing positive for COVID-19, and others who may have had the disease but were never tested and still produced antibodies.

Dr. Powell tested the milk in a small percentage of women and uploaded the study to the preprint server medRxiv. She reported that 14 out of 15 donors also had a significant level of COVID-19-reactive antibodies in their milk, which was enough to warrant moving forward with further investigation on a larger scale.

“There are a lot of reasons to believe this is worth exploring,” Dr. Powell says. “Milk antibodies are enriched with secretory antibodies and unique from those found in blood. Antibodies that are very dominant in milk are meant to be in the mucosal areas of the body, like the respiratory tract, and they would function well and be durable in this environment.” Secretory antibodies found in the gut and lungs are highly resistant and provide the first line of defense against many pathogens.

Since the SARS-CoV-2 virus, which leads to COVID-19, often begins in the respiratory tract, this is precisely the environment in which such antibodies would need to function.

Dr. Powell says the secretory antibodies from human milk could serve as a potential treatment in the same way blood antibodies do in antibody therapy, where the antibody-rich plasma from patients who have recovered from COVID-19 is transferred into patients with the disease. The Mount Sinai Health System was one of the first health providers in the nation to use this therapy.

The study’s data, Dr. Powell wrote, represents a “snapshot of what is likely a dynamic immune response. A much larger sample size and long-term follow-up study is needed to better understand SARS-CoV-2 immunity in milk, as well as whether a typical response is truly protective for breast-fed babies or if this response would generate sufficient antibodies to be purified and used therapeutically to treat COVID-19 illness.”

If a larger study ultimately supports the hypothesis, Dr. Powell says she envisions a potential therapy for patients with mild and severe cases of disease that could be administered directly into an individual’s lungs, much like the nebulizers that are used for treating asthma. She also says there is significant value in understanding how these secretory antibodies confer protection to breast-fed babies and for establishing a baseline for the protection they provide after vaccines become available.

“Unlike blood, human milk can be given daily and the supply can be increased by pumping,” Dr. Powell says. “There are likely many women in New York City who would donate their milk every day if they knew it could save lives.”

New Institute for Health Equity Research Studies Issues Spotlighted by COVID-19

Co-Director Lynne Richardson, MD, left, and Director Carol Horowitz, MD, MPH, are guiding the new Institute for Health Equity Research. View an interview with Dr. Richardson on racial disparities and COVID-19.

The Mount Sinai Health System’s new Institute for Health Equity Research is quickly acting on its mandate to rigorously study disparities in health issues, including COVID-19, with the intention of translating those discoveries into initiatives and policies that benefit communities in New York and the nation.

“Our extensive expertise in population health and serving one of the most socioeconomically, demographically, and culturally varied populations in the world makes us uniquely positioned to take on this enormous challenge,” says Dennis S. Charney, MD, the Anne and Joel Ehrenkranz Dean of the Icahn School of Medicine at Mount Sinai, and President for Academic Affairs of the Mount Sinai Health System.

The COVID-19 pandemic is shining a light on long-existing health inequities, according to the Institute’s Director, Carol Horowitz, MD, MPH, Professor of Population Health Science and Policy, and Medicine, and Dean for Gender Equity in Science, and its Co-Director, Lynne D. Richardson, MD, Professor and Vice Chair of Emergency Medicine, and Professor of Population Health Science and Policy.

“Who gets COVID-19, who lives and who dies, maps very well, unfortunately, with other kinds of maps we have in New York City,” Dr. Horowitz says. “This includes areas of poverty, areas of majority of low-income, Latinx, and African American people, areas of more pollution, areas of more linguistic isolation, areas that have had more redlining in the past and other structural inequities. If you look at any map of New York City, and where people are marginalized, don’t have equal opportunities, and have higher burdens of chronic diseases, these are the same areas where COVID-19 seems to be hitting the most.”

Initiatives in Progress

The Institute has a variety of initiatives in progress, including Speak Up on COVID-19, a survey that was just launched in partnership with more than 100 New York City community organizations. “Speak Up” will be available in 11 languages to anyone with access to a smartphone. It is seeking to enroll more than 10,000 participants and will explore medical, demographic, social determinants, and COVID-19-related attitudinal, behavioral, and psychological factors; and try to identify participants’ needs and risk-factors. The survey also offers a resource guide, Dr. Horowitz says, answering questions such as “What are the resources for food? What are the resources if you are a survivor of domestic violence, and you can’t get out of your house? What do you do if you are homeless? What do you do to help your kids learn? What do you do if you are pregnant and you have COVID-19?”

And studies are underway on subjects including:

  • The impact of gender-affirming hormone treatment on the clinical course of COVID-19 in transgender and gender-nonbinary patients;
  • Health outcomes for those living with HIV and COVID-19;
  • How patient care via telehealth can be delivered equitably and narrow the digital divide.

The New York City Department of Health reports that 81 percent of COVID-19 cases are in the Bronx, Brooklyn, and Queens, with higher numbers in neighborhoods that are lower income and have more underserved residents. Only 12 percent of cases are in Manhattan, and there are signs of health disparity there as well, “right in our area, since The Mount Sinai Hospital is at the border of East Harlem and the Upper East Side,” Dr. Horowitz says. The DOH reports that as of May 18, in the 10029 zip code—East Harlem—there were 1,698 COVID-19 cases and 182 deaths, in a population that is 84 percent African-American and Latino with a median yearly income of $34,000.  The toll was markedly lower in the adjacent 10028 zip code—the Upper East Side—where there were 603 cases of COVID-19 and 34 deaths, in a population that is 71 percent non-Hispanic white with a median income of $114,000.

The Mount Sinai Health System is well positioned to collect and study its own data on health care disparity because of years of groundwork, says Gary C. Butts, MD, Dean for Diversity Programs, Policy, and Community Affairs, Icahn School of Medicine. “Understanding disproportionality is important,” Dr. Butts says. “With the data we have assembled, we can study it better, and we can be positioned to close the gaps that we have been talking about for a long time. It’s the right thing to do, and it’s the smart thing to do.”

Collecting Data

Pamela Y. Abner, MPA, Vice President and Chief Administrative Officer, spearheaded the effort to make it a standard procedure across most of the Health System to collect data in Mount Sinai’s patient registration systems on race, ethnicity, language, and sexual orientation and gender identity. The data are available to clinicians and researchers to enhance patient care and further study on an innovative Disparities Dashboard, created with leaders including Dr. Richardson and Nina A. Bickell, MD, MPH, Professor of Population Health Science and Policy, and Medicine.

“In the case of COVID-19, it appears that African-American patients were coming into the hospital sicker,” says Ms. Abner, citing preliminary findings. “We will now be able to analyze our data to determine if there are socioeconomic factors that impact outcomes within our most vulnerable populations. For example, we might look at the relationship between race/ethnicity and those who were more acutely ill, based on ICU numbers or length of stay, and consider how that may have impacted clinical outcomes.”

Dr. Richardson has experienced the toll of the COVID-19 pandemic more directly than most. In addition to her administrative and research duties, she treats patients in the Emergency Department at The Mount Sinai Hospital and at Elmhurst Hospital, and recently recovered from COVID-19 herself. “Now that we have come through the worst of the COVID-19 pandemic, it is important that we thoroughly investigate all of the causes of its disproportionate impact on racial/ethnic minorities and vulnerable communities, which are layered on top of many longstanding, pre-existing health and health care disparities,” Dr. Richardson says.

The overarching goal is addressing needs of populations at risk of COVID-19 and other health issues, which includes many members of the Mount Sinai community. “Mount Sinai is the biggest employer in East Harlem,” Dr. Horowitz says. “These are the people who are delivering food, delivering medicine, driving people around, working as home attendants. These are heroes; these are the people who have not stopped. They are not staying home in isolation, because they can’t.”

“At this point, our ability to understand, partner with, and serve those who are most vulnerable to COVID-19 is a reflection of our commitment as human beings, as researchers, as clinicians and as a Health System,” Dr. Horowitz says. “We are only as good as how we care for our most vulnerable populations.”

A Stirring Musical Performance Lifts Spirits at The Mount Sinai Hospital

Actor, singer, and Broadway performer Ciarán Sheehan thanked health care workers at The Mount Sinai Hospital with a repertoire of emotional, uplifting Broadway tunes on Tuesday, May 19.  Mr. Sheehan completed the stirring musical performance before dozens of socially distanced patients, staff, and onlookers in the Guggenheim Pavilion with the hopes that his voice would echo throughout the Hospital.

“Mount Sinai holds a special place in my heart because my first son was born here,” said Mr. Sheehan of his desire to perform at the Hospital. “I wanted to say thank you for all that they are doing. I hope they enjoy it.”

Mr. Sheehan, who starred in Les Miserables and Phantom of the Opera on Broadway, performed various theatre standards including “Bring Him Home” and “Music of the Night” from the respective productions. He also performed “You’ll Never Walk Alone” from Carousel—a musical drama about love and loss—which may resonate with the difficulty faced by both patients and health care workers, many of whom have been compelled to distance themselves from friends and family during the COVID-19 pandemic.

“It is my favorite Rogers and Hammerstein song about overcoming adversity in life and being guided and cared for by those who love you, whether you can see them or not.” 

Saving Lives, One Mask at a Time

Icahn School of Medicine at Mount Sinai student Tyler McChane (MS3) delivered mask kits to the New York Common Pantry in East Harlem.

Aishwarya Raja, a rising fourth-year medical student at the Icahn School of Medicine at Mount Sinai, looked at the East Harlem community that surrounds Mount Sinai and knew she had to help her neighbors as the COVID-19 pandemic surged in New York City. She understood they often lacked the most basic health care necessities, and with a sizable number of them considered essential workers and unable to stay at home, she wanted them to remain safe. She was unsure they would even have access to one fundamental item needed to confront the SARS-CoV-2 virus that causes COVID-19—protective masks.

Then, she had an idea and founded Mask Transit, an initiative dedicated to delivering masks and educational materials to vulnerable neighbors, an effort to help slow the spread of COVID-19. She mobilized 50 medical students across 15 institutions in mid-April, and they began sourcing and delivering masks and creating educational materials.

The project was launched under the guidance of Yasmin S. Meah, MD, Associate Professor of Medicine, and Medical Education. Dr. Meah is the Program Director and Chief Medical Attending of the East Harlem Health Outreach Partnership (EHHOP), Mount Sinai’s student-run, physician-supervised clinic, which provides free primary, preventive, and mental health care to uninsured adults.

“These students have done an amazing job of serving the most vulnerable members in the community,” says Dr. Meah. “Many of them are essential workers, isolated from services, with low health literacy, so getting masks and information into their hands can be lifesaving.”

Icahn School of Medicine at Mount Sinai student Matthew Eveleth (SY) put together mask kits that were mailed and delivered to more than 250 EHHOP (East Harlem Health Outreach Partnership) households.

Reema Navalurkar (MS3), and Parth Trivedi (SY), education co-chairs, developed educational materials to explain why and how to wear a mask, and how to clean it, along with information about COVID-19. Materials are available in Spanish, French, Mandarin, and Arabic, in addition to English. Under the leadership of Tyler McChane (MS3), the team sourced face masks and fabric. They found local seamstresses willing to donate their time to sew masks, and they partnered with grass roots organizations to help distribute them. The team delivered mask kits, consisting of masks and information, to distribution points and to individuals. They created a website, raised funds for their initiative, and promoted the program throughout the community and through social media.

To date, Mask Transit has distributed more than 6,000 mask kits with a goal of distributing 100,000 by mid-June. In addition to partnering with EHHOP, they also work with New York Common Pantry and Little Sisters of the Assumption Family Health Services, an organization that helps families meet basic needs, and they recently broadened their reach to West Bronx. Mask Transit has also established branches in Boston, where they are partnering with Boston Healthcare for the Homeless Program, and in New Haven, where they are partnering with the HAVEN clinic, Yale School of Medicine’s student-run free clinic. Their new goal is to branch out to all five boroughs in New York City and to other cities across the United States.

Aishwarya Raja, a rising fourth-year medical student at the Icahn School of Medicine at Mount Sinai, oversees the Mask Transit initiative that she founded in April 2020.

“What has been most rewarding is that we have been able to harness the power of individuals to make a difference,” says Ms. Raja. “Everyone—students, businesses, seamstresses, and community organizations—has stepped up. They are great examples of how kind, generous, and resilient our community members can be in the city’s time of need.”

Anyone interested in donating masks or mask materials can click here. To find out more information about the organization, visit masktransit.org or contact them at contact@masktransit.org.

Overwhelming Antibody Response to COVID-19 is an Encouraging Sign, Researchers Say

Ania Wajnberg, MD, left, with Nurse Manager, Patricia Lazio, RN.

More than 99 percent of individuals who fully recovered from COVID-19 and had mild to moderate symptoms that did not require hospitalization went on to develop antibodies, according to a new study by researchers at the Mount Sinai Health System. The team looked at 1,343 people who either had confirmed cases of the disease or were suspected to have the disease between March 26 and April 10, 2020.

The study also showed that these IgG antibodies, or Immunoglobulin G—which appear after an acute infection and have the potential to confer immunity and protection against reinfection—were optimal for use in testing three to four weeks after the onset of COVID-19 and two weeks after the disease resolved.

“While we don’t know for certain whether having antibodies confers immunity at this point, or how long immunity would last, we are very encouraged that even those people who had mild cases of the disease did produce antibodies,” says the study’s first author, Ania Wajnberg, MD, Associate Professor of Medicine (General Internal Medicine) at the Icahn School of Medicine at Mount Sinai.

The encouraging findings support the potential of antibody-based blood tests to help understand the spread of COVID-19, the disease produced by the SARS-CoV-2 virus. The testing would provide lawmakers with a better understanding of how many people may possibly be immune and might be able to safely return to work as economies begin to reopen. At this time, there remains limited data worldwide on the development of antibodies to SARS-CoV-2, particularly the formation of IgG.

Mount Sinai has tested more than 22,000 individuals for antibodies since late March, when it became one of the first institutions in the world to begin treating COVID-19 patients with antibody-rich plasma from individuals who recovered from the disease. Mount Sinai identified individuals who had high titers, a measure of the concentration of antibodies, and referred them to the New York Blood Center, where they donated their plasma. As of May 11, more than 350 patients had received this convalescent plasma therapy through Mount Sinai, which is currently compiling data on the program.

The study also found that 19 percent of those who had recovered from COVID-19 still had evidence of the virus after receiving a nasopharyngeal swab of the back of their nose and throat. This has raised some concerns among patients who thought they may have been reinfected.

“More evidence is showing that people probably don’t need to be stressed about these positive swabs,” says Dr. Wajnberg. “We don’t know for certain why almost 20 percent of people had evidence of the virus weeks out from their symptoms. It is possible there’s some shedding of the virus still going on, but it is also possible that the test is picking up dead viral fragments. The scientific community is looking into this because it has major implications as to whether you need a negative swab to be cleared from this disease, which more people are thinking you don’t.”

One of the study’s authors, Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai, developed the antibody test that Mount Sinai uses. He says, “If you have higher titers you start to see neutralization. I can’t tell you that having a certain level of titers is protective against the virus, but we know from the vast majority of viral infections that neutralizing antibodies do protect you from getting infected. There are four human coronaviruses that give you a common cold, and in studies of those you get antibodies for one to three years and are protected during that time. In some cases you’re protected from getting reinfected, in other cases you might get a little infected but not have symptoms, and in other cases you may have symptoms but they’re much milder.”

In related news, the Mount Sinai Health System and California-based Sorrento Therapeutics, Inc. recently agreed to jointly develop antibody products that would act as a “protective shield” against SARS-CoV-2 coronavirus infection, potentially blocking and neutralizing the activity of the virus in at-risk populations, as well as recently exposed individuals.

How a Mount Sinai Program Is Helping Survivors of Sexual Assault and Intimate Partner Violence

In the midst of the COVID-19 pandemic, a very different health crisis is continuing unabated—sexual assault and intimate partner violence (IPV). An experienced and compassionate team at Mount Sinai is there to help.

“It’s been a little bit challenging, but we do not want to let that stop us from providing very critical services,” says Angela Fernandez, Assistant Director at the Sexual Assault and Violence Intervention (SAVI) Program, a team that includes physicians, social workers, and advocates. “We’re still operational.”

Founded in 1984, SAVI has offered free services and support to survivors in New York City for more than thirty years. Its most visible program trains 100 people a year to provide emotional first aid and bedside advocacy to survivors in emergency rooms throughout Manhattan, Brooklyn, and Queens. Volunteers undergo a 40-hour New York State Department of Health training and—following medical, background, and health screenings—commit to bimonthly, six-hour shifts in which they are on-call to be deployed when a participating emergency department has identified an instance of sexual assault or intimate partner violence. The volunteers are equipped to facilitate communication with law enforcement, counsel survivors on their rights, and help them identify and acquire basic needs like shelter. Ms. Fernandez sees advocates as a temporary best friend who can help survivors to navigate any uncertainty faced while in the emergency room.

This intimate, peer-to-peer service has been complicated by COVID-19, since in an abundance of caution, emergency rooms are barring most visitors. Fortunately, the Department of Health has mandated that all survivors are entitled to an advocate. SAVI began offering phone advocacy in mid-March to continue to provide this essential service while adhering to safety measures. Through phone advocacy, survivors can speak with an advocate—via a hospital line or their own mobile phone—to receive support, advice, and assistance.

“Our volunteers are still there. We are still responding to the need, albeit from a distance,” says Ms. Fernandez.

Fewer Domestic Violence Calls, but Not Necessarily Fewer Assaults

In early April, weeks after the “New York State Pause” closed most businesses and imposed social distancing, the New York Police Department released statistics showing a downward trajectory in crimes. For the month of March, domestic violence calls were down 15.3 percent.

“Sexual violence and intimate-partner violence was already grossly under-reported,” says Ms. Fernandez, who cautions that this downward trend does not mean that fewer assaults are being committed. “The fact that we are not seeing as many people making a police report is not surprising, because it’s already something that not a lot of people do.”

Additionally, survivors are not immune to troubling news reports about the pandemic. For a survivor, fear of contracting the virus when going to an emergency room may outweigh the need to seek help. This is particularly relevant for IPV survivors who, Ms. Fernandez notes, often do not seek medical care for the abuse itself but from underlying health conditions associated with abuse and trauma.

“It is in the middle of treating someone for a chronic stomach issue, an asthma attack, or a headache that will not go away in which it is disclosed that abuse is happening at home,” she says. “If a survivor knows that these symptoms cannot possibly be the virus, they may think—my issue isn’t serious enough.”

In fact, abusers may use the stay-at-home order, as well as the economic crisis caused by COVID-19, to further isolate survivors, forcing them to determine whether their home life is more or less threatening than potential exposure to the virus.

“It’s coming down to basic needs for many survivors, and an abusive person can exploit the situation, especially if they have food, shelter, and are even willing to pay someone’s phone bill,” says Ms. Fernandez.

SAVI employs licensed clinical social workers and mental health counselors who provide confidential, trauma-informed therapy to survivors who have left abusive situations as well as those currently in abusive situations. This service has largely shifted to HIPAA compliant virtual sessions—completed via phone or videoconferencing—although in-person sessions are available for emergency, high-risk cases.

“For some, the discussion is not about the abuse, it’s about survival. So many people have had to return to abusive situations, because they didn’t have anywhere else to go. Survivors are having to make really, really hard choices.”

Programs like SAVI hope to make these choices less daunting. Through phone advocacy, virtual counseling sessions, and ad-hoc in-person meetings, survivors can receive advice, assistance, and support from an experienced team dedicated to their physical and emotional safety.

“Survivors are very resilient,” says Ms. Fernandez. “This might not be the best time to make big decisions—like leaving an abuser. We understand that survivors know their situation best, and we are there for them every step of the way.”

If you or a loved one needs advice, assistance, or support regarding sexual assault or intimate partner violence; the Sexual Assault and Violence Intervention (SAVI) Program at Mount Sinai is available to help. For more information, visit the SAVI website or call 212-423-2140. 

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