Why the New Johnson & Johnson Vaccine Will Help Lead to the End of the Pandemic

Updated on Jun 30, 2022 | COVID-19, Featured, Vaccines

With the authorization of Johnson & Johnson’s new COVID-19 vaccine and its encouraging data, you might be wondering how it stacks up against the Pfizer-BioNTech and Moderna vaccines.

Mount Sinai infectious diseases experts participated in the clinical trials for Johnson & Johnson’s one-dose vaccine and are excited about its effectiveness against moderate and severe COVID-19. What is most remarkable is that 28 days after a single dose, no vaccine recipient had been hospitalized for COVID-19 or died from COVID-19. And, protection increased over time: 49 days after that single dose, there were no cases of severe COVID-19 among the recipients.

This protection was consistent among all age groups. The emergency use authorization of this vaccine by the U.S. Food and Drug Administration allows for increased supply and access to vaccine and will help turn COVID-19 into a controllable and much less dangerous disease.

Update: Is the Johnson & Johnson vaccine currently authorized for use? The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration paused distribution of the Johnson & Johnson COVID-19 vaccine to review isolated instances of people developing blood clots after receiving the vaccine. After reviewing the data, the CDC lifted the pause. The vaccine may now be used for all patients 18 and over in the United States, but will carry a warning label about rare blood clotting events. For more information from Mount Sinai, see our fact sheet.

Dana Mazo, MD, MSc

In this Q&A, Dana Mazo, MD, MSc, Assistant Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai, explains why this new vaccine’s ability to prevent hospitalizations and serious illness is so significant, and why this represents a potential game changer that can help lead to the end of the pandemic. Dr. Mazo, the Hospital Epidemiologist at Mount Sinai Queens, is also lead investigator of the Mount Sinai Queens COVID-19 clinical trials unit, which is a Johnson & Johnson COVID-19 vaccine trial site.

What does the data tell us about this new Johnson & Johnson vaccine?

The trials are ongoing, but the preliminary data is very exciting and shows really good protection against sickness severe enough to lead to hospitalization or death. The real excitement is that at 28 days after participants received the vaccine, there were no COVID-19-related hospital admissions or COVID-19 deaths.

How effective is the new vaccine from Johnson & Johnson?

In the United States, the vaccine had an efficacy of 72 percent against moderate and severe COVID-19, which is really impressive. That means the people who received the vaccine were 72 percent less likely to get moderate or severe disease. In all regions studied, the vaccine was 85 percent effective at preventing severe disease, and no one who received the vaccine needed to be hospitalized for COVID-19 or died related to COVID-19.

Some reports say this vaccine is less effective than others. Is that true, and is that important?

This is an important question that I get asked a lot. One of the differences with the Johnson & Johnson vaccine is that our trial was more recent, so the data we released is from this winter when we’re seeing more COVID-19 cases and new variants.

Looking at other countries, the Johnson & Johnson vaccine had lower efficacy in South America of 66 percent and South Africa of 57 percent, so the overall efficacy around the world was 66 percent.

It’s very important that the Johnson & Johnson trials included sites in eight countries, including sites in both South Africa and South America where new variants of SARS-CoV-2 are circulating. Even though the protection was not as high for those variants, it was still good protection at greater than 50 percent and there were no hospitalizations or deaths from COVID-19. That is really good news especially because we are concerned about these new variants. This is a huge piece of information we have for this vaccine that isn’t known for other vaccines, trials which were performed earlier in the pandemic so did not include communities where these highly transmissible variants were prevalent.

The Johnson & Johnson trial also included different racial and ethnic groups in the United States: 15 percent of trial participants identified as Hispanic and/or Latinx and 13 percent as Black/African American.

Another key aspect of the Johnson & Johnson vaccine is that it is only one dose. Other vaccines have released higher efficacy data at 90 percent or more, but that’s after two doses. The Johnson & Johnson vaccine has 72 percent efficacy after one. This is a huge benefit and has the potential to be a real game changer in our fight against the pandemic.

How does this vaccine compare with the other two vaccines? Is it better?

Each of the vaccines has pros and cons. The fact that the Johnson & Johnson vaccine is one dose is a real benefit because it allows more people to get full protection. Logistically it can be very hard for people to come back for the second dose required by other vaccines.

In addition, this vaccine is much easier to store and transport. Some of the other vaccines require ultra-cold storage, which is not possible for many places. This vaccine could be administered at a doctor’s office or community health fairs.

With one dose you may also have a lower risk of side effects, as opposed to two doses which present two opportunities for side effects. From the data already released, the Johnson & Johnson vaccine seems very well tolerated. Only nine percent of people reported fever after vaccination and 0.2 percent reported fevers bad enough to interfere with daily activities.

Does it matter which vaccine I get?

The first vaccine that you are able to get is what you should get. All these vaccines offer really good protection against severe COVID-19 disease, hospitalizations, and deaths. So just get the first vaccine that’s offered to you.

You were involved in the clinical trial. What did Mount Sinai do and why is that important?

There was a site at Mount Sinai Queens where I was the lead investigator, and there was a site at Mount Sinai Brooklyn. We recruited members of our community who were interested in taking part in a trial of an investigational vaccine and consented to participate knowing that they would either receive an injection of placebo (salt water) or the Johnson & Johnson vaccine. They then were asked twice a week if they had symptoms, and if anyone reported symptoms, we tested them to see if they had COVID-19.

Conducting clinical trials at Mount Sinai Queens and Mount Sinai Brooklyn opens up clinical research to our communities. We are located in areas that were hard hit by COVID-19, and in Queens we are near some of the most diverse neighborhoods in the world. We need to ensure that communities that were especially affected by COVID-19 have the opportunity to participate in trials and that a broad representation of people in the United States who could benefit from these treatments are included in the trials. We’re very happy to say that by having a site in Queens, we were able to include a diverse population.

 

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Researchers Identify a Promising New Antiviral Drug to Treat COVID-19

Updated on Jun 30, 2022 | COVID-19, Featured, Research

Plitidepsin is derived from Aplidium albicans, a marine organism that typically attaches itself to hard surfaces, such as reefs.

The search for better medical treatments for COVID-19 has led a team of scientists from the Icahn School of Medicine at Mount Sinai, with colleagues in San Francisco, to plitidepsin—a promising small molecule drug derived from a sea organism. When tested in human lung cells, plitidepsin was particularly effective in stopping the replication of SARS-CoV-2, the virus that causes COVID-19. In fact, in pre-clinical trials, plitidepsin was 28-fold more effective than remdesivir—the only antiviral drug currently approved by the U.S. Food and Drug Association (FDA) to treat COVID-19.

Kris M. White, PhD

The research team from Mount Sinai and the University of California at San Francisco recently published their work in Science, revealing one of the most promising efforts to date in identifying an already approved drug that could be successfully repurposed to fight COVID-19. Plitidepsin is approved in Australia—under the name Aplidin—as a treatment for multiple myeloma, a cancer that forms in a group of white blood cells.

One of plitidepsin’s strengths is that it inhibits eEF1A, a host protein within human cells that every variant of SARS-CoV-2 needs to survive. Viruses hijack a human’s cellular machinery in order to thrive and create more copies of themselves, but plitidepsin works by blocking an important pathway that would be used by SARS-CoV-2, its variants, and potentially other respiratory diseases such as respiratory syncytial virus and influenza. In a separate preliminary study in bioRxiv, the research team, and a group of colleagues in England, showed that plitidepsin was effective against b.1.1.7, the newly identified British variant of SARS-CoV-2.

“Aplidin is quite unique in its potency,” says one of the study’s corresponding authors, Kris M. White, PhD, Assistant Professor of Microbiology, and a member of the Global Health and Emerging Pathogens Institute at the Icahn School of Medicine. “It is likely going to be able to work against any variant of SARS-CoV-2 and other coronaviruses, including new pandemics that might happen in the future. eEF1A appears to be a broadly used protein for viruses because it has an important role in protein production, making it important for the host cell and also extremely important for the virus. Now we’re looking to test plitidepsin against these other viruses as well.”

Corresponding study author Adolfo García-Sastre, PhD, Professor of Microbiology and Director of the Emerging Pathogens Institute at the Icahn School of Medicine, says, “The ongoing pandemic created the immediate need for us to find antiviral therapeutics that could be moved into the clinic. This led us to screen clinically approved drugs with established data and safety profiles. We found that plitidepsin was a very promising therapeutic candidate.”

Adolfo García-Sastre, PhD

The decision to pursue plitidepsin resulted from research the team conducted last spring, when they identified 332 different host proteins that SARS-CoV-2 interacted with. The scientists looked to see which ones had FDA-approved drugs that targeted the host protein for cancer or other diseases and began following a trail that ultimately led them to Aplidin. Within a week after publishing their work in Nature, the researchers were contacted by PharmaMar, the drug’s small Madrid-based manufacturer.

In October, PharmaMar released the results of a phase 1,2 clinical trial of Aplidin for use against COVID-19, which showed the drug was safe and effective in helping hospitalized patients recover from the disease. By day seven after taking Aplidin, the patients’ viral load was reduced by 50 percent, and by day 15, viral load was reduced by 70 percent. More than 80 percent of patients had been discharged from the hospital on or before day 15.

The results of the clinical trial also confirmed the tolerability of Aplidin for patients with COVID-19. Tolerability had already been observed in studies of approximately 1,300 cancer patients who actually received higher doses of Aplidin than the COVID-19 patients. PharmaMar is currently establishing phase 3 clinical trials.

“The data has shown that it’s worth trying the drug in a phase 3 clinical trial,” says Dr. White. “There’s a good chance we might see efficacy and that it will be well tolerated by the patients at certain doses.” Like remdesivir, plitidepsin would be given intravenously in a hospital setting.

The researchers have proposed that the drug be tested for use alongside remdesivir and also dexamethasone, an anti-inflammatory authorized for use in severely ill COVID-19 patients. As with other antiviral drugs, plitidepsin would work only if given early in the disease cycle, in the active viral replication stage of COVID-19.

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Sixth Annual Mount Sinai Innovation Awards

Updated on Jun 30, 2022 | Community, COVID-19, Featured, Research

The Inventor of the Year team conducted research that led to diagnostic tests for antibodies to COVID-19. (Standing) Florian Krammer, PhD, PhD, Professor of Microbiology, left, and Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine. (Seated, from left) Daniel Stadlbauer, PhD, Postdoctoral Fellow; Fatima Amanat, Graduate Assistant; Adolfo Firpo-Betancourt, MD, Professor of Pathology, Molecular and Cell Based Medicine; Viviana Simon, MD, PhD, Professor of Microbiology; Ania Wajnberg, MD, Associate Professor of Medicine; and Damodara Rao Mendu, PhD, Director of Chemistry Laboratories, Department of Pathology, Molecular and Cell-Based Medicine.

Individuals and teams from the Mount Sinai Health System were honored for advances in biomedical research, technology, and medicine at the sixth annual Mount Sinai Innovation Awards ceremony, a virtual event held Tuesday, December 8, 2020.

Mount Sinai Innovation Partners (MSIP) presented the award for Inventor of the Year to an eight-member team led by renowned virologists and pathologists, whose efforts led to the development of multiple diagnostic tests for the detection of antibodies against the COVID-19 spike protein—the principal target of neutralizing antibodies.

The Innovation Awards also honored winners of the Faculty Idea Prize, the 4D Technology Development Award; the KiiLN Postdoctoral Entrepreneurship Award; and the Trainee Innovation Idea Award.

The event, which can be viewed here, was hosted by: SINAInnovations, MSIP, the Office of Faculty Development, the Graduate School of Biomedical Sciences, the Department of Medical Education, the Office of Postdoctoral Affairs, the Graduate Medical Education Office, and the Keystone for Incubating Innovation for Life Sciences Network (KiiLN).  

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Heart Disease and COVID-19: How to Reduce Your Risks

Updated on Jun 30, 2022 | COVID-19, Featured, Your Health

During the pandemic, you may be exercising less, limiting your trips outside, and no longer eating a healthy diet, and this may be taking its toll.  Some doctors say 25 percent of their patients have gained up to 20 pounds, and that can be leading to decline in mental health.

As a result, during this difficult period, experts at Mount Sinai are encouraging a focus on exercise, mental health, and nutrition, especially for those already at risk for heart disease, and they are sharing some tips on heart disease prevention to lower the risk of heart attack, stroke, and COVID-19.

Icilma Fergus, MD

“It is critical to stay physically fit and in your best personal health to combat heart disease, COVID-19 infection and the post-COVID effects,” says Icilma Fergus, MD, Director of Cardiovascular Disparities at The Mount Sinai Hospital. “During this pandemic some patients have expressed they’re dealing with stress, anxiety, insomnia, and depression. We discuss techniques to improve their mental and emotional wellness, which carries over to their cardiovascular health.”

Doctors say participating in home-exercise programs, taking a short walk, dancing, stretching, and even house cleaning will get you moving and make a difference.

“Keeping a good mental outlook is also key and it’s important for people to find ways to ensure that this happens by staying active, meditating, or simply doing things that make them happy,” says Dr. Fergus.

Tips for Lowering Heart Disease Risk

• Know your family history.

• Be aware of five key numbers cited by the American Heart Association: blood pressure, total cholesterol, HDL (or “good”) cholesterol, body mass index, and fasting glucose levels.

• Maintain a healthy diet, eating nutrient-rich food and eliminating sweets. Limit alcohol consumption to no more than one drink per day. Quit smoking. Watch your weight and exercise regularly.

• Learn the warning signs of heart attack and stroke, including chest discomfort; shortness of breath; pain in arms, back, neck, or jaw; breaking out in a cold sweat; and lightheadedness.

According to the American Heart Association, about one in three people with COVID-19 has cardiovascular disease, making it the most common underlying health condition. COVID-19 patients with underlying conditions are six times more likely to be hospitalized and 12 times more likely to die than patients without any chronic health problems.

Nearly half of adults in the United States—more than 121 million people—have some type of cardiovascular disease. It is the leading cause of death among men and women in the United States; nearly 650,000 die from it every year. Yet heart disease is preventable 80 percent of the time.

COVID-19’s Impact on the Heart and Recovery 

COVID-19 can cause an inflammatory response in the body, along with clotting that can impact the heart and how it functions.  Mount Sinai researchers discovered that some hospitalized COVID-19 patients have structural damage after cardiac injury that can be associated with deadly conditions including heart attack, pulmonary embolism, heart failure, and myocarditis, or inflammation of the heart.

Non-hospitalized COVID-19 patients can also experience complications including heart rhythm disorders, hypertension, myocarditis, and chest pain that feels similar to a heart attack. Cardiologists say it’s important for COVID-19 survivors—even without cardiac symptoms—to have a heart exam two to three weeks after recovery, as there could be residual effects that may go undetected and lead to future health problems.

“For anyone who developed heart issues post-COVID-19, exercise should be delayed two to three weeks after resolution of symptoms including chest pain, palpitations, and shortness of breath. Remember to ‘go slow’ as recovery from this illness is not a sprint; it is a marathon,” says Maryann McLaughlin, MD, Director of Cardiovascular Health and Wellness at Mount Sinai Heart. “Anyone who has been diagnosed with myocarditis needs to be under a physician’s direction when deciding to exercise, and competitive athletes may need three months to recover from the illness before returning to full routine.”

Recovered COVID-19 patients with a history of heart attack, coronary artery disease, or cardiac stents, should get a monitored stress test before getting back to a full workout. Anyone who had chest pain while sick with COVID-19 should talk to their doctor about evaluation with an echocardiogram or other cardiac imaging.

High-Risk Groups and COVID-19 Vaccinations  

Everyone is at risk of heart disease, but people are more susceptible to getting the disease if they have cardiovascular risk factors including high cholesterol, high blood pressure, being overweight, and using tobacco. Age is also a factor, specifically for women over 65 and men older than 55, along with those with a family history of heart disease and people who sleep less than six hours a night.

Certain minority groups including African Americans and Latinos are also at higher risk due to genetic predisposition, diet, lifestyle factors, and socio-economic factors. However, illness in any population can be prevented by taking simple steps towards a healthier lifestyle.

Mount Sinai cardiologists encourage those in these high-risk groups to get a COVID-19 vaccine when they qualify under state distribution guidelines.

“We have noticed some patients in these high-risk minority groups have been reluctant to get vaccinated, fearing it’s not safe. What is important for them to understand is that tremendous scientific advancements have led to the safe development of COVID-19 vaccines and we are encouraging them to get vaccinated,” says Johanna Contreras, MD, Director of Heart Failure and Transplantation at Mount Sinai Morningside.

 

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Mount Sinai Researchers Describe Viral Sanctuaries in the Gastrointestinal Tract of COVID-19 Patients

Updated on Jun 30, 2022 | COVID-19, Featured, Research

A new study published in the journal Nature by researchers at Mount Sinai in collaboration with two other labs at Rockefeller University and co-investigators from the California Institute of Technology and Weill Cornell Medicine describes for the first time a persistence of SARS-CoV-2 in the intestines long after clinical resolution.

The study, entitled “Evolution of antibody immunity to SARS-Cov-2” and published online January 18, 2021, suggests that the memory B cell response to SARS-Cov-2 evolves between 1.3 and 6.2 months after infection in a manner that is consistent with antigen persistence.

Saurabh Mehandru, MD

The authors studied intestinal biopsies obtained from asymptomatic individuals four months after the onset of COVID-19.

Minami Tokuyama, a medical student at the Icahn School of Medicine at Mount Sinai, and other members of the Mehandru Lab at the School of Medicine discovered that SARS-CoV-2 antigens persisted in the lining cells (epithelium) of the intestines long after (3-4 months post infection) resolution of clinical symptoms. The presence of such sanctuary sites could potentially enable continued maturation of the antibody response as was independently discovered by the Nussenzweig Lab at Rockefeller University.

“This finding is significant because it suggests that the memory B cell response does not wane after six months, providing reassurance that those who have previously been infected with the virus will likely mount a vigorous response if they are exposed a second time,” says study author Saurabh Mehandru, MD, Associate Professor of Gastroenterology at the Icahn School of Medicine and Director of the Mehandru Lab.

“Additionally, the presence of viral sanctuaries within the body needs to be better understood in COVID-19 patients with chronic symptoms, or ‘long haulers,’ which could help in identifying novel opportunities for the treatment of this group of patients,” says Dr. Mehandru.

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Mount Sinai Launches Global FREEDOM COVID Trial to Study Anticoagulant Therapies

Updated on Jun 30, 2022 | COVID-19, Featured, Research

Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.

Building on treatment protocols developed at the height of the COVID-19 pandemic, Mount Sinai Heart has launched the global FREEDOM COVID Anticoagulation Trial to determine the most effective dosage and regimen of anticoagulant therapy in improving the survival rate of hospitalized COVID-19 patients.

“While vaccines are being used and clinical trials are underway, there is an urgent need to determine how to best treat the next hundreds of thousands of COVID-19 patients around the world,” says Valentin Fuster, MD, PhD, Director of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital, and principal investigator of the FREEDOM trial. “This is a coordinated international effort, launched as an investigator-led trial to speed up the process.”

In March 2020, during the early days of the pandemic, Dr. Fuster closely observed patients with blood clots in their legs who had been admitted with COVID-19. After hearing from colleagues in China of other cases of small, pervasive, and unusual clotting that had triggered myocardial infarctions, strokes, and pulmonary embolisms, he initiated decisive action. “We became one of the first medical centers in the world to treat all COVID-19 patients with anticoagulant medications,” says Dr. Fuster, a pioneer in the study of atherothrombotic disease. “It was a decision that we believe saved many lives.”

That early protocol—based largely on intuition, Dr. Fuster says—led to groundbreaking research and insights by Mount Sinai into the role of anticoagulation in the management of COVID-19-infected patients. That work includes a study published in August 2020 in Journal of the American College of Cardiology that showed a 50 percent higher chance of survival compared to patients given no anticoagulant. The analysis was conducted by the Mount Sinai COVID Informatics Center.

Dr. Fuster says, “While our study was observational, it helped us design the large-scale FREEDOM COVID Anticoagulation Trial in partnership with more than 100 sites in 14 countries in order to reach 3,600 patients.”  The prospective study will be randomized to investigate the effectiveness and safety of the anticoagulants enoxaparin and apixaban in patients age 18 and older who have been hospitalized with confirmed COVID-19, but are not in an ICU or intubated. The trial is currently enrolling and set for completion in June 2021.

Clotting in organs including the lungs, brain, and heart can be a complication of COVID-19, autopsies have shown. And anticoagulation therapies are associated with better outcomes in hospitalized patients with the virus. The FREEDOM clinical trial will evaluate different regimens.

The FREEDOM trial is based on months of clinical observation and pathology work conducted as deaths from the COVID-19 pandemic mounted globally in spring 2020 and thromboembolism emerged as an important disease manifestation. Autopsy studies at Mount Sinai demonstrated a high incidence of macrothrombi and microthrombi, prompting the suggestion that in-hospital use of blood thinners could be beneficial to COVID-19 patients. To help clarify the pivotal questions of anticoagulant choice, dosing, and treatment duration, Mount Sinai began an observational study in May 2020 of 4,389 COVID-19-positive patients who were admitted to five hospitals in the Mount Sinai Health System.

“In this observational study, anticoagulation was associated with improved outcomes, and bleeding rates appeared to be low,” says corresponding author Anu Lala, MD, Assistant Professor of Medicine (Cardiology), and Director of Heart Failure Research at the Icahn School of Medicine at Mount Sinai. “As a clinician who has treated COVID-19 patients on the front lines, the importance of having answers as to what the best treatment for these patients entails is immeasurable. Ultimately, clinical trials are what will inform those answers.”

Researchers looked at six different anticoagulant regimens, including oral and intravenous dosing. They found that both therapeutic and prophylactic doses of anticoagulants were associated with significantly improved in-hospital survival, and with a 30 percent reduced risk of admission to an ICU or intubation. The researchers used a hazard score to estimate risk of death, which took relevant risk factors into account before evaluating the effectiveness of anticoagulation, including age, ethnicity, pre-existing conditions, and whether the patient was already on blood thinners.

Separately, the researchers looked at autopsy results of 26 COVID-19 patients and found that 11 of them (42 percent) had blood clots—pulmonary, brain, and/or heart—that were never suspected in the clinical setting. These findings suggest that treating COVID-19 patients with anticoagulants as a preventive measure may be associated with improved survival.

Researchers were further encouraged by the finding that overall rates of major bleeding were low (3 percent or less), though slightly higher in the therapeutic group compared to the prophylactic and no-blood-thinner groups. This suggested to the team that clinicians should evaluate COVID-19 patients on an individual basis, weighing the risks and benefits of anticoagulant therapy.

“These observational analyses were done with the highest level of statistical rigor and provide important insights into the association of anticoagulation with critical in-hospital outcomes of mortality and intubation,” says first author Girish Nadkarni, MD, Co-Founder and Co-Director of the Mount Sinai COVID Informatics Center, and Clinical Director of the Hasso Plattner Institute for Digital Health at Mount Sinai.

The study also provided a strong rationale for the FREEDOM Trial, says co-author Zahi Fayad, PhD, Professor of Medicine (Cardiology), and Diagnostic, Molecular and Interventional Radiology, and Director of Mount Sinai’s BioMedical Engineering and Imaging Institute. “This work highlights the need to better understand the disease from a diagnostic and therapeutic point of view and the importance of conducting properly designed diagnostic and interventional studies.”

Read more about Mount Sinai and COVID-19.

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