Infectious Diseases | Mount Sinai Today

Mount Sinai Awarded $42 Million to Prepare for Future Pandemics and Advance Influenza Research

May 25, 2021 | COVID-19, Featured, Research

Adolfo García-Sastre, PhD, left, and Shashank Tripathi, PhD, Assistant Professor of Microbiology. File photo

The National Institute of Allergy and Infectious Diseases (NIAID) has awarded the Icahn School of Medicine at Mount Sinai a seven-year contract valued at more than $42 million to advance basic research into influenza and COVID-19, and prepare for future pandemics.

This marks the third time Mount Sinai has received a seven-year NIAID contract under the leadership of Adolfo García-Sastre, PhD, Director of the Global Health and Emerging Pathogens Institute and Irene and Dr. Arthur M. Fishberg Professor of Medicine, who serves as Principal Investigator. Florian Krammer, PhD, Mount Sinai Professor in Vaccinology; and Viviana Simon, MD, PhD, Professor of Microbiology, Pathology, and Medicine (Infectious Diseases), will serve as the contract’s co-investigators.

“This contract represents 21 years of continuity in conducting research that leads to better treatments, better vaccines, better disease management, and better prevention of pandemics,” says Dr. García-Sastre.

The team’s work will lay the foundation for diagnostics, therapeutics, and clinical trials, but will not include the actual implementation of the clinical trials. The contract also calls for the surveillance of emerging pathogens, risk assessment studies on as many as 15 respiratory viruses each year, and training of postdoctoral fellows and graduate students. “Training is part of the fight against infectious diseases. You need the people and the weapons,” says Dr. García-Sastre.

Mount Sinai’s previous NIAID contracts have led to many advances. In response to the 2009 H1N1 flu pandemic, Dr. García-Sastre; Peter Palese, PhD, Chair of the Department of Microbiology; and Dr. Krammer launched their seminal work in developing a universal influenza vaccine. The vaccine— administered only once or twice in an individual’s life, rather than each year—has now undergone two phase 1 clinical trials and is expected to move toward a human challenge trial.

Since COVID-19, like influenza, will probably remain within the human population, Dr. García-Sastre says there may be a need to develop a universal COVID vaccine as well.

The new NIAID contract calls for funding of $6 million per year over seven years, but Dr. García-Sastre expects there will be room for additional funding. “The last contract did not have a specific amount of money for COVID-19 because there was no COVID-19 at the time,” he says, so when the pandemic started the government provided extra funding to study and find treatments for the new disease.

In fact, Mount Sinai’s research in influenza allowed the team to respond quickly to COVID-19. “Through this initiative we were able to develop and respond with diagnostics, treatments, and a vaccine,” Dr. García-Sastre says. “We were able to screen compounds that had potential for treatments and by testing COVID-19 proteins we identified targets and inhibitors of these targets.”

Work led by Dr. Palese, in collaboration with the University of Texas at Austin, produced a low-cost COVID-19 vaccine that is currently being tested in humans in Vietnam and Thailand, with clinical trials expected to begin in Brazil.

The team has also identified a promising small-molecule drug, plitidepsin, which appears to be particularly effective in stopping the replication of SARS-CoV-2, the virus that causes COVID-19. Clinical trials of plitidepsin are about to start in the United Kingdom, and the Spanish drug maker, PharmaMar, is negotiating with the U.S. Food and Drug Administration to begin clinical trials in this country as well.

While the new NIAID contract calls for Mount Sinai’s team to take a proactive response to future pandemics, they will also continue to focus on influenza, which remains a major international health concern. Influenza pandemics arise periodically, and according to the World Health Organization, the seasonal viruses infect as many as one billion individuals a year and lead to 650,000 deaths. There is much more to discover about how the human body responds to influenza, says Dr. García-Sastre, and the NIAID contract will support that important work.

I Have Long COVID. How Do I Get Back to Physical Activity?

May 19, 2021 | COVID-19, Rehab Medicine, Your Health

Older woman on work out bench lifting free weights

Millions of people across the United States have contracted and overcome a COVID-19 diagnosis. However, for some, the road to recovery has been difficult. Known as ‘long COVID,’ some patients continue to experience symptoms of COVID-19 weeks to months after their initial diagnosis.

While experts are unsure of its prevalence, the number of people with long COVID is significant and has prompted the creation of programs like the Mount Sinai Center for Post-COVID Care where patients are treated and researchers investigate the condition. Joseph Herrera, DO, Chair of Rehabilitation and Human Performance for the Mount Sinai Health System, and cardiology fellow Saman Setareh-Shenas, MD, explain what it means to be a COVID-19 long hauler and how the Mount Sinai Health System is working to get these patients back to physical activity.

What is long COVID patient?

Saman Setareh-Shenas, MD: This is a patient with Post-COVID Syndrome, which is a series of symptoms ranging from shortness of breath, chest pain, heart palpitations, heart racing, the inability to return to pre-COVID level of physical activity, and brain fog. These symptoms are present for weeks after their initial COVID-19 symptoms have resolved. We have seen patients experiencing these symptoms for six months, or even longer.

Joseph Herrera, DO: We are seeing some patients that have not even been hospitalized with COVID-19 who are having difficulty progressing their activity to pre-COVID-19 infection levels. They will have good days and bad days, and will try to push themselves physically. But, instead of taking two steps forward, they take 10 steps back. That is a common theme with our long haulers.

How do you guide a patient back to physical activity?

Dr. Herrera: Important for a patient’s physical and cognitive activity is understanding their submaximal exercise limits. This is a measure of a patient’s aerobic fitness and maximum oxygen uptake while doing rigorous—but not overly strenuous—activity like jogging on a treadmill or using an exercise bike. Some patients who have difficulty with physical exertion may also benefit from a formal breath work program that helps patients understand breathing techniques. At Mount Sinai, we progress patients using the rule of tens. This means that every 10 days we increase the intensity duration of the exercise by 10 percent. So, it does take some time to get ‘back to normal.’ But we advise our patients that their body needs that time to heal and rest. The symptoms resolve, but it does take a prolonged period for those symptoms to get better.

What advice do you have for long haulers who are trying to get back into exercise?

Dr. Herrera: If you have long COVID, you have to respect the symptoms you are experiencing and understand that your body is in the process of healing. I advise patients to create a diary of what they are experiencing and work with a physical therapist to address their concerns. Slowly working toward a gradual return to activity is the goal. You can’t rush this. Anytime our patients try to rush the process, they end up taking 10 steps back instead of three steps forward.

Dr. Setareh-Shenas: COVID-19 comes with a lot of inflammation and the body needs time to heal. Give yourself that time; go slowly, and gradually you can get back to your baseline. Normal household stuff is important, like walking and grocery shopping. Then, once you are comfortable, move on to exercising and boosting your exercise capacity.

Dr. Herrera: I think the most important message is, if you’re experiencing any symptoms of long COVID, don’t push yourself too hard but do see a specialist. Get evaluated to see if you qualify for any of the programs that we offer at Mount Sinai.

Get more COVID-19 information from Mount Sinai

I Recovered From COVID-19. How Do I Get Back In Shape?

May 17, 2021 | COVID-19, Rehab Medicine, Your Health

If you are one of the millions who contracted COVID-19 in the past year, you may still be in the process of regaining the physical fitness lost from when the virus forced you to slow down and heal.

Joseph Herrera, DO, Chair of Rehabilitation and Human Performance for the Mount Sinai Health System, and cardiology fellow Saman Setareh-Shenas, MD, explain how those who have recovered from COVID-19 can get back into their pre-illness shape and how the Mount Sinai Post-COVID Care Center can assist them on their road to recovery. Two key takeaways: Take it slow and consider seeing a specialist if you encounter any hurdles along the way.

How does the effect of COVID-19 on the body influence my recovery?

Joseph Herrera, DO: We are seeing a range of symptoms, from mild to severe, in patients after being infected with COVID-19. The virus affects them both physically and cognitively, everything from increased fatigue, shortness of breath, and tachycardia, a medical term of a rapid heartbeat, and difficulty concentrating, also known as brain fog. Because of this, some patients find it difficult to get back to their pre-COVID level of physical activity.

What about athletes? Does COVID-19 affect them differently?

Dr. Herrera: We’ve seen a range of people who have been impacted by COVID-19, from recreational athletes to marathon runners and professional athletes. I would say that they, similar to the general population, have a range of symptoms, some very mild all the way to severe. Overall, I don’t think your pre-infection conditioning really prevents anything.

Saman Setareh-Shenas, MD: COVID-19 doesn’t discriminate between athletes and non-athletes. We have seen major effects from the virus as well as post-COVID syndrome in very healthy athletes.

When is it safe to resume physical activity after recovering from COVID-19?

Dr. Herrera: We’ve been advising symptom-free patients to resume activity as tolerated. If they’ve been hospitalized due to COVID-19 or have spent a prolonged time in bed while recovering, whether in an intensive care unit bed or in their home, we want to make sure that they can return to normal activity before progressing to exercise.

Dr. Setareh-Shenas: Early on in the pandemic as the initial wave of patients were recovering, we started noticing a lot of our patients were not immediately able to go back to their baseline exercise level.

At the Mount Sinai Post-COVID Care Center, we help patients regain their pre-COVID strength and conditioning by using recommendations based on guidelines by the Leadership Council of the Sports and Exercise Cardiology Section of the American College of Cardiology and findings by British researchers. These guidelines advise those in recovery to return to exercise very gradually. Don’t go back to where your baseline was. Wait at least seven to 10 days, and then take it slowly from there.

Dr. Herrera: We guide patients using the ‘rule of tens.’ For example, if a patient were lifting a hundred pounds prior to getting infected with COVID-19, we have them cut everything in half—or even a quarter—of the weight they previously lifted. Then we apply the ‘rule of tens,’ by increasing either the intensity or the duration of exercise by 10 percent every 10 days. This way, they have a gradual increase in activity.

What precautions should post-COVID patients take when getting back to physical activity?

Dr. Setareh-Shenas: In the past year, we have seen a number of patients in our post-COVID population who are experiencing heart racing, palpitations, or a new arrhythmia. So, as a precaution, I would say that patients recovering from COVID-19 who have chest pains or shortness of breath, should be evaluated by their physician or by an expert cardiologist at a Post-COVID Center.

For example, in our Cardiology Clinic within the Post-COVID Care Center at Mount Sinai, we evaluate patients who have complaints of chest pain or shortness of breath and conduct exercise testing to see their maximal exercise capacity and evaluate for any arrythmia during exercise. We want to know: Do they have any symptoms when exercising on the treadmill? Does their heart go under strain that’s not equivalent for their age group and their risk factors? So, patients should be mindful of this, especially if they have a history of cardiac issues.

Dr. Herrera: Most importantly, don’t push yourself too hard but do see a specialist. Get evaluated to see if you qualify for any of the programs that we offer at Mount Sinai.

Get more COVID-19 information from Mount Sinai

What You Need to Know About COVID-19 Vaccination in 12- to 15-Year-Olds

May 13, 2021 | Children's Health, COVID-19, Featured, Vaccines, Your Health

Schools, playgrounds, and, most of all, our children will soon be better protected against COVID-19, thanks to the latest news from the U.S. Food and Drug Administration (FDA). The agency has announced that the Pfizer-BioNTech COVID-19 vaccine is safe and effective for children between the ages of 12 to 15 and authorized emergency use of the vaccine; the CDC also recommends the vaccine in this age group. You may have questions about this new development. Kristin Oliver, MD, MHS, Assistant Professor of Pediatrics, and Environmental Medicine and Public Health, at the Icahn School of Medicine at Mount Sinai, has answers.

How effective is the Pfizer-BioNTech COVID-19 vaccine in children aged 12 to 15?

All indications are that COVID-19 vaccination is highly effective in children ages 12 to 15. In the trial, the vaccine prevented 100 percent of COVID-19 cases among participants who got the vaccine. It’s important to remember that the results we see in clinical trials—called efficacy—may be slightly better than what we see when the vaccine is out in the world—effectiveness. People in the clinical trials always get the vaccine exactly as indicated, but this isn’t always the case in the real world. Once we start immunizing more and more people over time, we’ll have a better sense of the vaccine’s effectiveness for ages 12 to 15, but I expect this will also be really high.

Is it safe?

The COVID-19 vaccine is safe for children ages 12 to 15, just as it is for people 16 and older. In addition, the FDA will continue to monitor safety for another two years.

Researchers at the CDC are investigating a link between COVID-19 vaccines from Pfizer-BioNTech and Moderna and heart inflammation in young men and boys. Myocarditis and pericarditis can be serious but, fortunately, these side effects to vaccination are very rare and the cases connected to receiving the COVID-19 vaccine have been mild. So, the benefits of COVID-19 vaccination in this group still outweigh the risks of getting myocarditis from the vaccine.

Will our children experience any side effects from the vaccine?

We can expect children to have side effects similar to what we’ve seen in adults. The most common are pain and swelling at the injection site, tiredness, and headaches. In the study fewer than one in five 12- 15 year olds who get the shot, had a fever. The good news is that these side effects usually only last for a couple of days and can be treated with over-the-counter medication.

Remember: these types of side effects are a sign that the body’s immune system is responding to the vaccine, which is a good thing. We have seen more of these side effects to the COVID-19 vaccination than, say, the tetanus booster or HPV vaccine. For that reason, you might want to have your child take the vaccine on day when you know they can take is easy the next couple days.

Are there some 12- to 15-year-olds who should not take the vaccine?

Anyone who has had an allergic reaction to any component of the vaccine, or who had an allergic reaction to the first dose of the vaccine, shouldn’t take it.

But peanut, egg, and other food allergies are not a contraindication. If your child has any of these allergies, they can take the vaccine. If you have any questions about your child’s allergies and COVID-19 vaccine, check with your pediatrician.

If my child had COVID-19, do they still need to get a vaccine?

The U.S. Centers for Disease Control and Prevention has said that everyone who can get a COVID-19 vaccine should do so, even if they’ve already had COVID-19. In general, we don’t know how long protection against the virus lasts after an infection, or how well previous infection prevents infection with some of the new variants. In our efforts to keep everyone healthy, the recommendation is to get vaccinated.

What are the benefits of vaccinating children ages 12 to 15 against COVID-19?

Vaccines are an important tool in protecting us from developing COVID-19. It is exciting that children ages 12 to 15 can now get vaccinated—and it is important that they do so. While it is true that younger people are less likely than their elders to get seriously ill and die from COVID-19, they are not immune to the virus. Children can, and have, contracted the virus, gotten seriously ill, and even died. So the first benefit of vaccination is to protect them from the virus and its complications. Additionally, we know that children can transmit the virus to others who are more at risk for serious complications. By vaccinating young teens, we can help prevent that transmission as well as protect grandparents, babysitters, and other more vulnerable people who are in their orbit.

Get more COVID-19 vaccine information from Mount Sinai

Scientists Celebrate International Day of Immunology and Their Role in Advancing Breakthroughs for COVID-19

May 6, 2021 | COVID-19, Featured, Research

Renowned immunologist Miriam Merad, MD, PhD, center, and members of Mount Sinai’s Precision Immunology Institute created T-shirts that support COVID-19 vaccinations in honor of International Day of Immunology.

The significant role the human immune system has played in the spread and containment of the SARS-CoV-2 virus, which causes COVID-19, was the subject of an International Day of Immunology summit, held virtually on Thursday, April 29, 2021, and co-organized by pioneering immunologist Miriam Merad, MD, PhD, Director of the Precision Immunology Institute at the Icahn School of Medicine at Mount Sinai. Dr. Merad, who, in 2020, was elected to the National Academy of Sciences, also serves as Director of Mount Sinai’s Human Immune Monitoring Center.

Scores of prominent researchers from throughout the world gathered at the summit to celebrate the international collaboration that took place during the pandemic and the speed at which their work was translated into desperately needed treatments. Their deep understanding of the different ways in which the human immune system reacts to SARS-CoV-2 has helped guide the worldwide medical response.

Anthony S. Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases, gave opening remarks. “As an immunologist, physician, and U.S. government official, who, for decades, has helped lead the public health response to emerging diseases, it has become clear to me the important role that immunology plays in medicine and in infectious diseases,” he told the audience.

“People with healthy, intact immune systems—such as most young people—can control SARS-CoV-2 infection by limiting its effects to the upper airways in mild symptoms,” Dr. Fauci said. “In contrast, older people or individuals whose immunity is compromised by immunosuppressive agents, or an immune-compromising illness such as cancer, are unlikely to produce a robust immune response that can keep SARS-CoV-2 in check. When the history of this COVID-19 pandemic is written, the discipline of immunology will stand out for its important role in explaining the remarkable protean manifestations of SARS-CoV-2 infection and in enabling us to identify and exploit vulnerabilities in the virus to develop safe and effective vaccines to thwart its pandemic spread.”

Florian Krammer, PhD

The summit’s participants also included Özlem Türecki, MD, Co-founder and Chief Medical Officer of BioNTech, the company that partnered with Pfizer to produce the first authorized mRNA vaccine and the first vaccine to fight COVID-19; and Florian Krammer, PhD, Mount Sinai Professor in Vaccinology at the Icahn School of Medicine at Mount Sinai, who created one of the world’s first antibody tests for SARS-CoV-2.

Dr. Türecki described the development of BioNTech’s mRNA vaccine for COVID-19, which the company dubbed “project light speed,” beginning in January 2020 as soon as virus’ genetic sequence became known. She said BioNTech’s early investment in mRNA technology allowed the company to move quickly, particularly when their scientists expected the pandemic to spread “even faster” than it ultimately did.

BioNTech created 20 vaccine candidates at first, and then pared them down to four. By July, the company selected its “pivotal candidate” for phase 3 efficacy testing. In November, the vaccine was found to be 95 percent effective, and in December, the United States began administering the vaccine under the Food and Drug Administration’s Emergency Use Authorization.

According to Dr. Türecki, BioNTech was able to reach the market quickly by perfecting its manufacturing process at the same time it developed the vaccine. The Pfizer-BioNTech vaccine has now been authorized in more than 65 countries and administered to more than 260 million people.

Dr. Krammer said that eventually, scientists will “disentangle” the many questions that still remain about SARS-CoV-2 and the adaptive human immune system. For example, will people have long lasting immunity? He also questioned whether it would be advantageous to receive two different COVID-19 vaccines rather than the same one twice.

“But there’s a more pragmatic question here,” he said. “We are in a situation right now where we don’t have enough vaccines, and the production rate of the vaccines that are currently produced and licensed is not high enough to cover the globe and a lot of countries are struggling to get access to vaccines.” Improving the situation is critical.

Indeed, Ester C. Sabino, PhD, Professor, Institute of Tropical Medicine, at the University of São Paulo, Brazil, said, “If we don’t have access to vaccines, then probably herd immunity will never be reached.”

Panelist Adrian Hill, DPhil, Director of the Jenner Institute at Oxford University in England, and a co-developer of the AstraZeneca vaccine for COVID-19, concurred. “The biggest failing in responding to COVID-19 has not been in vaccine technology—they perform really well. And it hasn’t been in the speed of response—that’s been extraordinary,” he said. “It’s been in the lack of physical locations that manufacture vaccines widely around the world. We need to have facilities that can flip overnight to make outbreak pathogen vaccines.”

Thousands of Mothers Take Part in Mount Sinai Study of COVID-19 and Pregnancy

May 6, 2021 | BFWHRI, COVID-19, Featured, OB/GYN, Pregnancy, Research

Jill Schechter, with baby Jonah, says she was grateful to participate in the study of COVID-19 and pregnancy.

A multidisciplinary team at Mount Sinai is conducting the first large-scale prospective study to examine the impact of COVID-19 infection during pregnancy on maternal and child outcomes. The study is funded by a $1.8 million contract from the Centers for Disease Control and Prevention (CDC) and is expected to be conducted through May 2022. The team calls it “Generation C” because it is studying the maternal experience during the COVID-19 pandemic.

“Early in the pandemic, there were reports that women who tested positive during delivery might have a higher risk of birth complications,” says a co-investigator, Veerle Bergink, MD, PhD, Professor of Psychiatry, and Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai. “We want to know, not only for symptomatic women but also for the asymptomatic women, what exposure to COVID-19 means for your obstetric outcomes and for your baby.”

The research team intends to recruit a cohort of 3,000 pregnant patients at The Mount Sinai Hospital and Mount Sinai West, with more than 2,500 enrolled to date.

One participant in the study is also a co-investigator—Whitney Lieb, MD, MPH, MS, Assistant Professor of Obstetrics, Gynecology and Reproductive Science, Population Health Science and Policy, and Medical Education, Icahn Mount Sinai. “There is limited data about how COVID-19 affects moms and babies, and I think it is important to get as much data as possible,” says Dr. Lieb, who gave birth at Mount Sinai West in July 2020. “That is why I decided to join the study.”

Whitney Lieb, MD, with baby Jacob, is both a participant and a co-investigator in the study. “There is limited data about how COVID-19 affects moms and babies,” says Dr. Lieb, Assistant Professor of Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai.

Jill Schechter, who gave birth on Valentine’s Day at The Mount Sinai Hospital, joined for the same reason. Ms. Schechter was vaccinated for COVID-19 while pregnant and asked her physician if there were any studies she could participate in. “I work in health care, and I am aware of the importance of research,” Ms. Schechter says. “I’m grateful for being able to participate.”

In the study, researchers are examining plasma samples drawn as part of routine care at each trimester of pregnancy in all pregnant women at the two hospitals. Samples are tested for the immunoglobulin M and immunoglobulin G antibodies to SARS-CoV-2, the virus that causes COVID-19, at each trimester of pregnancy and delivery. The team is measuring a panel of inflammatory biomarkers at each trimester of pregnancy and at delivery. The hypothesis is that the level of inflammatory host response to SARS-CoV-2 exposure is related to the impact of the infection on maternal and child outcomes, and that timing is crucial.

The study is examining the subjects’ electronic medical records, obtaining data on obstetric complications, miscarriage, premature rupture of membranes, delivery type, maternal ICU admissions, acute respiratory distress syndrome, sepsis, and maternal death. In addition, the team is extracting data on fetal growth and neonatal outcomes, including birth weight, preterm birth, neonatal morbidities, neonatal intensive care admissions, congenital malformations, and fetal and neonatal death.

“We are looking at the impact and timing of SARS-CoV-2 infection and the development of COVID-19 on these acute and severe complications,” says co-principal investigator Joanne Stone, MD, Director of the Division of Maternal Fetal Medicine, Mount Sinai Health System, and Professor of Obstetrics, Gynecology and Reproductive Science. “The aim is to investigate whether SARS-CoV-2 infection and a strong inflammatory host response are related to preterm delivery and neonatal morbidity.”

Another aim of the study is to examine the extent to which COVID-19 disproportionately impacts pregnant women from underserved communities. This part of the study is taking full advantage of the diversity of Mount Sinai’s patient population. “We have women from the affluent Upper East Side of Manhattan, from the Bronx, from Harlem,” says co-principal investigator Siobhan Dolan, MD, MPH, Vice Chair for Research and Director of Genetics and Genomics, Department of Obstetrics, Gynecology and Reproductive Science, and Co-Director of the Blavatnik Family Women’s Health Research Center. “The ethnic and socioeconomic diversity of our patients means that we do a very good job of reflecting the United States population.”

The World Health Organization classifies pregnant women as at high risk for serious COVID-19-related morbidity and mortality. The Mount Sinai study was proposed in response to a CDC call for research that will bolster the very limited data now available on the effects of SARS-CoV-2. It was designed by Dr. Bergink and Elizabeth Howell, MD, MPP, who is now Chair of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania.

“This virus will be among us for a while,” Dr. Bergink says, “and it is good to have real-life data on the effects of COVID-19, especially in vulnerable groups, like pregnant women and high-risk populations.”

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