Mount Sinai Leaders Explore COVID-19 Vaccines, Treatments, and the Path Ahead in Aspen Ideas: Health Panel Discussion

Does convalescent plasma therapy work? Is a successful vaccine for COVID-19 on the way? Will it be suitable for senior citizens and available to minority communities that were hardest hit by the pandemic? These pressing topics are explored in a recent Aspen Ideas: Health panel discussion that was led by Kenneth L. Davis, MD, President and Chief Executive Officer of the Mount Sinai Health System. Mount Sinai’s renowned vaccinologist Florian Krammer, PhD, and infectious disease specialist, Judith A. Aberg, MD, weigh in with informative answers to some of the nation’s most important health care questions.

“Many vaccine trials fail,” says Dr. Krammer, “but if you go with diverse approaches to creating a vaccine, it is very likely that one or even more of these will succeed.” With regard to convalescent plasma therapy, Dr. Aberg says, timing is everything. Administer the treatment early on before patients develop their own antibodies. Mount Sinai, she adds, is educating at-risk communities about the need for COVID-19 vaccines. When vaccines are ready to be administered Mount Sinai will be there.

To learn more about the most promising vaccines under development, why the infection rate in New York City is relatively low at this time, and whether we should be concerned about mutations to the SARS-CoV-2 virus, go to Aspen Idea’s Perspectives in Health.

How Do I Prepare My Child to Go Back to School?

As children head back to school—whether in person or virtually—parents may have some concerns about how they will adapt to a new, potentially stressful academic year. Aliza Pressman, PhD, Co-Founding Director and Director of Clinical Programming for the Mount Sinai Parenting Center, answers some of your questions.

How can I address my children’s anxiety about going back to school in person?

Start by making sure that you are calm and not imposing your own anxiety onto the conversation. Your children will pick up on your energy and you want to be focused on their concerns. Also, remember that your anxiety—and your child’s anxiety—is very reasonable at this challenging time. If your child is anxious, don’t try to get rid of that anxiety. Instead, validate their feelings. Tell them that what they are feeling makes sense. Children have been out of school for a long time and for months have been hearing about the importance of staying away from people. Now they’re going to head back into a building full of people. Of course they are nervous.

Once you’ve validated your child’s emotions, explain that you would not send them back to school if you did not think they would be safe. Go over the precautions that the school is taking to protect teachers and students and, for younger children, remind them about what COVID-19 is and what individual measures they can take to keep themselves safe while at school.

Will my child’s learning be affected by having their teachers wear masks?

This is a natural concern. Our facial expressions are part of how we communicate and masks obscure half the face. One way to prepare your child is to practice communicating and reading people’s emotions when they are wearing a mask. Make a game of it. Have everyone at home wear a mask and guess what each person is trying to say by just using body language. Once your kids go back to school, you can reinforce the lessons they are receiving in the classroom; for instance, have them read to you. You’ll probably pick up cues from your children about what they need, and you can adjust accordingly. Remember, kids are incredibly adaptable, more so than adults.

How can I help my child connect with their friends while attending school remotely?

If your child is attending school remotely, they will probably miss spending time with their friends, and interactive screen time is a great way for them to safely connect. Since screen time may be your child’s only opportunity to socialize, you might even want to allow more screen time than you permitted before the pandemic. Just make sure it doesn’t interrupt family mealtime, homework, or replace outdoor activity.

Also, remember that some kids don’t enjoy online interaction. Some children enjoy a more passive interaction like being in the same virtual room as a friend while doing an art project. This allows children to chat with each other without the pressure of an ongoing conversation. As kids get older, they will be able to tell you how they want to connect with their friends. It may be through a video game, taking an exercise class together, or watching a movie together. Or, they may just want to talk on the phone or text.

How do I talk to my child about what is happening in the world?

Before you talk with your child about current events, make sure that you have come to terms with your own state of mind. You don’t want to enter the conversation with the weight of your own feelings. When you are ready to talk, determine what you want to discuss before beginning the conversation. Whether it is COVID-19, social unrest, or something else, begin by asking what they know and what they’re thinking about regarding the topic. You want to be your child’s first resource with any questions and concerns. Be prepared to explain your opinions.

When should I seek professional help?

If you or your child cannot manage to sleep or eat or are feeling out of control, consider seeking the guidance of a mental health professional. It is completely reasonable to feel overwhelmed; this is an enormously stressful time. And, remember, if your child sees that you are willing to seek help, they will know that it is okay for them to do the same.

What You Need to Know About Quarantine and COVID-19

Several months into the COVID-19 crisis, most people in the New York metropolitan area are intimately familiar with the first line of defense against the virus—social distancing, face coverings, and impeccable hand hygiene.

But, as reopening expands and more New Yorkers feel comfortable travelling, the risk of encountering someone who may have the virus increases. To combat a rise in cases due to this surge in movement, local leaders have implemented quarantine guidelines.

In this Q & A, Krystina Woods, MD, Hospital Epidemiologist and Medical Director of Infection Prevention at Mount Sinai West, answers questions about quarantine and explains why it is an essential tactic in preventing the spread of COVID-19. 

Who needs to quarantine? Why does it last 14 days?

Quarantine is recommended for someone who has had close contact with an individual who tested positive for COVID-19 as well as anyone who returns from international travel. Quarantine is required by law if someone has returned to New York State from one of the states listed on the quarantine list, as ordered by Governor Andrew M. Cuomo. This list also applies to residents of and visitors to New Jersey and Connecticut, where governors have put the same order in place. The list of states changes rapidly, so make sure you keep up to date. 

While we are still learning more about COVID-19, we know that patients typically develop symptoms between 2 and 14 days after being exposed to the virus. Quarantine guidelines are in line with this 14-day exposure window.

I just returned from a COVID-19 hot spot and need to quarantine. Does that mean I cannot leave my apartment for the entire two weeks?

If you are on quarantine you should not leave your apartment. In fact, it is against the law to do so if you are returning from a “hot spot” state.

Thankfully, we can get just about anything delivered. So, those who are under quarantine should plan on having groceries and other necessary items delivered. Also, you should not socialize with anyone outside of your household. Do not invite people over until your quarantine is complete.

If someone in your household did not travel to the COVID-19 hotspot and does not require quarantine, you should quarantine yourself from those household members.

What should I do if I begin exhibiting COVID-like symptoms during quarantine?

If you begin to exhibit symptoms of COVID-19 while quarantining, step back and consider how you are feeling. If you are well enough to treat yourself at home with rest, fluids, and medication for fever, then you should do so.

If you are not well enough to stay home, if your symptoms suddenly worsen, or if you are experiencing trouble breathing, difficulty maintaining consciousness, confusion, chest pain/pressure, or have blue lips, you should seek medical help immediately. If you need an ambulance to bring you to the emergency room, let the dispatcher know that you are having COVID-like symptoms. This will allow emergency medical personnel to take the proper precautions when taking care of you.

If I remain asymptomatic throughout the 14-day quarantine, should I still get tested for COVID-19?

No. If you have completed your 14-day quarantine and have not experienced symptoms throughout, you do not need to get tested for the virus.

Do you have any more advice for those who will need to self-quarantine?

If you are sharing your home with someone who does not need to quarantine, make sure you have ample cleaning supplies—particularly if you don’t have a separate bathroom—so you can clean high-touch surfaces like faucets, the toilet flusher, door knobs, and shower door handles. If possible, sleep in a separate bedroom–with the window open to allow for fresh air to circulate–and remain in that bedroom/separate space for as much of the day as possible. If you need to leave your separate room, make sure to wear a face covering and try not to touch anything more than is necessary.

Also, make sure you have a COVID-19 emergency care kit, stocked with a working thermometer and non-expired fever-reducing medications. And keep your doctor’s phone number handy, just in case you develop symptoms that require medical attention.

Remember, the purpose of the quarantine is to prevent spreading COVID-19 throughout our community. Currently, the New York metropolitan area has a very low COVID rate, and we want to keep it that way. Although you may feel well, those without symptoms have the potential to spread the virus. So it is important to take all precautions.

Is it Safe to Head Back to the Gym?

If you are one of the many New Yorkers who have missed the bench press, the elliptical, and the free weights at your local fitness center, you are in luck. Governor Andrew M. Cuomo officially gave the green light for gyms throughout New York State to open on Monday, August 24, with Mayor Bill de Blasio authorizing indoor workouts throughout the five boroughs starting in September.

Establishments will need to operate with a limited capacity and follow a slew of safety protocols. However, there are still a few things New Yorkers should keep in mind before heading back. Waleed Javaid, MD, Associate Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai, explains what every fitness enthusiast needs to know before heading back to the gym.

What precautions should you take when heading back to the gym?

There are three critical elements that we all need to consider:

Wear a face covering during all social interactions—this includes your gym workouts. Be sure to have on a surgical mask or a cloth face covering that shields your nose and mouth.

Hand hygiene is extremely important. When you enter and leave the gym, you should wash your hands with an alcohol-based sanitizer. Also, sanitize your hands when switching between machines or using new equipment.  

Maintain social distance as much as possible. Make sure you are keeping six feet away from everyone all the time. There will be exceptions to this rule when we might have to walk past somebody. That is fine, but should be limited.

Last, remember that we are still in the midst of a pandemic. So, if you are ill, you should not be going to a gym or be out in any public setting.

Are there health practices that gym goers should look for at their fitness center?

The Centers for Disease Control and Prevention (CDC) has come out with recommendations for gyms that include social distancing, masking requirements, making sure that hand sanitization is available, and limiting the amount of people who will be in the gym at any given time. In addition to the CDC’s guidelines, the New York State Health Department has issued air filtration guidance for establishments. Those planning to head to their gym should check that it regularly follows these guidelines.

I plan to hit the gym. Are there activities that are high risk for spreading COVID-19 that I should avoid?

Higher risk activities include anything that requires you to be close to another person—for example, bench presses. If your workouts involve close contact with another person, it might be helpful to have a regular gym buddy or maybe even a small group of people that you work out with regularly. But, you will need to make sure that everybody you work with or work closely with is extremely careful with their activities outside of the gym. Also, any activity that will require you to take your mask off should be avoided. For example, if you typically run on the treadmill for an hour, may not be able to wear a mask.  

Everyone should prepare to adopt these key practices for next six to eight months while we work on an effective treatment or vaccine for COVID-19.

Is the virus spread through sweat?

There is no clear evidence that COVID-19 is spread through sweat. We do know that the virus is spread through contact with respiratory droplets emitted from the nose and mouth. So, if a person with COVID-19 touches their face, they can contaminate their hands and other surfaces with the virus.

Studies have shown that people touch their face, on average, five times an hour. So, in terms of COVID-19 prevention, I would not worry about sweat in the gym. I would be more concerned about wiping down equipment with a disinfectant before use.

How risky is it to head back to the gym?

I’m not sure if I can put a number on the risk. It’s important to remember that any activity that increases our social interaction is going to increase our risk. Going to the grocery store, going out on the street with many people—that is risky. Heading to an indoor gym where people might be breathing heavily and where there might be close contact with others is certainly a higher risk.

One thing that New York City has recommended is that gyms install enhanced filters to increase air circulation. In addition to wearing a face covering, practicing social distance, and having excellent hand hygiene—I believe increased air circulation in these enclosed spaces might decrease the risk.

Do you have any additional advice for those thinking about hitting the gym?

I think following COVID-19 prevention guidance is going to be important. Social distance, wear a face covering, wash your hands extensively, and stay away from those who are obviously ill.

In the case of gyms, it will be especially important to make sure that machines and any fitness equipment that you use are disinfected properly. This should enhance your ability to stay away from this illness while working out at the gym.

Men Hospitalized for COVID-19 Were Younger and Healthier Than Women Who Were Hospitalized

Men who were hospitalized for COVID-19 in New York City during the early days of the pandemic were both younger and healthier on average than their female counterparts, according to a new study by researchers at the Icahn School of Medicine at Mount Sinai. The study, posted to the preprint server medRxiv, analyzed the electronic health records of 3,086 racially diverse COVID-19 patients who were admitted to five hospitals within the Mount Sinai Health System on or before April 13, 2020, and followed through June 2, 2020.

“Just being male seemed to be a risk factor in and of itself,” says the study’s first author, Tomi Jun, MD, a hematology and medical oncology Fellow at The Tisch Cancer Institute of the Mount Sinai Health System. Members of Mount Sinai’s Department of Genetics and Genomic Sciences, and Scientific Computing and Data Science, also contributed to the study.

Of those requiring hospitalization, 59.1 percent were male with a median age of 64, vs. 74 years of age for women. While the men were more likely to have a history of smoking, the women were more likely to have pre-existing comorbidities such as hypertension, diabetes, chronic obstructive pulmonary disease and asthma, and obesity. The mortality rate for men and women was equal.

Tomi Jun, MD

“This was during the early days when there was a surge of cases in New York and we did not have effective treatments,” says Dr. Jun. “Looking at the data, there were a disproportionate number of men being hospitalized. And these men seemed to be healthy enough to do well with COVID-19, because we know that older age and having more comorbidities are associated with worse outcomes. When you take all those things into account, being male seemed to increase your risk.”

Kuan-lin Huang, PhD, Assistant Professor of Genetics and Genomic Sciences, and the study’s senior author, says, “We know there are a lot of hormonal and immunological differences between men and women. There are certain genes on the X chromosome that are involved in the immune system and women have two X chromosomes. Women go through pregnancy, which can have strong effects on the immune system. And we know that women are at higher risk of developing an autoimmune disease. Likely, it’s a complex set of these factors that contributed to the results. Specifically what is it? I don’t think anyone knows for sure. But that is what we were trying to get closer to with this and subsequent studies.” Understanding the underpinning of why this is happening at the molecular level, he adds, will provide insights into potential treatments.

Kuan-lin Huang, PhD

The researchers found interesting results when they examined data about the patients’ blood. “COVID-19 is very inflammatory and all of the hospitalized patients had very high markers of inflammation,” says Dr. Jun. “But we observed that women tended to have lower markers of inflammation than men. We conducted exploratory analyses to look at how predictive these markers were for death and found that in some cases higher markers for inflammation were associated with higher risk in women than men. So, although women, in general, had less inflammation than men when they entered the hospital, having higher indicators of inflammation seemed to confer a greater risk for them.”

Dr. Huang says the current study is a jumping-off point for future investigations that was made possible by Mount Sinai’s policy of allowing its data and clinical scientists to access the electronic health records.

“If our hospitals hadn’t taken care of all these patients and we didn’t know their histories we wouldn’t be able to do this research,” he says. “We really hope this will lead to more precise patient management. We should have different considerations for men and women when we think about whether that may add on to the risk of a COVID-19 patient.”

Vaccines for COVID-19: How Protective Are They? When Will They Be Ready? A Leading Vaccinologist at Mount Sinai Weighs In

Florian Krammer, PhD

As the SARS-CoV-2 virus circulates throughout the world unchecked, researchers are racing to develop more than 135 vaccines. How well will these vaccines work and how soon will we be able to benefit from them? To answer these questions and more, Mount Sinai Today turned to a leader in SARS-CoV-2 antibody research, Florian Krammer, PhD, Mount Sinai Professor in Vaccinology at the Icahn School of Medicine at Mount Sinai. Dr. Krammer is an experienced virologist whose Mount Sinai lab is working on a universal flu vaccine.

What does the vaccine landscape look like?

Vaccines have been made in record time, and they use different platforms. Two candidates use RNA technology, which has never been used in a vaccine before. Typical vaccine development can take up to 15 years but this is now getting shortened to months. Right now, there are more than 20 candidates already in clinical development around the world. Five of these are being developed in the United States. This makes me happy because there is not a single vaccine that can meet the entire demand of the market and if some fail there are alternatives.

Do any of the vaccine candidates look promising?

I am very positive about what we are seeing so far. We’ve seen pretty encouraging results from preclinical models, the phase 1 and phase 2 trials. But none of this means anything yet because the proof will be in the results from the phase 3 trials. That’s where we will learn about the actual efficacy and safety. In terms of efficacy, I don’t think we will end up with a vaccine that gives us 100 percent protection from infection (meaning sterilizing immunity). But we do not need a perfect vaccine, and I am relatively hopeful that several vaccine candidates will lead to solid protection from disease. I think a vaccine will probably also dampen transmission. This will help people who aren’t able to get vaccinated or mount a strong response after they are vaccinated.

When can we expect to see phase 3 trials?

Phase 3 trials are already ongoing. I assume we’ll have pretty good data sets by late fall or early winter, especially from interim analysis of the phase 3 trials. It’s very important that we don’t cut corners in terms of safety or efficacy even if countries like Russia are licensing vaccines right now, and China is giving its vaccine to the military. We really need to see what the phase 3 trials tell us and we need to rely on the U.S. Food and Drug Administration to make a judgment call and only license vaccines that are safe and that work even if they are not perfect in terms of efficacy.

What can go wrong in a phase 3 trial?

If you don’t see efficacy, you don’t go forward. A lot of other things can go wrong. Vaccines can trigger an unintended neurological issue or an autoimmune disease in rare cases. You wouldn’t see this in a few hundred people in phase 1/2 trials, but you would see one, two, or three cases in a few thousand people. An example of this happened in 1976, after an outbreak of swine flu among soldiers at Fort Dix, New Jersey, led to massive vaccination campaigns and increased cases of Guillain-Barré syndrome.

Do we know how the vaccines will work in children or the elderly?

All COVID-19 vaccines tested so far in the clinic show relatively high but acceptable reactogenicity—adverse reactions, including fever and a sore arm at the injection site. Since there is often a lot more reactogenicity in kids than in adults, we need to see if that is also an acceptable level in children. In terms of age de-escalation, I’m not sure what the vaccine producers are planning for phase 3 trials. Typically, you would start testing in healthy young adults and work your way down in age. But if you see a safety signal that’s unacceptable, you may end up with a vaccine that is licensed for adults but not below a certain age group in children. I am not too worried about safety in older people but I am worried about their immune response. We know we have a lot of trouble inducing immune response with flu vaccines in older people and we even have special vaccine formulations for that age group. It’s not clear if we will run into the same problems with COVID-19 vaccines. Some of the phase 3 trials will include people in their 70s, up to 80, so this is something we should know about soon.

What could complicate the rollout of an effective vaccine?

Large-scale production is difficult, and a couple of front runners in this race have never produced a vaccine for the market. A lot of the technologies being used are new and there is little experience with scaling them up. Also, we don’t know who will get the vaccine first. Probably health care workers and high-risk individuals, but I would like to see a discussion about this and understand what the public thinks. Also, distribution and administration of that many vaccine doses needs to be coordinated well and will be a huge effort. You also have to take into account that there will not be instantaneous protection. You may need two shots, and it could take a few weeks to a month until you mount protective immunity. In the United States alone we will need 660 million doses (two shots per person). Globally, we will need 16 billion doses. It’s almost unimaginable how much vaccine we will need.

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