What You Need to Know About COVID-19 Vaccines

Nov 12, 2020 | COVID-19, Featured, Vaccines, Your Health

There are new headlines every day about the rapid development of vaccines to prevent COVID-19.In this Q&A, Gopi Patel, MD, Hospital Epidemiologist at The Mount Sinai Hospital, Medical Director for Antimicrobial Stewardship for the Mount Sinai Health System, and Associate Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai, addresses some of the most pressing COVID-19 vaccine questions.

New Guidance on COVID-19 Vaccines: In April 2023, the Food and Drug Administration and the Centers for Disease Control and Prevention announced some major changes for COVID-19 vaccines. Click here to read more about what you need to know.

In general, how do vaccines work?

Vaccines expose us to pieces of either a bacterium or a virus, and our body mounts an immune response by making antibodies against those pieces. Antibodies are proteins that fight germs like viruses and bacteria by latching onto and disabling them. The goal is that our body will then recognize those pieces and use the antibodies to fight off any future exposure to the real bacteria or virus.

Can a COVID-19 vaccine give me COVID-19?

No.  None of the vaccines in advanced clinical trials can give you COVID-19.

Gopi Patel, MD

Should I get a COVID-19 vaccine if I already have antibodies?

We are learning a lot more about the human response to COVID-19. A lot of people who have had COVID-19 did mount an antibody response, but we don’t know yet how long that response might last. So right now, if you have a history of COVID-19 it is still worthwhile to get a COVID-19 vaccine when they become available.

How will we know if a COVID-19 vaccine is safe?

The Food and Drug Administration (FDA), pharmaceutical companies, and scientists who are involved in vaccine development are all very committed to developing a safe and effective vaccine. There is rigorous testing for all vaccines to ensure safety. During any vaccine clinical trial, side effects or adverse events—health problems that happen after the vaccine is given, which may or may not have been caused by the vaccine—are recorded and monitored by safety monitoring boards before the vaccine becomes publicly available through either an Emergency Use Authorization or through FDA approval. All that data is made available and will be quite transparent. The goal is a safe and effective COVID-19 vaccine.

What if many people do not get a COVID-19 vaccine?

It is hard to say. Currently, the recommendation from the FDA is that if a COVID-19 vaccine is made available, it has to be at least 50 percent effective. That means when you test the vaccine in clinical trials, the group of people who got the vaccine has at least 50 percent fewer cases of COVID-19 than the “placebo” group who didn’t get the vaccine. I think there are lots of questions about how many individuals need to be vaccinated to reach what we call herd immunity, where the rate of immunity throughout a community makes the spread of a particular disease between individuals less likely.

What is herd immunity?

Herd immunity is the idea that you can protect vulnerable people if most of the population gets vaccinated and develops an immune response. We talked about this with something that hit New York hard in 2019, which was the measles. In the case of measles, when most people are vaccinated, that protects those individuals who cannot get vaccinated—the very young or those who have immune systems that can’t respond to the vaccine. So that’s the idea of herd immunity. It is very unclear at this point what herd immunity means for COVID-19. It may be that a lot of people may make antibodies, but we also have to make sure people don’t transmit infection. So practices like wearing masks, washing hands, and watching your distance are still really important, even in the setting of a vaccine.

How is Mount Sinai involved in the testing of a COVID-19 vaccine?

We’re very lucky at the Mount Sinai Health System in that we are actually involved in trials of COVID-19 vaccines. We’ve been involved in the trial of the Pfizer vaccine, one of the candidates that is furthest along in the process, and we’re starting enrollment in other trials soon. So we are prepared in terms of looking at the safety and efficacy of the four vaccines that are most advanced in Phase 3 clinical trials.

How is Mount Sinai planning for administering a vaccine once it becomes available?

Mount Sinai is already looking at how we would distribute and allocate a vaccine. It is important to remember that this vaccine would be administered under an Emergency Use Authorization from the FDA. So what would that look like? Who would we offer vaccination to, and how would we monitor those individuals? How would we make sure that we offer the vaccine to those who are most vulnerable to COVID-19 infection, whether it be in the community or in the health care setting? We know our health care workers are at risk. But we also know there are essential workers outside of health care who may be at risk. We’re working with our public health authorities—including the New York State Department of Health and our New York City Department of Health and Mental Hygiene—and watching the safety and efficacy data closely. Members of our Icahn School of Medicine at Mount Sinai faculty are working with New York State on the safety, efficacy, and evaluation of any vaccine candidate that becomes available in the next few months.

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New England Journal of Medicine Study of Marine Recruits Provides Lessons in Controlling the Spread of COVID-19

Nov 12, 2020 | COVID-19, Featured, Research

To effectively control the spread of SARS-CoV-2, the virus that causes COVID-19, public health measures such as wearing face masks, social distancing, and handwashing must be combined with repeated and widespread testing. That is the conclusion of a new study in The New England Journal of Medicine by researchers from the Icahn School of Medicine at Mount Sinai and the Naval Medical Research Center, who looked at disease transmission among 1848 Marine recruits between May and July 2020.

The researchers studied the Marine recruits, the majority of whom were male and between the ages of 18 and 20, while they were in a two-week supervised quarantine. The study results, published on November 11, showed that few infected recruits had symptoms before diagnosis of SARS-CoV-2 infection, that transmission occurred despite implementing many best-practice public health measures, and that diagnoses were made only by scheduled tests, not by tests performed in response to the daily temperature checks and symptom screening of the recruits.

“If you rely only on testing you are going to miss cases and the virus will escape, and if you just use public health measures it’s not going to be sufficient,” says the study’s senior author, Stuart Sealfon, MD, the Sara B. and Seth M. Glickenhaus Professor of Neurology at the Icahn School of Medicine at Mount Sinai. “If you do both of them together you should be able to control this highly infectious virus. We hope this information helps in developing more effective measures to keep military installations and schools safe.”

The study data revealed asymptomatic spread of the virus even under strict military orders for quarantine and public health measures that most likely experienced better compliance than would be possible in other youth settings like college campuses. The researchers noted that the virus was largely transmitted within a given platoon group which trained and ate together while maintaining social distancing, handwashing, and other methods of infection control.

The study enrolled participants from nine different Marine recruit classes, each containing 350 to 450 recruits, between May 15 and the end of July. The participants were offered enrollment in a prospective, longitudinal study after self-quarantining at home for two weeks prior to arrival at basic training. Once they arrived, they were required to follow strict group quarantine measures with two-person rooms for two weeks—the duration of the study period—before the start of the actual training. The supervised group quarantine took place at a college used only for this purpose. Each recruit class was housed in different buildings and had different dining times and training schedules, so the classes did not interact.

Each weekly class was further divided into platoons of 50-60. During the study period, all recruits wore cloth masks, practiced social distancing of at least six feet, and regularly washed their hands. Most of their instruction, including exercising and learning military customs and traditions, was done outdoors. After each class finished quarantine, a deep cleaning, using bleach on surfaces, occurred in all rooms and common areas of the dormitories before the arrival of the next class.

To determine asymptomatic and symptomatic SARS-CoV-2 prevalence and transmission during supervised quarantine, participants were tested within 2 days of arrival, at 7 days, and at 14 days using a nasal swab (PCR) test authorized for emergency use by the U.S. Food and Drug Administration. Analysis of viral genomes from infected recruits identified multiple clusters that were temporally, spatially, and epidemiologically linked, revealing multiple local transmission events during quarantine.

“The identification of six independent transmission clusters defined by distinct mutations indicates that there were multiple independent SARS-CoV-2 introductions and outbreaks during the supervised quarantine,” says the study’s co-senior author, Harm van Bakel, PhD, Assistant Professor of Genetics and Genomic Sciences at the Icahn School of Medicine at Mount Sinai. “The data from this large study indicates that in order to curtail coronavirus transmission in group settings and prevent spill-over to the wider community, we need to establish widespread initial and repeated surveillance testing of all individuals regardless of symptoms.”

Insight into COVID-19 characteristics and SARS-CoV-2 transmission in military personnel has relevance to developing safer approaches for related settings composed primarily of young adults such as schools, sports, and camps.

This work was supported by the Defense Health Agency through the Naval Medical Research Center and the Defense Advanced Research Projects Agency.

Overwhelming Majority of People Mount a Strong Immune Response to COVID-19: A Good Sign for Future Vaccines

Nov 11, 2020 | COVID-19, Featured, Research, Vaccines

Patient samples to be tested for SARS-CoV-2 antibodies. Credit: Centers for Disease Control and Prevention/James Gathany

More than 90 percent of people who recovered at home from mild and moderate cases of COVID-19 produced a robust and possibly protective level of antibodies that remained relatively stable for at least five months, according to a new study by researchers at the Icahn School of Medicine at Mount Sinai.

The study, published in the latest issue of Science, was one of the largest of its kind ever conducted. It included 30,082 individuals who were screened at the Mount Sinai Health System. The patients, of diverse ages and ethnic and socioeconomic backgrounds, presented with a range of symptoms—from those who had almost none to those who spent several weeks in bed.

The findings are important because they provide irrefutable evidence that the body, in most cases, responds to COVID-19 by producing neutralizing antibodies that characterize a protective immune response, which does not quickly fade. Also significant, the findings apply to the majority of people who actually get COVID-19—those with mild to moderate cases.

This latest data confirms the strength and reliability of Mount Sinai’s ELISA antibody test, which was the first to detect the presence of antibodies to SARS-CoV-2, the virus that causes COVID-19 and the first to measure the amount of antibodies present in the blood.

“We will continue to follow a subset of these individuals over time to see how long these antibodies last, but so far the data are encouraging in terms of possible protection and the potential of vaccines working,” says the study’s first author, Ania Wajnberg, MD, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai. “You can see that at five months the antibodies declined slightly, which is expected in a virus like this. But they certainly did not rapidly decline to zero, as had been reported in some press articles. That is not what we’re finding.”

Dr. Wajnberg says Mount Sinai’s leading microbiologists are working toward a better understanding of the precise level of antibody titers that would actually prevent an individual from getting sick from COVID-19 again. “That is going to take time,” she says. “We don’t want people with antibodies to think they can ignore guidelines around social distancing, masks, etc. But this is encouraging data.” Dr. Wajnberg says the team did not delve into the reasons why a very small segment of the patients did not mount a robust immune response, though this is seen in different viruses and may be an area of future research.

The study authors wrote that “Although we cannot provide conclusive evidence that these antibody responses protect from reinfection, we believe it is very likely that they will decrease the odds of getting reinfected and may attenuate the disease in the case of a breakthrough infection.”

“Vaccines generally work by eliciting an antibody response, and ongoing vaccine trials may also contribute to our understanding about the protective effects and duration of SARS CoV 2 antibodies,” says the study’s corresponding author Carlos Cordon-Cardo, MD, PhD, the Irene Heinz Given and John LaPorte Given Professor and Chair in Pathology, at the Icahn School of Medicine at Mount Sinai.

How to Safely Celebrate With Family This Holiday Season

Nov 9, 2020 | COVID-19, Your Health

Cozy family gatherings are a staple of the winter holiday season. But this year, with COVID-19 continuing to circulate throughout the country, getting together with family will look decidedly different.

In this Q & A, Krystina Woods, MD, Hospital Epidemiologist and Medical Director of Infection Prevention at Mount Sinai West, answers questions about how families can celebrate the holiday season while preventing the spread of COVID-19. 

Read the latest recommendations from the CDC urging Americans to stay home this holiday season

How can families in the tristate area safely celebrate together this holiday season?

This year, in particular, everyone is really looking forward to holiday festivities because this has been a year in which we have had to keep our distance from friends and family. However, like with the rest of the year, the safest thing to do this holiday season is to gather virtually. Throughout the COVID-19 pandemic, we have learned that gathering outdoors presents a lower transmission risk than gathering indoors. But in the northeast, most of the holidays that we look forward to are going to be in colder weather which makes meeting outdoors impossible or, at the very least, uncomfortable.

I know that there are many people who are not looking forward to celebrating virtually, but in terms of safety, the best thing to do is to not meet in person.

I am hosting a small holiday dinner. Are there health-related questions I should ask guests before arriving?

If you are going to take the risk of gathering indoors, the most important thing to do is to make sure that everyone in attendance is taking precautions outside of the gathering. If you—the host—are very careful about masking, washing your hands, limiting outside activities, and you are working from home, then your risk for contracting COVID-19 is going to be low. So, you want to think about the people coming into your home. They should have a similar risk profile to yours.

It defeats the purpose for you to be super careful, and then invite someone to your home who is taking risks, like going out to a lot of events or parties. So, it is a good idea to get a sense of a guest’s risk profile if you don’t already know.

In a blog post on how to safely date during a pandemic, Mount Sinai pulmonologist Lina Miyakawa, MD, advised asking potential partners the following risk profile questions. They provide a great start in assessing anyone who enters your home for a holiday get-together.

To assess your guest’s risk profile, you can ask them these questions:
  • How many contacts do you have on a daily basis?
  • Who do you live with?
  • Do you leave the house? If so, where do you go?
  • Do you follow the recommendations to mitigate the risk of exposure, like wearing a mask and practicing social distancing?
  • Do you work in situations with high exposure risk?

If families choose to gather, what precautions should they take to minimize the risk of spreading COVID-19?

Here are five suggestions:

Head outdoors. If families insist on meeting in person, the most important thing would be to try to gather outside. But again, with the weather being what it is in the tristate area for the winter holidays, that will be tough.

Keep it brief. Although it goes against what we all think about holiday celebrations and how to enjoy them, keep any gatherings relatively brief. The longer you are with a group of people, the more chance you have of possibly getting sick.

Keep the numbers small. This isn’t the time for large extended family gatherings. This is the time to think about keeping the group smaller.

Increase the air flow. If you have to be indoors, make sure that the space is well ventilated. While it is not environmentally friendly to have windows open while the heat is on, it is essential to have fresh air coming in.

Mask up and keep your distance. If you are going to gather indoors, wear face coverings for as much of the gathering as possible. That may feel strange since you are inviting a sister or a parent to your home, but given the pandemic, it would make an indoor gathering safer for everyone. It is also important to keep six feet of distance from others, even if you’re wearing masks inside, and especially when you’re eating.

Should changes be made in how food is served?

Buffet-style meals are not ideal because you don’t want a whole lot of people handling utensils.

There are two different ways to serve food in a safer way. The first is that everybody brings their own dish which, would not work for a holiday like Thanksgiving because you will have a ton of food leftover. The second is that you have one person serve everyone, preventing each family members from touching the tongs, the spoons, the forks, etc., when filling their plate. This person should be masked and should clean their hands before touching any dishes or utensils. 

Also, when sitting to eat, you should try to distance people by six feet. More space is better, but those who live in and around the New York metropolitan area don’t always have the luxury of ample space. However, if you will be gathering, try spacing out with six feet being the minimum.

Is it safer to gather indoors if all family members get tested for COVID-19 prior to gathering?

There are a lot of questions about using testing as a sort of permission slip to meet up with others.

If you test before you have a get-together, it is helpful if someone comes back with a positive test result. At that point, you know for sure that this person should be excluded from the gathering. However, it is not so helpful when someone receives a negative test because it does not give you an idea of their potential to turn positive within the next day or the next few days.

For example, if I receive a negative test on Monday, this result does not tell me what my status will be on Tuesday or Wednesday. So, if I attend a family gathering on Wednesday and I start experiencing COVID-19 symptoms on Thursday, everyone who I met at that family gathering will have been exposed to the virus.

Unfortunately, I think testing is giving people a false sense of security. You should continue to take all precautionary steps, specifically if your test result is negative. And, if it is positive, you know that you should be isolating at home and taking care of yourself.

How can families maintain safety in the 14-day window following an indoor gathering?

After any gathering, especially one that is indoors, keep your distance from other people in the two weeks following. This limits the potential that you unwittingly expose anyone to COVID-19. Also, if you go to a party and two days afterward an attendee tests positive, you will have to quarantine. So, if you kept to yourself for those two days after the party, you will not need to worry that you exposed a friend, colleague, or loved one to the virus.

See this flyer for more tips from Mount Sinai for how to have a safe holiday season

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Mount Sinai Physicians Create an Effective Road Map for Treating COVID-19

Nov 5, 2020 | COVID-19, Featured, Research

Carlos Cordon-Cardo, MD, PhD

Experts at the Mount Sinai Health System have created a road map for clinicians to follow when providing care to COVID-19 patients, which characterizes four distinct stages of the COVID-19 disease cycle and outlines specific testing and treatment protocols for them. The new approach—called staging—is featured in the latest issue of Cancer Cell and is modeled after the way in which cancer and other complex diseases, such as chronic renal disease, are managed.

“COVID-19 parallels other very difficult diseases in that it manifests specific clinical phases of progression,” says the study’s corresponding author, Carlos Cordon-Cardo, MD, PhD, the Irene Heinz Given and John LaPorte Given Professor and Chair in Pathology, at the Icahn School of Medicine at Mount Sinai. “In the absence of clear guidance we thought staging this disease could help physicians navigate better by linking the right tests to the most appropriate interventions. We want to give patients a better chance of being cured based on objective laboratory data and clinical information that is appropriate at different stages of the disease.”

The study lists stage 1 as viral entry; stage 2 as viral dissemination; stage 3 as multi-system inflammation (severe); and stage 4 as endothelial damage, thrombosis, and multi-organ dysfunction (critical), which affects a minority of patients. The study authors draw comparisons between the spread of the SARS-CoV2 virus, which causes COVID-19, within the body, and the spread of cancer, which metastasizes throughout the body—both resulting from disease-producing agents that create a cascade of dysfunction.

Staging requires knowing more about the patient than simply whether they tested positive or negative for COVID-19. Physicians, and the community at large, would benefit from tests that would also offer an indication of the level of viral particles affecting the patient, either high or low; since a patient with a high viral load and comorbidities such as advanced age, hypertension, diabetes, and coronary artery disease would be at higher risk for a poor prognosis.

Visual Summary of COVID-19 Stages

Since the beginning of the pandemic, physicians have learned important lessons about giving treatments early in the disease cycle, when they are most effective. One example is convalescent plasma therapy, which is best given before the patient develops their own antibodies to COVID-19.

“Analogous to the way we treat cancer, COVID-19 treatments have to be adapted to the evolution of the disease,” says study author, Luis Isola, MD, Professor of Medicine (Hematology and Medical Oncology), and Pediatrics, at the Icahn School of Medicine at Mount Sinai. “Treatments that may be effective early on no longer impact late disease. Conversely, treatments that help patients with advanced disease may not help or be justifiable when they present with it.”

The study’s authors say it is important to have a systematic approach to COVID-19 diagnostics and treatments that would keep the disease from progressing in those who might develop severe cases. “The idea is for us to provide guidelines for people to understand that this is not a simple disease, but one that is more complex,” says Dr. Cordon-Cardo.

In May, Mount Sinai released an autopsy study of 67 individuals with COVID-19 who had been admitted to one of the Health System’s eight hospitals from March 20 to April 29. The study showed the degree to which COVID-19 can lead to excessive blood clots and multi-organ failure.

David Reich, MD, President and Chief Operating Officer of The Mount Sinai Hospital, and one the study’s authors, says, “We learned a huge amount from the autopsy and innovative laboratory data collected from the very large number of COVID-19 patients cared for in the Mount Sinai Health System. Synthesizing all of these data led to this staging concept that has the potential to help clinicians worldwide in their understanding of the stages of this disease and in guiding the appropriate use of emerging therapies.”

Mount Sinai’s road map would also help COVID-19 patients understand the state of their own health during the disease cycle. Cancer patients at stage 2, for example, understand the course of their disease will be easier than it would be at stage 3 or 4, when they would require more aggressive treatments. The same holds true for COVID-19.

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Should I Wait to Have My Child’s Vision Checked?

Oct 26, 2020 | Children's Health, COVID-19, Ophthalmology, Your Health

This academic school year—in addition to the usual school supply lists and purchasing of new shoes—parents must think about COVID-19 positivity rates, appropriate face coverings, and reliable in-home internet access. Whether your child will be learning in the school room or remotely, their eye health is important and should not be overlooked. Douglas R. Fredrick, MD, Professor of Ophthalmology and Pediatrics at the Icahn School of Medicine at Mount Sinai, explains what parents need to know about their child’s vision.

Should I wait until after the COVID-19 pandemic to get my child’s vision checked?  

Please do not delay having your children examined. It is important to make sure their vision is sharp and their eyes are healthy. Most of our sensory connection to the world is through our eyes. Children who do not see properly can have difficulty developing academically and socially. If we catch and correct vision problems early, we can improve children’s day-to-day life and functioning in school. We can also detect eye conditions that could lead to further problems down the line.

While COVID-19 is still of great concern,  Mount Sinai Health System has gone to extraordinary lengths to make sure every patient receives the best possible care in a safe environment. We have developed stringent protocols to protect your family and our community. For instance, face coverings are mandatory and social distancing is enforced throughout the Health System. Additionally, we disinfect continually and regularly test our staff for COVID-19.

How often should I have my child’s eyes checked?

The American Academy of Ophthalmology and the American Academy of Pediatrics recommend that pediatricians and family practitioners examine the eyes and check vision in newborns, age two months, six months, one year, then annually until age six, then every other year until age 18. Most pediatricians check vision every year during their annual exam, and many school districts perform screening each year, beginning at age five or six.

What are the signs that my child has vision issues?

If you notice your child squinting or tilting their head to see objects that are far away, rubbing their eyes after reading, or if their eyes drift toward the nose or outward—as though they are trying to see their ears—you should schedule an appointment with your child’s pediatrician for a vision exam. The same is true if your child complains about fuzzy or foggy vision. I also recommend that parents check in with their child’s teacher as they may see vision impairment related behaviors in the classroom.

My child is struggling with vision issues. How can I help?

The first step is to see your child’s primary care provider who will check for any other health conditions that may be contributing to your child’s difficulties. If the pediatrician finds decreased vision on a screening exam or has any other concerns, they will refer you to a pediatric ophthalmologist. These ophthalmologists have additional training in caring for children and often have specialized equipment and child-friendly offices.

During the examination, the ophthalmologist will do a thorough exam of your child’s eye—probably using dilating eye drops. If the doctor finds that your child is nearsighted or has another vision issue, they may prescribe glasses. If the examination is completely normal but your child is still having a problem with reading or learning, your primary care provider may refer you to an educational specialist or school learning specialist to test for learning disorders and make recommendations.

My child will be learning remotely this school year and I am concerned about eye strain. I’ve heard that blue light glasses can help with this issue. Is this true?

Blue light glasses are special eyewear that block or filter the high-energy blue light coming from computer, tablet, and phone screens. It is not clear that they help with eye strain or eye disease. A recent study performed at the State University of New York School of Optometry found that these glasses did not decrease eye strain with “near work”—activities that require near vision such as reading, writing, and watching television.

While it won’t hurt to use these glasses, there are better ways to reduce eye strain. For instance, have your child hold their reading material, laptop, or tablet at the appropriate distance and make sure they have enough light to see—but not so much it causes glare on the screen. It can also help to have your child take breaks every 20 to 30 minutes when they are doing screen work. I recommend giving your child a task that gets them on their feet and their eyes off the screen, like feeding your pet or taking out the trash.

Should I limit how much time my children spend on screens?

All children will be spending more time with their eyes on the screen this year than in the past and that is going to make it hard to limit screen time to the typical recommendation of two hours a day. This year, instead of enforcing strict limits, try to keep track of what they’re doing with their screen time. Although most of their screen use should be educational, you’ll need to allow time for play—both to relax and to enable them to have social time with friends. Physical activity should also be a part of their daily routine. The key is finding a balance. For more on how—or whether—to limit your child’s screen time, read this blog post from Mount Sinai pediatrician Micah Resnick, MD.

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