How Will We Know Any New COVID-19 Vaccine Is Safe?

Vaccines for COVID-19 are in the news these days. For many pediatricians and preventive medicine specialists, vaccines have always been one of their most important tools and one of their most trusted measures for keeping patients healthy. In this Q&A, Kristin Oliver, MD, MHS, a pediatrician and preventive medicine physician at the Mount Sinai Health System and an Assistant Professor of Pediatrics, and Environmental Medicine and Public Health, at the Icahn School of Medicine at Mount Sinai, explains why.

Why are vaccines so important?

Vaccines are one of the best tools we have to prevent disease and death in both children and adults. Getting vaccinated is one of the easiest things that we can do to keep ourselves and our children healthy. When I think about all the things I do to stay healthy—eat well, exercise, manage stress—that’s a lot of work. But it’s easy for me to go and get my flu shot, or bring my kids in to get their vaccines. And when I do that, I’m preventing disease, not just in myself and my family, but also in the communities where I live and work.

How do you measure the effectiveness of a vaccine?

There are two measures of how well a vaccine works. One is called “efficacy,” and that’s how well a vaccine works in a clinical trial. That’s a perfect situation where everybody in the trial who is getting the vaccine doses is getting them exactly when they’re supposed to, and they’re being watched really carefully. Later on, we look at “effectiveness.” That’s in the real world—what happens when people get that second dose a little bit late, or things aren’t in such a controlled setting? For both measures, we compare a group of people who got the vaccine to a group of people who did not get the vaccine, and see how many cases of the disease are in one group compared to the other. You hope that there’s a lot less disease in the group of patients who got the vaccine.

In general, how effective are vaccines?

When you get a disease, how long you have protection from getting it again can vary from person to person and from disease to disease. In the same way, how well a vaccine works also varies depending on the disease and the vaccine. Some vaccines have a really high efficacy rate.  For instance the MMR vaccine that protects against measles has 98 to 99 percent efficacy. Other vaccines are not quite as high. The pertussis (whooping cough) vaccine is closer to 80 to 90 percent. The flu vaccine effectiveness varies from year to year, and is closer to 50 percent. Obviously higher is better. We’re hoping that for COVID-19, vaccine efficacy and effectiveness are closer to 90 percent. But we know that’s not always realistic for every vaccine.

Do we know if the COVID-19 vaccine will be effective for the general population, including children and the elderly?

Right now, we still don’t have a complete answer. Early data from some of the clinical trials looks good. As far as children are concerned, the youngest who have started to receive the trial vaccines are 12. We don’t have enough data yet to know how well the vaccine is going to work in these groups.

If I received the COVID-19 vaccine, can I stop wearing a face mask and social distancing?

Not yet. We don’t know how effective the vaccine is going to be, or how many people are going to receive it.  The recommendation is continue to practice social distancing, wear a face mask, and really good hand-washing. We’re going to have to do this for a little while longer.

How long does a vaccine protect you from a disease?

The protection that you get from a disease, either by having the disease itself and recovering, or by getting the protection from the vaccine, is what we call immunity. This protection depends a lot on the type of disease, and the type of vaccine. Unfortunately, right now, we don’t know how long immunity lasts when you get the disease or when you get the vaccine.

Will a vaccine for COVID-19 get us closer to herd immunity for the virus?

It will definitely get us closer. Immunity is the protection you get either from having the disease, or from getting vaccinated against the disease. With herd immunity, enough people in the community have this protection so that even if someone gets the disease, it is not likely to spread widely. At that point even people who aren’t immune won’t catch it. Right now, we still don’t know what percentage of immunity we need to reach herd immunity.

Can we reach herd immunity by letting everyone get infected?

For diseases where we have safe and effective vaccines, it is much better to reach herd immunity by getting everyone vaccinated than it is by waiting to have everyone get infected. We know the severe, terrible consequences of COVID-19, and so we’re looking for a safe vaccine that can prevent the infection.

Once a vaccine is available to the general public, how do we continue to make sure it is safe?

In the United States, we have incredible systems to track vaccine safety. One system allows everybody to report if they’ve had an adverse event—a bad side effect—after they get a vaccine. That’s not just doctors and nurses; it’s anybody in the public who may have received the vaccine. A group of scientists, working through the U.S. Centers for Disease Control and Prevention (CDC), investigate all of those cases to see if there’s a potential problem. Other systems look at big databases and compare people who have gotten the vaccine to people who didn’t get the vaccine, and look for potential side effects or adverse events, really rare things. They compare the rate in the group who get the vaccine to the group who did not get the vaccine to see if there is a cause between the vaccine and that rare side effect. With all these systems in place, I’m comfortable giving vaccines to my patients, and to my children, because I know that these systems work.

What You Need to Know About COVID-19 Vaccines

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.

How to Safely Celebrate With Family This Holiday Season

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. 

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.

How to Manage Migraines During Stressful Situations

Migraine headaches can be debilitating, and undue stress can exacerbate the condition, creating new problems. Lauren R. Natbony, MD, a headache specialist at the Mount Sinai Center for Headache and Facial Pain and an Assistant Professor of Neurology at the Icahn School of Medicine at Mount Sinai, provides some suggestions for how to manage your headaches when life gets stressful.

What’s the difference between a migraine and a regular headache?

Headache is a catchall term for any type of pain in the head. Almost everyone has experienced a headache in his or her life. Migraine, however, is more than just a headache. It is a chronic and disabling neurologic disease that affects the way the brain processes pain. Headache is only one symptom of migraine and typically presents with moderate to severe pain on one side of the head. The pain tends to have a pounding or throbbing quality and it often gets worse with movement. Other symptoms include sensitivity to light, sound or smells, nausea and vomiting. Some people may also see spots or flashing lights in their vision. We think that migraine is likely genetic, meaning that it runs in families and is inherited.

How does stress affect migraine sufferers?

Stress can cause migraine and migraine can cause stress. Since they both feed each other, it can turn into an endless cycle. Stress causes various chemical and hormonal changes in the body. In some people, these changes can trigger a migraine. And, if your body is accustomed to daily stress, a day without stress—like a weekend or special event—can result in a letdown migraine. This can be a real bummer and can ruin any attempt to unwind.

How should migraine patients cope with unexpected stressors?

The COVID-19 pandemic is a great example of an abrupt, unexpected stressor and a change from normalcy. First, it is important to recognize that the migraine brain is very sensitive to change. Thus, keeping a consistent schedule every day to minimize change is crucial for migraine sufferers. Multiple lifestyle modifications can also help the brain cope better with stress.

What can patients do to help manage their migraines?

First, establish a sleep routine, as sleep is essential for brain health. Try to go to bed at the same time every night and wake up at the same time every morning. While it can be difficult to get good quality sleep during stressful times, it’s something that should be prioritized for everyone—especially migraine sufferers. It is also important to have a morning routine, whether it’s going outside for some fresh air after waking, talking on the phone to a loved one, or drinking a hot beverage while reading the newspaper.

You should also eat something rich in protein within 30 to 60 minutes of waking up. Throughout the day, eat healthy, nutritious meals with plenty of fruits, vegetables, and protein. Try to eat something with protein every three to four hours. Protein helps to stabilize blood sugar levels, and abrupt changes in these levels can trigger migraine. Also, be sure to stay hydrated by drinking at least 64 ounces of water a day.

Another thing that can be helpful is exercise, which is a great stress reliever. Engaging in regular physical activity—ideally at least 30 minutes, five days a week—will help reduce stress not only in the moment but also over time. Relaxation techniques like yoga and meditation are also helpful and have evidence for benefit in migraine

Do I need to schedule an office visit with a headache specialist or are video visits just as worthwhile?

Video visits are a great option for those with migraine and headaches. The fact is, patients with migraine do not love coming into the office. Travel to the office itself can be a stressor. Likewise, the office can seem bright and noisy and trigger a migraine for some.

Seeing patients in their own space is extremely helpful. For example, I have patients who do not know all the medications they are taking. During video visits, I have them walk over to their medicine cabinets and show me the bottles. We review the medications—and their doses—and I can give them much better advice. I also have patients who will tell me they do not have space to exercise. During video visits, I can see their home and together we can carve out a space for exercise. I can also suggest different lifestyle techniques based on their living environment to improve headaches.

Why see a specialist?

It’s important that migraine sufferers work with doctors who understand the condition. There are many treatments available, but treatments should be tailored to each patient’s lifestyle and health concerns. I aim to help my patients control their headaches, especially during stressful life events.

At the Mount Sinai Center for Headache and Facial Pain, we understand what you are going through and are committed to working with you to get you the relief you need.

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

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.

Is It Safe to Seek Screening and Treatment for Breast Cancer During the Pandemic?

Managing breast cancer screening and treatment can be worrisome in the best of times. During the COVID-19 pandemic, you may be even more uncertain. Elisa Port, MD, Director of the Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai, answers some of your questions.

I’m due for my annual mammogram but I’m scared of getting COVID-19. Should I delay until there’s a vaccine?

At the height of the pandemic in New York City, we were not recommending women come in for screenings. We asked women seeking elective care and routine follow-up appointments to wait. But the number of cases in New York has dropped dramatically, and we have instituted stringent protocols making our hospitals and medical facilities extremely safe. We hope everyone will get back on track with routine screening tests, including mammograms.

I feel a lump in my breast. Should I get it checked out or wait and hope it goes away?

Any woman who thinks she might have a lump in her breast should get it checked out. While many lumps are benign, women of all ages and backgrounds can get breast cancer. It’s important not to dismiss your concern and assume a lump will go away. I recommend that you make an appointment with your primary care physician to receive a full evaluation. Your doctor might perform a physical exam and order imaging tests such as mammograms or ultrasounds or even a biopsy.     

I successfully completed my breast cancer treatment. Am I immunocompromised and at increased risk of developing COVID-19?  

A history of breast cancer does not increase your risk of contracting COVID-19 and neither does receiving cancer treatment—including hormonal therapies and other medications. However, women who are actively receiving chemotherapy and who are immunocompromised, may be at higher risk. The signs of COVID-19 are generally the same for breast cancer patient as they for anyone else. At Mount Sinai, we screen everyone coming into our facilities for issues such as fever, cough, and travel from an area with a high positivity rate (“red zone”).

I’m feeling stressed because of the pandemic. Do you have any suggestions on how to cope?

Stress management is very personal. Coping mechanisms, too, are very personal. The most important thing is to make sure that you don’t spiral into negative behaviors, such as overeating or drinking too much. Try to find healthy outlets for your stress. That can include physical activities like walking your dog or exercising; social activities such as spending time with friends and family; or doing things that bring you joy, like reading, listening to music, or playing a musical instrument. For more on how to cope during the COVID-19 pandemic, read this article on resiliency featuring Rachel Yehuda, PhD, Professor of Psychiatry and Neuroscience at the Icahn School of Medicine at Mount Sinai.

Do you have any other thoughts about breast health?

Remember that breast cancer is an extremely treatable and curable cancer—and early detection and diagnosis are key to successful treatment. The best way to find a cancer early is by getting regular screenings. Starting treatment when a cancer is in the early stages is most effective as it can also mean using less aggressive treatment.

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