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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.”

Athlete Finds a Team to Help Her Beat Multiple Sclerosis

May 4, 2021 | Featured, Patient Stories

“Ten years ago I thought my life was over. I did not think I could find the right partner or even have children. Being a part of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai has helped me and my family so much.” — Jessica March

In 2009, when Jessica March was 29 years old, she began experiencing tingling in her toes and blurry vision. She was an athlete, and thought she was training too much for a 100-mile bike ride.

“You find all these excuses,” she said. “I remember waking up one morning, I opened my eyes, and I was completely paralyzed.” Mrs. March was terrified. “I felt like my body was in a straitjacket,” she said. She panicked and was screaming while pulling herself along the ground. “I didn’t know what was wrong with me, I was crying for days,” she said.

The first doctor she saw was a general neurologist who told her she had fibromyalgia. However, when she got her test results from the hospital, she started doing her own research and suspected multiple sclerosis (MS), a condition she had never heard of prior.

Jessica found a specialist for multiple sclerosis who started treating her for MS. This specialist referred her to Stephen Krieger, MD, Professor of Neurology, at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai. “It’s been over 10 years, and I have never looked back,” she said.

Her diagnosis and treatment started with an MRI and medications. But with Dr. Krieger and the Corinne Goldsmith Dickinson Center, her treatment also emphasized the overall wellness of her life and how to thrive while living with this condition.

“He introduced me to the MS support group, and I was exposed to studies and data showing that people with MS can thrive,” Mrs. March said. In addition to her medications, her treatment includes nutrition, exercise, stress management, and mental health.

“Working with this team, I feel more confident talking to others and helping them,” she said. “I started in this dark place. Ten years ago I thought my life was over. I did not think I could find the right partner or even have children. Being a part of the MS Center has helped me and my family so much.” She is married and has two children.

Why should patients with multiple sclerosis choose Mount Sinai? “This faculty is the best in the world for researching and treating MS,” said Mrs. March, who credits Dr. Krieger, clinical neuropsychologist James Sumowski, PhD, and Ilana Katz-Sand, MD, along with the nurses and fellows, and the entire office staff at the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai.

“Their life mission is to support patients and caregivers,” she says. “It’s not just about a prescription on a prescription pad, it’s about your whole life. This group really cares.”

Mount Sinai Creates First Experimental Personalized Vaccine for a Variety of Cancers

May 3, 2021 | Featured, Research

The image of this Phase 1 trial shows the progress of one patient who began to mount a robust immune response to their cancer six months after receiving the full 10 dose-regimen of Mount Sinai’s experimental cancer vaccine. (T cells are represented by black dots, as seen in the bottom row.)

The first personalized cancer vaccine administered to patients prior to evidence of spread but after surgery or a stem cell transplant, was shown to be safe, well tolerated, and potentially beneficial in preventing disease recurrence in a phase 1 clinical trial at The Tisch Cancer Institute of the Mount Sinai Health System.

The results of the trial were presented virtually, in April, at the American Association for Cancer Research (AACR) Annual Meeting and generated excitement among attendees. It was the first time a personalized vaccine of this sort had been given to patients with a variety of cancers—including lung, breast, ovarian, and head and neck cancers as well as multiple myeloma, a disease of the white blood cells. Prior to receiving the vaccine, the patients either had surgery or an autologous stem cell transplant as a standard-of-care treatment. After an average follow-up of 880 days, 4 of the 13 patients in the trial had no evidence of disease.

Thomas Marron, MD, PhD

“Most of the patients in our study had well over a 50 percent chance of the cancer coming back,” says trial co-leader Thomas Marron, MD, PhD, Assistant Professor of Medicine (Hematology and Medical Oncology), and Director of The Tisch Cancer Institute’s Early Phase Trial Unit. “The No. 1 thing we were interested in was, did we successfully teach the patient’s T cells, their immune cells, what to look out for and what to kill in case there were microscopic pieces of the tumors that remained in the body? Hopefully, if the patient does have residual disease, those T cells can hunt it down and kill it.”

Immunotherapies are usually given after the patient’s cancer has already metastasized or spread to other parts of the body. But Mount Sinai administered its personalized vaccine before there was evidence of spread, so the vaccine could teach the body’s immune cells what to be on the lookout for in case remaining tumor cells were still circulating after surgery or stem cell transplant.

Another unique aspect of the trial was that each patient’s genetic information, including their normal DNA as well as their tumor’s DNA and RNA, were sequenced and run through OpenVax, Mount Sinai’s proprietary, computer program.

OpenVax compared the genetic information from the patient and the tumor to define which mutations, or changes, were unique to the tumor, and then identified 10 “foreign” proteins in each patient’s tumor that the patient would most likely develop an immune response to. A personalized vaccine for each patient was then created from synthetic versions of each of those 10 proteins in Mount Sinai’s Vaccine and Cell Therapy Laboratory, a highly specialized unit that meets the manufacturing standards of the U.S. Food and Drug Administration. The laboratory is run by the trial’s senior leader, Nina Bhardwaj, MD, PhD, Ward-Coleman Chair in Cancer Research, and Director of Immunotherapy at Icahn Mount Sinai.

Since the cost of developing each of these personalized vaccines is extremely high, it is unlikely that there will be a phase 2 of this particular trial, according to Dr. Marron. The goal of the trial “really is about informing future novel therapies,” he says. “Ideally, we will be able to get to the point where we do a biopsy and send it off to a lab and receive a vaccine, but that is very difficult to do now and very expensive. As the technology improves it may become possible.”

Nina Bhardwaj, MD, PhD

During their next phase of research, the Mount Sinai team plans to develop vaccines that can be administered to groups of patients who have the same cancerous mutations, instead of focusing on each patient’s unique DNA.

This research is being informed by Dr. Bhardwaj, who was the senior author of a paper in the December 10, 2020, issue of the journal Cell, which found that similar mutations appeared in a subset of patients with stomach, colon, and endometrial cancers.

“I’m looking forward to creating what we call ‘shared neoantigen vaccines,’” Dr. Marron adds. “This is based on our understanding that certain mutations exist in a high percentage of lung cancers, pancreatic cancers, colon cancers, and other types of cancer. If we were able to make a vaccine that covers, say, 100 different mutations, we would have a vaccine that could help a majority of cancer patients in the world.”

Currently, Dr. Marron and other top researchers at Mount Sinai are making inroads in an area of cancer vaccine development called in situ or “at the site of” vaccines, with at least eight early trials now under way. These vaccines are being administered to patients whose cancerous tumors have metastasized following their first round of standard-of-care treatment, such as surgery, chemotherapy, or radiation. Patients receive an injection directly into one of their tumors of an adjuvant that revs up the immune system, which instructs the immune system to find and kill other pieces of the tumor that may remain in the body.

Compassion and Connection: Caring for Patients in a Time of Need

Updated on Jun 30, 2022 | Community, Featured

Patient Experience Week, observed Monday, April 26, through Friday, April 30, honors the people who improve the patient experience every day and celebrates their accomplishments.

From nurses and physicians to support staff and executive professionals, all Mount Sinai employees are part of the patient experience.

This year Mount Sinai is recognizing how employees connected with patients through compassion during COVID-19. In this video, you can see how in many different ways, teams across many Mount Sinai locations—both clinical and non-clinical, remote and in-person—rose to the occasion, moved past barriers, showed compassion, and innovated to effectively care for patients in a time of need.

Watch Mount Sinai Brooklyn

Watch Mount Sinai West

Watch Mount Sinai Beth Israel

Watch NYEE

Watch Mount Sinai Queens

Mount Sinai Doctors

Mount Sinai South Nassau

Mount Sinai Morningside

The Mount Sinai Hospital