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Esteemed Vaccinologist Weighs in on New Vaccines and the ‘Beginning of the End of the Pandemic’

Nov 17, 2020 | COVID-19, Featured, Research, Vaccines

Florian Krammer, PhD, right, filled out the paperwork needed to participate in Pfizer’s COVID-19 clinical trial and discussed the trial with Judith A. Aberg, MD, left, the Dr. George Baehr Professor of Clinical Medicine, and Chief of the Division of Infectious Diseases for the Mount Sinai Health System.

“Dear world, we have a vaccine!”

Florian Krammer, PhD, Professor of Vaccinology at the Icahn School of Medicine at Mount Sinai recently tweeted this in response to news of the interim results to Pfizer Inc.’s COVID-19 vaccine clinical trial, which showed high efficacy in the final, phase 3 round of human testing. “This is the best news since January 10,” Dr. Krammer added. On that date, China released the genome of SARS-CoV-2, the virus that causes COVID-19. Dr. Krammer’s laboratory at Mount Sinai immediately moved from developing a universal flu vaccine to creating the first test to detect the presence of antibodies to SARS-CoV-2 and the first to measure the amount of antibodies.

By November 17, Pfizer had updated its phase 3 results to report that its vaccine was 95 percent effective against COVID-19, across age, gender, race, and ethnicity demographics. Only one day earlier, Moderna Inc. confirmed that its COVID-19 vaccine candidate had a very high efficacy rate in its first interim analysis of its phase 3 study, prompting Dr. Krammer to tweet, “Dear world, we have a second vaccine.”

Both the Pfizer and Moderna vaccines are based on new RNA technology. Rather than containing pieces of an actual virus, as traditional vaccines do, these vaccines contain molecular instructions in the form of messenger RNA (mRNA) that tell human cells to make the virus’s spike protein, the immune system’s key target for the virus. If all goes well, the patient’s immune system will react by making antibodies to the spike protein—and these antibodies will also latch on to the spike protein of the real virus and disable the virus.

“This is the beginning of the end of the pandemic,” says Dr. Krammer. But important questions concerning COVID-19 vaccines still remain. This fall, he volunteered to take part in the Pfizer COVID-19 vaccine clinical trial under way at Mount Sinai and other locations in the United States and abroad. Like the other 43,538 trial participants, Dr. Krammer does not know whether he received a placebo or the real vaccine, which is how the placebo-controlled, randomized, observer-blinded vaccine trial is designed.

Mount Sinai Today recently asked Dr. Krammer to explain Pfizer’s phase 3 vaccine results.

Why are you enthusiastic about the Pfizer vaccine?

The results from the phase 3 trial have to be seen in the context of preclinical data, phase 1 and phase 2 trials, where Pfizer showed the vaccine worked in nonhuman primates. Also, in early clinical trials the vaccine induced good neutralizing antibody responses. Now, in addition to that, we get efficacy results—reduction of the incidence of disease in the vaccinated group—that are in the 95 percent range. Ninety-five percent is pretty good. Even a vaccine that affords 50 percent protection against severe disease would be positive news.

What questions do you have concerning the Pfizer vaccine?

Right now, Pfizer is reporting that the vaccine has 95 percent efficacy against symptomatic disease. That will likely protect at-risk individuals from severe disease outcomes. But we still don’t know if the vaccine can protect from asymptomatic infection. If it doesn’t, would it stop vaccinated individuals from spreading the virus to others? It will be difficult to determine if the Pfizer vaccine can achieve this, because it would involve routinely testing trial participants for the presence of virus, and you can’t do that with almost 45,000 people. Also, how long-lasting will the protection be? In other words, will the vaccine’s efficacy decrease over time, requiring people to get revaccinated?

Do Pfizer’s interim results bode well for other COVID-19 vaccines in the pipeline?

This is looking good for many of the other vaccine candidates. The fact that Pfizer’s vaccine is based on inducing neutralizing antibodies that protect from symptomatic infection might mean that many other vaccines are likely to work as well. Moderna’s vaccine is almost identical in terms of the immune response. Others are similar too.

What are Pfizer’s next steps?

Now that Pfizer has filed an Emergency Use Authorization application with the U.S. Food and Drug Administration (FDA) and the FDA has authorized the emergency use of the vaccine, it is likely that the vaccine will only be available for high-risk groups and front-line workers at first. Over time more people will get vaccinated but this will take months. Now, while we wait for the vaccine, we must keep the virus circulation down. Mask up, physically distance, and stick to guidelines and regulations.

Do any of these concerns dampen your enthusiasm for the vaccine?

No. From my point of view there is a light at the end of the tunnel. Right now, we need a vaccine that works, even if it would only protect for a few months or doesn’t completely stop transmission. That’s what we need to get halfway back to normal. We’ve been in this for 10 months. We can do it for a few more. We have to be patient.

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.

Get more COVID-19 vaccination information from Mount Sinai

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.

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.

Rock Garden of Hope at Mount Sinai Queens Grew From Nurse’s Inspiration

Oct 29, 2020 | Community, Featured

The Rock Garden of Hope is a homegrown memorial at Mount Sinai Queens for those lost to COVID-19. At the ribbon-cutting, from left, Chaplain Rachelle Zazzu; Fionnuala Quigley, RN, who originated the project; and another organizer, Diane Lydon.

Mount Sinai Queens (MSQ) recently dedicated the Rock Garden of Hope near its Emergency Department to remember those lost to COVID-19. It is a small tribute—a bed of painted rocks surrounded by a low iron fence—but it is heartfelt.

Staff members for months have been painting river rocks with flowers, hearts, smiles, and messages such as “Here Comes the Sun” and “You Are Loved.” But it all started in June with one nurse, Fionnuala Quigley, RN. She grew up in the neighborhood and worked in the Emergency Department at MSQ throughout the pandemic, and she has vivid memories of those days and of the trailers that held many who had passed away. Every day, she walked past the spot where the trailers had stood, and finally, she says, “I just wanted to change the perspective of what was once there into something happy.”

Ms. Quigley picked out a bare plot and cleared it of debris. Then she started decorating rocks with acrylic markers and placing them on the ground in a makeshift memorial. At that point, she asked the hospital chaplain, the Rev. Dr. Rachelle Zazzu, MA, DDS, to seek official permission for the project and help reach out to volunteers. The idea quickly took hold. Ms. Quigley says Donna Smith Jordan, Assistant Director of Emergency Medicine, and Jeofrey Gacad, unit clerk in the ED, were instrumental in spreading the word. Most of the rocks are supplied by Diane Lydon, unit clerk in the ED, who brings them back from the Neversink River in the Catskills.

“Donna, Fionnuala, and Jeofrey also hosted a few painting sessions in the ED during break hours,” says Jonathan Nover, RN, MBA, Senior Director of Nursing for the Emergency Department. “This has been very therapeutic for all.” Fully embracing the project, the hospital installed a fence, lights, and a small plaque at the garden plot, and held a ribbon-cutting on Friday, Oct. 2.

“All are welcome to bring a rock to the garden to remember someone who has passed or leave a message of optimism for the future,” Caryn A. Schwab, Executive Director of Mount Sinai Queens, and Jill Goldstein, MA, MS, RN, Deputy Chief Nursing Officer, said in a message announcing the event.

The Rock Garden of Hope is growing bit by bit as staff and neighbors continue to paint and place rocks. (View some of them on an Instagram page, Emergency Rocks.) Ms. Quigley says that at first some were worried that people might take rocks from the garden, but none have disappeared since the commemorative sign went up. And she is philosophical on this point: “I think if someone takes a rock, they needed it.

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