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Vaccines, Variants, and Measured Expectations—A Question and Answer Session with Judith A. Aberg, MD, a Leader in Infectious Diseases at Mount Sinai

Updated on Jun 30, 2022 | COVID-19, Featured, Vaccines

Judith A. Aberg, MD

Several worrisome new variants of SARS-CoV-2, the virus that causes COVID-19, have been detected within the United States since the COVID-19 vaccine rollout began in December, raising concerns about the nation’s ability to return to normal in 2021. Chief among these concerns is whether the national effort to vaccinate as many Americans as possible—and as quickly as possible—will be able to offset the virus’s enhanced ability to spread. At the heart of that question lies another: Will the authorized vaccines from Moderna, Inc., Pfizer/BioNTech, and Johnson & Johnson offer adequate protection against these new variants?

To answer these questions and more, Mount Sinai Today recently turned to Judith A. Aberg, MD, Dean of System Operations for Clinical Sciences, and Chief of the Division of Infectious Diseases, at the Icahn School of Medicine at Mount Sinai. Dr. Aberg, the Dr. George Baehr Professor of Clinical Medicine, leads the Mount Sinai Health System’s COVID-19 treatment and vaccine clinical trial efforts.

“We have to be clear that we are in unknown territory,” she says. “Every day we are learning something new. Individuals must have a realistic view of the immediate future and continue doing what we know works best: get vaccinated, wear masks, and practice social distancing—even after they are fully vaccinated.”

Do the vaccines from Moderna and Pfizer/BioNTech protect us from the new variants?

Dr. Aberg: At this time no one has sufficient data to really provide us with a definitive answer. We have indications from both Moderna and Pfizer/BioNTech that their vaccines produce enough effective antibodies to overcome the variants, but people may still become mildly ill from the variants although not severely ill. Both companies have also mentioned they are looking into making modifications to their vaccines, so there is the likelihood we will see them introduce booster shots in the coming months that may be more effective against new variants.

How effective is the Johnson & Johnson (J&J) vaccine that was just authorized by the Food and Drug Administration?

Dr. Aberg: I am very encouraged about the J&J vaccine, which is a single dose. We ran clinical trials at two of our hospitals, Mount Sinai Queens and Mount Sinai Brooklyn. In the United States, J&J found the vaccine was 72 percent effective. When they tested it in Brazil and South Africa—where new variants are widely circulating—the company found there were no deaths and it prevented people from developing severe disease. J&J is also looking into creating a booster dose and I imagine it will be very beneficial.

Will these variants prevent us from beating this pandemic?

Dr. Aberg: I suspect there are going to be more variants and we’re going to have to deal with them. Viruses want to live and they keep reproducing and mutating—whether it’s the human immunodeficiency virus (HIV), which causes AIDS, or the influenza virus, which develops different strains. Each year when I get the flu vaccine I hope that I won’t get the flu. There is still a chance, but the flu vaccine probably prevents me from developing a severe case.

With SARS-CoV-2, which causes COVID-19, you have variants. And until we have more data on vaccine durability and efficacy against the variants we’re going to have to do what we’re doing now. Vaccinated individuals should still follow safe practices but can feel some reassurance. And for those who aren’t yet vaccinated, don’t delay in getting whichever vaccine becomes available to you.

Is it okay to mix vaccines for the first and second doses or take more than one vaccine?

Dr. Aberg: Do not mix vaccines. Finish two doses of the same vaccine or, for Johnson & Johnson, take only the single dose. We do not know if the antibody response you get to one vaccine will impair your immune response to the other vaccine. Each vaccine, even Moderna’s and Pfizer/BioNTech’s, which are based on the same mRNA technology, is different enough.

Should vaccinated individuals test their antibody levels to make sure they are protected?

Dr. Aberg: No, we do not advise this. It is not informative. First, the vast majority of commercial antibody tests do not measure the antibodies you get from vaccines—they measure the antibodies you get from having COVID-19. These commercial serology results are not designed to detect immune response to the vaccine. There are tests that look for antibodies against the N protein or nucleocapsid. This is not coded for by the vaccine and will only inform about prior infection—nothing about your response to the vaccine. Second, the vaccine manufacturers have not reported what the antibody levels should be if you were to get a test that detects the S protein or spike, which is what the vaccines make antibodies against. We only know that people who were vaccinated had tremendous efficacy against getting COVID-19, and it may be irrespective of what their antibody levels are. There is more to immunity than just antibody production.

Do you recommend COVID-19 vaccinations for individuals who are immune-compromised?

Dr. Aberg: We do not have enough data to tell patients with compromised immune systems or who are on chemotherapies whether or not the vaccines are going to be effective for them. We are not saying they shouldn’t get vaccinated, we just don’t have enough data to determine how much protection they would receive. At Mount Sinai, we are involved in clinical testing of a hyperimmune globulin therapy—a purified, highly concentrated product of antibodies derived from antibody-rich plasma of people who have been infected by COVID-19 and recovered—which may benefit this population whose immune systems are impaired and cannot produce antibodies.

What is your advice for individuals who have been fully vaccinated?

Dr. Aberg: These vaccines are a very important part of our prevention toolbox. We cannot rely on just one thing. We don’t want to set expectations that you’re not going to get COVID-19, but the vaccines decrease your chances of getting really sick or being hospitalized. So until the virus is under better control and we do not see such a high incidence anymore, we still need to be careful. Don’t engage in magical thinking. I hear people say, “Now that I’m vaccinated I can go and do this and that.” And I say, “No, not really.” Everything in moderation.

Mount Sinai Researchers Report Significant Secondhand Marijuana Smoke Exposure In New York City Apartments

Updated on Jun 30, 2022 | Featured, Your Health

Mount Sinai researchers have raised concerns about significant exposure to marijuana secondhand smoke in New York City apartments.

Data from a new study suggesting nearly one third of families smell marijuana smoke when their children are present raises concerns about the potential impact of legalized marijuana on vulnerable populations, particularly children, according to the researchers.

The researchers described their findings in a study published recently in Academic Pediatrics. The study looked at secondhand smoke and thirdhand smoke—the particles from secondhand smoke that settle on furniture, carpets, and clothing—in multi-unit households, typically apartment buildings.

The lead author of the study is Lodoe Sangmo, a fourth year medical student at the Icahn School of Medicine at Mount Sinai who will graduate in May with Distinction in Research. Karen Wilson, MD, MPH, the Debra and Leon Black Division Chief of General Pediatrics at Icahn Mount Sinai, is the senior author on the study and an international expert on secondhand and thirdhand smoke exposure—what researchers call “incursions.” Dr. Wilson led an investigation in 2018 that found high levels of marijuana metabolite tetrahydrocannabinol carboxylic acid in the urine of young children whose parents also smoked tobacco. That study was published in Pediatrics.

Karen Wilson, MD, MPH

Researchers say the new study of families living in multi-unit housing in New York City builds on these earlier findings, suggesting that regulators take a close look at the impact on children when considering marijuana legalization.

“As we move towards the legalization of recreational marijuana in New York State, this study serves as a warning that our most vulnerable patient populations who live in multi-use housing will likely experience much higher levels of smoke incursions unless we are intentional about regulating exposure, particularly among children,” says Dr. Wilson, who is also Vice Chair for Clinical and Translational Research for the Jack and Lucy Clark Department of Pediatrics at Icahn Mount Sinai. Dr. Wilson notes that while most states with legal marijuana use restrict its use in public indoor and outdoor spaces, they do not have any restrictions on combustible marijuana use in the presence of children.

For their study, the researchers surveyed parents at four pediatric practices in the Mount Sinai Health System, collecting a total of 382 surveys between September 2018 and December 2019.

Parents were asked, “Do you ever smell marijuana smoke in your room/apartment/ condominium coming from another apartment, when you are with your child?” and “Do you ever smell marijuana smoke in common areas such as the hallway or stairwell, when you are with your child?”

Almost one third (30.6 percent) of participants reported both secondhand and thirdhand smoke, while 47.9 percent had neither incursion, with the remaining 21 percent reporting one or the other incursion.

Participants who identified as non-Hispanic black or Hispanic were more likely to report smelling secondhand smoke than non-Hispanic white participants, a finding that is consistent with disparities in secondhand smoke exposure, caused in part by unequal access and enforcement of comprehensive smoke-free policies within multi-unit housing, according to the researchers.

“In light of these findings, we hope to see the expansion of current policies that solely restrict tobacco smoke to include restrictions on marijuana smoke in order to mitigate disparities and protect vulnerable populations exposed to dual smoke exposure,” says Dr. Wilson.

The study was funded by the Children’s Center Foundation Board of Directors of the Mount Sinai Kravis Children’s Hospital at Icahn Mount Sinai.

According to Dr. Wilson, who chairs the American Academy of Pediatrics Tobacco Consortium, while many states have moved ahead with legalization efforts, research on the effects of secondhand marijuana smoke is still in its infancy.

“We do know that prenatal exposure to marijuana smoke affects brain development and behavior but we don’t know about post-natal impacts, nor about the long-term health effects. We know much more about the detrimental effects of tobacco smoke on children’s health,” says Dr. Wilson. “Studies have linked even low levels of cotinine, a biological marker of secondhand tobacco smoke, with decreased scores on cognitive testing, and asthma. Theoretically, that could suggest that low levels of marijuana could potentially be damaging to the brains and lungs of children.”

Young, Asymptomatic People Can Get Reinfected With COVID-19 and Spread it More Than Once, Study Shows

Updated on Jun 30, 2022 | COVID-19, Featured, Research

A prospective study of 3,249 Marine recruits—who were mostly male and between the ages of 18 and 20—shows a significant risk of reinfection among those who have antibodies to SARS-CoV-2, the virus that leads to COVID-19.

The study, posted on MedRxiv, was led by researchers at the Icahn School of Medicine at Mount Sinai working with the Naval Medical Research Center. It found that the risk of reinfection in those with antibodies was 18 percent of the risk of infection in those without antibodies. Most of the reinfected Marines were asymptomatic, and none required hospitalization. The infections were detected by PCR tests.

The findings support the importance of vaccinating all segments of the population, including individuals who have SARS-CoV-2 antibodies but were never actually diagnosed with COVID-19, and those who were diagnosed, recovered, and think they are now safe from another infection. The study also points to the fact that young people, who are typically asymptomatic, may unknowingly spread the disease to others more than once.

“It is important that we don’t neglect this college-age group of the population,” says the study’s lead author, Stuart Sealfon, MD, the Sara B. and Seth M. Glickenhaus Professor of Neurology, Neuroscience, and Pharmacology and Systems Therapeutics at Icahn Mount Sinai. “They are such an important group in spreading the disease. Many young people have this ‘get it and get over it mentality’ and unfortunately they still have a surprisingly high risk of recontracting it and possibly spreading the virus to others.”

The six-week study was highly controlled. It involved two separate periods of quarantine and multiple tests for COVID-19 before the recruits entered basic training at Marine Corps Recruit Depot, Parris Island, in South Carolina. The study found that among those with antibodies, the reinfected individuals had lower antibody levels and more often lacked detectable levels of the virus-neutralizing antibody activity that blocks infection.

According to Dr. Sealfon, the findings should help resolve any concerns over whether people who have already had COVID-19 should receive the vaccine, particularly in light of current vaccine shortages.

Stuart Sealfon, MD,

“That’s an important take-home message,” says Dr. Sealfon. “Certainly we can show from this study that there’s a fairly high risk of reinfection and not everybody who has had infection will generate effective immunity. So you really want to vaccinate everyone and not worry if they’ve had it or not.”

Why some people fail to generate persistent immunity against reinfection from COVID-19 remains unknown. But highly variable responses to any disease are actually beneficial for evolution.

“When a new disease shows up, individual immune responses are variable to ensure survival at a population level,” says Dr. Sealfon. “People have different genetics that make up their immune systems. They have different previous exposure histories that train the immune system in how to respond to new infections. Immunity uses combinatorial systems to hedge its bets to try and generate the best response it can within an individual and to vary what’s happening across individuals. As a result of individual differences, some people generate more effective long-term immune responses than others.”

In the November 11, 2020, issue of The New England Journal of Medicine, Dr. Sealfon published an earlier study of these marine recruits during their initial supervised quarantine period. He showed that strict public health measures including wearing face masks, social distancing, hand washing, and widespread testing did not completely suppress transmission of SARS-CoV-2.

Why the New Johnson & Johnson Vaccine Will Help Lead to the End of the Pandemic

Updated on Jun 30, 2022 | COVID-19, Featured, Vaccines

With the authorization of Johnson & Johnson’s new COVID-19 vaccine and its encouraging data, you might be wondering how it stacks up against the Pfizer-BioNTech and Moderna vaccines.

Mount Sinai infectious diseases experts participated in the clinical trials for Johnson & Johnson’s one-dose vaccine and are excited about its effectiveness against moderate and severe COVID-19. What is most remarkable is that 28 days after a single dose, no vaccine recipient had been hospitalized for COVID-19 or died from COVID-19. And, protection increased over time: 49 days after that single dose, there were no cases of severe COVID-19 among the recipients.

This protection was consistent among all age groups. The emergency use authorization of this vaccine by the U.S. Food and Drug Administration allows for increased supply and access to vaccine and will help turn COVID-19 into a controllable and much less dangerous disease.

Update: Is the Johnson & Johnson vaccine currently authorized for use? The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration paused distribution of the Johnson & Johnson COVID-19 vaccine to review isolated instances of people developing blood clots after receiving the vaccine. After reviewing the data, the CDC lifted the pause. The vaccine may now be used for all patients 18 and over in the United States, but will carry a warning label about rare blood clotting events. For more information from Mount Sinai, see our fact sheet.

Dana Mazo, MD, MSc

In this Q&A, Dana Mazo, MD, MSc, Assistant Professor of Medicine (Infectious Diseases) at the Icahn School of Medicine at Mount Sinai, explains why this new vaccine’s ability to prevent hospitalizations and serious illness is so significant, and why this represents a potential game changer that can help lead to the end of the pandemic. Dr. Mazo, the Hospital Epidemiologist at Mount Sinai Queens, is also lead investigator of the Mount Sinai Queens COVID-19 clinical trials unit, which is a Johnson & Johnson COVID-19 vaccine trial site.

What does the data tell us about this new Johnson & Johnson vaccine?

The trials are ongoing, but the preliminary data is very exciting and shows really good protection against sickness severe enough to lead to hospitalization or death. The real excitement is that at 28 days after participants received the vaccine, there were no COVID-19-related hospital admissions or COVID-19 deaths.

How effective is the new vaccine from Johnson & Johnson?

In the United States, the vaccine had an efficacy of 72 percent against moderate and severe COVID-19, which is really impressive. That means the people who received the vaccine were 72 percent less likely to get moderate or severe disease. In all regions studied, the vaccine was 85 percent effective at preventing severe disease, and no one who received the vaccine needed to be hospitalized for COVID-19 or died related to COVID-19.

Some reports say this vaccine is less effective than others. Is that true, and is that important?

This is an important question that I get asked a lot. One of the differences with the Johnson & Johnson vaccine is that our trial was more recent, so the data we released is from this winter when we’re seeing more COVID-19 cases and new variants.

Looking at other countries, the Johnson & Johnson vaccine had lower efficacy in South America of 66 percent and South Africa of 57 percent, so the overall efficacy around the world was 66 percent.

It’s very important that the Johnson & Johnson trials included sites in eight countries, including sites in both South Africa and South America where new variants of SARS-CoV-2 are circulating. Even though the protection was not as high for those variants, it was still good protection at greater than 50 percent and there were no hospitalizations or deaths from COVID-19. That is really good news especially because we are concerned about these new variants. This is a huge piece of information we have for this vaccine that isn’t known for other vaccines, trials which were performed earlier in the pandemic so did not include communities where these highly transmissible variants were prevalent.

The Johnson & Johnson trial also included different racial and ethnic groups in the United States: 15 percent of trial participants identified as Hispanic and/or Latinx and 13 percent as Black/African American.

Another key aspect of the Johnson & Johnson vaccine is that it is only one dose. Other vaccines have released higher efficacy data at 90 percent or more, but that’s after two doses. The Johnson & Johnson vaccine has 72 percent efficacy after one. This is a huge benefit and has the potential to be a real game changer in our fight against the pandemic.

How does this vaccine compare with the other two vaccines? Is it better?

Each of the vaccines has pros and cons. The fact that the Johnson & Johnson vaccine is one dose is a real benefit because it allows more people to get full protection. Logistically it can be very hard for people to come back for the second dose required by other vaccines.

In addition, this vaccine is much easier to store and transport. Some of the other vaccines require ultra-cold storage, which is not possible for many places. This vaccine could be administered at a doctor’s office or community health fairs.

With one dose you may also have a lower risk of side effects, as opposed to two doses which present two opportunities for side effects. From the data already released, the Johnson & Johnson vaccine seems very well tolerated. Only nine percent of people reported fever after vaccination and 0.2 percent reported fevers bad enough to interfere with daily activities.

Does it matter which vaccine I get?

The first vaccine that you are able to get is what you should get. All these vaccines offer really good protection against severe COVID-19 disease, hospitalizations, and deaths. So just get the first vaccine that’s offered to you.

You were involved in the clinical trial. What did Mount Sinai do and why is that important?

There was a site at Mount Sinai Queens where I was the lead investigator, and there was a site at Mount Sinai Brooklyn. We recruited members of our community who were interested in taking part in a trial of an investigational vaccine and consented to participate knowing that they would either receive an injection of placebo (salt water) or the Johnson & Johnson vaccine. They then were asked twice a week if they had symptoms, and if anyone reported symptoms, we tested them to see if they had COVID-19.

Conducting clinical trials at Mount Sinai Queens and Mount Sinai Brooklyn opens up clinical research to our communities. We are located in areas that were hard hit by COVID-19, and in Queens we are near some of the most diverse neighborhoods in the world. We need to ensure that communities that were especially affected by COVID-19 have the opportunity to participate in trials and that a broad representation of people in the United States who could benefit from these treatments are included in the trials. We’re very happy to say that by having a site in Queens, we were able to include a diverse population.

Researchers Identify a Promising New Antiviral Drug to Treat COVID-19

Updated on Jun 30, 2022 | COVID-19, Featured, Research

Plitidepsin is derived from Aplidium albicans, a marine organism that typically attaches itself to hard surfaces, such as reefs.

The search for better medical treatments for COVID-19 has led a team of scientists from the Icahn School of Medicine at Mount Sinai, with colleagues in San Francisco, to plitidepsin—a promising small molecule drug derived from a sea organism. When tested in human lung cells, plitidepsin was particularly effective in stopping the replication of SARS-CoV-2, the virus that causes COVID-19. In fact, in pre-clinical trials, plitidepsin was 28-fold more effective than remdesivir—the only antiviral drug currently approved by the U.S. Food and Drug Association (FDA) to treat COVID-19.

Kris M. White, PhD

The research team from Mount Sinai and the University of California at San Francisco recently published their work in Science, revealing one of the most promising efforts to date in identifying an already approved drug that could be successfully repurposed to fight COVID-19. Plitidepsin is approved in Australia—under the name Aplidin—as a treatment for multiple myeloma, a cancer that forms in a group of white blood cells.

One of plitidepsin’s strengths is that it inhibits eEF1A, a host protein within human cells that every variant of SARS-CoV-2 needs to survive. Viruses hijack a human’s cellular machinery in order to thrive and create more copies of themselves, but plitidepsin works by blocking an important pathway that would be used by SARS-CoV-2, its variants, and potentially other respiratory diseases such as respiratory syncytial virus and influenza. In a separate preliminary study in bioRxiv, the research team, and a group of colleagues in England, showed that plitidepsin was effective against b.1.1.7, the newly identified British variant of SARS-CoV-2.

“Aplidin is quite unique in its potency,” says one of the study’s corresponding authors, Kris M. White, PhD, Assistant Professor of Microbiology, and a member of the Global Health and Emerging Pathogens Institute at the Icahn School of Medicine. “It is likely going to be able to work against any variant of SARS-CoV-2 and other coronaviruses, including new pandemics that might happen in the future. eEF1A appears to be a broadly used protein for viruses because it has an important role in protein production, making it important for the host cell and also extremely important for the virus. Now we’re looking to test plitidepsin against these other viruses as well.”

Corresponding study author Adolfo García-Sastre, PhD, Professor of Microbiology and Director of the Emerging Pathogens Institute at the Icahn School of Medicine, says, “The ongoing pandemic created the immediate need for us to find antiviral therapeutics that could be moved into the clinic. This led us to screen clinically approved drugs with established data and safety profiles. We found that plitidepsin was a very promising therapeutic candidate.”

Adolfo García-Sastre, PhD

The decision to pursue plitidepsin resulted from research the team conducted last spring, when they identified 332 different host proteins that SARS-CoV-2 interacted with. The scientists looked to see which ones had FDA-approved drugs that targeted the host protein for cancer or other diseases and began following a trail that ultimately led them to Aplidin. Within a week after publishing their work in Nature, the researchers were contacted by PharmaMar, the drug’s small Madrid-based manufacturer.

In October, PharmaMar released the results of a phase 1,2 clinical trial of Aplidin for use against COVID-19, which showed the drug was safe and effective in helping hospitalized patients recover from the disease. By day seven after taking Aplidin, the patients’ viral load was reduced by 50 percent, and by day 15, viral load was reduced by 70 percent. More than 80 percent of patients had been discharged from the hospital on or before day 15.

The results of the clinical trial also confirmed the tolerability of Aplidin for patients with COVID-19. Tolerability had already been observed in studies of approximately 1,300 cancer patients who actually received higher doses of Aplidin than the COVID-19 patients. PharmaMar is currently establishing phase 3 clinical trials.

“The data has shown that it’s worth trying the drug in a phase 3 clinical trial,” says Dr. White. “There’s a good chance we might see efficacy and that it will be well tolerated by the patients at certain doses.” Like remdesivir, plitidepsin would be given intravenously in a hospital setting.

The researchers have proposed that the drug be tested for use alongside remdesivir and also dexamethasone, an anti-inflammatory authorized for use in severely ill COVID-19 patients. As with other antiviral drugs, plitidepsin would work only if given early in the disease cycle, in the active viral replication stage of COVID-19.

Sixth Annual Mount Sinai Innovation Awards

Updated on Jun 30, 2022 | Community, COVID-19, Featured, Research

The Inventor of the Year team conducted research that led to diagnostic tests for antibodies to COVID-19. (Standing) Florian Krammer, PhD, PhD, Professor of Microbiology, left, and Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine. (Seated, from left) Daniel Stadlbauer, PhD, Postdoctoral Fellow; Fatima Amanat, Graduate Assistant; Adolfo Firpo-Betancourt, MD, Professor of Pathology, Molecular and Cell Based Medicine; Viviana Simon, MD, PhD, Professor of Microbiology; Ania Wajnberg, MD, Associate Professor of Medicine; and Damodara Rao Mendu, PhD, Director of Chemistry Laboratories, Department of Pathology, Molecular and Cell-Based Medicine.

Individuals and teams from the Mount Sinai Health System were honored for advances in biomedical research, technology, and medicine at the sixth annual Mount Sinai Innovation Awards ceremony, a virtual event held Tuesday, December 8, 2020.

Mount Sinai Innovation Partners (MSIP) presented the award for Inventor of the Year to an eight-member team led by renowned virologists and pathologists, whose efforts led to the development of multiple diagnostic tests for the detection of antibodies against the COVID-19 spike protein—the principal target of neutralizing antibodies.

The Innovation Award s also honored winners of the Faculty Idea Prize, the 4D Technology Development Award; the KiiLN Postdoctoral Entrepreneurship Award; and the Trainee Innovation Idea Award.

The event, which can be viewed here, was hosted by: SINAInnovations, MSIP, the Office of Faculty Development, the Graduate School of Biomedical Sciences, the Department of Medical Education, the Office of Postdoctoral Affairs, the Graduate Medical Education Office, and the Keystone for Incubating Innovation for Life Sciences Network (KiiLN).

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