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.

Flowers Help Lift Spirits and Raise Money for a Heartfelt Cause

Elyse Meltzer, CPNP

Elyse Meltzer, CPNP, works in one of the Mount Sinai Health System’s Pediatrics School Based Health Centers. The clinic is located in a New York City public school in East Harlem, where she provides primary care for the students. She has also been involved for many years with the Mount Sinai Perinatal and Pediatric Bereavement Program, which offers bereavement services to families experiencing losses during pregnancy, infancy, or childhood.  The following is an excerpt of a letter that Elyse sent to colleagues about her plan to support the program in a brand new way during these unprecedented times.

“In the early stages of the COVID-19 pandemic, when we were all on ‘lockdown,’ and things were looking grimmer and grimmer, I found my salvation by taking walks, and running in Central Park.  As the typical New Yorker, I was forced to slow down, and something unexpected happened. I began to notice my surroundings and the little things I had been oblivious to for more than two decades as a resident of the Upper West Side.

Spring was rolling in, and along with it, an abundance of beautiful flowers were blooming just outside my front door, often in the most unexpected places.  I didn’t seek them out, but there seemed to be a magnetic force drawing me toward every flower in my path.  I started taking pictures with my iPhone, and before I knew it, I had amassed a huge spring floral collection.

I wanted to share these amazing photos with others, but how? One day while running, I sprouted the idea of showcasing them in a calendar that I would design from the heart.  Then I thought, how great would it be if I could share this with others while raising money for a cause that I’ve been dedicated to for the past fifteen years as a facilitator of the Mount Sinai Perinatal Bereavement Support Group.

I hope that in 2021, you will find the peace, beauty, and happiness I saw during these trying times with each month of the calendar.”

Learn more about the Perinatal Pediatric Bereavement Program here, and learn more about the fund-raiser here.

 

The Mount Sinai Hospital Included in New Ranking of Best Specialized Hospitals from Newsweek

The Mount Sinai Hospital is included in a new ranking from Newsweek of the best specialized hospitals in the world.

The digestive diseases-gastroenterology service line at The Mount Sinai Hospital was ranked No. 2 in the world, behind Mayo Clinic, and Mount Sinai Heart was ranked No. 5 in cardiology, behind Cleveland Clinic, Mayo Clinic, Brigham and Women’s Hospital, and Massachusetts General Hospital. The Mount Sinai Hospital was ranked No. 19 in neurology, No. 26 in oncology, and No. 44 in endocrinology. The full list of best specialized hospitals is available on the Newsweek website.

“The World’s Best Specialized Hospitals 2021” list identifies and honors the best hospitals around the world that specialize in cardiology, gastroenterology, endocrinology, neurology, and oncology.

The rankings include the top 200 hospitals in cardiology, gastroenterology, neurology, and oncology, and the top 100 hospitals in endocrinology. The ranking is based solely on peer recommendations for specific areas of expertise from a global survey of medical professionals.

This is the first of what will be an annual listing. To create the list, Newsweek partnered with Statista Inc., a global market research and consumer data firm. They conducted an online survey of about 40,000 medical experts in more than 20 countries between May and July 2020.

Behind the Scenes With Judith Aberg, MD, a Leader in Mount Sinai’s COVID-19 Response

Judith A. Aberg, MD, is the principal investigator of multiple COVID-19 prevention and treatment trials at the Mount Sinai Health System.

“I did not anticipate how difficult it was—both for me and for the people who were turning to me for answers—to hear myself saying, ‘I just don’t know’ as often as I did during the early days of the pandemic.” Insights like this, and a look at the progress of COVID-19 vaccines, are offered by Judith A. Aberg, MD, a central figure in the Mount Sinai Health System’s pandemic response. Dr. Aberg, the Dr. George Baehr Professor of Clinical Medicine at the Icahn School of Medicine at Mount Sinai, is principal investigator of multiple COVID-19 prevention and treatment trials.

What was your most challenging day during the pandemic?

During the peak of the pandemic, there were so many challenging days and sleepless nights that it is difficult to choose just one!  There were challenges, but there were also so many times that I felt pride in my own Infectious Diseases (ID) and Infection Prevention faculty and also in all the amazing triumphs occurring throughout the Mount Sinai Health System. We had so little knowledge about this disease and so few therapies to offer patients, yet there was the expectation that ID would have the answers.

As Chief, I needed to gather and disseminate the best available evidence, whether from our own observations, from preprint research or press releases, or from discussions with colleagues across the globe, in order to maintain the ID Division’s optimism and confidence in our recommendations. I have always been comfortable acknowledging the limitations of my own knowledge, but I did not anticipate how difficult it was—both for me and for the people who were turning to me for answers—to hear myself saying, “I just don’t know” as often as I did during the early days of the pandemic.

Nevertheless, we proceeded with the development of system-wide treatment guidelines based on best available evidence at the time, which would be frequently revised as more data became available. I am also proud that, despite the considerable clinical burden that COVID-19 placed on ID, we immediately launched into clinical trials and emergency use of investigational therapeutics. I am an experienced clinical trialist, but many of my faculty and our trainees are not. We all had to learn how to consent patients or their family members remotely, which is unprecedented in my experience, but necessary because family were not allowed to visit in person, and often they themselves were in quarantine. It was heartbreaking, listening to their stories and knowing that I had no answers or even the words to alleviate their fear and sadness.

At times, tensions ran high; it seemed as though everyone wanted their loved one to get whatever latest therapy was in the news. I received frequent calls and e-mails from patients’ family and friends, all advocating for their loved one to receive a potential therapy, regardless of limited supplies or use restrictions. It was a fine line, having to remind desperate families that every sick person is somebody to someone, while still maintaining compassion for their specific, personal grief. There were many nights when I would come home past midnight and sit with my laptop and phone, answering requests for help with what I hoped was reassurance and support, despite having no proven therapies to offer. Each patient lost was a tragedy, but the seemingly constant despair, particularly of those whose loved ones were rapidly worsening toward needing mechanical ventilators, was cumulatively overwhelming.

We were all just learning this disease, and yet therapeutic decisions still had to be made—so that is what I did. We have learned so much more now, even that some of our choices were not helpful, if not outright wrong. But at the time, we could only do what we thought was best.

How did the COVID-19 response affect you personally?

Like many, I have lost all semblance of balance between my work and personal life. And like many, I have lost colleagues and friends to the wrath of COVID-19. My ID faculty and staff know me as a person who is always on top of everything and available for them, but I have had to learn to let go and to accept that I just cannot do everything that I would like to. Since February, COVID has consumed almost every waking moment. I have seen my family only a handful of times and missed a few once-in-your-lifetime events of my grandchildren, and I haven’t turned off my cell or taken a day without work emails. COVID-19 has disrupted my life in ways both big and small. Fortunately, my family understands my sense of obligation and is supportive of my personal mission to push forward studies of potentially life-saving therapeutic and preventive interventions via the COVID Clinical Trials Unit.

What are the biggest challenges ahead in the search for a COVID-19 vaccine?

The first challenge was deciding which of the many vaccine studies we would offer. In consultation with the basic scientists, I learned as much as possible about the various novel vaccine platforms being developed and then made an executive decision to offer the trials of three vaccines, in addition to any that may be developed at Mount Sinai. One of the three vaccine uses messenger RNA (mRNA) to carry genetic instructions that prompt human cells to produce antibodies to COVID-19; another uses DNA to carry this kind of instruction; and the third, more traditional, vaccine uses a common adenovirus as a vector, or delivery system. Then we had to decide which sponsors to contract with. We have completed enrollment of 280 diverse participants in the Pfizer mRNA vaccine trial, which is expected to be the first vaccine to get an emergency use authorization at the end of this year or early next year. And this week, we opened the Janssen/Johnson & Johnson adenovirus vector vaccine at Mount Sinai Brooklyn and Mount Sinai Queens. 

The biggest challenge will be assuring that every vaccine given emergency use authorization (EUA) has adequate safety, tolerability, immunogenicity, and efficacy despite the record pace at which they are being developed and tested. An EUA designation means that the vaccine may be beneficial; it does not mean that it is beneficial, which is a subtle distinction for the general public. If a vaccine is rushed into EUA and is later found to be unsafe or ineffective, there could be grave consequences for future vaccine acceptance and public trust. Appropriate expectations for the vaccine also have to be clearly conveyed. It will likely not bring an immediate end to COVID-19 by itself, but rather will become one of many measures in the prevention toolbox. We still will need to wear masks, use hand hygiene, social distance, and stay home when sick.

The other major issue is how the vaccines will be distributed globally. Who receives the vaccine first? Who will distribute it, and how? Some of the vaccines currently in clinical trials require storage in a deep freeze and are only stable for a short time, but most pharmacies and doctors’ offices do not have ultralow freezers. Some vaccines require two doses, which doubles the effort required to deliver it. Even if an EUA is issued, vaccine trials will still need to continue, possibly for years, to determine which vaccine is the safest, most well tolerated, and most effective at preventing infection or disease. To do so, vaccine trial participants will need to be willing to continue in the trial, not knowing if they have received vaccine or placebo, even when they become eligible to receive vaccine through the EUA process. The trial sponsors will need to assure that those who received the placebo will eventually be offered an active vaccine when available.

There are many challenges, but there is also much optimism that globally we can end this pandemic together. Never before have we had so many tools and resources at hand to rapidly employ and implement yet still had so much uncertainty of what the future will bring.

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

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

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

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

In general, how do vaccines work?

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

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

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

Gopi Patel, MD

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

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

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

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

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

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

What is herd immunity?

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

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

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

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

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

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