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.

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.

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.

Petrona Ennis-Welch, RN, is one of the first employees to receive the first COVID-19 vaccine from David Reich, MD, President and Chief Operating Officer of The Mount Sinai Hospital and Mount Sinai Queens.

The first health care workers throughout the Mount Sinai Health System received the first new COVID-19 vaccine on Tuesday, December 15. For many, it was an exciting and emotional moment. For these front-line workers, and for the Health System, receiving the vaccine represented a key milestone in the continuing fight against the pandemic, and a critical first step in what remains a long journey back to normal for the New York metropolitan area.

Afterward, some took a moment to explain why they were eager to receive the new vaccine.

“I feel a sense of moral obligation to get vaccinated if it means I’ll be less likely to contribute to further spread of the disease,” said Jamie Piekarski, NP, who provides emergency psychiatric care to patients when they first enter Mount Sinai Beth Israel. Like many others, she decided to receive the vaccine in order to keep herself, her patients, and her family safe. She felt lucky to be among the first employees offered the vaccine. “This is our quickest way back to something close to normal.”

“Getting the vaccine is very emotional for me,” said Matthew Bai, MD, an emergency medicine doctor at Mount Sinai Queens, and an Assistant Professor of Emergency Medicine at the Icahn School of Medicine at Mount Sinai. “We have all been dealing with the pandemic for what seems like an eternity, and every day going to work, COVID-19 is always in the back of your mind. This is a symbol, an actual step toward going back to a normal life.”

He added: “I was not very nervous about the side effects. When you think about it and weigh it against getting COVID-19, then I’ll take the vaccine. So I was happy to get it … I have trust in the science and all the testing that’s been done with the vaccine. I believe it is 100 percent safe. It’s the first effective step we have ever had to actually combat this disease. Before, it was about keeping people alive, and now we are actually trying to stop it in its tracks … This is the light at the end of a very long, dark tunnel.”

Deborah Dean, MD, FACEP, Director of Emergency Medicine, was the first Mount Sinai Brooklyn employee to receive the vaccine, and she was joined by ED Nursing Director Bobby Lynch and ED Administrative Director Sue Stefko, who also received the vaccine.

“I was so excited to receive the COVID-19 vaccine, which I hope marks the beginning of the end of this devastating virus. While it’s disheartening to see so many struggling, I’m encouraged by the hope that this innovative vaccine brings by helping my body create its own antibodies through mRNA,” she said.

“People of color have been disproportionately affected by COVID and, despite our history with health care in this country, I chose faith over fear and will do all I can to protect myself, my loved ones, and my community.”

Ugo A. Ezenkwele, MD, chief of the Mount Sinai Queens Emergency Department and an Associate Professor of Emergency Medicine at the Icahn School of Medicine, said he and all of the staff were excited about the vaccine becoming available. He received the vaccine in order to help protect his colleagues and his family.

“I decided to get the vaccine because this offers some hope. We have been through a lot,” he said. “Furthermore, the science is sound. There have been a lot of people involved in the clinical trials. We also have to thank the scientists who have been working for years in order to get this vaccine to where it is now.”

Amanda Bates, MD, an emergency medicine doctor at Mount Sinai Queens, was looking forward to receiving the vaccine as soon as it was offered. “I have been working in emergency rooms since the pandemic started, and it has been incredibly devastating for patients and their families. I have seen a lot of complications that come from COVID-19 and it’s not something I want for myself, my family, or my patients,” she said. “I trust the vaccine. It is new, but the science behind it isn’t new. I feel confident that any risks that come with a new vaccine are far less severe than the risks that come with getting COVID-19. I think it’s the right thing to do to protect yourself and your community.”

Jonathan Nover, RN, MBA, Senior Director of Nursing in the Mount Sinai Queens Emergency Department, added: “I want to set an example for my team and my family, and I want to put all this behind us. Vaccines are safe, they are proven, and we need to move our lives forward. I feel very lucky and blessed for this opportunity, and I feel happy to let my staff, my family, and my friends know I was able to get the vaccine. I feel really proud of that.”

Althea Reid, is a Patient Care Associate on a behavioral health unit at Mount Sinai Beth Israel. She has been covering on a surge unit while COVID-19 cases increase. She received her COVID-19 vaccine because she wants to do her part to help end the pandemic. “The vaccine also gives me a sense of security and a sense of relief, especially on the bus and train, as I feel nervous about others being as responsible as I want to be,” she said.

Mateow Espinosa, a Care Team Assistant and Scribe at Mount Sinai Beth Israel, said: “A lot of people around me are hesitant to get the vaccine. I feel like it is necessary for me to take the vaccine as a way to educate the people around me. It is also important for me to keep myself and family safe.”

Luis Coello, a security officer at Mount Sinai Beth Israel: “I decided to take the vaccine because I do not want to get COVID-19, and I want to keep my family safe.”

Young Lee, MD, ICU Medical Director at Mount Sinai Beth Israel and an Assistant Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine) at the Icahn School of Medicine: “It was much less painful than the flu vaccine. I decided to take this vaccine to protect myself, as well as my patients and my family.”

Farah Ali, a physician assistant in an emergency department at Mount Sinai Beth Israel: “What a whirlwind, brilliant year for medical science. It is surreal, a little scary, but overall exciting to be among the very first to get this vaccine. I got the vaccine for my Gramma and Grampa.”

Crystal Toribo, PharmD, a pharmacy resident at Mount Sinai Beth Israel: “The side effects of this vaccine are very similar to the flu shot. For anyone who is hesitant to take it, please know that there are so many people here in the hospital to speak to about it, so always feel free to ask questions about side effects and safety. To me, it is important that I get vaccinated so I can protect others, myself, and my family members.”

Michael Ruzzo, RN, who works in an intensive care unit at Mount Sinai Beth Israel: “I have family with pre-existing conditions and I’ve been paranoid about bringing home COVID-19 to them. I also did not see my fiancé for four months during the spring. This vaccine changes all of that.”

Watch a slideshow as employees who work at The Mount Sinai Hospital receive the first COVID-19 vaccine.