So it’s no surprise that when Pfizer was ready to begin trials for its coronavirus vaccine in May 2020, “I raised my hand,” Mulligan said in a recent interview with 60 Minutes. Fast-forward seven months later: On December 11, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the vaccine, which Pfizer developed with the German biotechnology company BioNTech. It was the first COVID-19 vaccine to receive an FDA-issued EUA. A week later, Moderna’s vaccine became the second. Mulligan attributes the unprecedented speed with which these vaccines were developed to a number of things. Chief among them were a shared sense of extreme urgency and a willingness to take a gamble. “The FDA and the pharmaceutical companies understood that in an emergency like this, some of the things that normally were done in sequence could be done in parallel,” he tells Everyday Health. “The companies went ahead at risk and made a lot of vaccine before they even knew if it would be effective. So once we had the data that the vaccine is safe and effective, as we now have for both, there was a supply ready to deploy.” Deployment of the vaccines, however, has been a very different story. High hopes of vaccinating 20 million Americans by the end of 2020 were dashed as the vaccine rollout was hindered by a lack of coordination, communication, and resources. “Our problem right now is not a supply problem,” Mulligan says. “We have to do better with the distribution and with the implementation at the state, at the city, and even at the hospital and clinic level.” Citing a colleague, he adds: “Vaccines don’t save lives. Vaccinations do.” In a recent interview with Everyday Health, Mulligan discussed representation in clinical trials, anti-vaxxers, and how something known as mRNA helped speed vaccine development. The following are some highlights from an edited transcript. Mark Mulligan: You know, I have to say yes. The magnitude of this has exceeded anything that I thought we were going to end up facing. So it really has been surprising to me how widely serious and severe this has been, and in terms of our readiness for it. GV: The silver lining, of course, has been the arrival of vaccines — Pfizer’s and Moderna’s, and more to come. The speed was remarkable. MM: I entirely agree, we have a wonderful silver lining. We now have two vaccines that are highly effective. So how were they developed so quickly? I think it’s a couple of things. One, we’re using a platform that was ripe for the picking. You could say RNA vaccines had been in development for a decade and a half or more … for several diseases. They had an excellent safety profile in that other preliminary work. And it’s relatively simple from a scientific point of view to convert that platform to a COVID-19 vaccine. Then I think it was intense effort by the pharmaceutical companies, by Pfizer and Moderna, by the NIH (National Institutes of Health), and the clinical trial sites. We had in two phase 3 trials, over 75,000 humans participating around the world. I can’t tell you how many times in the clinical trials, when I ask a study participant why they’re doing this, they say, “Well, I want to be able to see my grandkids.” It was very, very striking and heartwarming to hear the stories and the reasons people were so excited. GV: What do you think in terms of extending clinical trials to other groups, like kids and pregnant women? MM: It’s very true that need to start studying the vaccines now in these other groups. In fact, pregnant women can get the vaccine under the EUA. Given that we’re in this emergency, I would encourage pregnant women if they’re interested to get the vaccine. It’s not a live virus vaccine. Those vaccines we do not give to pregnant women because they’re a little bit immunosuppressed; it’s part of pregnancy. So we avoid that. There were children participating in the Pfizer trial. So older children can get the vaccine. A number of trials are ongoing and we’ll be hearing in coming months about children at much younger ages, as young as 5 years of age and perhaps even younger. GV: As far as minority representation in the clinical trials, there’ve been some questions about skepticism in the Black American and the Hispanic communities about participating in these trials. What was their representation like? MM: This is so important because minority communities are overrepresented in COVID illness, COVID deaths, severe COVID cases. We know that these communities are most affected by COVID. So we had to be sure to include proper, adequate representation in the trials. And I think we did pretty well actually, better than has often been done in the past. We had in the range of 30 to 40 percent minority participation, which is really quite good, I think. There’s another aspect here that I think your question gets at, and that has to do with trust. It has to do with a historic legacy of abuse and ongoing inequity, ongoing lack of access, ongoing institutional racism. And all of this is part of an even lower acceptance of vaccines, any vaccine. There’s a lot of healing that has to happen — a lot of education, engagement, spending time with these communities, doing town hall meetings, answering questions, gaining trust. It’s really a matter of trust. GV: You mentioned synthetic messenger RNA (mRNA). Can you explain a little bit about how that works and how it differs from other vaccines? MM: This is a novel platform. It’s never been licensed, even now. It’s not licensed but authorized for emergency use. I’m very confident it will be licensed in a few months. It differs in this way: Think of it as the vaccine is messaging the cells in our body. It’s an instruction or a blueprint to the cells. The cells receive the message to make the “spike” protein. Then the body says, “Wait, that’s not a human protein. I better respond to that. That looks like something dangerous.” Happily, we now know that immune response is protective. GV: I know so many people who can’t wait to get vaccinated. And I know there are so many people who don’t want to get the vaccine. Some of them are chronic anti-vaxxers. Some of them are just concerned these vaccines have been so rushed that they’re not safe. What would you say to them? MM: We all want the same thing. We want to be healthy and safe, and we want to protect our loved ones. Vaccines for the COVID pandemic have moved quickly, but no corners were cut on the safety evaluations. We did everything we normally do, everything we’ve done for all of the safe and effective vaccines that are out there. And then I’d like to ask the person who’s hesitant or not sure, “What would you like to know? What are your concerns?” I would just remind them that 75,000 people participated in the two phase 3 trials, and there were no serious side effects. We have some sore arms and occasionally more than that, a little chill or fever. That’s actually a good thing. That’s what I call an expected vaccine reaction that tells you, “Hey, my body’s recognizing the vaccine and doing what it’s supposed to.” You might feel that you don’t need the vaccine. Maybe you’re young and healthy, and heard that it’s not as severe in younger people. But I would say that maybe you should think about the vulnerable people that you interact with, perhaps a grandparent or someone who has HIV or who is a liver transplant patient, or someone who’s immune compromised. You can protect them by getting vaccinated yourself. I’ve taken the vaccine. I got my second shot about three or four days ago. I feel great. I can’t wait for my 88-year-old mother, who’s out in Colorado, to get her vaccine. She lives in an independent living facility, one of these group homes, and so she’s at risk. So I really want her to get the vaccine. GV: What do we know in terms of what the vaccine actually can prevent and what it can’t protect against? Should we not fool ourselves and think that this solves everything and we don’t have to wear masks and take any other precautions? MM: We do need to continue with masks, social distancing, hand-washing, and not gathering in large groups. As to what we know: The vaccines protect against infection and disease — 95 percent protection — and even more impressive, severe disease. What we don’t know is if the vaccine would protect against infection without symptoms. We will get that information. The studies will have that, but it hasn’t yet been released. GV: Viruses constantly mutate. Do you anticipate that these vaccines will be able to tackle all the variants? MM: I do think that will be the case. RNA viruses mutate. They’re always changing, as you said. In one of the papers published for one of the RNA vaccines, they looked at 17 different variants. They were all equally well neutralized. So it’s already been looked at for a number of variants and the vaccines have protected, at least in the test tube. GV: Dr. Anthony Fauci (director of the National Institute of Allergy and Infectious Diseases) recently predicted that if we do everything right, maybe we can get to some semblance of normality by the fall. What do you think? MM: This is the million-dollar question. It’s what we all want. We just want to get back to our lives as we had them before we ever knew how good we had it. It’s wonderful that now we have a hope. That’s what the vaccines have done. They’ve given us hope. The exact time frame will depend on something called herd immunity — that is, getting enough people vaccinated that the virus can’t continue to spread in our communities. How many people, what percentage we don’t know for sure. The initial estimate for this virus was maybe 75 percent. More recently, there’s been talk that maybe this one spreads a little more efficiently than we thought. And so maybe it needs to be 85 percent. So we really have to get most of the population, most of our communities, most of our members of society vaccinated, so that we achieve that herd immunity and stop the pandemic.
