Last year, Zika stunned public health officials when it was discovered that the virus, which otherwise evoked mild or no symptoms, caused devastating birth defects in babies born to women who became infected during pregnancy.
With the U.S. mosquito season ahead, scientists and medical officials are once again preparing to protect Americans from infection, and while a vaccine hasn’t yet hit the public, testing is set to begin on people. Research led by the National Institutes of Health, the government’s agency that funds medical research, will continue to determine whether the vaccines are safe and effective at protecting people from the virus.
The U.S. already is more prepared than it was during last year’s outbreak, when funding became mired in politics. This year, the NIH received an increase of $2 billion for the agency overall, and a public health emergency fund has been created to handle outbreaks such as Zika.
Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, spoke with the Washington Examiner at his NIH campus office in Bethesda, Md., about how the Zika vaccine options are coming along and what lessons have been learned from other infectious disease outbreaks.
Washington Examiner: Four vaccines against Zika are in the works. Is one of them further along?
Fauci: The first thing I would say about vaccines and clinical trials is that sometimes people get the impression, understandably so, that the vaccine that goes into trial first and is at a more advanced stage is the better vaccine. We don’t know right now what the better or best vaccine will be or whether they will all be good.
Washington Examiner: Are there any safety issues that have come up?
Fauci: No red flags at all. None at all. We’re fine.
Washington Examiner: How long until a vaccine is released for the general public?
Fauci: It’s an interesting question to which there is not a cogent answer, and the reason is that how soon you get a vaccine available for distribution is dependent on two critical factors: One is how good the vaccine is to begin with. The better the vaccine, the quicker you know the answer. The poorer the vaccine, you may get an answer, but it’s not the answer you want, namely that you’ve got to move on to the next candidate. Another thing that’s very important in the time frame of when you’ll get an answer is how much infection there is out there. So if all of a sudden the infection rate goes way down — it’s never going to disappear because Zika isn’t going to just disappear, just the same way dengue came, and you have a low level of dengue, chikungunya came, you have a low level of chikungunya, West Nile comes, you have a low level — so it’s not going to disappear. We could know by the beginning of 2018 whether something really works or not. If the level of infection goes down to a very low level, it may take an additional two-plus years to know if it works or not.
Washington Examiner: Because you need to be able to test it enough?
Fauci: You need an adequate number of data points to determine if it works or not.
Washington Examiner: How many more years would it take before a vaccine is ready to be used in pregnant women?
Fauci: Pregnant women are not the target, and that’s a common misperception about this. By the time a woman is pregnant and knows she’s pregnant, if that woman was bitten by a mosquito, it’s too late. So the target population will be ultimately years ahead. There will actually be two types who are targeted. There will be people who live in areas where there is endemicity of Zika. If in fact Zika becomes endemic in some countries, whatever those countries may be — Perú, Venezuela, Colombia, Puerto Rico — it is likely that you would want to protect women of childbearing age before they become of childbearing age. You want to get them protected so that when they do get pregnant, they are already protected. There’s a model for that, and that model is rubella. Back in the 1960s there were about 20,000 congenital rubella syndrome babies per year in the United States. And the reason for that is there’s some analogies between rubella and Zika in that for most people it’s a relatively benign disease. Now back in the old days before there was a rubella vaccine, many kids — most kids, including me — got infected with “German measles” when you were a kid. But there were some kids who just didn’t get infected. Then when women got pregnant and happened to unfortunately get infected, that’s how they get a congenital rubella syndrome. So in order to get around that we developed a rubella vaccine, and instead of worrying about giving it to pregnant women, we went back and started giving it to all the children to protect them so that when they get of childbearing age, they don’t have to worry. Now there’s a little bit of a twist with Zika because since Zika is sexually transmitted also, you also want to protect the boys who will be the men that will be the sexual partners of the women who are getting infected. So you’re going to want everybody to be protected. That’s the long-range plan for an endemic area.
Washington Examiner: What about for those who go to an area where Zika is endemic?
Fauci: That’s going to be for travel-related, for military and for people who are going to be temporarily putting themselves at risk. There’s going to be two groups of individuals. Ultimately, we are going to want to do vaccine testing on pregnant women, but for the time being, we are not because that is not going to be the target.
Washington Examiner: Do you expect to see any pushback when it comes to vaccinating women before childbearing age? The way some parents raise concerns about their children being vaccinated against HPV?Fauci: The pushback has been more of a psychological one in that, “Well it’s a sexually transmitted disease, and no way no chance my child is going to have a sexually transmitted disease,” which is not a realistic approach toward life. I don’t think there is going to be that with Zika. Because this is protection against a mosquito-borne infection that can be devastating to a pregnant woman. I don’t think there is going to be pushback. Washington Examiner: What other agencies is the NIH involved with?
Fauci: We work very closely with the Centers for Disease Control and Prevention in determining what the sites are going to be and where we’ll do the vaccine because they’ll tell us where the outbreak is occurring. We are on conference calls with the CDC literally on a weekly basis and sometimes on a daily basis. Washington Examiner: The NIH just received $2 billion in extra funding, and a public health emergency fund has been created. Will that be helpful with these clinical trials?
Fauci: For the trials we were given money that came from various sources – $92 million – for the Zika activities. For 2017 we were given $152 million of the supplemental fund that was originally given before, and we already have a substantial amount of that obligated, and we’ll obligate the rest of that before the end of the year. So we have enough money now to do the trials that we’re talking about. If it turns out that in the future we need to do much more expanded trials, then we will obviously request money for that.
Washington Examiner: Anything that you want to bring up regarding work with Congress?
Fauci: We are fortunate in that at the NIH we have very good bipartisan support. I have been at the NIH for a long time, and we’ve always had good bipartisan and bicameral support. The Senate, the House, the Republicans and the Democrats have always been very supportive of it. Right now, with regard to Zika, we had [Health and Human Services] Secretary [Tom] Price and myself and [acting CDC Director] Anne Schuchat on the phone with the governors with the states that could potentially be involved with Zika, giving them information they need. Washington Examiner: Do governors sound concerned?
Fauci: They were just trying to get information about where we stand and where are we with the season, what does it look like with mosquito season. They asked where we are with vaccines. They are obviously very interested parties, particularly the governors and the individuals along the gulf states, like Texas and Florida. We are very much engaged. Washington Examiner: Back to the clinical trials. Is it hard to get volunteers for them?
Fauci: We have no trouble getting people, either for Phase 1 or Phase 2. In fact, the people who are in the areas we talked about are very enthusiastic. They want to participate in solving a problem. They realize there’s a problem, and they want to be part of the solution.
Washington Examiner: Is there anyone who can’t participate other than pregnant women? Fauci: There are certain medical criteria that you have to have normal lab tests, be of a certain age, you can’t be pregnant. But there’s no discriminatory aspect like if you’re too short or too tall. They have the regular protocol entry criteria.Washington Examiner: In working with private companies, is there anything notable there? Fauci: Not every company wants to get involved in a vaccine that might not be a big hit. Some companies generally step to the plate and get involved in vaccines that are of global health importance, companies like Sanofi Pasteur and GlaxoSmithKline. We have a history of working with them over the years on things like Ebola. Vaccine work in companies is not a very high profit margin for them. That’s the reason they need the kind of collaboration with the government and government agencies in order to do it. They just decide “I’m going to make a vaccine for Zika.” There is no guarantee anyone is going to use the vaccine, so it is a major investment, as opposed to a blockbuster drug. That’s why almost invariably they end up getting involved with the federal government and other agencies to get things done, which is exactly what’s going on with some of our candidates here.
Washington Examiner: You raised rubella as a similar example to Zika. Are there any other major outbreaks from recent years or a few decades back where you have been able to draw parallels?
Fauci: Nothing as strictly analogous as this. The similarities, relatively minor viral infection, most people recover, no problem. When they recover, they are immune, no problem, they are protected for life. Can you get a vaccine in an outbreak situation? The answer is, yes, you can. We did it pretty well with Ebola. We would have done it with SARS, but SARS disappeared by itself because of good public health measures. We were well on our way to developing a vaccine for SARS, and then all the sudden SARS disappeared. We stopped. We stopped at Phase 1. It was immunogenic — it was safe — but then we tried to go into a Phase 2, but we couldn’t go into a Phase 2 because there were no more cases of SARS. You have to have cases to go into a Phase 2 to check them out. Washington Examiner: Could that happen with Zika?
Fauci: I don’t think it’s going to disappear. Not at all. I think when you have a vector-borne disease that stays indolent in the population, it’s much much more difficult to eliminate a disease that’s a vector-borne disease than a disease in which you can have good public health and isolate and quarantine. When you have mosquitoes, it’s almost impossible to eliminate them. You could decrease the amount, but to get rid of it, you almost certainly have to have a vaccine. You have to have mosquito control and a vaccine, the way we did with yellow fever. Yellow fever was a major problem in the U.S. back in the colonial days and the early 20th century, and then all of a sudden a vaccine came along, and, boom, it disappeared in the Northern Hemisphere. Washington Examiner: What do you think about the idea of eradicating mosquitoes completely, as some have suggested?
Fauci: I think we need to have better control of mosquitoes. I brought that up myself. Are they doing any good? Environmentalists say that there is such an ecological balance that you are going to get into trouble if you try to eliminate a species. But there are some species of mosquitoes that you really want to definitely be able to control. Aedes Aegypti is a bad-news mosquito. It bites in the day, in the night, in the morning, in the afternoon, inside, outside — it’s very, very tough to get rid of them. So we need to use more creative ways to control them. We got rid of malaria in the United States, and we got rid of yellow fever in the United States. We didn’t get rid of every mosquito, but we did very good mosquito control to break the cycle of disease. You still have mosquitoes, but you don’t have disease, so that’s what you’ve got to do.
