--- title: FDA Approves First RSV Vaccine for Pregnant Women description: The shot is intended to protect newborns in the first few months after birth from respiratory syncytial virus. canonical: https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/ author: Alice Park article:opinion: false article:content_tier: free article:published_time: 2023-08-21T21:42:08.000Z article:modified_time: 2026-08-04T07:50:58.648Z article:section: Health og:title: FDA Approves First RSV Vaccine for Pregnant Women og:description: The shot is intended to protect newborns in the first few months after birth from respiratory syncytial virus. og:url: https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt81c5d401e642df32/698a3fb009208f612b41aa23/GettyImages-1322499124.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 og:image:width: 2119 og:image:height: 1192 og:image:alt: Pregnant woman taking a vaccination og:type: article twitter:card: summary_large_image twitter:title: FDA Approves First RSV Vaccine for Pregnant Women twitter:description: The shot is intended to protect newborns in the first few months after birth from respiratory syncytial virus. twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt81c5d401e642df32/698a3fb009208f612b41aa23/GettyImages-1322499124.jpg?branch=production&width=1200&quality=75&auto=webp&crop=16:9 ---  # FDA Approves the First RSV Vaccine for Pregnant Women > Sponsored content. 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New CDC Director Mandy Cohen talks about abortion, COVID-19, public mistrust in the federal agency, and more._  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Aug 21, 2023 9:42 PM UTC  Pregnant woman taking a vaccination Pregnant woman taking a vaccination Getty Images  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Aug 21, 2023 9:42 PM UTC The US Food and Drug Administration (FDA) today (Aug. 21) [approved the first vaccine for respiratory syncytial virus](https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants) (RSV) for pregnant women, which is designed to protect newborns from the infection. The shot becomes the second RSV vaccine, and third new intervention against the disease this year. In May, the FDA approved the Abrysvo vaccine for preventing RSV in people 60 years and older. The same vaccine is now approved for pregnant people in their third trimester. And in July, the agency [approved nirsevimab](https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers), an antibody-based injection that protects babies immediately after birth from RSV. The new interventions have been a long time coming in RSV treatment, which in the U.S. sends 58,000 to 80,000 children under age five to the hospital each year and kills 100 to 300 annually. Pfizer, which makes Abrysvo for both older people and now those who are pregnant, has been developing the shot since the 2010s, after scientists at the National Institutes of Health [discovered](https://time.com/6275289/rsv-vaccine-history/) just the right form of RSV to capture in the vaccine and present to the immune system. In a [study](https://www.nejm.org/doi/full/10.1056/NEJMoa2216480) reviewed by the FDA involving pregnant women in 18 countries, the vaccine was 81.8% effective in preventing severe respiratory illness needing medical attention in babies in the first 90 days after birth. **_Read More:_**[_Why It Took So Long to Finally Get An RSV Vaccine_](https://time.com/6275289/rsv-vaccine-history/) ### More From TIME ## Vaccinating mothers to protect infants Preventing infection is critical to protecting the health of newborn babies, says Dr. Melissa Squires, a pediatric neuroclinical care doctor at Cincinnati Children’s Hospital who joined the study when she was pregnant with her second child in 2019\. Part of the reason she enrolled to become a participant in the trial was personal experience—when her first daughter, Teresa, was three months old, she became very sick with a respiratory infection and couldn’t breathe well or eat or drink properly. “Those were a very tense few days,” she says. “I don’t know what she had because we didn’t have her tested, but she was quite sick. Anything I can do to prevent anyone going through that, I was very onboard with exploring.” Her experience with her second daughter has been very different. Natalie was born in December 2021, during RSV and flu season, so joining the trial was “a great opportunity to prevent illness in my baby who was going to be born in the middle of respiratory disease season,” says Squires. So far, Natalie hasn't had a major infection through the first year of her life. While Squires doesn’t know if she received the vaccine or a placebo, she and her husband are happy to be spared the anxiety of worrying about a sick newborn. Abrysvo works by co-opting the expectant mother’s immune system, prompting it to produce antibodies against RSV. Those antibodies are then passed on through the placenta to the developing fetus, so that at delivery, the baby has amassed a certain level of immune defenses that can protect it from any viruses it encounters. “I’m a big believer in maternal vaccination,” says Dr. Elizabeth Schlaudecker, medical director of the division of infectious diseases at Cincinnati Children’s and one of the principal investigators of the study. “It’s a very safe and effective way to protect young babies when their immune systems are not working well on their own quite yet.” Schlaudecker notes there is precedent to such maternal immunization, including tetanus, diphtheria and pertussis as well as flu vaccines, all of which pregnant women get during the third trimester to protect their babies after delivery. Babies under six months old are the most vulnerable to infections, since their immune systems aren’t developed enough yet to fend off bacteria and viruses. “Even if we were to give them vaccines, a lot of them would be unable to mount an immune response because they are just too young,” says Schlaudecker. Babies are particularly susceptible to getting severely ill from RSV, since their airways are so small, and any inflammation caused by the virus can make it difficult for them to breathe or clear fluids from their tiny lungs. Studies from Pfizer show that newborns can be protected at least through their first RSV season; studies on how long the protection lasts are ongoing. The upcoming fall and winter season in the northern hemisphere will be a test of sorts for a new RSV treatment strategy for infants and young children. With the approval of Abrysvo for pregnant people, and nirsevamab, which is meant for newborns in their first RSV season, doctors now have effective ways to prevent infection for the first time. They will have to figure out the best way to utilize both the maternal vaccine and the antibody treatment for infants to optimize protection from the virus. Some of that guidance will come from the Centers for Disease Control’s Advisory Committee for Immunization Practices, which will detail when doctors should use the new vaccine. ## Knowing what vaccine to give “This is a definitely an unprecedented time,” says Schlaudecker. "There are some unique challenges to figuring out which one to give and when.” She notes the maternal vaccine will fit relatively easily into the current schedule of shots that expectant mothers receive, and ideally, most pregnant moms would get the RSV vaccine in their third trimester. If, however, the mother isn’t able to get vaccinated, or if she delivers early and before her scheduled RSV shot, then the antibody treatment could be an important back up to protect the baby. Any babies with weakened immune systems, or additional health issues such as congenital diseases that might make them more vulnerable to infections, could also get nirsevimab treatment even if they already have antibodies from their mothers, as an additional layer of protection. The details of which babies might benefit from both having their mothers vaccinated, and nirsevimab, will become clearer once more data is collected from babies getting these therapies after a year or two. “I do expect that yes, we will continue to do research to look at how to incorporate these two products together,” says Schlaudecker. In the meantime, Squires sees the benefit of taking advantage of the maternal vaccine for RSV. “I’m a fan of any kind of prevention for RSV,” she says. “Babies can receive vaccines after the first year of life, but even after they do, it takes a while before the body responds with those antibodies. So let mom do the work. Let mom make those antibodies and give them to the baby. That way, on day one they are ready to face that virus.” ## Transcript Data is the oxygen that powers our ability to respond to threats and so if we don't have access to that data we are not as strong enough asset to respond to threats. So we definitely do need more work to do. Both the build the pipes on connecting all these different data sources but also to have the authority to say you we need to we need to do this in order to protect our country and to have a national security asset that can respond to those threats. One of the issues I think that people are grappling with right now and the agency isn't mistrust in science in general. But I think in the CDC in particular, I'd love to get your perspective on that perspective. Both coming from the outside as Secretariat in North Carolina and now that your director how you how you plan to address that will first, I think trust is absolutely foundational. I think change happens at the pace of trust it. So it it underlies, everything that we do and I will say, as Health and Human Services, secretary for North Carolina. We called out and named trust as Central to how we responded to the covid crisis. We thought about it every day and we measured it importantly. And what we saw over the course of leading through that crisis, we saw trust actually increase in the department that Iran which was different than what we were seeing and some other parts of the country. And I think We were able to build trust, cuz we focused on three things. One, we focus on really building relationships to, we were incredibly transparent. We use Simple communication. We did 170 press conferences. I think an 18 months. So we were answering questions all the time because we were learning new things and then third, we made sure that folks were knowing that we were performing every day for them, that we were delivering, the vaccines were the tests that they needed to protect themselves. So we focus on those three aspects. We talked about it and we measured it. So I think we, we did a great job in North Carolina. I'm hoping to bring those that work in those lessons at 2 to the work here at CTC. How concerned are you about the increasing hospitalizations from covid? Be cuz you know since we're not tracking cases, so much anymore. Opposition's is like a good litmus test for, you know, like severe case there are people getting sick or from from their infections. How concerned are you about that? Trend. So we are seeing hospitalizations go up for here in August of 2023. And it's reminding us that we are living with code. That's right. It is not gone. And that means we need to continue to Avail ourselves of the tools that protect us. Vaccines testing and treatment. Luckily, we have more tools than ever before going into these next season and we're going to have a new booster that comes out in the middle of September. So we have the tools, we just need to use them but I'd say about the current level, I'm not concerned right now but you know, we're going to continue to watch that. If you saw the highest number of hospitalizations we had last year is about 45,000 for about ten thousand right now. So we're much lower than we were. The peak last year but we have to keep Vigilant than making sure that were using the tool to protect ourselves. If you're going to hear us talk a lot about vaccines testing and treatment, that things are safe and effective. If we have great test, that can rapidly identify what you have and then treatment that works, but you have to use it right away. Can we look at some of the big health issues especially in the past year that, you know, the country is facing? I think women's reproductive Health has been really a Hot Topic with some of the restrictions that have been placed on choices that women have regarding contraception and abortion. What role does the CDC has in ensuring that we would continue to have access to as many healthy and, you know, evidence-based choices as possible. The mission of the CDC is to protect and improve health. And in order to be able to do that, we need to make sure that folks have access to the tools that can keep them healthy at all moments of their life, whether they're thinking about becoming pregnant during their pregnancy. Or even after when they're young mom and we have a lot of data and best practices and evidence that we can bring to bear to show that when we work with Mom, so that they are getting pregnant when they are ready and want to meeting that they have access to contraception. So they're not getting pregnant if it's not. Right time for them and their family. That means babies have better outcomes as do Mom. And just this week, we've seen another blow in in the form of the the appeals court decisions, you know, backing the Texas judge's ruling on Meet the Press Stone. It remains available, but this is going to be debated in the court. How much of an impediment is that this is something that there is good science behind and yet we're looking, you know, to a whole different system. The legal system to kind of decide whether women can have access to it or not as a as a physician and as a public health leader, how does that strike you? So disappointed that we are here and that we are having the conversation to revisit whether or not women should have access to health care when they need it. I will say as both a mom of two daughters a physician and now the director of the CDC know I'm going to continue to make sure that we are working to make sure women has access to Care when they need it, that they have medical treatment when they need and that's all parts of their life. The issues. I think that has impart led to the mistress in the skepticism of the agency in science and journal was the politicization of Health. It became a political rather than a scientific issue. You know, based on strong scientific evidence. As secretary North Carolina, did you see some of that in your own State? And as you saw it on the national level, what concerns you had, and also how you plan to address that now is director of CDC. Well, I think it's always important for us to have good discourse and good dialogue. I think it's important when we're wrestling with heart issues that we hear from different folks. But what we want to make sure is that that dialogue is respectful. I saw that in North Carolina, credibly good, relationships across the aisle. I worked for a Democratic governor but we had a super majority of Republicans in our state legislature. But we had good relationships and I think it's because we were willing to answer questions that we were transparent, folks knew that they could get me on the phone to answer questions and I was happy to do. It doesn't mean We always agreed on every issue, but we were able to have that respectful dialogue as I get to know members of Congress and in my new role. And that's what I see as well as having building those relationships being available to answer their questions and focusing on the places where I see a lot of consensus. And I do see consensus on making sure we have an asset for our country, that is identifying threats and responding quickly to them. So, if we haven't a new virus or a new chemical, or what have you that, we are able to respond quickly. So I see a lot of consensus around having that ass. I also see a lot of consensus on addressing mental health. We all know that mental health unfortunately has seen, you know, a lot of challenges that happens in any crisis whether it's a hurricane or a pandemic. And so I feel a lot of consensus on coming together to think about ways to address that. I was just talking to a couple of members of Congress and how do we work together and suicide, prevention, for example. In the third area consensus. I really see it around young families thinking about, how do we get Upstream from some of the issues? We see John thring whether that's diabetes or mental health issues in addiction. There are ways proven ways with evidence that we know, we can prevent we know that we are a stronger country if we are healthy and what does it take to become that? So those are the areas you're going to hear me focus on right? Making sure we have that asset to respond to threats that we address our mental health issues, and that we're also doing the prevention to make us the healthiest country, we possibly can be ```json [{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/","mainEntityOfPage":{"@type":"WebPage","@id":"https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/"},"headline":"FDA Approves the First RSV Vaccine for Pregnant Women","datePublished":"2023-08-21T21:42:08.000Z","dateModified":"2026-08-04T07:50:58.648Z","description":"The shot is intended to protect newborns in the first few months after birth.","url":"https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/","keywords":["Vaccines"],"thumbnailUrl":"https://static.time.com/v3/assets/bltea6093859af6183b/blt81c5d401e642df32/698a3fb009208f612b41aa23/GettyImages-1322499124.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","author":[{"@type":"Person","name":"Alice Park","jobTitle":"Senior Correspondent","url":"https://time.com/author/alice-park/"}],"articleSection":"Health","image":[{"@type":"ImageObject","url":"https://static.time.com/v3/assets/bltea6093859af6183b/blt81c5d401e642df32/698a3fb009208f612b41aa23/GettyImages-1322499124.jpg?branch=production&width=1200&quality=75&auto=webp&crop=1200:675&height=675","width":1200,"height":675,"headline":"Pregnant woman taking a vaccination","caption":"Pregnant woman taking a vaccination","creditText":"Getty Images","representativeOfPage":true}],"publisher":{"@type":"Organization","name":"Time","url":"https://time.com/","logo":{"@type":"ImageObject","url":"https://time.com/images/logo.png","width":528,"height":156},"foundingDate":"March 3, 1923","sameAs":["https://www.facebook.com/time","https://www.instagram.com/time/?hl=en","https://twitter.com/time","https://www.pinterest.com/timemagazine"]}},{"@context":"https://schema.org","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"item":{"@id":"/section/health/","name":"Health"}},{"@type":"ListItem","position":2,"item":{"@id":"/tag/vaccines/","name":"Vaccines"}},{"@type":"ListItem","position":3,"item":{"@id":"https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/","name":"FDA Approves the First RSV Vaccine for Pregnant Women"}}]},{"@context":"https://schema.org","@type":"VideoObject","name":"New CDC Director Mandy Cohen on Abortion, COVID-19, and More","description":"New CDC Director Mandy Cohen talks about abortion, COVID-19, public mistrust in the federal agency, and more.","thumbnailUrl":"https://cdn.jwplayer.com/v2/media/HNgVhsur/poster.jpg?width=720","uploadDate":"2023-08-21T21:07:16.000Z","contentUrl":"https://cdn.jwplayer.com/manifests/HNgVhsur.m3u8","embedUrl":"https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/","duration":"PT8M31S","potentialAction":{"@type":"SeekToAction","target":"https://time.com/6306970/emabrgoed-fda-approves-first-rsv-vaccine-for-pregnant-women/?jw_start={seek_to_second_number}","startOffset-input":"required name=seek_to_second_number"}}] ```