Wirus syncytialny oddechowy (rsv)
Zapobieganie i profilaktyka

Wirus syncytialny oddechowy (RSV) jest istotnym patogenem układu oddechowego, szczególnie niebezpiecznym dla niemowląt oraz osób starszych. Obecnie dostępne są trzy szczepionki dla dorosłych: AREXVY (GSK), ABRYSVO (Pfizer) oraz mRESVIA (Moderna), które wykazują wysoką skuteczność (AREXVY: 83-94%, ABRYSVO: 62-86%) w zapobieganiu ciężkim postaciom zakażeń RSV. Szczepienia zaleca się osobom ≥75 lat, a także osobom 60-74 lata z chorobami współistniejącymi oraz mieszkańcom placówek opieki długoterminowej. Szczepionka ABRYSVO jest jedyną dopuszczoną do stosowania u kobiet w ciąży (32.-36. tydzień), zapewniającą ochronę niemowląt przez około 6 miesięcy po urodzeniu, z efektywnością zmniejszającą hospitalizacje o 57% w pierwszym półroczu życia. Profilaktyka niemowląt obejmuje także podanie przeciwciał monoklonalnych: nirsewimab (Beyfortus) lub paliwizumab (Synagis), z nirsewimabem wykazującym skuteczność 79-90% w zapobieganiu ciężkim postaciom RSV i podawanym jako pojedyncza dawka na sezon (ok. 5 miesięcy). Szczepionki i przeciwciała można podawać jednocześnie z innymi szczepieniami, a optymalny czas immunizacji to okres przedsezonowy RSV (późne lato/jesień dla dorosłych, wrzesień-styczeń dla kobiet w ciąży, październik-marzec dla niemowląt).

Wirus syncytialny oddechowy (RSV) – profilaktyka i zapobieganie

Wirus syncytialny oddechowy (RSV) to powszechnie występujący patogen, który wywołuje zakażenia układu oddechowego od łagodnych objawów przypominających przeziębienie po ciężkie choroby dolnych dróg oddechowych. Chociaż większość osób zdrowieje w ciągu jednego do dwóch tygodni, RSV może prowadzić do poważnych powikłań, szczególnie u niemowląt i osób starszych. W ostatnich latach opracowano nowe strategie profilaktyczne, które znacząco zmieniły podejście do zapobiegania ciężkim zakażeniom RSV.12

Szczepienia przeciwko RSV dla osób dorosłych

Aktualnie dostępne są trzy szczepionki przeciwko RSV dla osób dorosłych – AREXVY (GSK), ABRYSVO (Pfizer) oraz mRESVIA (Moderna). Zgodnie z zaleceniami Centrów Kontroli i Prewencji Chorób (CDC), szczepionkę przeciwko RSV powinni otrzymać:1234

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W przypadku szczepionki AREXVY, dopuszczona została również immunizacja osób w wieku 50-59 lat, które są narażone na zwiększone ryzyko choroby dolnych dróg oddechowych wywołanej przez RSV. Natomiast szczepionka ABRYSVO posiada najszersze wskazania, gdyż jest dopuszczona również do stosowania u osób w wieku 18-59 lat z podwyższonym ryzykiem.123

Zgodnie z aktualnymi zaleceniami, szczepionka przeciwko RSV dla osób dorosłych podawana jest jako pojedyncza dawka i nie jest obecnie szczepionką roczną – nie ma potrzeby powtarzania szczepienia w kolejnych sezonach. Badania wykazały, że szczepionki zapewniają ochronę przed RSV przez co najmniej dwa sezony.123

Szczepionki przeciwko RSV wykazały wysoką skuteczność w zapobieganiu ciężkim przebiegom choroby. W badaniach klinicznych:1

  • Szczepionka AREXVY (RSVPreF3) wykazała 83% skuteczności w zapobieganiu chorobie dolnych dróg oddechowych związanej z RSV i 94% skuteczności w zapobieganiu ciężkiej chorobie dolnych dróg oddechowych związanej z RSV u osób w wieku 60 lat i starszych
  • Szczepionka ABRYSVO (RSVpreF) wykazała 62-86% skuteczności w zapobieganiu ostrym chorobom układu oddechowego związanym z RSV w zależności od nasilenia objawów
  • Badania w warunkach rzeczywistych wykazały 75-80% skuteczność w zapobieganiu hospitalizacjom związanym z RSV wśród dorosłych w wieku 60 lat i starszych

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Najlepszym czasem na podanie szczepionki przeciwko RSV jest późne lato lub wczesna jesień, tuż przed sezonem RSV, który zazwyczaj rozpoczyna się jesienią i osiąga szczyt w zimie. Szczepionki przeciwko RSV mogą być podawane jednocześnie z innymi szczepionkami dla dorosłych, np. przeciwko grypie czy COVID-19.123

Strategie ochrony niemowląt przed RSV

Do ochrony niemowląt przed ciężkim przebiegiem zakażenia RSV dostępne są dwie główne strategie profilaktyczne:12

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W większości przypadków zaleca się stosowanie tylko jednej z tych metod, choć w szczególnych przypadkach mogą być stosowane obie.12

Szczepienie matki w okresie ciąży

Szczepionka ABRYSVO (Pfizer) jest jedyną szczepionką przeciwko RSV zatwierdzoną do stosowania u kobiet w ciąży. Jest podawana między 32. a 36. tygodniem ciąży, najlepiej od września do stycznia w większości obszarów kontynentalnych Stanów Zjednoczonych (w innych regionach należy dostosować się do lokalnej sezonowości RSV).123

Przeciwciała wytwarzane przez matkę po szczepieniu przechodzą przez łożysko do płodu, co zapewnia niemowlęciu ochronę po urodzeniu przez około 6 miesięcy – w okresie, gdy jest najbardziej narażone na ciężki przebieg RSV.12

Badania kliniczne wykazały, że szczepionka ABRYSVO podana w ciąży:1

  • Zmniejsza ryzyko hospitalizacji z powodu RSV u niemowląt o 57% w pierwszych sześciu miesiącach życia
  • Jest skuteczna w 82-91% w zapobieganiu ciężkiemu RSV w pierwszych trzech miesiącach po urodzeniu
  • Jest skuteczna w 69-77% przez pierwsze sześć miesięcy

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Szczepionkę ABRYSVO można bezpiecznie podawać jednocześnie z innymi szczepionkami rutynowo zalecanymi podczas ciąży, takimi jak szczepionka przeciw błonicy, tężcowi i krztuścowi (dTpa) oraz szczepionka przeciw grypie.12

Profilaktyka za pomocą przeciwciał monoklonalnych

Dla niemowląt dostępne są dwa przeciwciała monoklonalne do ochrony przed RSV:12

  • Nirsewimab (Beyfortus) – nowe długo działające przeciwciało monoklonalne
  • Paliwizumab (Synagis) – starsze przeciwciało monoklonalne przeznaczone głównie dla niemowląt z grup wysokiego ryzyka

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Nirsewimab jest zalecany dla:12

  • Wszystkich niemowląt w wieku poniżej 8 miesięcy, urodzonych podczas lub wchodzących w swój pierwszy sezon RSV, jeśli matka nie otrzymała szczepionki przeciwko RSV podczas ciąży, status szczepienia matki jest nieznany lub niemowlę urodziło się w ciągu 14 dni od szczepienia matki
  • Niektórych dzieci w wieku 8-19 miesięcy, które pozostają w grupie zwiększonego ryzyka ciężkiego RSV i wchodzą w swój drugi sezon RSV

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Nirsewimab podawany jest jako pojedyncza dawka, która zapewnia ochronę przez cały sezon RSV (około 5 miesięcy). Badania kliniczne i dane z praktyki klinicznej wykazały, że nirsewimab:12

  • Jest skuteczny w 79-80% w zapobieganiu chorobie dolnych dróg oddechowych związanej z RSV wymagającej pomocy medycznej
  • Jest skuteczny w 80-90% w zapobieganiu hospitalizacjom związanym z RSV
  • Jest skuteczny w 90% w zapobieganiu przyjęciom na OIOM z powodu RSV

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Nirsewimab można podawać jednocześnie ze szczepionkami rutynowo zalecanymi dla niemowląt i małych dzieci. Nie jest konieczne zachowanie odstępu między nirsewimabem a żywymi szczepionkami (takimi jak szczepionka przeciw odrze, śwince i różyczce czy ospie wietrznej).12

Paliwizumab pozostaje opcją profilaktyczną dla niemowląt i małych dzieci z określonymi stanami wysokiego ryzyka, takimi jak wcześniactwo (poniżej 29. tygodnia ciąży) lub czynniki ryzyka sercowo-płucnego. W przeciwieństwie do nirsewimabu, wymaga comiesięcznych dawek w trakcie sezonu RSV.12

Sezonowość i czas podania szczepionek i profilaktyki RSV

Optymalne czasy podania środków profilaktycznych przeciwko RSV są ściśle związane z sezonowością wirusa:12

  • Szczepionka dla kobiet w ciąży (ABRYSVO): Zalecana w okresie od września do stycznia w większości kontynentalnych Stanów Zjednoczonych, podawana pomiędzy 32. a 36. tygodniem ciąży
  • Nirsewimab dla niemowląt: Zalecany od października do marca w większości kontynentalnych Stanów Zjednoczonych
  • Szczepionki dla dorosłych: Mogą być podawane przez cały rok, ale najlepiej w późnym lecie lub wczesnej jesieni, przed początkiem sezonu RSV

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Sezon RSV zazwyczaj rozpoczyna się jesienią, osiąga szczyt zimą (grudzień-styczeń) i trwa do wiosny. Profilaktyka jest najskuteczniejsza, gdy zostanie zastosowana przed rozpoczęciem sezonu RSV.12

Efektywność kosztowa profilaktyki RSV

Badania nad efektywnością kosztową szczepionek przeciwko RSV i przeciwciał monoklonalnych wykazały, że:1

  • Zarówno szczepionka dla kobiet w ciąży, jak i nirsewimab są kosztowo efektywne w określonych sytuacjach
  • Szacuje się, że przy 50% zasięgu wśród kwalifikujących się niemowląt w USA, nirsewimab mógłby zapobiec 107 253 wizytom ambulatoryjnym, 38 204 wizytom na SOR i 14 341 hospitalizacjom rocznie
  • Koszt pojedynczej dawki szczepionki dla kobiet w ciąży wynosi około 295 USD, podczas gdy koszt rynkowy nirsewimabu wynosi około 495 USD

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Modele ekonomiczne wykazały również, że szczepienie dorosłych w wieku 60 lat i starszych przeciwko RSV może zapobiec prawie 3 milionom objawowych przypadków RSV w ciągu 3 lat, w tym ponad 1,5 miliona wizyt ambulatoryjnych, ponad 200 000 hospitalizacji i prawie 17 000 zgonów w porównaniu z brakiem szczepień.12

Perspektywy globalne i wyzwania w dostępie do profilaktyki RSV

Dostęp do nowych narzędzi profilaktycznych przeciwko RSV różni się znacząco na świecie. Podczas gdy kraje o wysokich dochodach wdrażają szeroko szczepionki i przeciwciała monoklonalne, w krajach o niskich i średnich dochodach dostęp pozostaje ograniczony.12

Wyzwania w globalnym dostępie do profilaktyki RSV obejmują:12

  • Wysokie koszty szczepionek i przeciwciał monoklonalnych
  • Ograniczona infrastruktura zdrowia publicznego w niektórych regionach
  • Potrzeba dostosowania do istniejących programów zdrowia publicznego
  • Konieczność rozwoju systemów nadzoru chorób układu oddechowego

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Eksperci podkreślają potrzebę wdrożenia modeli cenowych uwzględniających możliwości krajów o różnych dochodach oraz zwiększenia lokalnej produkcji, aby poprawić dostęp do profilaktyki RSV na całym świecie.1

Przyszłość profilaktyki RSV

Rozwój szczepionek i przeciwciał monoklonalnych przeciwko RSV stanowi przełom w profilaktyce tej choroby. Obecnie w opracowaniu znajduje się ponad 30 kandydatów na szczepionki i przeciwciała monoklonalne przeciwko RSV, wykorzystujących różne podejścia technologiczne:12

  • Szczepionki wektorowe
  • Szczepionki podjednostkowe
  • Szczepionki oparte na cząstkach
  • Szczepionki żywe atenuowane
  • Szczepionki chimeryczne
  • Szczepionki na bazie kwasów nukleinowych
  • Przeciwciała monoklonalne o przedłużonym działaniu

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Przyszłe kierunki rozwoju profilaktyki RSV obejmują prace nad:12

  • Szczepionkami dla starszych niemowląt i małych dzieci
  • Zwiększeniem skuteczności i długości ochrony
  • Rozszerzeniem wskazań dla różnych grup pacjentów
  • Potencjalnymi szczepionkami skojarzonymi z innymi patogenami układu oddechowego

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Badania nad żywymi atenuowanymi szczepionkami przeciwko RSV dla dzieci są również obiecujące, szczególnie dla populacji szczególnie narażonych, takich jak dzieci bez zakażenia HIV, ale narażone na HIV z powodu statusu matki.1

Nowe narzędzia profilaktyczne przeciwko RSV mają potencjał znaczącego zmniejszenia obciążenia chorobą, zmniejszenia liczby hospitalizacji i poprawy wyników zdrowotnych dla najbardziej wrażliwych populacji – niemowląt i osób starszych.12

Kolejne rozdziały

Zapraszamy do dalszego czytania naszego leksykonu.

Wybierz kolejny rozdział z menu poniżej, aby otworzyć nową podstronę kompedium wiedzy i uzyskać szczegółowe informację o leku, substancji lub chorobie.

  1. 09.04.2026
  2. www.leksykon.com.pl

Materiały źródłowe

  • #1 RSV (Respiratory Syncytial Virus) Immunizations | CDC
    https://www.cdc.gov/vaccines/vpd/rsv/index.html
    Respiratory syncytial (sin-SISH-uhl) virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious. Infants and older adults are more likely to develop severe RSV and need hospitalization. Vaccines are available to protect older adults from severe RSV. Vaccines for pregnant women or monoclonal antibody products are available to protect infants and young children from severe RSV. […] RSV Vaccine Guidance for Pregnant Women […] RSV Vaccine Guidance for Older Adults.
  • #1 Update: What RSV preventatives mean for those with PI | Immune Deficiency Foundation
    https://primaryimmune.org/resources/news-articles/update-what-rsv-preventatives-mean-those-pi
    Vaccines and monoclonal antibodies approved for the prevention of lower respiratory tract infections caused by RSV. Three vaccines and a monoclonal antibody are approved for the prevention of lower respiratory tract infections caused by RSV in the U.S. […] The U.S. Food and Drug Administration (FDA) has approved four preventative products for RSV in less than a year: Abrysvo and Arexvy, two protein subunit vaccines. […] As of June 2024, there are three approved RSV vaccines for adults and a long-lasting monoclonal antibody for infants. […] Abrysvo, Arexvy, and mRESVIA are all vaccines, which means they rely on a persons immune system to generate antibodies and/or T cells that will protect that person from RSV infection. […] Arexvy is also approved for people 50-59 years of age who are at high risk, including those who are immunocompromised.
  • #1 RSV Vaccine Guidance for Older Adults | RSV | CDC
    https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html
    CDC recommends a single dose of RSV vaccine for older adults to help prevent serious RSV infection and hospitalization. […] Currently, CDC recommends only a single dose of RSV vaccine for all adults ages 75 and older and for adults ages 6074 with increased risk of severe RSV disease. […] The RSV vaccine is not currently an annual vaccine, meaning eligible adults do not need to get a dose every RSV season. […] Eligible adults who have not previously received RSV vaccination may be vaccinated at any time of year, but vaccination will have the most benefit if administered in late summer or early fall, just before the RSV season. […] RSV vaccines can be coadministered with other adult vaccines during the same visit. […] Adverse events after RSV vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS), even if it is not clear that the vaccine caused the adverse event. […] CDC will continue to monitor real-world RSV vaccine effectiveness during each respiratory virus season.
  • #1 Respiratory Syncytial Virus (RSV) Vaccines | CDC Recommendations | AAFP
    https://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/disease-pop-immunization/rsv-vaccine.html
    The AAFP endorses the following RSV vaccination recommendations from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention: All adults 75 and older should receive a single dose of an RSV vaccine. Adults 60 to 74 who are at increased risk for severe RSV illness should receive a single dose of an RSV vaccine. […] The RSV vaccine is not currently an annual vaccine, so people who have previously received it do not need to get another dose. […] The GSK RSV vaccine (Arexvy) is NOT approved for use during pregnancy.
  • #1 RSV vaccination as the optimal prevention strategy for older adults
    https://pmc.ncbi.nlm.nih.gov/articles/PMC11627484/
    The two newly developed protein-based RSV vaccines are the recombinant, adjuvanted RSV pre-fusion F glycoprotein (RSVPreF3) introduced by GSK with the commercial name of Arexvy, and the bivalent RSV prefusion F protein-based (RSVPreF) vaccine containing F glycoproteins from RSV subtype A and subtype B, named Abrysvo, by Pfizer. These vaccines utilize protein subunits to elicit an immune response, providing targeted protection against the respiratory syncytial virus, and are both approved for the treatment of adults 60 years of age and older. […] The availability of these three vaccines provides a wide range of options for RSV-related severe LRTS prevention, allowing vaccination strategies to be tailored to the diverse needs of the population. […] Continuous education and training for healthcare providers regarding the benefits of RSV vaccination and the specific characteristics of each vaccine are essential. Well-informed healthcare providers are crucial for promoting vaccination and addressing patients questions and concerns.
  • #1 Respiratory Syncytial Virus (RSV) – Institute for Vaccine Safety
    https://www.vaccinesafety.edu/rsv/
    RSVpreF vaccine (AbrysvoTM) is routinely recommended during weeks 32-36 of pregnancy using seasonal administration (September-January in most of the continental US; in jurisdictions with differing seasonality, follow local guidance).2 […] Two RSV vaccines are licensed for use among adults at least 60 years of age in the United States: RSVPreF3 (Arexvy) and RSVpreF (Abrysvo). […] RSVPreF3 includes an AS01 adjuvant, and RSVpreF is bivalent.5,8,9 RSVpreF is also licensed for use among pregnant individuals between 32 and 36 weeks gestational age.8,10 […] Clinical trials found RSVPreF3 to be 83% effective against RSV-associated LRTD and 94% effective against severe RSV-associated LRTD among adults at least 60 years of age.14 […] Clinical trials among adults at least 60 years of age found RSVpreF to be 62% effective against RSV-associated acute respiratory illness, 67% effective against RSV-associated LRTD with at least two symptoms, and 86% effective against RSV-associated LRTD with at least three symptoms.15
  • #1 RSV vaccines: Questions patients may have and how to answer | American Medical Association
    https://www.ama-assn.org/delivering-care/public-health/rsv-vaccines-questions-patients-may-have-and-how-answer
    Respiratory syncytial virus (RSV) season often starts in the fall and peaks in winter. RSV vaccines are available to help reduce risk for severe illness. […] The first vaccines for RSV were licensed by the Food and Drug Administration (FDA) in 2023 for older adults. There are now three RSV vaccines recommended for those 75 or older and for adults 60-74 years old who are at increased risk of severe RSV disease. […] For now, only one dose of the RSV vaccine is recommended. So far, RSV vaccines appear to provide some protection for at least two RSV seasons. […] Vaccination should occur before the onset of the fall and winter RSV season. […] Two immunization products are available for the prevention of severe RSV disease in infants. The maternal RSV vaccine (Pfizer’s Abrysvo) is given during weeks 32 through 36 of pregnancy during September through January in most of the U.S. Maternal antibodies protect the baby against RSV for approximately 6 months after birth.
  • #1 Immunizations to Protect Infants | RSV | CDC
    https://www.cdc.gov/rsv/vaccines/protect-infants.html
    CDC recommends all babies be protected from severe RSV by one of two immunization options: A maternal RSV vaccine given to the mother during pregnancy or an RSV antibody given to your baby. Most babies do not need both. […] The maternal RSV vaccine (Pfizer’s Abrysvo) is given during weeks 32 through 36 of pregnancy. Maternal antibodies protect the baby against RSV for approximately 6 months after birth. […] An RSV antibody (nirsevimab) can be given to babies and some young children. This antibody provides immediate protection against RSV and lasts at least 5 months. […] Protection will last during your baby’s first 6 months, while they are at highest risk of severe RSV. […] An RSV antibody (nirsevimab) is recommended for all babies younger than 8 months of age born to mothers who did not receive a maternal RSV vaccine (Pfizers Abrysvo) during pregnancy.
  • #1 RSV Immunization Guidance for Infants and Young Children | RSV | CDC
    https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html
    To prevent severe RSV disease in infants, either maternal RSV vaccination or infant immunization with the RSV monoclonal antibody (nirsevimab) is recommended. Most infants will not need both. […] Nirsevimab is highly effective in preventing RSV-associated hospitalization. […] Nirsevimab is recommended for infants younger than 8 months of age who are born during or are entering their first RSV season (typically fall through spring) if: The mother did not receive RSV vaccine during pregnancy, or The mothers RSV vaccination status is unknown, or The infant was born within 14 days of maternal RSV vaccination. […] Providers should talk to parents and recommend nirsevimab for eligible babies. […] Nirsevimab should be administered October through the end of March in most of the continental United States.
  • #1 Maternal Respiratory Syncytial Virus Vaccination | ACOG
    https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination
    This Practice Advisory provides guidance for the use of respiratory syncytial virus (RSV) vaccine during pregnancy for the prevention of severe RSV disease in young infants. Pfizers RSVpreF vaccine (trade name Abrysvo) is the only RSV vaccine approved by the U.S. Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) for use during pregnancy to prevent severe illness in young infants. […] The American College of Obstetricians and Gynecologists (ACOG) recommends a single dose of Pfizers RSV vaccine (Abrysvo) for eligible pregnant individuals between 32 0/7 and 36 6/7 weeks of gestation who do not have a planned delivery within 2 weeks, using seasonal administration, to prevent RSV lower respiratory tract infection (LRTI) in infants. […] Clinicians should counsel patients about the maternal RSV vaccine and the monoclonal antibody nirsevimab as safe and effective ways to prevent severe LRTI caused by RSV in infants.
  • #1 Respiratory Syncytial Virus (RSV) – Institute for Vaccine Safety
    https://www.vaccinesafety.edu/rsv/
    Clinical trials among pregnant individuals found RSVpreF to be 82% effective within 90 days after birth and 69% effective within 180 days after birth against RSV-associated severe LRTD; and among the subgroup vaccinated between 32 and 36 weeks gestational age, trials found RSVpreF to be 91% effective within 90 days after birth and 77% effective within 180 days after birth against RSV-associated severe LRTD.10 […] Clinical trials found nirsevimab to reduce medically attended RSV-associated LRTD by 79% and RSV-associated hospitalization by 81% among infants in their first RSV season.1,11 […] The good news about RSV is that there are two effective vaccines for older adults and one for pregnant individuals, as well as one antibody shot for infants and children under 2. […] RSV vaccines are over 60% effective in protecting older adults against RSV […] RSV vaccines given between 32 and 36 weeks of pregnancy are over 90% effective in protecting infants less than 3 months old against severe RSV disease.
  • #1 High level of RSV cases shows room for improvement in vaccine awareness | Association of Health Care Journalists
    https://healthjournalism.org/blog/2025/01/high-level-of-rsv-cases-shows-room-for-improvement-in-vaccine-awareness/
    Maternal RSV vaccine uptake was too low to assess its effectiveness, but nirsevimab was 89% effective against RSV needing medical attention and 93% effective against RSV hospitalization. […] The maternal RSVPreF vaccine (Abryso, made by Pfizer), approved in August 2023, is recommended to be administered between 32-36 weeks of pregnancy so that the antibodies pass through the placenta to the fetus and provide the newborn with antibodies against RSV from birth. […] Based on clinical trial data, the vaccine is approximately 82-91% effective against severe RSV in the first three months after birth and 69-77% effective through six months. […] Nirsevimab is not a vaccine since it does not induce the body to create its own antibodies, but its often referred to informally as one. […] Its a monoclonal antibody that also provides passive immunization by giving the infant preformed antibodies against RSV.
  • #1 Maternal Respiratory Syncytial Virus Vaccination | ACOG
    https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination
    It is critically important that pregnant patients receive all recommended vaccines. Maternal RSV vaccine can be safely administered at the same time as other vaccines routinely recommended during pregnancy. […] The only RSV vaccine approved for use during pregnancy is Pfizers bivalent RSVpreF vaccine, Abrysvo. […] Importantly, while there are RSV vaccines from GSK and Moderna approved for use in older adults, these are not approved for use in pregnancy. Currently, the only RSV vaccine approved for use in pregnancy is Pfizers bivalent RSVpreF vaccine, Abrysvo. […] The Centers for Disease Control and Prevention recommends one dose of nirsevimab for all infants younger than 8 months, born during or entering their first RSV season. […] All infants are recommended to be protected from severe RSV disease by either the maternal RSV vaccine or nirsevimab for RSV season. Both are safe and effective interventions available for RSV prevention in infants, and the CDC has not recommended a preferred approach.
  • #1 Update: What RSV preventatives mean for those with PI | Immune Deficiency Foundation
    https://primaryimmune.org/resources/news-articles/update-what-rsv-preventatives-mean-those-pi
    Importantly, none of the three vaccines contain live virus (or even whole virus), so they cannot cause RSV infections in individuals with PI. […] Based on these trials, the CDCs Advisory Committee on Immunization Practices (ACIP) recommends that everyone 75 and older receive an RSV vaccine in late summer or early fall before RSV season begins. […] ACIP also recommends that those 60-74 years old who are at high risk from RSV speak with their healthcare provider about getting an RSV vaccine. […] Two passive forms of immunity, which do not rely on an individuals immune response, are now available to protect infants: maternal vaccination with Abrysvo and nirsevimab, a long-lasting monoclonal antibody made by AstraZeneca and Sanofi under the trade name Beyfortus. […] In the Abrysvo maternal vaccination trial, vaccination at 24-36 weeks of pregnancy was 81.8% effective in preventing severe RSV in newborns from birth through 6 months of age.
  • #1 U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease
    https://www.businesswire.com/news/home/20241018199265/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-RSV-Vaccine-ABRYSVO%C2%AE-for-Adults-Aged-18-to-59-at-Increased-Risk-for-Disease
    U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO for Adults Aged 18 to 59 at Increased Risk for Disease. […] First and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50. […] Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV. […] Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. […] ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older.
  • #1 RSV vaccines: Questions patients may have and how to answer | American Medical Association
    https://www.ama-assn.org/delivering-care/public-health/rsv-vaccines-questions-patients-may-have-and-how-answer
    There is also an immunization for babies called nirsevimab that can reduce the risk of RSV disease and hospitalizations in infants. […] The CDC recommends one dose of nirsevimab for all infants younger than 8 months, born during or entering their first RSV season, which is typically fall through spring. […] For infants born during or entering their very first RSV season, nirsevimab was 79% effective against RSV medically attended lower respiratory tract illness and 80% effective at preventing hospitalization. […] Both vaccines for older adults are also extremely effective at preventing serious illness from RSV infection.
  • #1 RSV Immunization Guidance for Infants and Young Children | RSV | CDC
    https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html
    Nirsevimab is a monoclonal antibody recommended to children for the prevention of severe RSV disease. It is not a vaccine. RSV vaccines (GSK’s AREXVY, Pfizer’s ABRYSVO, and Moderna’s mResvia) have been approved for adults but are NOT approved for use in infants or young children. […] Early real-world data show that nirsevimab was at least 80-90% effective in preventing babies from being hospitalized with RSV. […] Nirsevimab and routine childhood vaccines can be administered during the same visit. No interval between nirsevimab and live vaccines (such as measles, mumps, and rubella [MMR] and varicella) is necessary.
  • #1 SYNAGIS (palivizumab) for Prevention of Severe RSV Disease
    https://www.synagis.com/what-is-synagis.html
    SYNAGIS helps protect your high-risk baby from severe RSV disease. SYNAGIS helps protect babies from RSV through virus-blocking antibodies. SYNAGIS is not a vaccine; it’s an injection given once a month throughout RSV season, which usually starts in the fall and continues into spring. SYNAGIS gives babies who are born prematurely the virus-blocking antibodies they lack, helping protect their vulnerable lungs from RSV. SYNAGIS can help protect children with certain lung or heart conditions who are at high risk for severe RSV disease. Remember, SYNAGIS is not a vaccine. Children can still get severe RSV disease despite receiving SYNAGIS. Each dose of SYNAGIS helps protect your child from severe RSV disease for about a month. SYNAGIS should be given to high-risk babies every 28-30 days during RSV season. It’s important that babies at high risk for severe RSV disease get every injection of SYNAGIS on time throughout the RSV season. SYNAGIS is used to prevent RSV, and not to treat children who already have RSV.
  • #1 CDC Offers Guidance on Infant RSV Prevention Options – Pulmonology Advisor
    https://www.pulmonologyadvisor.com/news/cdc-offers-guidance-on-infant-rsv-prevention-options/
    Abrysvo, the maternal vaccine for preventing infant RSV, is now available, and nirsevimab, which is administered to infants, should be available in early October. […] The CDC now recommends 2 treatment options for the prevention of RSV in infants: the RSV vaccine (Abrysvo) for seasonal RSV vaccination for pregnant people in 32 through 36 weeks gestation, and (Beyfortus) for all infants less than 8 months of age who are born during or entering their first RSV season and for infants and children aged 8 months through 19 months who are at increased risk for severe RSV and entering their second RSV season. […] The RSV vaccine and nirsevimab are both ACIP-recognized vaccines and will be covered under the Affordable Care Act (ACA). […] Although both the maternal vaccination and infant use of nirsevimab are recommended options for preventing RSV lower respiratory tract infection in infants, the administration of only one of these products is recommended in most infants, according to CDC webinar presenter Jefferson Jones, MD, co-lead of the CDCs RSV Vaccines Pediatric/Maternal Work Group.
  • #1 Immunizations to Protect Infants | RSV | CDC
    https://www.cdc.gov/rsv/vaccines/protect-infants.html
    Nirsevimab is also recommended for a small group of young children 8 through 19 months of age who are at increased risk for severe RSV. […] RSV vaccine (Abrysvo) recommended during week 32-36 of pregnancy: September through January. Nirsevimab recommended for infant: October through March. Immunizations are not recommended to protect infants outside of RSV season. […] It is important for your baby to have protection before RSV season. RSV typically peaks between December and January.
  • #1 RSV prevention tools somewhat cost-effective, studies show | CIDRAP
    https://www.cidrap.umn.edu/respiratory-syncytial-virus-rsv/rsv-prevention-tools-somewhat-cost-effective-studies-show
    University of Michigan and Centers for Disease Control and Prevention (CDC) investigators determined that both maternal respiratory syncytial virus (RSV) vaccination and the monoclonal antibody nirsevimab are likely cost effective in certain situations for RSV. […] Both studies assessed the cost-effectiveness of these products for infants in their first RSV season; the maternal vaccine is administered during weeks 32 to 36 of pregnancy, with maternal antibodies passed through the placenta. […] The monoclonal antibody is given as a one-time injection to infants under 8 months before their first RSV season if they did not benefit from maternal vaccination. […] For nirsevimab, the antibody proved highly effective in preventing RSV-related hospitalizations and other severe outcomes, resulting in an ICER of $153,517 per QALY saved, assuming a cost of $495 in the private sector and $395 through the Vaccines for Children program.
  • #1 RSV prevention tools somewhat cost-effective, studies show | CIDRAP
    https://www.cidrap.umn.edu/respiratory-syncytial-virus-rsv/rsv-prevention-tools-somewhat-cost-effective-studies-show
    The researchers estimated that 107,253 outpatient visits, 38,204 ED visits, and 14,341 hospitalizations could be averted each year if half of eligible US babies receive nirsevimab. […] Though both interventions prove cost-saving, the high market prices for the products, especially nirsevimab, mean the interventions come with significant societal costs. […] The cost of a single dose of maternal vaccine is $295, whereas the market cost of nirsevimab is $495.
  • #1
    https://link.springer.com/article/10.1007/s40121-024-00939-w
    Respiratory syncytial virus (RSV) is an important cause of lower respiratory tract disease in older adults, resulting in substantial morbidity and mortality. […] This study modeled the public health impact of vaccinating older adults in the United States with the adjuvanted RSVPreF3 vaccine. Vaccination was given once at the start of the analysis and the impact was assessed over 3 years. […] Assuming the same vaccination coverage as for influenza vaccines, adjuvanted RSVPreF3 vaccination was estimated to prevent nearly 3 million symptomatic RSV cases over 3 years, including over 1.5 million outpatient visits, over 200,000 hospitalizations, and nearly 17,000 deaths compared with no vaccination. […] Vaccinating adults aged 60 years and older with the adjuvanted RSVPreF3 vaccine provides substantial public health benefits in the United States.
  • #1 The RSV Prevention Divide | Think Global Health
    https://www.thinkglobalhealth.org/article/rsv-prevention-divide
    As the202425 respiratory syncytial virus (RSV) season nears, clinicians in the United States are working to prevent infections. […] In 2023, to protect the country’s youngest and most vulnerable, the United States approved and recommended the RSVpreF vaccine for pregnant women and the monoclonal antibody (mAb) nirsevimab for infants under the age of 2. […] The vaccine reduces the odds of hospitalization during a newborn’s early months of life by 57%; the efficacy of the antibody is 80%. […] This inequity has RSV experts calling for increased access to preventive interventions in LMICs. […] „If those products are authorized and start to be used within the next few years, then there’ll be competition. Prices will likely come down,” Feikin said. […] Given the current landscape, scaling up the production of Pfizers RSVpreF and bolstering maternal vaccination campaigns is the most likely option.
  • #1 The RSV Prevention Divide | Think Global Health
    https://www.thinkglobalhealth.org/article/rsv-prevention-divide
    „Civil society, patients, and health-care workers need to become more vocal about the need for these interventions to be deployed in settings where it’s most required,” he says. […] „We have to start moving away from a complete dependency on external support for the introduction of these life-saving interventions into immunization programs,” he says.
  • #1 Respiratory Syncytial Virus Prevention within Reach: The Vaccine and Monoclonal Antibody Landscape
    https://pmc.ncbi.nlm.nih.gov/articles/PMC9896921/
    Leading strategies for the pediatric population include passive immunoprophylaxis with mAbs for young infants (6 months) and live-attenuated vaccines for active immunization of older infants ( 6 months). Young infants may also be protected by passively transferred antibodies in immunized pregnant women. Stabilized pre-F subunit vaccines are in late-phase development for maternal vaccination. Finally, for older adults three vaccination approaches (nucleic acid, subunit and vector-based) that employ pre-F antigen are in late phase trials. […] RSV prevention appears to be on the horizon with market access expected for nirsevimab within the next 12 to 24 months. This approval may be followed shortly by approval of a maternal vaccine and a vaccine for older adults (subunit, vector-based and nucleic vaccines in late phase trials). In this case a situation will emerge in which multiple RSV vaccine candidates are approved. If all current phase III trials generate positive results, relative efficacy and safety trial data, delivery strategies, and costs may determine vaccine uptake for different maternal and older adult candidates.
  • #1 Respiratory Syncytial Virus Prevention within Reach: The Vaccine and Monoclonal Antibody Landscape
    https://pmc.ncbi.nlm.nih.gov/articles/PMC9896921/
    Respiratory syncytial virus (RSV) is the second most common cause of infant mortality and an important cause of morbidity and mortality in older adults. Efforts to develop an RSV vaccine or immunoprophylaxis remain highly active. Thirty-three RSV prevention candidates are in clinical development using six different approaches: recombinant vector, subunit, particle-based, live-attenuated, chimeric, and nucleic acid in addition to monoclonal antibodies (mAbs). Eight candidates are in phase III clinical trials. Understanding the epitopes targeted by highly neutralizing antibodies has resulted in a shift from empirical to rational and structure-based vaccine and mAb design. An extended half-life mAb for all infants is likely within one year of regulatory approval for high income countries. Live-attenuated vaccines are in development for older infants. Subunit vaccines are in late-stage trials for pregnant women to protect infants, while vector, subunit and nucleic acid approaches are being developed for older adults. Urgent next steps include ensuring access and affordability of an RSV vaccine globally. This review gives an overview of RSV vaccines and mAbs in clinical development highlighting different target populations, antigens, and latest trial results.
  • #1 Addressing the Impact of RSV and Vaccine Hesitancy
    https://www.clevelandclinicmeded.com/online/rsv/decisions/prevention/
    In the Addressing the Impact of RSV and Vaccine Hesitancy educational series, we explore the efficacy of RSV vaccines and discuss preventive strategies aimed at reducing the occurrence of severe RSV respiratory illness in infants, children, and older adults. […] Describe how the risk of RSV infection can be reduced.
  • #1 Treatment and prophylaxis of respiratory syncytial virus (RSV) disease – Scientific guideline | European Medicines Agency (EMA)
    https://www.ema.europa.eu/en/treatment-prophylaxis-respiratory-syncytial-virus-rsv-disease-scientific-guideline
    The guideline covers the clinical development of vaccines and monoclonal antibodies for the prevention of RSV disease and direct acting antiviral agents (DAAs) for the treatment of RSV disease. […] The guideline also addresses vaccination of pregnant women with the aim of preventing RSV disease in their infants. […] The draft guideline proposes some considerations on nonclinical investigations of efficacy and risk of vaccine-associated enhanced disease to support clinical trials with preventive or therapeutic products directed at RSV. […] This concept paper proposes the development of a guideline on the clinical evaluation of medicinal products indicated for the treatment and prophylaxis of respiratory syncytial virus (RSV) infections for which there is no regulatory guidance currently available in the EU.
  • #1 Live-Attenuated RSV Vaccines Supported for HIV-Exposed Uninfected Pediatric Patients
    https://www.infectiousdiseaseadvisor.com/news/live-attenuated-rsv-vaccines-immunogenic-in-hiv-exposed-uninfected-pediatric-patients/
    Given the high morbidity and mortality from respiratory syncytial virus (RSV) among HIV-exposed uninfected pediatric patients during early childhood, live-attenuated RSV vaccine candidates should be prioritized for this population. […] Live-attenuated respiratory syncytial virus (RSV) vaccines are highly immunogenic among HIV-exposed uninfected (HEU) pediatric patients, according to results of a study published in Open Forum Infectious Diseases. […] Given their increased morbidity and mortality during early childhood from RSV ALRI and other infections, HEU children should be prioritized for vaccination as the RSV vaccines currently under development become available. […] Given their increased morbidity and mortality during early childhood from RSV ALRI [acute lower respiratory infection] and other infections, HEU children should be prioritized for vaccination as the RSV vaccines currently under development become available, the researchers concluded.
  • #1 RSV Vaccines Effective, But More People Need to Get Them | URMC Newsroom
    https://www.urmc.rochester.edu/news/story/rsv-vaccines-effective-but-more-people-need-to-get-them
    Since their introduction last year, researchers have been monitoring the real-world impact of the new respiratory syncytial virus (RSV) vaccines. The evidence is clear; individuals should get vaccinated if they have conditions that place them at risk for severe disease. For older adults and those with chronic conditions, RSV should be considered as serious as the flu, and they should get vaccinated, said Branche. […] In 2023, the FDA approved three RSV vaccines for older adults. Studies have shown these vaccines to be effective, with the Pfizer, GSK, and Moderna vaccines preventing RSV pneumonia and bronchitis in more than 80 percent of participants. A recent study published in The Lancet assessed the effectiveness of RSV vaccines using data from a large electronic health record network involving the Centers for Disease Control and Prevention (CDC) and multiple US healthcare systems. The study found that RSV vaccines were 80 percent effective in preventing hospitalization, ICU admission, and death among adults aged 60 and older.
  • #2 RSV Immunization Guidance for Infants and Young Children | RSV | CDC
    https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html
    To prevent severe RSV disease in infants, either maternal RSV vaccination or infant immunization with the RSV monoclonal antibody (nirsevimab) is recommended. Most infants will not need both. […] Nirsevimab is highly effective in preventing RSV-associated hospitalization. […] Nirsevimab is recommended for infants younger than 8 months of age who are born during or are entering their first RSV season (typically fall through spring) if: The mother did not receive RSV vaccine during pregnancy, or The mothers RSV vaccination status is unknown, or The infant was born within 14 days of maternal RSV vaccination. […] Providers should talk to parents and recommend nirsevimab for eligible babies. […] Nirsevimab should be administered October through the end of March in most of the continental United States.
  • #2 Update: What RSV preventatives mean for those with PI | Immune Deficiency Foundation
    https://primaryimmune.org/resources/news-articles/update-what-rsv-preventatives-mean-those-pi
    Importantly, none of the three vaccines contain live virus (or even whole virus), so they cannot cause RSV infections in individuals with PI. […] Based on these trials, the CDCs Advisory Committee on Immunization Practices (ACIP) recommends that everyone 75 and older receive an RSV vaccine in late summer or early fall before RSV season begins. […] ACIP also recommends that those 60-74 years old who are at high risk from RSV speak with their healthcare provider about getting an RSV vaccine. […] Two passive forms of immunity, which do not rely on an individuals immune response, are now available to protect infants: maternal vaccination with Abrysvo and nirsevimab, a long-lasting monoclonal antibody made by AstraZeneca and Sanofi under the trade name Beyfortus. […] In the Abrysvo maternal vaccination trial, vaccination at 24-36 weeks of pregnancy was 81.8% effective in preventing severe RSV in newborns from birth through 6 months of age.
  • #2 Respiratory Syncytial Virus (RSV): The Disease, Vaccines & Monoclonal Antibody | Children’s Hospital of Philadelphia
    https://www.chop.edu/vaccine-education-center/vaccine-details/rsv-vaccine-monoclonal-antibody
    In 2023, tools for preventing RSV became available for two of the most susceptible age groups infants and the elderly. However, each tool works differently. For the elderly, the new tool is a traditional vaccine. For infants, two methods of protection became available: a monoclonal antibody given directly to the infant or vaccination of the pregnant person before delivery. Both methods for protecting babies are forms of passive immunization, meaning using antibodies not generated by the infants own immune system to afford short-term protection. […] Adults 75 years and older are recommended to get a single dose of an RSV vaccine (either Abrysvo, Arexvy, or Mresvia). […] Those 60 to 74 years of age who have conditions that increase their risk of experiencing severe disease are also recommended to get one dose of any of the three RSV vaccines.
  • #2 U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease
    https://www.businesswire.com/news/home/20241018199265/en/U.S.-FDA-Approves-Pfizer%E2%80%99s-RSV-Vaccine-ABRYSVO%C2%AE-for-Adults-Aged-18-to-59-at-Increased-Risk-for-Disease
    U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO for Adults Aged 18 to 59 at Increased Risk for Disease. […] First and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50. […] Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV. […] Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. […] ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older.
  • #2 RSV Vaccine Guidance for Older Adults | RSV | CDC
    https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html
    CDC recommends a single dose of RSV vaccine for older adults to help prevent serious RSV infection and hospitalization. […] Currently, CDC recommends only a single dose of RSV vaccine for all adults ages 75 and older and for adults ages 6074 with increased risk of severe RSV disease. […] The RSV vaccine is not currently an annual vaccine, meaning eligible adults do not need to get a dose every RSV season. […] Eligible adults who have not previously received RSV vaccination may be vaccinated at any time of year, but vaccination will have the most benefit if administered in late summer or early fall, just before the RSV season. […] RSV vaccines can be coadministered with other adult vaccines during the same visit. […] Adverse events after RSV vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS), even if it is not clear that the vaccine caused the adverse event. […] CDC will continue to monitor real-world RSV vaccine effectiveness during each respiratory virus season.
  • #2 News & Views — RSV Prevention in Adults: A Year in Review | Children’s Hospital of Philadelphia
    https://www.chop.edu/vaccine-update-healthcare-professionals/newsletter/news-views-rsv-prevention-adults-year-review
    After a season of experience, real world data, which included more elderly and chronically ill people, demonstrated similar vaccine effectiveness. […] A 75%-80% effectiveness against RSV-associated hospitalization among adults 60 years and older […] A 77% effectiveness against any RSV infection based on visits to the emergency room, visits to urgent care and hospitalization […] A 73%-83% effectiveness against hospitalization among immune-compromised individuals 60 years and older […] A 75% effectiveness against hospitalization among patients 65 years and older with end-stage renal disease. […] The following adults are currently recommended to get RSV vaccine: All adults 75 years and older; Adults 60 to 74 years of age with chronic conditions that put them at increased risk for severe RSV disease.
  • #2 What’s New
    https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Immunization/RSV.aspx
    RSV immunizations are recommended for older adults, pregnant people, and infants. […] RSV vaccines can help protect adults aged 75 and older and adults aged 60-74 who are at increased risk of severe RSV. […] You can get your RSV vaccine at the same visit as your flu and COVID-19 vaccines. […] Two immunization products are recommended by CDC to help children fight RSV infections and protect children from getting very sick from RSV: an RSV vaccine given during pregnancy or an RSV immunization given to a child after birth. […] RSV vaccine is recommended for pregnant people at 32 through 36 weeks of pregnancy during the months of September through January to prevent RSV infections in their infants. […] An RSV immunization called nirsevimab (Beyfortus) can help protect infants and toddlers from severe RSV illness. […] RSV immunizations for children should be covered by most private insurance plans.
  • #2 RSV Vaccines | RSV | CDC
    https://www.cdc.gov/rsv/vaccines/index.html
    RSV vaccines are recommended for all adults ages 75 and older and adults ages 60 74 who are at increased risk for severe RSV. […] There are two immunizations recommended to protect infants from severe RSV: a maternal RSV vaccine (Pfizer’s Abrysvo) given during pregnancy or an RSV antibody given to infants after birth. […] Immunizations to protect against severe RSV – Vaccine for adults ages 60 and over, babies during infancy, including vaccine given to mother during pregnancy.
  • #2 CDC Offers Guidance on Infant RSV Prevention Options – Pulmonology Advisor
    https://www.pulmonologyadvisor.com/news/cdc-offers-guidance-on-infant-rsv-prevention-options/
    Abrysvo, the maternal vaccine for preventing infant RSV, is now available, and nirsevimab, which is administered to infants, should be available in early October. […] The CDC now recommends 2 treatment options for the prevention of RSV in infants: the RSV vaccine (Abrysvo) for seasonal RSV vaccination for pregnant people in 32 through 36 weeks gestation, and (Beyfortus) for all infants less than 8 months of age who are born during or entering their first RSV season and for infants and children aged 8 months through 19 months who are at increased risk for severe RSV and entering their second RSV season. […] The RSV vaccine and nirsevimab are both ACIP-recognized vaccines and will be covered under the Affordable Care Act (ACA). […] Although both the maternal vaccination and infant use of nirsevimab are recommended options for preventing RSV lower respiratory tract infection in infants, the administration of only one of these products is recommended in most infants, according to CDC webinar presenter Jefferson Jones, MD, co-lead of the CDCs RSV Vaccines Pediatric/Maternal Work Group.
  • #2 Maternal Respiratory Syncytial Virus Vaccination | ACOG
    https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination
    It is critically important that pregnant patients receive all recommended vaccines. Maternal RSV vaccine can be safely administered at the same time as other vaccines routinely recommended during pregnancy. […] The only RSV vaccine approved for use during pregnancy is Pfizers bivalent RSVpreF vaccine, Abrysvo. […] Importantly, while there are RSV vaccines from GSK and Moderna approved for use in older adults, these are not approved for use in pregnancy. Currently, the only RSV vaccine approved for use in pregnancy is Pfizers bivalent RSVpreF vaccine, Abrysvo. […] The Centers for Disease Control and Prevention recommends one dose of nirsevimab for all infants younger than 8 months, born during or entering their first RSV season. […] All infants are recommended to be protected from severe RSV disease by either the maternal RSV vaccine or nirsevimab for RSV season. Both are safe and effective interventions available for RSV prevention in infants, and the CDC has not recommended a preferred approach.
  • #2 RSV vaccines: Questions patients may have and how to answer | American Medical Association
    https://www.ama-assn.org/delivering-care/public-health/rsv-vaccines-questions-patients-may-have-and-how-answer
    Respiratory syncytial virus (RSV) season often starts in the fall and peaks in winter. RSV vaccines are available to help reduce risk for severe illness. […] The first vaccines for RSV were licensed by the Food and Drug Administration (FDA) in 2023 for older adults. There are now three RSV vaccines recommended for those 75 or older and for adults 60-74 years old who are at increased risk of severe RSV disease. […] For now, only one dose of the RSV vaccine is recommended. So far, RSV vaccines appear to provide some protection for at least two RSV seasons. […] Vaccination should occur before the onset of the fall and winter RSV season. […] Two immunization products are available for the prevention of severe RSV disease in infants. The maternal RSV vaccine (Pfizer’s Abrysvo) is given during weeks 32 through 36 of pregnancy during September through January in most of the U.S. Maternal antibodies protect the baby against RSV for approximately 6 months after birth.
  • #2 Respiratory syncytial virus prevention is finally here: An overview of safety
    https://www1.racgp.org.au/ajgp/2024/october/respiratory-syncytial-virus-prevention-is-finally
    The products recently approved appropriately focus on highest risk periods, aiming to prevent severe RSV disease in infants and older adults. […] Two RSV vaccines have been approved for adults 60 years in Australia: Arexvy, the GlaxoSmithKline (GSK) RSV vaccine and Abrysvo, the Pfizer RSV vaccine. […] Both are currently recommended as a single-dose course, and can be given at any time of year. […] Arexvy and Abrysvo are both recombinant vaccines containing RSV pre-fusion F protein antigen. […] Abrysvo has been registered for use in pregnancy between 24 and 36 weeks gestation in Australia. […] It is licensed as a single-dose course; in the future this might change to being recommended in each pregnancy. […] Clinical trials of Abrysvo in pregnancy indicated vaccine efficacy of 69% in preventing medically attended severe RSV-associated lower respiratory tract illness (LRTI) and 57% in preventing RSV-associated hospitalisation among infants in the first six months.
  • #2
    https://www.health.nsw.gov.au/immunisation/Pages/respiratory-syncytial-virus.aspx
    The new NSW RSV Prevention Program aims to protect newborn and at-risk infants against RSV and reduce RSV-associated infections and hospitalisations through the transfer of maternal antibodies to the fetus during pregnancy, or provision of passive immunisation to infants not protected by maternal vaccination and eligible at-risk infants. […] Achieving high maternal vaccination coverage is the overarching aim of the program. All pregnant women should be encouraged to be vaccinated with Abrysvo. […] Abrysvo is the only RSV vaccine available for administration to pregnant women. […] A single dose of Abrysvo should be offered year-round to all pregnant women at the 28-week antenatal visit (recommended between 28 to 36 weeks gestation). […] Abrysvo can be co-administered with other antenatal vaccinations including diphtheria, tetanus and pertussis (dTpa) vaccine and influenza vaccines.
  • #2 Update: What RSV preventatives mean for those with PI | Immune Deficiency Foundation
    https://primaryimmune.org/resources/news-articles/update-what-rsv-preventatives-mean-those-pi
    Nirsevimab is a monoclonal antibody that targets the same RSV surface protein as palivizumab and all three vaccines, blocking RSVs ability to infect human cells. […] To protect infants born during RSV season, the CDC recommends either maternal vaccination at 32-36 weeks gestation or immunization with nirsevimab within the first week after birth.
  • #2 Expert Insights on Advances in RSV Prevention and Treatment – NFID
    https://www.nfid.org/expert-insights-on-advances-in-rsv-prevention-and-treatment/
    There are a number of RSV vaccine candidates coming down the pike for children, pregnant women, and adults, that we hope will see the light of day very soon. There also are monoclonal antibodies that exist now for prevention in the highest-risk populations, primarily in premature infants under 29 weeks of age. […] New and innovative tools to prevent and treat RSV have the potential to significantly reduce the burden of disease in young children and older adults in the US. Successful implementation of these tools will rely on raising awareness about RSV and the burden of disease, and on appreciation of the benefits of prevention.
  • #2 RSV (Respiratory Syncytial Virus) Preventive Antibody Immunization Information Statement | CDC
    https://www.cdc.gov/vaccines/vpd/rsv/immunization-information-statement.html
    A respiratory syncytial virus (RSV) preventive antibody can prevent severe lung disease caused by RSV. […] The RSV preventive antibody (generic name nirsevimab, trade name Beyfortus) is a shot that prevents severe RSV disease in infants and young children. […] Infants born during the RSV season (typically fall through spring) should receive a single dose of the RSV Immunization within 1 week after birth. […] Some infants and young children who are at increased risk for severe RSV disease may need a single dose of the RSV antibody before or during their second RSV season. […] RSV preventive antibodies can be given at the same time as vaccines routinely recommended for infants and young children.
  • #2 Immunizations to Protect Infants | RSV | CDC
    https://www.cdc.gov/rsv/vaccines/protect-infants.html
    Nirsevimab is also recommended for a small group of young children 8 through 19 months of age who are at increased risk for severe RSV. […] RSV vaccine (Abrysvo) recommended during week 32-36 of pregnancy: September through January. Nirsevimab recommended for infant: October through March. Immunizations are not recommended to protect infants outside of RSV season. […] It is important for your baby to have protection before RSV season. RSV typically peaks between December and January.
  • #2
    https://www.health.nsw.gov.au/immunisation/Pages/respiratory-syncytial-virus.aspx
    Nirsevimab is a long-acting monoclonal antibody (mAB) and was approved by the TGA in November 2023 for the prevention of RSV lower respiratory tract disease in: neonates and infants born during or entering their first RSV season; children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season. […] Nirsevimab is funded by NSW Health for eligible infants and children. […] Nirsevimab can be given at the same time as routine childhood vaccines. […] In clinical trials a single dose of nirsevimab showed efficacy of 77% against both RSV hospitalisation and very severe medically attended RSV-associated LRTI for up to 150 days after immunisation. […] Early real-world data show that nirsevimab was over 80% effective in preventing infants less than 6 months from being hospitalised with severe RSV. […] Abrysvo was approved for use in pregnant women between 24 to 36 weeks gestation for the prevention of RSV in infants by the Therapeutic Goods Administration (TGA) in March 2024.
  • #2 High level of RSV cases shows room for improvement in vaccine awareness | Association of Health Care Journalists
    https://healthjournalism.org/blog/2025/01/high-level-of-rsv-cases-shows-room-for-improvement-in-vaccine-awareness/
    Maternal RSV vaccine uptake was too low to assess its effectiveness, but nirsevimab was 89% effective against RSV needing medical attention and 93% effective against RSV hospitalization. […] The maternal RSVPreF vaccine (Abryso, made by Pfizer), approved in August 2023, is recommended to be administered between 32-36 weeks of pregnancy so that the antibodies pass through the placenta to the fetus and provide the newborn with antibodies against RSV from birth. […] Based on clinical trial data, the vaccine is approximately 82-91% effective against severe RSV in the first three months after birth and 69-77% effective through six months. […] Nirsevimab is not a vaccine since it does not induce the body to create its own antibodies, but its often referred to informally as one. […] Its a monoclonal antibody that also provides passive immunization by giving the infant preformed antibodies against RSV.
  • #2 CDC Offers Guidance on Infant RSV Prevention Options – Pulmonology Advisor
    https://www.pulmonologyadvisor.com/news/cdc-offers-guidance-on-infant-rsv-prevention-options/
    Seasonal vaccination is recommended September through January in most of the US, but nirsevimab is recommended for infants born outside of the RSV season or less than 34 weeks gestation. […] Providers are advised to inform pregnant patients about both treatment options and to use shared clinical decision-making to determine which treatment option works best for the patient.
  • #2 RSV Adult Vaccine – Schedule Your RSV Vaccine Appointment at CVS
    https://www.cvs.com/immunizations/rsv
    The Centers for Disease Control and Prevention (CDC) recommends getting the RSV vaccine in late summer or early fall for those who are eligible. People can contract RSV any time of the year, but RSV begins to spread more in the fall and winter, and infections usually peak in December and January. A single dose of the RSV vaccine can help prevent severe illness and lung infections due to RSV in adults 60 and over for at least two RSV seasons. If you’re 60 or over, discuss your vaccination options with your health care provider or pharmacist to help you determine if the RSV vaccine is the right choice for your specific needs. […] Research has shown that the available vaccines can help prevent serious RSV-related lung infections in adults ages 60 and older with healthy immune systems. According to the Centers for Disease Control and Prevention (CDC), the RSV vaccine may also help prevent serious illness in people with compromised immune systems due to chronic conditions. The RSV vaccines help your body create an immune response against the virus. Specific effectiveness varies from person to person. Your body’s response to the vaccine may aid in preventing serious illness if you catch RSV.
  • #2 511 – RSV Prophylaxis, PrEP to Prevent HIV, Preventing Physician Suicide
    https://www.carilionclinic.org/news/511—rsv-prophylaxis-prep-to-prevent-hiv-preventing-physician-suicide/
    The effectiveness of the early infancy dose (in per-protocol evaluations of premature and term infants compared to placebo) was 79% to prevent medically-attended RSV, 80% to prevent RSV hospitalization and 90% to prevent RSV ICU admission. […] The cost effectiveness data are telling. For infants 8 months, nirsevimab costs $102,811 per quality-adjusted life year (QALY). For high-risk children 9-18 months, nirsevimab is estimated to cost $1,557,544 per QALY.
  • #2
    https://link.springer.com/article/10.1007/s40121-024-00939-w
    These findings highlight the potential of the adjuvanted RSVPreF3 vaccine to substantially reduce RSV disease burden among US older adults aged 60 years. […] The objective of this study was to estimate the public health impact of RSV vaccination with the adjuvanted RSVPreF3 vaccine compared with no vaccination in US adults aged 60 years. […] The current models results were robust to a wide range of uncertainties in key parameters used to estimate the clinical burden of symptomatic RSV-ARI cases and HCRU avoided with the adjuvanted RSVPreF3 vaccine. […] The present study includes several assumptions and limitations that should be noted. […] This vaccine provides the opportunity to avoid nearly 3 million symptomatic RSV-ARI cases in US older adults over a 3-year period, which would have a considerable impact on associated morbidity and mortality.
  • #2
    https://www.who.int/teams/immunization-vaccines-and-biologicals/diseases/respiratory-syncytial-virus-(rsv)
    The development of Respiratory Syncytial Virus (RSV) vaccines and monoclonal antibodies (mAbs) has been identified as a priority for WHO’s Vaccine Product and Delivery Research Unit, through PDVAC consultation. […] WHO has engaged with PATH through the Advancing Maternal Immunization (AMI) collaboration to develop a more detailed gap analysis describing the evidence, information, and policy needs of global and country decision-makers, public health program planners, and implementers who might be involved in decision-making and introducing maternal RSV vaccines. […] WHO is also engaging with PATH and other partners to raise awareness about RSV and new products on the horizon, to support global, regional, and country decision-making around RSV prevention, policy, and implementation preparedness.
  • #2 The RSV Prevention Divide | Think Global Health
    https://www.thinkglobalhealth.org/article/rsv-prevention-divide
    RSV experts caution that relying solely on RSVpreF cannot be the only solution because it does not address the broader issue of how public health advancements are often developed and implemented without considering LMICs. […] For a vaccine or antibody to be successfully integrated into LMICs, it should align with existing public health infrastructure and be accepted by the target population. […] Developers also need to demonstrate the efficacy of RSV-preventive interventions to LMIC governments to encourage their adoption. […] Supporting the development of respiratory surveillance systems is also critical. […] To ensure immediate change, researchers such as Madhi stress the importance of pressuring pharmaceutical companies to implement tiered pricing that makes vaccines affordable for all LMICs.
  • #2 RSV vaccine and mAb snapshot | PATH
    https://www.path.org/our-impact/resources/rsv-vaccine-and-mab-snapshot/
    This slide provides a snapshot of the respiratory syncytial virus (RSV) vaccine and monoclonal antibody (mAb) technology landscape, in the effort to track the development of RSV vaccine and mAb candidates and provide a summary of the various vaccine approaches being worked on around the world. […] This snapshot pairs with the RSV and mAb Trial Tracker, which provides publicly available information on clinical trials of RSV candidate vaccines and mAbs intended for prevention.
  • #2 Expert Insights on Advances in RSV Prevention and Treatment – NFID
    https://www.nfid.org/expert-insights-on-advances-in-rsv-prevention-and-treatment/
    RSV Vaccines and Monoclonal Antibodies in Development New tools in the prevention and treatment of respiratory syncytial virus (RSV) are moving through the development pipeline, undergoing regulatory review, and under discussion at the Advisory Committee on Immunization Practices (ACIP). As these tools are licensed and ultimately recommended, new options will be available to help reduce the burden of this serious, yet often underappreciated public health threat. […] New tools in development to prevent RSV include vaccines and monoclonal antibodies targeting specific populations, including infants, young children, older adults, pregnant women, and individuals with compromised immune systems. Following approval by the Food and Drug Administration (FDA) and recommendation by the Centers for Disease Control and Prevention (CDC), these tools will be critical for improving disease prevention in future respiratory seasons.
  • #2 RSV Vaccines Effective, But More People Need to Get Them | URMC Newsroom
    https://www.urmc.rochester.edu/news/story/rsv-vaccines-effective-but-more-people-need-to-get-them
    Based on these findings, the US Advisory Committee on Immunization Practices (ACIP) updated guidelines in June 2024 to recommend RSV vaccination for all adults aged 75 and older, those 60 and older in long-term care facilities or with chronic and high-risk health conditions. New research shows that vaccines that target multiple strains of the RSV virus, called bivalent vaccines, may provide longer protection. The vaccine effectively prevented severe RSV-related lower respiratory tract illnesses over two RSV seasons, with an overall efficacy of more than 80 percent.
  • #3 RSV Vaccine VIS | Vaccines & Immunizations | CDC
    https://www.cdc.gov/vaccines/hcp/current-vis/rsv.html
    RSV vaccine can prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV). […] CDC recommends a one-time dose of RSV vaccine for pregnant women from week 32 through week 36 of pregnancy for the prevention of RSV disease in their infants during the first 6 months of life. […] CDC recommends a one-time-dose of RSV vaccine for everyone 75 years and older and for adults 60 through 74 years of age who are at increased risk of severe RSV disease. […] RSV vaccine may be given at the same time as other vaccines.
  • #3 FDA Approves Abrysvo RSV Vaccine for Adults at Increased Risk
    https://www.ajmc.com/view/fda-approves-abrysvo-rsv-vaccine-for-adults-at-increased-risk
    Abrysvo is now approved for adults aged 18-59 years at increased risk for RSV due to chronic conditions, expanding its previous indications. […] The FDA’s decision is based on a phase 3 trial showing safety and efficacy in adults with chronic conditions. […] CDC recommends RSV vaccination for adults over 60 and those at increased risk, using vaccines like Abrysvo. […] Abrysvo is the first and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50 years. […] The FDA has approved Pfizers respiratory syncytial virus (RSV) vaccine, Abrysvo, for adults aged 18 to 59 years who are at increased risk for the disease. […] With this approval, we are proud that Abrysvo is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women.
  • #3 News & Views — RSV Prevention in Adults: A Year in Review | Children’s Hospital of Philadelphia
    https://www.chop.edu/vaccine-update-healthcare-professionals/newsletter/news-views-rsv-prevention-adults-year-review
    Importantly, adults who got an RSV vaccine last fall do NOT need another dose this year. […] With additional data and the benefit of experience related to implementation, the recommendations were updated for 2024. Specifically, clinical trials confirmed the vaccine effectiveness and safety in older adults. […] However, the clinical trial data suggested that it will be as effective as the protein-based vaccines; therefore, the CDC did not make a preferential recommendation for any of the RSV vaccines.
  • #3 CDC study finds RSV vaccines protect older adults from hospitalization | AHA News
    https://www.aha.org/news/headline/2024-09-05-cdc-study-finds-rsv-vaccines-protect-older-adults-hospitalization
    The Centers for Disease Control and Prevention Sept. 4 published a study in JAMA which found older adults who receive a respiratory syncytial virus vaccine are 75% less likely to be hospitalized from RSV compared to those who dont. […] The CDC last month updated RSV vaccine guidance for adults 60 and older, recommending those aged 60-74 at risk for RSV and all aged 75 and older receive one dose of the GSK, Pfizer or Moderna vaccine.
  • #3 RSV Vaccine Guidance for Older Adults | RSV | CDC
    https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html
    CDC recommends a single dose of RSV vaccine for older adults to help prevent serious RSV infection and hospitalization. […] Currently, CDC recommends only a single dose of RSV vaccine for all adults ages 75 and older and for adults ages 6074 with increased risk of severe RSV disease. […] The RSV vaccine is not currently an annual vaccine, meaning eligible adults do not need to get a dose every RSV season. […] Eligible adults who have not previously received RSV vaccination may be vaccinated at any time of year, but vaccination will have the most benefit if administered in late summer or early fall, just before the RSV season. […] RSV vaccines can be coadministered with other adult vaccines during the same visit. […] Adverse events after RSV vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS), even if it is not clear that the vaccine caused the adverse event. […] CDC will continue to monitor real-world RSV vaccine effectiveness during each respiratory virus season.
  • #3 Respiratory Syncytial Virus (RSV) Vaccines | CDC Recommendations | AAFP
    https://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/disease-pop-immunization/rsv-vaccine.html
    Many older adults may not know that they should get an RSV vaccine. Incorporating your patients’ vaccination needs into their regular visits whether for chronic disease management, wellness exams or acute care can help normalize getting vaccinated as part of comprehensive care. […] The AAFP RSV recommendations for pregnant patients: The bivalent RSVpreF maternal RSV vaccine for pregnant patients during 32 through 36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in infants. […] CDC advises healthcare providers to return to recommendations put forward by CDC and the Advisory Committee on Immunization Practices (ACIP) on use of nirsevimab in young children. Infants and children recommended to receive nirsevimab should be immunized as quickly as possible.
  • #3 Respiratory Syncytial Virus (RSV): The Disease, Vaccines & Monoclonal Antibody | Children’s Hospital of Philadelphia
    https://www.chop.edu/vaccine-education-center/vaccine-details/rsv-vaccine-monoclonal-antibody
    In clinical trials, a single dose of the RSV vaccine administered during pregnancy reduced the risk of an RSV infection leading to hospitalization during the first six months of life in 57 of 100 infants born to vaccinated individuals. […] Yes. Babies who get nirsevimab are less likely to require medical intervention for an RSV infection, including going to the emergency room, being hospitalized, ending up in the intensive care unit or needing oxygen. […] The RSV vaccine for adults can cause mild side effects. On the other hand, RSV typically hospitalizes between 60,000-160,000 adults and kills up to 10,000 people each year. […] The RSV vaccine for pregnant people can cause mild side effects. The vaccination benefits the baby from the time of delivery through their first RSV season. […] The RSV monoclonal antibody for infants can cause mild side effects, including injection site reactions and, for some, a rash.
  • #3 High level of RSV cases shows room for improvement in vaccine awareness | Association of Health Care Journalists
    https://healthjournalism.org/blog/2025/01/high-level-of-rsv-cases-shows-room-for-improvement-in-vaccine-awareness/
    In clinical trials, it was approximately 80% effective against RSV for 5 months, which is about the length of a typical RSV season. […] Data from the 2023-2024 RSV season from electronic medical records analysis showed nirsevimab to be 77% effective against RSV-related emergency room visits and 98% effective against RSV-related hospitalization.
  • #4 Closing the Gap in RSV Prevention
    https://www.nfid.org/closing-the-gap-in-rsv-prevention/
    We are now well into the second RSV season since the approval and introduction of new tools to help reduce the risk of severe RSV disease in infants and older adults. […] To help protect older adults, there are now 3 approved RSV vaccines to choose from, and 1 dose of RSV vaccine is recommended for all adults age 75 years and older and those age 60-74 years who are at increased risk for severe RSV. […] To help protect young children, 1 RSV vaccine is recommended for pregnant women late in pregnancy to provide passive immunity to their infants, and a long-acting monoclonal antibody is recommended for any infant born to a mother who did not receive RSV vaccination while pregnant. […] According to the Centers for Disease Control and Prevention (CDC), only about 35% of eligible older adults and 35% of pregnant women have been vaccinated against RSV as of January 4, 2025, and approximately 40% of infants received nirsevimab in 2023-2024.