Wirus syncytialny oddechowy (rsv) – Diagnostyka i diagnoza

Wirus syncytialny oddechowy (rsv)
Diagnostyka i diagnoza

Diagnostyka zakażenia wirusem syncytialnym oddechowym (RSV) u dorosłych opiera się głównie na testach molekularnych, zwłaszcza jednopleksowej reakcji RT-PCR, która wykazuje najwyższą czułość. Wykorzystanie różnych próbek, takich jak plwocina (zwiększenie wykrywalności 1,5-krotnie) czy wymaz z gardła (1,3-krotnie), poprawia skuteczność diagnostyki w porównaniu do standardowego wymazu z nosogardzieli. Testy antygenowe, choć mniej czułe, oferują szybsze wyniki, a izolacja wirusa w hodowli pozostaje metodą tradycyjną. Diagnostyka różnicowa powinna uwzględniać sezonowość i objawy kliniczne, a w przypadku podejrzenia powikłań RSV wskazane jest wykonanie badań obrazowych i laboratoryjnych. Szczepionki zatwierdzone przez FDA w 2023-2024 roku dla dorosłych ≥60 lat to: RSVpreF (Abrysvo), RSVPreF3 (Arexvy) oraz mRNA-135 (mRESVIA), z różnymi wskazaniami i mechanizmami działania. Szczepienia kobiet w ciąży między 32 a 36 tygodniem ciąży zmniejszają ryzyko ciężkiego zakażenia RSV u noworodków o około 82% w ciągu pierwszych 90 dni życia.

Diagnostyka wirusa syncytialnego oddechowego (RSV)

Właściwe rozpoznanie zakażenia wirusem syncytialnym oddechowym (RSV) jest kluczowym elementem podejmowania decyzji terapeutycznych oraz odpowiedniego zastosowania szczepionek i immunizacji. Ze względu na niespecyficzne objawy kliniczne, podobne do innych infekcji układu oddechowego, diagnostyka laboratoryjna odgrywa istotną rolę w potwierdzeniu zakażenia RSV¹².

Metody diagnostyczne RSV

Do potwierdzenia zakażenia RSV dostępnych jest kilka typów testów laboratoryjnych. Najczęściej stosowane metody diagnostyczne to:¹

Testy amplifikacji kwasów nukleinowych (NAATs), takie jak reakcja łańcuchowa polimerazy z odwrotną transkryptazą w czasie rzeczywistym (rRT-PCR) – charakteryzują się wysoką czułością w wykrywaniu wirusa¹²
Testy antygenowe – mają zwykle niższą czułość niż NAATs, ale mogą zapewnić szybsze wyniki¹
Izolacja wirusa w hodowli – tradycyjna metoda diagnostyczna³
Wykrywanie antygenów metodą ELISA lub immunofluorescencji³

Zgodnie z systematycznym przeglądem i metaanalizą badań przeprowadzonych między styczniem 2000 a grudniem 2021 roku, jednopleksowa reakcja RT-PCR jest najbardziej czułą metodą diagnostyczną dla RSV u dorosłych⁴. Zastosowanie różnych rodzajów próbek znacząco zwiększa wykrywalność RSV – np. badanie RT-PCR z plwociny zwiększa wykrywalność 1,5-krotnie, a z wymazu z gardła 1,3-krotnie w porównaniu do standardowego wymazu z nosogardzieli⁴.

Kliniczna diagnostyka RSV

Lekarz może podejrzewać zakażenie RSV na podstawie wyników badania fizykalnego oraz pory roku, w której występują objawy. Podczas badania lekarz osłuchuje płuca stetoskopem, aby sprawdzić, czy występują świsty lub inne nieprawidłowe dźwięki⁵. W podstawowej opiece zdrowotnej diagnoza zwykle opiera się na objawach i lokalnej epidemiologii⁶.

RSV jest niedodiagnozowany i niedostatecznie zgłaszany u dorosłych, częściowo dlatego, że standardowe procedury pobierania próbek stosowane do diagnostyki RSV (RT-PCR z wymazów z nosogardzieli) mają ograniczenia u dorosłych, którzy mogą mieć niższe miana wirusa niż zakażone dzieci⁷.

Badania laboratoryjne i obrazowe zazwyczaj nie są konieczne. Jednak mogą pomóc w zdiagnozowaniu powikłań RSV lub wykluczeniu innych stanów, które mogą powodować podobne objawy⁸. Personel medyczny powinien rozważyć RSV w diagnostyce różnicowej pacjentów z chorobą układu oddechowego, szczególnie w sezonie RSV⁹.

Diagnostyka w kontekście szczepień przeciwko RSV

W badaniach klinicznych szczepionek przeciwko RSV, potwierdzenie przypadków RSV było określane za pomocą ilościowej reakcji łańcuchowej polimerazy z odwrotną transkryptazą (RT-PCR) na wymazie z nosogardzieli podczas wszystkich epizodów ostrych infekcji dróg oddechowych¹⁰.

U pacjentów z typowymi objawami zapalenia wielomięśniowego (PMR), ważne jest, aby klinicyści dokładnie przeanalizowali historię szczepień, aby wykluczyć wszelkie potencjalnie związane działania niepożądane. Odnotowano przypadek 72-letniego mężczyzny, u którego wystąpił nowy początek obustronnego bólu barku i sztywności trzy dni po otrzymaniu szczepionki Abrysvo przeciwko RSV¹¹.

Szczepionki przeciwko RSV i diagnostyka

W 2023 i 2024 roku, FDA zatwierdziła trzy szczepionki przeciwko RSV dla dorosłych:¹²

RSVpreF (Abrysvo; Pfizer) – szczepionka dwuwalentna wskazana dla dorosłych w wieku 60 lat i starszych oraz dla kobiet w ciąży w celu zapewnienia ochrony noworodkom¹³
RSVPreF3 (Arexvy; GlaxoSmithKline) – szczepionka z adiuwantem zatwierdzona dla dorosłych w wieku 60 lat i starszych oraz dorosłych w wieku 50-59 lat z podwyższonym ryzykiem choroby dolnych dróg oddechowych związanej z RSV¹⁴
mRNA-135 (mRESVIA; Moderna) – szczepionka mRNA zatwierdzona dla dorosłych w wieku 60 lat i starszych¹⁵¹⁶

Diagnostyka po szczepieniu przeciwko RSV

Ważnym aspektem jest monitorowanie działań niepożądanych po szczepieniu przeciwko RSV. Jeśli dziecko otrzymało profilaktyczne przeciwciało przeciwko RSV bez jednoczesnego szczepienia, a podejrzewasz działanie niepożądane, ty lub twój lekarz możecie złożyć raport za pośrednictwem https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program lub telefonicznie pod numerem 1-800-FDA-1088¹⁷.

Jeśli dziecko otrzymało profilaktyczne przeciwciało przeciwko RSV i szczepionkę jednocześnie, a podejrzewasz działanie niepożądane, ty lub twój lekarz powinniście zgłosić to do Systemu Raportowania Zdarzeń Niepożądanych po Szczepieniach (VAERS) https://vaers.hhs.gov/ lub zadzwonić pod numer 1-800-822-7967¹⁸.

Działania niepożądane po szczepieniu przeciwko RSV powinny być zgłaszane do Systemu Raportowania Zdarzeń Niepożądanych po Szczepieniach (VAERS), nawet jeśli nie jest jasne, czy szczepionka spowodowała działanie niepożądane¹⁹.

Diagnostyka ryzyka zespołu Guillaina-Barrégo po szczepieniu

U niektórych osób starszych po szczepieniu przeciwko RSV zgłaszano poważne schorzenia neurologiczne, w tym zespół Guillaina-Barrégo (GBS). W chwili obecnej nie można potwierdzić ani wykluczyć zwiększonego ryzyka GBS po szczepionce przeciwko RSV u osób w wieku 60 lat i starszych²⁰²¹.

FDA przeprowadziła obserwacyjne badanie po wprowadzeniu do obrotu, które oceniało ryzyko zespołu Guillaina-Barrégo po szczepieniu szczepionkami Abrysvo i Arexvy. Badanie wykorzystywało dane z roszczeń Medicare między majem 2023 a lipcem 2024 roku²².

Wyniki z tego badania serii przypadków z samokontrolą wykazały zwiększone ryzyko GBS w ciągu 42 dni po szczepieniu szczepionką Abrysvo (9 dodatkowych przypadków na milion dawek; wskaźnik częstości występowania [przypadki GBS w oknie ryzyka/oknie kontrolnym], 2,02 [95% CI, 0,93-4,40]) i Arexvy (7 dodatkowych przypadków na milion dawek; wskaźnik częstości występowania, 2,46 [95% CI, 1,19-5,08])²³.

Wyniki tego badania, w połączeniu z danymi z badań klinicznych i raportami do Systemu Raportowania Zdarzeń Niepożądanych po Szczepieniach (VAERS), sugerują zwiększone ryzyko GBS po tych szczepionkach, chociaż nie można było ustalić związku przyczynowego ze względu na niewystarczające dowody²⁴.

Pracownicy służby zdrowia powinni być czujni na oznaki i objawy GBS, aby zapewnić prawidłową diagnozę w celu rozpoczęcia odpowiedniej opieki wspierającej i leczenia oraz wykluczenia innych przyczyn²⁵.

Interpretacja wyników diagnostycznych RSV

Zarówno testy rRT-PCR, jak i testy wykrywania antygenów są skutecznymi metodami diagnozowania RSV. Pracownicy służby zdrowia powinni konsultować się z doświadczonymi laborantami, aby uzyskać więcej informacji na temat rodzaju próbki z dróg oddechowych, którą należy pobrać, interpretacji wyników i oczekiwanej wydajności konkretnego testu²⁶.

Ze względu na niespecyficzne objawy kliniczne i radiograficzne zakażenia RSV, ostateczna diagnoza wymaga wykazania żywego wirusa w hodowli, komponentów wirusowych (antygen RSV), pozytywnej ostrej serologii wirusowej lub RNA wirusa²⁷.

Preferowane są metody molekularne ze względu na wysoką czułość, wysoką swoistość i szybki czas realizacji w ciągu kilku godzin²⁸.

Kodowanie i raportowanie diagnostyki RSV

Kody produktów przeciwciał monoklonalnych RSV znajdują się w sekcji „Immune Globulins, Serum or Recombinant Products” CPT. Nie są to technicznie szczepionki, więc nie należy ich zgłaszać za pomocą tradycyjnych kodów podania szczepionki (np. 90460)²⁹.

Istnieją różne kody do raportowania dostępnych szczepionek przeciwko RSV (obecnie zalecanych dla dorosłych w wieku 60 lat i starszych, a także dla kobiet w ciąży). Należy zgłaszać szczepionki za pomocą następujących kodów, w zależności od produktu:³⁰

90678 – Szczepionka przeciwko wirusowi syncytialnemu układu oddechowego, preF, podjednostkowa, dwuwalentna, do stosowania domięśniowego (dorośli w wieku 60 lat i starsi, plus pacjentki w ciąży w 32-36 tygodniu ciąży)³¹
90679 – Szczepionka przeciwko wirusowi syncytialnemu układu oddechowego, preF, rekombinowana, podjednostkowa, z adiuwantem, do stosowania domięśniowego (dorośli w wieku 60 lat i starsi)³²
90683 – Szczepionka przeciwko wirusowi syncytialnemu układu oddechowego, mRNA nanocząsteczki lipidowe, do stosowania domięśniowego (dorośli w wieku 60 lat i starsi)³³

Należy zgłaszać podanie szczepionek przeciwko RSV za pomocą odpowiedniego kodu podania szczepionki, takiego jak 90471³⁴.

Podczas dokumentowania podania szczepionki Abrysvo kobietom w ciąży, należy udokumentować wiek ciążowy w momencie szczepienia za pomocą prawidłowych kodów diagnostycznych ICD-10-CM (Z3A.32 do Z3A.36). Należy również uwzględnić dodatkowe odpowiednie kody ICD-10-CM wskazujące, że szczepionka została podana podczas wizyty w ciąży: Z23 (szczepienie) lub Z29.11 (spotkanie w celu profilaktycznej immunoterapii przeciwko RSV)³⁵³⁶.

Znaczenie diagnostyki w kontekście szczepień przeciwko RSV

Skuteczna diagnostyka RSV jest kluczowa dla właściwego zastosowania dostępnych szczepionek i produktów przeciwciał monoklonalnych. CDC będzie nadal monitorować skuteczność szczepionki przeciwko RSV w warunkach rzeczywistych w każdym sezonie wirusów oddechowych³⁷.

Dane dotyczące bezpieczeństwa i skuteczności szczepionki AREXVY u osób z czynnikami ryzyka ciężkiej choroby RSV opisanymi przez CDC mogą być ograniczone³⁸.

Skuteczność szczepionki przeciwko RSV zależy od wieku odbiorcy i rodzaju szczepionki. CDC informuje, że badania skuteczności szczepionki Arexvy w rzeczywistych warunkach podczas sezonu wirusów oddechowych 2023-2024 wykazały, że szczepionka jest skuteczna w około 77% w zapobieganiu wizytom w izbie przyjęć związanych z RSV i w 83% w zapobieganiu hospitalizacjom związanym z RSV u dorosłych w wieku 60 lat i starszych³⁹.

Abrysvo okazało się skuteczne w około 79% w zapobieganiu wizytom w izbie przyjęć związanym z RSV i w 73% w zapobieganiu hospitalizacjom związanym z RSV u dorosłych w wieku 60 lat i starszych⁴⁰.

Skuteczność diagnostyki w ocenie szczepionek dla niemowląt

W badaniu kobiet w ciąży, które otrzymały Abrysvo, noworodki miały prawie 82% zmniejszone ryzyko ciężkiego zakażenia dolnych dróg oddechowych w ciągu 90 dni po urodzeniu, jeśli ich matka została zaszczepiona⁴¹.

Badania kliniczne Abrysvo wykazały, że stosowanie szczepionki Abrysvo u kobiet w ciąży zapewniało niemowlętom dobrą ochronę przed ciężkim RSV; ryzyko hospitalizacji z powodu zakażenia RSV zostało zmniejszone o około 60% u niemowląt w ciągu pierwszych 6 miesięcy życia⁴².

Wczesne dane z rzeczywistych warunków pokazują, że nirsewimab był skuteczny w 80-90% w zapobieganiu hospitalizacji niemowląt z powodu RSV⁴³⁴⁴.

Badanie kliniczne fazy 3 wykazało, że nirsewimab zmniejszył infekcje dolnych dróg oddechowych wywołane przez RSV, wymagające opieki medycznej o 76,4%, oraz zmniejszył hospitalizacje związane z RSV u zdrowych donoszonych i prawie donoszonych niemowląt o 76,8%⁴⁵.

Wyzwania i przyszłość diagnostyki RSV w kontekście szczepień

Obciążenie RSV u osób starszych jest niedoszacowane, ponieważ procedury pobierania próbek typowo stosowane do diagnozy RSV (RT-PCR z wymazów z nosogardzieli) mają ograniczenia u dorosłych, którzy mogą mieć niższe miana wirusa niż zakażone dzieci⁴⁶.

Głównym wyzwaniem dla podejścia do szczepień przeciwko RSV jest zrównoważenie osłabienia i immunogenności. Przez kilka dekad niewiele żywych atenuowanych i oczyszczonych kandydatów na szczepionki opartych na białku fuzyjnym lub podjednostkowych przeszło do późnych faz badań, tylko po to, by dać niezadowalające wyniki skuteczności⁴⁷.

Struktura postfuzyjnego F (postF) została określona w 2011 roku. Określenie struktury prefuzyjnego F (preF) okazało się trudniejsze i potrzebne było przeciwciało monoklonalne (mAb), aby zablokować białko w tej metastabilnej aktywnej konformacji⁴⁸.

Perspektywy diagnostyczne w rozwoju szczepionek przeciwko RSV

Pole badań nad RSV jest w bezprecedensowym momencie. W celu ochrony niemowląt przed chorobą RSV, mAby nirsewimab i clesrovimab o przedłużonym okresie półtrwania (YTE) są zatwierdzone na rynku lub zbliżają się do zakończenia oceny fazy 3⁴⁹.

Maternalna dwuwalentna szczepionka podjednostkowa RSVpreF Abrysvo została zatwierdzona przez FDA do podawania między 32 a 36 tygodniem ciąży⁵⁰.

Najbardziej zaawansowane mAb, nirsewimab (nazwa handlowa Beyfortus), wiąże miejsce antygenowe i ma 50-krotnie wyższą aktywność neutralizującą niż paliwizumab. Nirsewimab został zatwierdzony na rynku w Europie i Wielkiej Brytanii oraz został zatwierdzony przez FDA w lipcu 2023 roku⁵¹.

Clesrowimab (MK-1654) jest drugim mAb o przedłużonym okresie półtrwania, który jest w trakcie badań fazy 3⁵².

Alternatywnym podejściem do ochrony niemowląt przez pierwsze kilka miesięcy życia jest szczepienie matczyne, które opiera się na przezłożyskowym przenoszeniu przeciwciał neutralizujących⁵³.

Kandydat na podjednostkową szczepionkę RSV A preF RSVPreF3 został przetestowany w wielu dawkach u nieciężarnych kobiet przed dalszymi testami w dawkach 60 i 120 μg podczas ciąży⁵⁴.

Biorąc pod uwagę postęp zarówno w zakresie nowej generacji mAb, jak i szczepionek matczynych do ochrony małych niemowląt, podejścia te mogą się wzajemnie uzupełniać w zależności od praktyk szczepień, które mogą znacznie różnić się w zależności od lokalizacji⁵⁵.

Wreszcie, udostępnianie wszelkich dostępnych danych z późnej fazy badań, pomimo zakończenia programów szczepionek u osób starszych i niemowląt, będzie kluczowe dla naszego zrozumienia ochronnej odporności i informowania o przyszłym projektowaniu badań klinicznych i wdrażaniu szczepionek⁵⁶.

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Materiały źródłowe

#1 Diagnostic Testing for RSV | RSV | CDC
https://www.cdc.gov/rsv/hcp/clinical-overview/diagnostic-testing.html
Several types of laboratory tests can confirm RSV infection. […] Nucleic acid amplification tests (NAATs), such as PCR tests, are highly sensitive and can be used to diagnose anyone with RSV. Antigen tests are also available. […] Several types of laboratory tests are available to confirm RSV infection. […] The most commonly used types of RSV clinical laboratory tests are: […] Nucleic acid amplification tests (NAATs), such as real-time reverse transcription-polymerase chain reaction (rRT-PCR), are highly sensitive tests for virus detection. […] Antigen tests are generally less sensitive than NAATs but can provide quicker results. […] Both rRT-PCR and antigen detection tests are effective methods for diagnosing RSV. Healthcare providers should consult experienced laboratorians for more information on the type of respiratory specimen to be collected, interpretation of results, and expected performance of the specific test to be used.
#2 RSV Diagnosis, Prevention, and Management | GSK US Medical Affairs
https://gskusmedicalaffairs.com/vaccines/respiratory-syncytial-virus/rsv-diagnosis-prevention-and-management/
RSV Diagnosis, Prevention, and Management […] Testing for RSV is key for diagnosis1,2 […] Diagnosis in primary care is usually based on symptoms and local epidemiology3 RSV is under-diagnosed and under-reported in adults, in part because: […] Different laboratory tests are available to confirm RSV infection:1,2 […] RNA detection by RT-PCR1,2 […] Antigen detection by ELISA or immunofluorescence1,2 […] Culture isolation1,2 […] Currently no specific treatments for RSV are available for adults5 […] The mainstay of therapy for acute infection is supportive care5-7 […] Testing for RSV is key for diagnosis, and the mainstay of therapy is supportive care.
#2 Vaccination for Respiratory Syncytial Virus: A Narrative Review and Primer for Clinicians
https://pmc.ncbi.nlm.nih.gov/articles/PMC10747850/
Molecular methods are preferred, given high sensitivity, high specificity, and rapid turnaround times within hours. […] According to a systematic review and meta-analysis of studies conducted between January 2000 and December 2021, singleplex reverse transcription polymerase chain reaction (RT-PCR) is the most sensitive diagnostic method for RSV in adults. […] The addition of various specimen types to nasopharyngeal swab RT-PCR testing significantly increased RSV detection rates, e.g., sputum RT-PCR increases detection by 1.5 times, and oropharyngeal RT-PCR increases detection by 1.3 times. […] To prevent RSV-associated lower respiratory tract infections in infants born during their first RSV season or entering it, administering maternal RSVpreF vaccination between 24 and 36 weeks of gestation during pregnancy is an alternative to providing immunoprophylaxis.
#3 RSV Diagnosis, Prevention, and Management | GSK US Medical Affairs
https://gskusmedicalaffairs.com/vaccines/respiratory-syncytial-virus/rsv-diagnosis-prevention-and-management/
RSV Diagnosis, Prevention, and Management […] Testing for RSV is key for diagnosis1,2 […] Diagnosis in primary care is usually based on symptoms and local epidemiology3 RSV is under-diagnosed and under-reported in adults, in part because: […] Different laboratory tests are available to confirm RSV infection:1,2 […] RNA detection by RT-PCR1,2 […] Antigen detection by ELISA or immunofluorescence1,2 […] Culture isolation1,2 […] Currently no specific treatments for RSV are available for adults5 […] The mainstay of therapy for acute infection is supportive care5-7 […] Testing for RSV is key for diagnosis, and the mainstay of therapy is supportive care.
#4 Vaccination for Respiratory Syncytial Virus: A Narrative Review and Primer for Clinicians
https://pmc.ncbi.nlm.nih.gov/articles/PMC10747850/
Molecular methods are preferred, given high sensitivity, high specificity, and rapid turnaround times within hours. […] According to a systematic review and meta-analysis of studies conducted between January 2000 and December 2021, singleplex reverse transcription polymerase chain reaction (RT-PCR) is the most sensitive diagnostic method for RSV in adults. […] The addition of various specimen types to nasopharyngeal swab RT-PCR testing significantly increased RSV detection rates, e.g., sputum RT-PCR increases detection by 1.5 times, and oropharyngeal RT-PCR increases detection by 1.3 times. […] To prevent RSV-associated lower respiratory tract infections in infants born during their first RSV season or entering it, administering maternal RSVpreF vaccination between 24 and 36 weeks of gestation during pregnancy is an alternative to providing immunoprophylaxis.
#5 Respiratory syncytial virus (RSV) – Diagnosis & treatment – Mayo Clinic
https://www.mayoclinic.org/diseases-conditions/respiratory-syncytial-virus/diagnosis-treatment/drc-20353104
Your doctor may suspect respiratory syncytial virus based on the findings of a physical exam and the time of year the symptoms occur. During the exam, the doctor will listen to the lungs with a stethoscope to check for wheezing or other abnormal sounds. […] Laboratory and imaging tests aren’t usually needed. However, they can help diagnose respiratory syncytial virus (RSV) complications or rule out other conditions that may cause similar symptoms. Tests may include: […] What tests might be needed? […] FDA approves first vaccine for pregnant individuals to prevent RSV in infants. […] FDA grants vaccine approval for moms-to-be to prevent RSV in newborns.
#6 RSV Diagnosis, Prevention, and Management | GSK US Medical Affairs
https://gskusmedicalaffairs.com/vaccines/respiratory-syncytial-virus/rsv-diagnosis-prevention-and-management/
RSV Diagnosis, Prevention, and Management […] Testing for RSV is key for diagnosis1,2 […] Diagnosis in primary care is usually based on symptoms and local epidemiology3 RSV is under-diagnosed and under-reported in adults, in part because: […] Different laboratory tests are available to confirm RSV infection:1,2 […] RNA detection by RT-PCR1,2 […] Antigen detection by ELISA or immunofluorescence1,2 […] Culture isolation1,2 […] Currently no specific treatments for RSV are available for adults5 […] The mainstay of therapy for acute infection is supportive care5-7 […] Testing for RSV is key for diagnosis, and the mainstay of therapy is supportive care.
#7 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
After decades of work, several interventions to prevent severe respiratory syncytial virus (RSV) disease in high-risk infant and older adult populations have finally been approved. […] The burden of RSV in older adults is underestimated because sampling procedures typically used for RSV diagnosis (RT-PCR from nasopharyngeal swabs) have limitations in adults who can have lower viral titers than infected children. […] Vaccines and other countermeasures that can be used broadly to combat the impact of RSV on these high-risk populations are urgently needed. […] The RSV vaccine field encountered tragedy shortly after discovery of the virus. […] The unexpected failure of FI-RSV made developers balk and approach testing, particularly in antigen-nave infants, with a high degree of caution.
#8 Respiratory syncytial virus (RSV) – Diagnosis & treatment – Mayo Clinic
https://www.mayoclinic.org/diseases-conditions/respiratory-syncytial-virus/diagnosis-treatment/drc-20353104
Your doctor may suspect respiratory syncytial virus based on the findings of a physical exam and the time of year the symptoms occur. During the exam, the doctor will listen to the lungs with a stethoscope to check for wheezing or other abnormal sounds. […] Laboratory and imaging tests aren’t usually needed. However, they can help diagnose respiratory syncytial virus (RSV) complications or rule out other conditions that may cause similar symptoms. Tests may include: […] What tests might be needed? […] FDA approves first vaccine for pregnant individuals to prevent RSV in infants. […] FDA grants vaccine approval for moms-to-be to prevent RSV in newborns.
#9 Clinical Overview of RSV | RSV | CDC
https://www.cdc.gov/rsv/hcp/clinical-overview/index.html
CDC recommends a single dose of RSV vaccine to protect all adults ages 75 and older and adults ages 6074 who are at increased risk of severe RSV. […] To protect infants from severe RSV, CDC recommends an RSV vaccine for pregnant women (Pfizer’s Abrysvo) or a monoclonal antibody (nirsevimab) given to the baby. […] Healthcare providers should consider RSV in the differential diagnosis of patients with respiratory illness, particularly during the RSV season. […] Epidemiologic evidence indicates that all adults ages 75 or older and adults ages 6074 with certain risk factors are at increased risk of severe RSV. […] Health care providers caring for adults aged 6074 years residing in these communities may use clinical judgement, knowledge of local RSV epidemiology, and community incidence of RSV-associated hospitalization to recommend vaccination for a broader population in this age group.
#10 RSV Vaccine | AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)
https://arexvyhcp.com/
AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: individuals 60 years of age and older; individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. […] Vaccination may not protect all recipients. […] The primary objective was to demonstrate the efficacy of AREXVY in the prevention of a first episode of confirmed RSV-A and/or B-associated LRTD during the first season. Confirmed RSV cases were determined by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) on a nasopharyngeal swab during all ARI episodes. […] Data on the safety and efficacy of AREXVY in individuals with these risk factors for severe RSV disease as described by CDC may be limited. […] AREXVY is the first RSV vaccine approved for patients 50-59 years of age who are at increased risk for RSV-LRTD. […] The immunobridging criteria were met in the comparison of adults 50 to 59 years of age with increased risk for RSV-LRTD to adults 60 years of age and older.
#11
https://www.ejcrim.com/index.php/EJCRIM/article/view/4636
Polymyalgia rheumatica (PMR) is a chronic inflammatory disorder that causes stiffness and pain in the proximal joints, including the shoulders, hips and neck. […] The Food and Drug Administration approved the respiratory syncytial virus (RSV) vaccine, which is a recombinant protein vaccine for adults over 60, in May 2023. […] No previous reports of polymyalgia rheumatica onset or relapse have been linked to the RSV vaccine. […] A 72-year-old man experienced a new onset of bilateral shoulder pain and stiffness three days after receiving the Abrysvo RSV vaccine. […] In patients with typical PMR symptoms, it is important for clinicians to carefully review immunisation history to rule out any potentially related adverse effects.
#12 RSV immunization in adults and children: A practical guide for clinicians | Cleveland Clinic Journal of Medicine
https://www.ccjm.org/content/91/9_suppl_1/S11
In 2023 and 2024, 3 vaccines were approved by the US Food and Drug Administration (FDA) against respiratory syncytial virus (RSV) in adults. […] RSVpreF (Abrysvo; Pfizer) is a bivalent vaccine indicated for adults aged 60 and older and also for pregnant women to provide protection in their newborns. […] RSVPreF3 (Arexvy; GlaxoSmithKline) is an adjuvanted vaccine approved for adults aged 60 and older and adults 50 to 59 years of age at an increased risk of RSV-associated lower respiratory tract disease. […] mRNA-135 (mRESVIA; Moderna) is a messenger RNA vaccine approved for adults age 60 and older. […] This review aims to provide clinicians with the tools needed to counsel patients and their families on the risks of RSV infection, the efficacy and safety of RSV immunizations, and the recommendations for their use.
#13 RSV immunization in adults and children: A practical guide for clinicians | Cleveland Clinic Journal of Medicine
https://www.ccjm.org/content/91/9_suppl_1/S11
In 2023 and 2024, 3 vaccines were approved by the US Food and Drug Administration (FDA) against respiratory syncytial virus (RSV) in adults. […] RSVpreF (Abrysvo; Pfizer) is a bivalent vaccine indicated for adults aged 60 and older and also for pregnant women to provide protection in their newborns. […] RSVPreF3 (Arexvy; GlaxoSmithKline) is an adjuvanted vaccine approved for adults aged 60 and older and adults 50 to 59 years of age at an increased risk of RSV-associated lower respiratory tract disease. […] mRNA-135 (mRESVIA; Moderna) is a messenger RNA vaccine approved for adults age 60 and older. […] This review aims to provide clinicians with the tools needed to counsel patients and their families on the risks of RSV infection, the efficacy and safety of RSV immunizations, and the recommendations for their use.
#14 RSV immunization in adults and children: A practical guide for clinicians | Cleveland Clinic Journal of Medicine
https://www.ccjm.org/content/91/9_suppl_1/S11
In 2023 and 2024, 3 vaccines were approved by the US Food and Drug Administration (FDA) against respiratory syncytial virus (RSV) in adults. […] RSVpreF (Abrysvo; Pfizer) is a bivalent vaccine indicated for adults aged 60 and older and also for pregnant women to provide protection in their newborns. […] RSVPreF3 (Arexvy; GlaxoSmithKline) is an adjuvanted vaccine approved for adults aged 60 and older and adults 50 to 59 years of age at an increased risk of RSV-associated lower respiratory tract disease. […] mRNA-135 (mRESVIA; Moderna) is a messenger RNA vaccine approved for adults age 60 and older. […] This review aims to provide clinicians with the tools needed to counsel patients and their families on the risks of RSV infection, the efficacy and safety of RSV immunizations, and the recommendations for their use.
#15 RSV immunization in adults and children: A practical guide for clinicians | Cleveland Clinic Journal of Medicine
https://www.ccjm.org/content/91/9_suppl_1/S11
In 2023 and 2024, 3 vaccines were approved by the US Food and Drug Administration (FDA) against respiratory syncytial virus (RSV) in adults. […] RSVpreF (Abrysvo; Pfizer) is a bivalent vaccine indicated for adults aged 60 and older and also for pregnant women to provide protection in their newborns. […] RSVPreF3 (Arexvy; GlaxoSmithKline) is an adjuvanted vaccine approved for adults aged 60 and older and adults 50 to 59 years of age at an increased risk of RSV-associated lower respiratory tract disease. […] mRNA-135 (mRESVIA; Moderna) is a messenger RNA vaccine approved for adults age 60 and older. […] This review aims to provide clinicians with the tools needed to counsel patients and their families on the risks of RSV infection, the efficacy and safety of RSV immunizations, and the recommendations for their use.
#16 A new vaccine is here to protect you and your loved ones from RSV this winter | NIH MedlinePlus Magazine
https://magazine.medlineplus.gov/article/a-new-vaccine-is-here-to-protect-you-and-your-loved-ones-from-rsv-this-winter
Adults ages 65 and older are at increased risk for RSV infection. […] In the spring of 2024, FDA licensed a new RSV vaccine, called MRESVIA, for adults 60 years of age and older. […] Different RSV immunizations are recommended based on age, risk factors, and pregnancy. […] A doctor can diagnose RSV. They can do tests, such as X-rays and blood or urine tests, to check for complications in people with severe infections. A doctor can also order lab tests, but they are usually for people with severe infections. […] The CDC recommends everyone ages 75 and older (and adults ages 60 to 74 who are at increased risk of severe infection) get an RSV vaccine. Pregnant people during their 32nd through 36th week of pregnancy are also advised to get the ABRYSVO vaccine. Young infants whose mothers did not receive one during pregnancy can receive a protective RSV antibody (different from a vaccine). Talk with your health care provider about the best time to get your vaccine. If you have already gotten an RSV vaccine, you do not need to get another one.
#17 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. […] If your child got an RSV preventive antibody without getting a vaccine at the same time, and you suspect an adverse reaction, you or your health care provider can submit a report through https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or by phone at 1-800-FDA-1088. […] If your child got an RSV preventive antibody and a vaccine at the same time and you suspect an adverse reaction, you or your health care provider should report it to the Vaccine Adverse Event Reporting System (VAERS) https://vaers.hhs.gov/ or call 1-800-822-7967.
#18 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. […] If your child got an RSV preventive antibody without getting a vaccine at the same time, and you suspect an adverse reaction, you or your health care provider can submit a report through https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or by phone at 1-800-FDA-1088. […] If your child got an RSV preventive antibody and a vaccine at the same time and you suspect an adverse reaction, you or your health care provider should report it to the Vaccine Adverse Event Reporting System (VAERS) https://vaers.hhs.gov/ or call 1-800-822-7967.
#19 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. […] 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.
#20 RSV (respiratory syncytial virus) vaccine – what you need to know: MedlinePlus Medical EncyclopediaLock
https://medlineplus.gov/ency/article/007797.htm
RSV vaccine can prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild, cold-like symptoms. […] 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. […] Serious neurologic conditions, including Guillain-BarrÃ© syndrome (GBS), have been reported after RSV vaccination in some older adults. At this time, an increased risk of GBS following RSV vaccine among persons aged 60 years and older cannot be confirmed or ruled out. […] Preterm birth and high blood pressure during pregnancy, including pre-eclampsia, have been reported among pregnant women who received RSV vaccine. It is unclear whether these events were caused by the vaccine.
#21 RSV (respiratory syncytial virus) vaccine – what you need to know Information | Mount Sinai – New York
https://www.mountsinai.org/health-library/special-topic/rsv-respiratory-syncytial-virus-vaccine-what-you-need-to-know
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. […] Serious neurologic conditions, including Guillain-BarrÃ© syndrome (GBS), have been reported after RSV vaccination in some older adults. At this time, an increased risk of GBS following RSV vaccine among persons aged 60 years and older cannot be confirmed or ruled out. […] Preterm birth and high blood pressure during pregnancy, including pre-eclampsia, have been reported among pregnant women who received RSV vaccine. It is unclear whether these events were caused by the vaccine.
#22 RSV Vaccine Labeling Updated With Guillain-BarrÃ© Syndrome Warning
https://www.pulmonologyadvisor.com/news/rsv-vaccine-labeling-updated-with-guillain-barre-syndrome-warning/
According to the FDA, the benefits of vaccination with Abrysvo and Arexvy continue to outweigh the potential risks. […] To assess the risk of GBS with these vaccines, the FDA conducted a postmarketing observational study that used Medicare claims data between May 2023 and July 2024. […] Findings from this self-controlled case series showed an increased risk of GBS during the 42 days following vaccination with Abrysvo (9 excess cases per million doses; incidence rate ratio [GBS cases in the risk window/control window], 2.02 [95% CI, 0.93-4.40]) and Arexvy (7 excess cases per million doses; incidence rate ratio, 2.46 [95% CI, 1.19-5.08]). […] Results of this study, coupled with clinical trial data and reports to the Vaccine Adverse Event Reporting System (VAERS), suggest an increased risk of GBS with these vaccines, though a causal relationship could not be established due to insufficient evidence.
#23 RSV Vaccine Labeling Updated With Guillain-BarrÃ© Syndrome Warning
https://www.pulmonologyadvisor.com/news/rsv-vaccine-labeling-updated-with-guillain-barre-syndrome-warning/
According to the FDA, the benefits of vaccination with Abrysvo and Arexvy continue to outweigh the potential risks. […] To assess the risk of GBS with these vaccines, the FDA conducted a postmarketing observational study that used Medicare claims data between May 2023 and July 2024. […] Findings from this self-controlled case series showed an increased risk of GBS during the 42 days following vaccination with Abrysvo (9 excess cases per million doses; incidence rate ratio [GBS cases in the risk window/control window], 2.02 [95% CI, 0.93-4.40]) and Arexvy (7 excess cases per million doses; incidence rate ratio, 2.46 [95% CI, 1.19-5.08]). […] Results of this study, coupled with clinical trial data and reports to the Vaccine Adverse Event Reporting System (VAERS), suggest an increased risk of GBS with these vaccines, though a causal relationship could not be established due to insufficient evidence.
#24 RSV Vaccine Labeling Updated With Guillain-BarrÃ© Syndrome Warning
https://www.pulmonologyadvisor.com/news/rsv-vaccine-labeling-updated-with-guillain-barre-syndrome-warning/
According to the FDA, the benefits of vaccination with Abrysvo and Arexvy continue to outweigh the potential risks. […] To assess the risk of GBS with these vaccines, the FDA conducted a postmarketing observational study that used Medicare claims data between May 2023 and July 2024. […] Findings from this self-controlled case series showed an increased risk of GBS during the 42 days following vaccination with Abrysvo (9 excess cases per million doses; incidence rate ratio [GBS cases in the risk window/control window], 2.02 [95% CI, 0.93-4.40]) and Arexvy (7 excess cases per million doses; incidence rate ratio, 2.46 [95% CI, 1.19-5.08]). […] Results of this study, coupled with clinical trial data and reports to the Vaccine Adverse Event Reporting System (VAERS), suggest an increased risk of GBS with these vaccines, though a causal relationship could not be established due to insufficient evidence.
#25
https://www.gov.uk/government/publications/respiratory-syncytial-virus-rsv-programme-information-for-healthcare-professionals/rsv-vaccination-of-older-adults-information-for-healthcare-practioners
Overall, the benefits of RSV protection in the eligible group are highly favourable relative to the risks of serious adverse reactions. […] Healthcare professionals should be alert to the signs and symptoms of GBS, to ensure correct diagnosis in order to initiate adequate supportive care and treatment and to rule out other causes. […] Vaccination offers the best protection against RSV infection.
#26 Diagnostic Testing for RSV | RSV | CDC
https://www.cdc.gov/rsv/hcp/clinical-overview/diagnostic-testing.html
Several types of laboratory tests can confirm RSV infection. […] Nucleic acid amplification tests (NAATs), such as PCR tests, are highly sensitive and can be used to diagnose anyone with RSV. Antigen tests are also available. […] Several types of laboratory tests are available to confirm RSV infection. […] The most commonly used types of RSV clinical laboratory tests are: […] Nucleic acid amplification tests (NAATs), such as real-time reverse transcription-polymerase chain reaction (rRT-PCR), are highly sensitive tests for virus detection. […] Antigen tests are generally less sensitive than NAATs but can provide quicker results. […] Both rRT-PCR and antigen detection tests are effective methods for diagnosing RSV. Healthcare providers should consult experienced laboratorians for more information on the type of respiratory specimen to be collected, interpretation of results, and expected performance of the specific test to be used.
#27 Vaccination for Respiratory Syncytial Virus: A Narrative Review and Primer for Clinicians
https://pmc.ncbi.nlm.nih.gov/articles/PMC10747850/
Respiratory syncytial virus (RSV) poses a significant burden on public health, causing lower respiratory tract infections in infants, young children, older adults, and immunocompromised individuals. Recent development and licensure of effective RSV vaccines provide a promising approach to lessening the associated morbidity and mortality of severe infections. […] The paper explores the available RSV vaccines and existing evidence regarding their efficacy and safety in diverse populations. […] With an improved understanding of both RSV infection and RSV vaccination, clinicians can then better guide patients regarding RSV vaccination. […] Given nonspecific clinical and radiographic findings of RSV infection, definitive diagnosis requires demonstration of live virus in culture, viral components (RSV antigen), positive acute viral serology, or viral RNA.
#28 Vaccination for Respiratory Syncytial Virus: A Narrative Review and Primer for Clinicians
https://pmc.ncbi.nlm.nih.gov/articles/PMC10747850/
Molecular methods are preferred, given high sensitivity, high specificity, and rapid turnaround times within hours. […] According to a systematic review and meta-analysis of studies conducted between January 2000 and December 2021, singleplex reverse transcription polymerase chain reaction (RT-PCR) is the most sensitive diagnostic method for RSV in adults. […] The addition of various specimen types to nasopharyngeal swab RT-PCR testing significantly increased RSV detection rates, e.g., sputum RT-PCR increases detection by 1.5 times, and oropharyngeal RT-PCR increases detection by 1.3 times. […] To prevent RSV-associated lower respiratory tract infections in infants born during their first RSV season or entering it, administering maternal RSVpreF vaccination between 24 and 36 weeks of gestation during pregnancy is an alternative to providing immunoprophylaxis.
#29 How to code RSV antibody injections and vaccines | AAFP
https://www.aafp.org/pubs/fpm/blogs/gettingpaid/entry/rsv-antibody-vaccines.html
RSV monoclonal antibody product codes are in CPTs Immune Globulins, Serum or Recombinant Products section. They are not technically vaccines, so you should not report them with traditional vaccine administration codes (e.g., 90460, Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered). […] There are different codes for reporting the available RSV vaccines (currently recommended for adults age 60 and up, as well as pregnant women). […] Report the vaccines with the following codes, depending on the product: 90678 – Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use (adults 60 years and older, plus pregnant patients at 3236 weeks gestation), 90679 Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use (adults 60 years and older), 90683 Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use (adults 60 years and older). […] Report administration of RSV vaccines with the appropriate code for vaccine administration, such as 90471, Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid).
#30 How to code RSV antibody injections and vaccines | AAFP
https://www.aafp.org/pubs/fpm/blogs/gettingpaid/entry/rsv-antibody-vaccines.html
RSV monoclonal antibody product codes are in CPTs Immune Globulins, Serum or Recombinant Products section. They are not technically vaccines, so you should not report them with traditional vaccine administration codes (e.g., 90460, Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered). […] There are different codes for reporting the available RSV vaccines (currently recommended for adults age 60 and up, as well as pregnant women). […] Report the vaccines with the following codes, depending on the product: 90678 – Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use (adults 60 years and older, plus pregnant patients at 3236 weeks gestation), 90679 Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use (adults 60 years and older), 90683 Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use (adults 60 years and older). […] Report administration of RSV vaccines with the appropriate code for vaccine administration, such as 90471, Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid).
#31 How to code RSV antibody injections and vaccines | AAFP
https://www.aafp.org/pubs/fpm/blogs/gettingpaid/entry/rsv-antibody-vaccines.html
RSV monoclonal antibody product codes are in CPTs Immune Globulins, Serum or Recombinant Products section. They are not technically vaccines, so you should not report them with traditional vaccine administration codes (e.g., 90460, Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered). […] There are different codes for reporting the available RSV vaccines (currently recommended for adults age 60 and up, as well as pregnant women). […] Report the vaccines with the following codes, depending on the product: 90678 – Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use (adults 60 years and older, plus pregnant patients at 3236 weeks gestation), 90679 Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use (adults 60 years and older), 90683 Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use (adults 60 years and older). […] Report administration of RSV vaccines with the appropriate code for vaccine administration, such as 90471, Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid).
#32 How to code RSV antibody injections and vaccines | AAFP
https://www.aafp.org/pubs/fpm/blogs/gettingpaid/entry/rsv-antibody-vaccines.html
RSV monoclonal antibody product codes are in CPTs Immune Globulins, Serum or Recombinant Products section. They are not technically vaccines, so you should not report them with traditional vaccine administration codes (e.g., 90460, Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered). […] There are different codes for reporting the available RSV vaccines (currently recommended for adults age 60 and up, as well as pregnant women). […] Report the vaccines with the following codes, depending on the product: 90678 – Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use (adults 60 years and older, plus pregnant patients at 3236 weeks gestation), 90679 Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use (adults 60 years and older), 90683 Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use (adults 60 years and older). […] Report administration of RSV vaccines with the appropriate code for vaccine administration, such as 90471, Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid).
#33 How to code RSV antibody injections and vaccines | AAFP
https://www.aafp.org/pubs/fpm/blogs/gettingpaid/entry/rsv-antibody-vaccines.html
RSV monoclonal antibody product codes are in CPTs Immune Globulins, Serum or Recombinant Products section. They are not technically vaccines, so you should not report them with traditional vaccine administration codes (e.g., 90460, Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered). […] There are different codes for reporting the available RSV vaccines (currently recommended for adults age 60 and up, as well as pregnant women). […] Report the vaccines with the following codes, depending on the product: 90678 – Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use (adults 60 years and older, plus pregnant patients at 3236 weeks gestation), 90679 Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use (adults 60 years and older), 90683 Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use (adults 60 years and older). […] Report administration of RSV vaccines with the appropriate code for vaccine administration, such as 90471, Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid).
#34 How to code RSV antibody injections and vaccines | AAFP
https://www.aafp.org/pubs/fpm/blogs/gettingpaid/entry/rsv-antibody-vaccines.html
RSV monoclonal antibody product codes are in CPTs Immune Globulins, Serum or Recombinant Products section. They are not technically vaccines, so you should not report them with traditional vaccine administration codes (e.g., 90460, Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered). […] There are different codes for reporting the available RSV vaccines (currently recommended for adults age 60 and up, as well as pregnant women). […] Report the vaccines with the following codes, depending on the product: 90678 – Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use (adults 60 years and older, plus pregnant patients at 3236 weeks gestation), 90679 Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use (adults 60 years and older), 90683 Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use (adults 60 years and older). […] Report administration of RSV vaccines with the appropriate code for vaccine administration, such as 90471, Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid).
#35 Respiratory Syncytial Virus (RSV) Vaccine (Abrysvo) Administration, Storage and Coding Tips | ACOG
https://www.acog.org/practice-management/coding/coding-library/respiratory-syncytial-virus-vaccine-abrysvo-administration-storage-and-coding-tips
The maternal respiratory syncytial virus (RSV) vaccine (Pfizers Abrysvo) now has a new seasonal CPT code for administration, effective for dates of service on and after October 6, 2023. […] Administering Abrysvo to pregnant patients can help protect newborns and infants against severe RSV lower respiratory tract infection (LRTI) in the first six months after birth. […] Administer Abrysvo within the correct timeframe to ensure full reimbursement. It can be given to pregnant patients at 32 0/7 through 36 6/7 weeks gestation in a single dose. Administration beyond 36 weeks 6 days is not recommended, as there may not be enough time for antibodies to transfer and provide protection. […] Document the gestational age at the time of vaccination using the correct ICD-10-CM diagnosis codes (Z3A.32 through Z3A.36).
#36 Respiratory Syncytial Virus (RSV) Vaccine (Abrysvo) Administration, Storage and Coding Tips | ACOG
https://www.acog.org/practice-management/coding/coding-library/respiratory-syncytial-virus-vaccine-abrysvo-administration-storage-and-coding-tips
Include additional relevant ICD-10-CM codes indicating a vaccine was administered during a pregnancy visit: Z23 (vaccine encounter). If Z23 is not accepted as the primary diagnosis, try Z29.11 (encounter for prophylactic immunotherapy for RSV). […] Check payer-specific coding requirements for Abrysvo. […] Document the Abrysvo CPT code (90678).
#37 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. […] 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.
#38 RSV Vaccine | AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)
https://arexvyhcp.com/
AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in: individuals 60 years of age and older; individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. […] Vaccination may not protect all recipients. […] The primary objective was to demonstrate the efficacy of AREXVY in the prevention of a first episode of confirmed RSV-A and/or B-associated LRTD during the first season. Confirmed RSV cases were determined by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) on a nasopharyngeal swab during all ARI episodes. […] Data on the safety and efficacy of AREXVY in individuals with these risk factors for severe RSV disease as described by CDC may be limited. […] AREXVY is the first RSV vaccine approved for patients 50-59 years of age who are at increased risk for RSV-LRTD. […] The immunobridging criteria were met in the comparison of adults 50 to 59 years of age with increased risk for RSV-LRTD to adults 60 years of age and older.
#39 RSV Vaccine: What It Is, Who Should Get It, Cost
https://www.everydayhealth.com/lung-respiratory/respiratory-syncytial-virus-vaccine/
The RSV vaccine protects against RSV (respiratory syncytial virus), a common seasonal virus that infects the nose, throat, and lungs. […] RSV vaccination can help prevent dire outcomes. […] Currently, there are three RSV vaccine options. […] The FDA has deemed all these vaccines to be safe and effective based on data from clinical trials. […] The effectiveness of the RSV vaccine depends on the age of the recipient and the type of vaccine. […] The CDC says that studies of the real-world effectiveness of Arexvy during the 20232024 respiratory virus season showed the vaccine to be about 77 percent effective in preventing RSV-associated emergency room visits and 83 percent effective in preventing RSV-associated hospitalizations in adults 60 and older. […] Abrysvo was found to be about 79 percent effective in preventing RSV-associated emergency room visits and 73 percent effective in preventing RSV-related hospitalizations in adults 60 and older.
#40 RSV Vaccine: What It Is, Who Should Get It, Cost
https://www.everydayhealth.com/lung-respiratory/respiratory-syncytial-virus-vaccine/
The RSV vaccine protects against RSV (respiratory syncytial virus), a common seasonal virus that infects the nose, throat, and lungs. […] RSV vaccination can help prevent dire outcomes. […] Currently, there are three RSV vaccine options. […] The FDA has deemed all these vaccines to be safe and effective based on data from clinical trials. […] The effectiveness of the RSV vaccine depends on the age of the recipient and the type of vaccine. […] The CDC says that studies of the real-world effectiveness of Arexvy during the 20232024 respiratory virus season showed the vaccine to be about 77 percent effective in preventing RSV-associated emergency room visits and 83 percent effective in preventing RSV-associated hospitalizations in adults 60 and older. […] Abrysvo was found to be about 79 percent effective in preventing RSV-associated emergency room visits and 73 percent effective in preventing RSV-related hospitalizations in adults 60 and older.
#41 RSV Vaccine: What It Is, Who Should Get It, Cost
https://www.everydayhealth.com/lung-respiratory/respiratory-syncytial-virus-vaccine/
In a study of pregnant individuals who received Abrysvo, newborns had nearly an 82 percent reduced risk of severe lower respiratory tract infection within 90 days after birth if their mother had been vaccinated. […] The FDA has approved only one maternal RSV vaccine, Abrysvo. […] The CDC recommends the RSV vaccine for the following groups. […] The CDC advises eligible older adults to receive whichever brand of RSV vaccine is available, and doesn’t recommend one type over another. […] The effectiveness of the RSV vaccine depends on the age of the recipient and the type of vaccine. […] The FDA has deemed RSV vaccination to be both safe and effective after an evaluation of data from clinical trials. […] In rare instances, a person may experience an extreme allergic reaction (anaphylaxis) to vaccination, causing hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, or weakness. […] The cost of the RSV vaccine depends on your health insurance plan.
#42 Respiratory syncytial virus (RSV) FAQs | NCIRS
https://ncirs.org.au/ncirs-fact-sheets-faqs-and-other-resources/respiratory-syncytial-virus-rsv-frequently-asked
Two types of RSV monoclonal antibody products are available for administration to infants; one RSV vaccine is available for administration to pregnant women to protect the newborn infant. […] In Australia: Abrysvo, an RSV vaccine for pregnant women for protection of their infants, was registered by the Therapeutic Goods Administration (TGA) in March 2024. It is now being funded for pregnant women in Australia under the National Immunisation Program (NIP). […] Beyfortus (nirsevimab), a long-acting monoclonal antibody, was registered by the TGA in November 2023 for use as a single injection in infants. […] Clinical trials for Abyrsvo have shown that use of the Abrysvo vaccine in pregnant women provided infants with good protection from severe RSV; the risk of hospitalisation from RSV infection was reduced by around 60% in infants during their first 6 months of life. […] Clinical trials for Arexvy, Abrysvo and mRESVIA (Moderna; not yet available in Australia) showed good protection against severe RSV disease in adults aged 60 years and over, with around an 80-95% reduction in the risk of severe lower respiratory tract disease in vaccinated individuals.
#43 RSV (Respiratory Syncytial Virus) | Vermont Department of Health
https://www.healthvermont.gov/disease-control/immunizations/rsv-respiratory-syncytial-virus
RSV vaccines are available to protect older adults from severe RSV. Vaccines for pregnant people or an RSV antibody is available to protect babies from severe RSV. […] There are three RSV vaccines approved for use in adults 60 and older: GSK’s AREXVY, Moderna’s mRESVIA, and Pfizer’s ABRYSVO. […] RSV is the leading cause of hospitalization in infants in the U.S. Babies are at higher risk for developing severe RSV because their immune systems and lungs are still developing. […] All babies are recommended to be protected from severe RSV by one of two immunization options. […] The maternal RSV vaccine (Pfizers Abrysvo) is recommended if you are between 32 and 36 weeks pregnant during September through January in most of the U.S. […] 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. […] Early real-world data show that nirsevimab was 80-90% effective in preventing babies from being hospitalized with RSV.
#44 RSV Immunization Guidance for Infants and Young Children | RSV | CDC
https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html
There are limited data with administering nirsevimab with other childhood vaccines. However, nirsevimab is not expected to interfere with the immune response to vaccine products. […] Early real-world data show that nirsevimab was at least 80-90% effective in preventing babies from being hospitalized with RSV. […] In clinical studies in infants who were born during or entering their first RSV season, efficacy was evaluated through 150 days after injection. […] Adverse reactions might occur after administration of nirsevimab alone; these reactions may be reported to MedWatch online, by fax, by mail, or by contacting FDA at 1-800-FDA-1088. […] To learn more about RSV vaccine safety, go to the following page: Respiratory Syncytial Virus (RSV) Vaccine Safety Learn safety information about the Respiratory Syncytial Virus (RSV) vaccine.
#45 Should You Get an RSV Vaccine? > News > Yale Medicine
https://www.yalemedicine.org/news/should-you-get-an-rsv-vaccine
The vaccine is available from September to January to provide protection of newborns when infection rates are expected to be at their highest, between October and March. […] ABRYSVO has been shown to reduce the risk of RSV hospitalization for babies by 57% in the first six months after birth, according to the CDC. […] A Phase 3 clinical trial showed that nirsevimab reduced RSV-triggered lower respiratory tract infections serious enough to require medical care by 76.4% and cut RSV hospitalizations in healthy full-term and near-full-term infants by 76.8%. […] The antibody reduces hospitalization significantly. […] Both doctors say the benefits of the new vaccines for older adults outweigh the potential harms in cases where RSV could be life-threatening. […] According to the CDC, experts are still learning about how long a dose of an RSV vaccine will last, but they note that in people 60 and older, it is expected to last at least two years.
#46 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
After decades of work, several interventions to prevent severe respiratory syncytial virus (RSV) disease in high-risk infant and older adult populations have finally been approved. […] The burden of RSV in older adults is underestimated because sampling procedures typically used for RSV diagnosis (RT-PCR from nasopharyngeal swabs) have limitations in adults who can have lower viral titers than infected children. […] Vaccines and other countermeasures that can be used broadly to combat the impact of RSV on these high-risk populations are urgently needed. […] The RSV vaccine field encountered tragedy shortly after discovery of the virus. […] The unexpected failure of FI-RSV made developers balk and approach testing, particularly in antigen-nave infants, with a high degree of caution.
#47 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
A major challenge for this approach has been balancing attenuation and immunogenicity. […] For several decades, few live attenuated and purified fusion protein or subunit-based vaccine candidates advanced to late-phase testing only to yield unsatisfying efficacy results. […] The structure of postfusion F (postF) was determined in 2011. […] Determining the structure of prefusion F (preF) proved more difficult, and a monoclonal antibody (mAb) was needed to lock the protein in this metastable active conformation. […] Therefore, to elicit the most potent antibodies and in turn, confer the most protection, F-based vaccines need to retain antigenic sites and V. […] The RSV field is at an unprecedented moment. […] For protection of infants from RSV disease, the nirsevimab and clesrovimab half-life extended (YTE) mAbs are market-approved or nearing completion of phase 3 evaluation, respectively.
#48 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
A major challenge for this approach has been balancing attenuation and immunogenicity. […] For several decades, few live attenuated and purified fusion protein or subunit-based vaccine candidates advanced to late-phase testing only to yield unsatisfying efficacy results. […] The structure of postfusion F (postF) was determined in 2011. […] Determining the structure of prefusion F (preF) proved more difficult, and a monoclonal antibody (mAb) was needed to lock the protein in this metastable active conformation. […] Therefore, to elicit the most potent antibodies and in turn, confer the most protection, F-based vaccines need to retain antigenic sites and V. […] The RSV field is at an unprecedented moment. […] For protection of infants from RSV disease, the nirsevimab and clesrovimab half-life extended (YTE) mAbs are market-approved or nearing completion of phase 3 evaluation, respectively.
#49 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
A major challenge for this approach has been balancing attenuation and immunogenicity. […] For several decades, few live attenuated and purified fusion protein or subunit-based vaccine candidates advanced to late-phase testing only to yield unsatisfying efficacy results. […] The structure of postfusion F (postF) was determined in 2011. […] Determining the structure of prefusion F (preF) proved more difficult, and a monoclonal antibody (mAb) was needed to lock the protein in this metastable active conformation. […] Therefore, to elicit the most potent antibodies and in turn, confer the most protection, F-based vaccines need to retain antigenic sites and V. […] The RSV field is at an unprecedented moment. […] For protection of infants from RSV disease, the nirsevimab and clesrovimab half-life extended (YTE) mAbs are market-approved or nearing completion of phase 3 evaluation, respectively.
#50 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
The maternal RSVpreF bivalent subunit vaccine Abrysvo has been FDA approved for administration between 32 and 36 weeks of pregnancy. […] The most advanced mAb, nirsevimab (trade name Beyfortus), binds antigenic site and has 50-fold higher neutralizing activity than palivizumab. […] Nirsevimab has been market-approved in Europe and the UK and was approved by the Food and Drug Administration (FDA) in July 2023. […] Site IV-targeting clesrovimab (MK-1654) is a second half-life extended mAb undergoing phase 3 testing. […] The alternative approach to protect infants through the first several months of life is maternal vaccination, which relies on the transplacental transfer of neutralizing antibodies. […] The RSV A subtype preF subunit candidate RSVPreF3 was tested at multiple doses in nonpregnant women before further testing at 60 and 120g doses during pregnancy.
#51 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
The maternal RSVpreF bivalent subunit vaccine Abrysvo has been FDA approved for administration between 32 and 36 weeks of pregnancy. […] The most advanced mAb, nirsevimab (trade name Beyfortus), binds antigenic site and has 50-fold higher neutralizing activity than palivizumab. […] Nirsevimab has been market-approved in Europe and the UK and was approved by the Food and Drug Administration (FDA) in July 2023. […] Site IV-targeting clesrovimab (MK-1654) is a second half-life extended mAb undergoing phase 3 testing. […] The alternative approach to protect infants through the first several months of life is maternal vaccination, which relies on the transplacental transfer of neutralizing antibodies. […] The RSV A subtype preF subunit candidate RSVPreF3 was tested at multiple doses in nonpregnant women before further testing at 60 and 120g doses during pregnancy.
#52 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
The maternal RSVpreF bivalent subunit vaccine Abrysvo has been FDA approved for administration between 32 and 36 weeks of pregnancy. […] The most advanced mAb, nirsevimab (trade name Beyfortus), binds antigenic site and has 50-fold higher neutralizing activity than palivizumab. […] Nirsevimab has been market-approved in Europe and the UK and was approved by the Food and Drug Administration (FDA) in July 2023. […] Site IV-targeting clesrovimab (MK-1654) is a second half-life extended mAb undergoing phase 3 testing. […] The alternative approach to protect infants through the first several months of life is maternal vaccination, which relies on the transplacental transfer of neutralizing antibodies. […] The RSV A subtype preF subunit candidate RSVPreF3 was tested at multiple doses in nonpregnant women before further testing at 60 and 120g doses during pregnancy.
#53 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
The maternal RSVpreF bivalent subunit vaccine Abrysvo has been FDA approved for administration between 32 and 36 weeks of pregnancy. […] The most advanced mAb, nirsevimab (trade name Beyfortus), binds antigenic site and has 50-fold higher neutralizing activity than palivizumab. […] Nirsevimab has been market-approved in Europe and the UK and was approved by the Food and Drug Administration (FDA) in July 2023. […] Site IV-targeting clesrovimab (MK-1654) is a second half-life extended mAb undergoing phase 3 testing. […] The alternative approach to protect infants through the first several months of life is maternal vaccination, which relies on the transplacental transfer of neutralizing antibodies. […] The RSV A subtype preF subunit candidate RSVPreF3 was tested at multiple doses in nonpregnant women before further testing at 60 and 120g doses during pregnancy.
#54 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
The maternal RSVpreF bivalent subunit vaccine Abrysvo has been FDA approved for administration between 32 and 36 weeks of pregnancy. […] The most advanced mAb, nirsevimab (trade name Beyfortus), binds antigenic site and has 50-fold higher neutralizing activity than palivizumab. […] Nirsevimab has been market-approved in Europe and the UK and was approved by the Food and Drug Administration (FDA) in July 2023. […] Site IV-targeting clesrovimab (MK-1654) is a second half-life extended mAb undergoing phase 3 testing. […] The alternative approach to protect infants through the first several months of life is maternal vaccination, which relies on the transplacental transfer of neutralizing antibodies. […] The RSV A subtype preF subunit candidate RSVPreF3 was tested at multiple doses in nonpregnant women before further testing at 60 and 120g doses during pregnancy.
#55 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
Given the advancement of both next generation mAbs and maternal vaccines for the protection of young infants, these approaches may complement each other depending on vaccination practices, which may vary greatly by location. […] Several vaccines for protection of older adults are completing phase 3 pivotal trials. […] Arexvy was approved by the FDA for use in adults over 60 on May 3, 2023, making it the worlds first approved RSV vaccine. […] Abrysvo, recently approved for prevention of RSV disease in infants of vaccinated mothers, also protects older adults from disease. […] Finally, sharing of any available late-phase data despite the termination of vaccine programs in older adults and infants will be vital for our understanding of protective immunity and to inform future trial design and implementation of vaccines going forward.
#56 The road to approved vaccines for respiratory syncytial virus | npj Vaccines
https://www.nature.com/articles/s41541-023-00734-7
Given the advancement of both next generation mAbs and maternal vaccines for the protection of young infants, these approaches may complement each other depending on vaccination practices, which may vary greatly by location. […] Several vaccines for protection of older adults are completing phase 3 pivotal trials. […] Arexvy was approved by the FDA for use in adults over 60 on May 3, 2023, making it the worlds first approved RSV vaccine. […] Abrysvo, recently approved for prevention of RSV disease in infants of vaccinated mothers, also protects older adults from disease. […] Finally, sharing of any available late-phase data despite the termination of vaccine programs in older adults and infants will be vital for our understanding of protective immunity and to inform future trial design and implementation of vaccines going forward.