Uso de vacinas contra o vírus sincicial respiratório em idosos: recomendações do Comitê Consultivo sobre Práticas de Imunização — Estados Unidos, 2023
Jul 05, 2023Semanalmente / 21 de julho de 2023 / 72(29);793–801
Michael Melgar, MD1; Amadea Britton, MD1; Lauren E. Roper, MPH1; H. Keipp Talbot, MD2; Sarah S. Longa, MD3; Camille N. Kotton, MD4; Fiona P. Havers, MD1 (ver afiliações dos autores)
O que já se sabe sobre este tema?
O vírus sincicial respiratório (VSR) causa morbidade e mortalidade substanciais em adultos mais velhos. Em maio de 2023, a Food and Drug Administration aprovou as duas primeiras vacinas para prevenção da doença do trato respiratório inferior por VSR (LRTD) para uso em adultos com idade ≥60 anos.
O que é acrescentado por este relatório?
Para ambas as vacinas, a vacinação com uma dose única da vacina contra o VSR demonstrou eficácia moderada a elevada na prevenção de LRTD sintomática associada ao VSR entre adultos com idade ≥60 anos. Em 21 de junho de 2023, o Comitê Consultivo em Práticas de Imunização recomendou que pessoas com idade ≥60 anos pudessem receber uma dose única da vacina contra o VSR, utilizando a tomada de decisão clínica compartilhada.
Quais são as implicações para a prática de saúde pública?
A vacinação contra o VSR pode prevenir morbidade substancial em idosos com risco de doença grave por VSR; a vigilância pós-comercialização para segurança e eficácia orientará as orientações futuras.
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O vírus sincicial respiratório (RSV) é uma causa de doença respiratória grave em idosos. Em maio de 2023, a Food and Drug Administration aprovou as primeiras vacinas para prevenção de doenças do trato respiratório inferior associadas ao VSR em adultos com idade ≥60 anos. Desde maio de 2022, o Grupo de Trabalho de Vacinas contra o Vírus Sincicial Respiratório para Adultos do Comitê Consultivo em Práticas de Imunização (ACIP) se reuniu pelo menos mensalmente para revisar as evidências disponíveis sobre a segurança, imunogenicidade e eficácia dessas vacinas entre adultos com idade ≥60 anos. Em 21 de junho de 2023, o ACIP votou para recomendar que adultos com idade ≥60 anos possam receber uma dose única da vacina contra o VSR, usando uma tomada de decisão clínica compartilhada. Este relatório resume o conjunto de evidências consideradas para esta recomendação e fornece orientação clínica para o uso de vacinas contra VSR em adultos com idade ≥60 anos. As vacinas contra o VSR demonstraram eficácia moderada a alta na prevenção de doenças do trato respiratório inferior associadas ao VSR e têm o potencial de prevenir morbidade e mortalidade substanciais entre adultos mais velhos; a vigilância pós-comercialização orientará as orientações futuras.
Principal
Nos Estados Unidos, o vírus sincicial respiratório (RSV) causa epidemias sazonais de doenças respiratórias. Embora a pandemia de COVID-19 tenha interrompido a circulação sazonal do VSR, o momento e o número de casos incidentes da epidemia de outono e inverno de 2022–23 sugeriram um provável regresso gradual à sazonalidade pré-pandémica (1).
A cada estação, o VSR causa morbidade e mortalidade substanciais em idosos, incluindo doenças do trato respiratório inferior (LRTD), hospitalização e morte. As estimativas de incidência variam amplamente e são afetadas pela subtestagem e pela sensibilidade potencialmente baixa dos testes diagnósticos padrão entre adultos (2–5). A maioria dos casos de doença por VSR em adultos ocorre entre adultos mais velhos, com uma estimativa de 60.000–160.000 hospitalizações e 6.000–10.000 mortes anualmente entre adultos com idade ≥65 anos (5–10).
Adultos com certas condições médicas, incluindo doença pulmonar obstrutiva crônica, asma, insuficiência cardíaca congestiva, doença arterial coronariana, doença cerebrovascular, diabetes mellitus e doença renal crônica, apresentam risco aumentado de hospitalização associada ao VSR (11–13), assim como residentes de instituições de cuidados de longa permanência (14) e pessoas frágeis* ou de idade avançada (a incidência de hospitalização associada ao VSR entre adultos aumenta com a idade, com as taxas mais altas entre aqueles com idade ≥75 anos) (6,15) . O VSR também pode causar doença grave em pessoas com imunidade comprometida, incluindo receptores de transplante de células-tronco hematopoiéticas e pacientes que tomam medicamentos imunossupressores (por exemplo, para transplante de órgãos sólidos, tratamento de câncer ou outras condições) (16,17).
14 days after injection and person-time available from the manufacturer’s pivotal phase 3 trial. Estimates are adjusted for participant age and region./p>1 day. For RSVpreF estimates in this report, LRTD refers to the RSVpreF trial endpoint of LRTI with three or more signs or symptoms./p>14 days after injection and person-time available from the manufacturer’s pivotal phase 3 trial. Estimates are not adjusted./p>14 days after injection and person-time available from the manufacturer’s pivotal phase 3 trial. Estimates adjusted for participant age and region.† LRTD defined as two or more lower respiratory symptoms (new or increased sputum, cough, and dyspnea) or signs (new or increased wheezing, crackles or rhonchi detected during chest auscultation, respiratory rate ≥20 respirations per minute, low or decreased oxygen saturation [<95% or ≤90% if baseline was <95%], and need for oxygen supplementation) for ≥24 hours, including one or more lower respiratory signs, or three or more lower respiratory symptoms for ≥24 hours.§ Medically attended RSV-associated LRTD defined as LRTD plus attention at one or more inpatient or outpatient health care services. Estimates were not included in per-protocol assessments.¶ Season 1 vaccine efficacy estimates reflect efficacy against first events occurring during the first complete RSV season for Northern Hemisphere participants and a partial first RSV season for Southern Hemisphere participants (May 2021–April 2022; exact study-defined season dates were site-dependent).** 96.95% CI; the CI for primary trial endpoint was adjusted for multiplicity.†† 95% CI.§§ Season 2 vaccine efficacy estimates reflect efficacy against first events occurring during the second complete Northern Hemisphere RSV season for Northern Hemisphere participants (August 2022–March 2023; exact study-defined season dates were site-dependent). In addition to Northern Hemisphere participants, Southern Hemisphere participants were also included in these analyses, but this time span reflects an interseason period with low RSV incidence in the Southern Hemisphere.¶¶ Interim analysis underpowered to estimate efficacy.*** Combined season 1 and 2 (interim) vaccine efficacy estimates reflect efficacy against first events occurring any time during Season 1 or Season 2. The mean time from start to end of efficacy surveillance was approximately 15 months per participant.††† 97.5% CI; the CI for primary trial endpoint was adjusted for multiplicity./p>3.9” (>100 mm). For fever, grade 3 corresponded to a temperature >102.2°F (>39°C). For all other reactions, grade 3 corresponded to reactions that prevented normal, everyday activities. Grade 4 events were not defined in these trials.§§ Defined by the Advisory Committee on Immunization Practices Respiratory Syncytial Virus Vaccines Adult Work Group as GBS (including GBS variants), chronic inflammatory demyelinating polyneuropathy, or acute central nervous system inflammation (e.g., transverse myelitis or acute disseminated encephalomyelitis) occurring ≤42 days after vaccination.¶¶ No inflammatory neurologic events were reported in either the phase 3 or phase 1/2 trials. However, across all RSVPreF3 trials inflammatory neurologic events were reported in three of 17,922 adults vaccinated with RSVPreF3. Events included one case of GBS in an open-label phase 3 clinical trial, and two cases of acute disseminated encephalomyelitis among participants in a randomized phase 3 study of coadministration of RSVPreF3 and standard dose seasonal influenza vaccine. Relative risk could not be calculated because neither trial had a placebo-controlled comparator group./p>14 days after injection and person-time available from the manufacturer’s pivotal phase 3 trial. Estimates are unadjusted.† The RSVpreF trial had two co-primary endpoints, defined as RSV LRTI with two or more lower respiratory signs or symptoms lasting >1 day, and RSV LRTI with three or more lower respiratory signs or symptoms lasting >1 day. Lower respiratory signs and symptoms included new or worsened cough, sputum production, wheezing, shortness of breath, and tachypnea. For RSVpreF estimates in this report, LRTD refers to the RSVpreF trial endpoint of RSV LRTI with three or more lower respiratory signs or symptoms.§ Medically attended RSV-associated LRTD was defined as LRTD prompting any health care visit (any outpatient or inpatient visit such as hospitalization, emergency department visit, urgent care visit, home health care services, primary care physician office visit, pulmonologist office visit, specialist office visit, other visit, or telehealth contact). Estimates were not included in per-protocol assessments.¶ Season 1 vaccine efficacy estimates reflect efficacy against first events occurring during the first complete RSV season for Northern and Southern Hemisphere participants (August 2021–October 2022; exact study-defined season dates were site-dependent).** Season 2 (interim) vaccine efficacy estimates reflect efficacy against first events occurring during the second complete RSV season for Northern Hemisphere participants only (July 2022–January 2023; Southern Hemisphere data not yet available).†† Interim analysis underpowered to estimate efficacy.§§ Combined season 1 and 2 (interim) vaccine efficacy estimates reflect efficacy against first events occurring any time during season 1 or season 2. The mean time from start to end of efficacy surveillance was approximately 12 months per participant./p>3.9” (>100 mm) from e-diary or severe grade from adverse event case report form. For fever, grade 3 corresponded to a temperature >102°F (>38.9°C) from e-diary or severe grade from adverse event case report form. For all other reactions, grade 3 corresponded to reactions that prevented normal, everyday activities. Grade 4 event corresponded only to a fever >104°F (>40°C).§§ Defined by the Advisory Committee on Immunization Practices Work Group as GBS (including GBS variants), chronic inflammatory demyelinating polyneuropathy, or acute central nervous system inflammation (e.g., transverse myelitis or acute disseminated encephalomyelitis) occurring ≤42 days after vaccination.¶¶ Across all RSVpreF clinical trials, including trials other than the phase 3 and phase 1/2 trials summarized in this table, inflammatory neurologic events were reported in three of 20,255 adults ≤42 days after vaccination with RSVpreF (all in the phase 3 trial). The events included GBS, Miller Fisher syndrome (a GBS variant), and undifferentiated motor-sensory axonal polyneuropathy. Relative risk could not be calculated because no events were observed in the placebo-controlled comparator group./p>
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