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ホームページ / ニュース / 高齢者における呼吸器合胞体ウイルスワクチンの使用: 予防接種実施に関する諮問委員会の推奨事項 — 米国、2023
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高齢者における呼吸器合胞体ウイルスワクチンの使用: 予防接種実施に関する諮問委員会の推奨事項 — 米国、2023

Jul 05, 2023Jul 05, 2023

週刊 / 2023年7月21日 / 72(29);793–801

マイケル・メルガー、MD1; アマデア・ブリットン、MD1; ローレン E. ローパー、MPH1; H. ケイプ・タルボット医学博士。 サラ・S・ロング、MD3; カミーユ・N・コットン、MD4; Fiona P. Havers、MD1 (著者の所属を表示)

このトピックについてすでにわかっていることは何ですか?

RS ウイルス (RSV) は、高齢者の重大な罹患率と死亡率を引き起こします。 2023年5月、食品医薬品局は、RSV下気道疾患(LRTD)予防のための最初の2つのワクチンを60歳以上の成人に使用することを承認した。

この報告書によって何が追加されましたか?

どちらのワクチン製品でも、単一用量の RSV ワクチンによるワクチン接種は、60 歳以上の成人における症候性 RSV 関連 LRTD の予防において中程度から高い効果を実証しました。 2023 年 6 月 21 日、予防接種の実施に関する諮問委員会は、臨床上の意思決定を共有して、60 歳以上の人が RSV ワクチンの単回接種を受けることを推奨しました。

公衆衛生の実践にはどのような影響がありますか?

RSウイルスワクチン接種は、重度のRウイルス感染症のリスクがある高齢者の重大な罹患を防ぐ可能性がある。 安全性と有効性に関する市販後調査が将来の指針となります。

閲覧数はページビューと PDF ダウンロードの合計に相当します

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RSウイルス(RSV)は、高齢者の重篤な呼吸器疾患の原因となります。 2023年5月、食品医薬品局は60歳以上の成人を対象としたRSV関連下気道疾患の予防のための最初のワクチンを承認した。 2022年5月以来、予防接種の実施に関する諮問委員会(ACIP)呼吸器合胞体ウイルスワクチン成人作業グループは少なくとも毎月会合を開き、60歳以上の成人におけるこれらのワクチンの安全性、免疫原性、有効性に関する入手可能な証拠を検討している。 2023 年 6 月 21 日、ACIP は共通の臨床上の意思決定に基づき、60 歳以上の成人に RSV ワクチンの単回接種を推奨することを決議しました。 この報告書は、この推奨のために検討された一連の証拠を要約し、60 歳以上の成人における RSV ワクチンの使用に関する臨床ガイダンスを提供します。 RSV ワクチンは、RSV 関連の下気道疾患の予防において中程度から高い効果を示しており、高齢者の実質的な罹患率と死亡率を防ぐ可能性があります。 市販後調査が将来の指針となるでしょう。

米国では、呼吸器合胞体ウイルス (RSV) が季節性の呼吸器疾患の流行を引き起こしています。 新型コロナウイルス感染症(COVID-19)のパンデミックにより季節性RSウイルスの流行が中断されたものの、2022年から2023年の秋から冬にかけての流行の時期と発生症例数は、パンデミック前の季節性に徐々に戻る可能性が高いことを示唆していた(1)。

RSV は季節ごとに、下気道疾患 (LRTD)、入院、死亡など、高齢者のかなりの罹患率と死亡率を引き起こします。 発生率の推定値は大きく異なり、成人における標準診断検査の過小検査と潜在的に低い感度の影響を受けます(2-5)。 成人の RSV 感染症のほとんどは高齢者に発生しており、65 歳以上(5 ~ 10 歳)の成人では年間 60,000 ~ 160,000 人が入院し、6,000 ~ 10,000 人が死亡していると推定されています。

慢性閉塞性肺疾患、喘息、うっ血性心不全、冠動脈疾患、脳血管疾患、糖尿病、慢性腎臓病などの特定の病状を患っている成人は、RSウイルス関連入院のリスクが高くなります(11-13)。長期介護施設の入居者(14)、虚弱者*または高齢者(成人におけるRSウイルス関連入院の発生率は年齢とともに増加し、75歳以上で最も高い率となる)(6,15) 。 RSV はまた、造血幹細胞移植のレシピエントや免疫抑制薬を服用している患者(固形臓器移植、がん治療、またはその他の症状のため)など、免疫力が低下している人に重篤な疾患を引き起こす可能性があります (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>