此為全港首款針對60歲或以上長者和嬰兒（於孕婦懷孕期間接種）之RSV疫苗
- 全球首個及唯一一款能夠連續兩個週期針對RSV A亞型和RSV B亞型的二價單劑疫苗已於2024年4月獲香港衛生署獲批使用；另於2024年1月亦獲得澳門藥物監督管理局批准使用
- 預計這款RSV二價疫苗將於2024年6月前在澳門，及其後於2024年8月前在香港推出
香港和澳門2024年5月8日 /美通社/ — 輝瑞今天宣布獲香港衛生署批准推出用於針對由RSV引起的下呼吸道疾病（LRTD）和嚴重LRTD的 RSV融合前F蛋白（RSVpreF）二價疫苗，為60歲或以上長者及初生至六個月大嬰兒提供保護*。
輝瑞是目前唯一一間公司提供同時適用於長者及孕婦之RSV疫苗。RSV是一種傳染性病毒，是造成全球各地呼吸系統疾病的常見起因。1,2 RSV病毒會損害病人的肺部和呼吸道，因此有機會導致嬰兒（尤其是早產或6個月以下嬰兒）以及高風險長者出現嚴重併發症或死亡。2-4 於2019年，全球已錄得3,300萬宗與RSV相關的急性下呼吸道感染，而其中有101,400宗死亡個案涉及5歲或以下兒童。5 至於65歲或以上長者，在 2015 年全球疾病負擔數字估計有33.6萬人入院，14,100人在住院期間死亡。6 在香港，RSV病毒是導致1歲以下幼童住院的最常見呼吸道病毒（佔多過一半病例）。7
輝瑞香港及澳門區域總經理Krishnamoorthy Sundaresan指出：「為改善病人生活質素，輝瑞針對免疫力較弱的長者及嬰兒，3,4 推出一款全新呼吸道合胞病毒疫苗，簡稱RSV疫苗。該疫苗在香港推出後，有助保護嬰兒及長者中因RSV引起的下呼吸道疾病。我們致力加快進度，務求儘快將疫苗推出市場。」
RSV疾病主要由RSV A及RSV B兩種病毒亞群引起，兩種亞群可共同流行或隨著每個週期交替主導。這款二價疫苗不含佐劑，並由兩種融合前F蛋白組成，以發揮針對RSV A和B病毒種類的最佳理想效果，並已證明為安全有效。
衛生署的決定基於兩項臨床試驗的數據：分別是針對長者的RENOIR，以及針對初生嬰兒及幼兒的MATISSE。
RENOIR 是一項全球性、隨機進行的關鍵性第三階段雙盲安慰劑對照臨床試驗（NCT05035212），旨在評估用於60歲或以上長者的單劑疫苗。該研究共招募約37,000名參加者，以1:1的比例隨機使用RSVpreF 120 μg或安慰劑。
MATISSE 則是另一項隨機進行的關鍵性第三階段雙盲安慰劑對照臨床試驗（NCT04424316），旨在評估疫苗能否在妊娠期間接種疫苗的健康婦女所生的嬰兒中，針對因RSV引起的LRTD及嚴重LRTD。
輝瑞香港及澳門醫學總監Eugenia Ng表示：「經過兩個完整RSV週期的疫苗研究，我們對於所得出的結果感到鼓舞，因為這些新數據顯示，接種二價疫苗有機會能同時抵抗兩種能引致疾病的亞型 ― RSV A和RSV B，為接種者提供廣泛而持久的保護。」
該款二價疫苗預計於2024年6月前在澳門，及其後於2024年8月前在香港推出。如欲了解更多疫苗相關資訊，請向所屬地區的醫護人員查詢。
*有關建議的懷孕週期接種時間表，請參閱各地區的處方信息。
About RSVpreF Vaccine
Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as infants through maternal immunization. This bivalent vaccine was designed to provide broad protection against all RSV-LRTD, regardless of the virus subgroup. The RSV fusion protein (F) in the prefusion conformation is a major target of virus infection blocking antibodies and is the basis of Pfizer’s RSV vaccine. Sequence variability in F between RSV subgroup A and B strains clusters in potent neutralizing antibody binding sites on prefusion F.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.hk. In addition, to learn more, please visit us on www.Pfizer.com.hk.
References:
- World Health Organization. Respiratory Syncytial Virus (RSV) disease. Available at: www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/respiratory-syncytial-virus-disease. Accessed May 2024.
- Centers for Disease Control and Prevention. RSV transmission. Available at: www.cdc.gov/rsv/about/transmission.html. Accessed May 2024.
- Centers for Disease Control and Prevention. Respiratory syncytial virus infection (RSV) – Older adults are at high risk for severe RSV infection fact sheet. Available at: www.cdc.gov/rsv/factsheet-older-adults.pdf. Accessed May 2024.
- Centers for Disease Control and Prevention. RSV in Infants and Young Children. Available at: www.cdc.gov/rsv/high-risk/infants-young-children.html. Accessed May 2024.
- Li Y, Wang X, Blau DM, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022;399:2047-2064.
- Shi T, Denouel A, Tietjen AK, et al. Global disease burden estimates of respiratory syncytial virus-associated acute respiratory infection in older adults in 2015: A systematic review and meta-analysis. J Infect Dis 2020;222:S577-S583.
- Chan PKS, Tam WWS, Lee TC, et al. Hospitalization incidence, mortality and seasonality of common respiratory viruses over a period of 15 years in a developed subtropical city. Medicine (Baltimore) 2015;94:e2024.
PP-RES-HKG-0066 MAY 2024