產品簡介

高端新冠肺炎疫苗(MVC COVID-19 Vaccine)為含SARS-CoV-2重組棘蛋白之次單位疫苗,業經衛生福利部食品藥物管理署核准專案製造。

有關專案製造核准資訊,請見衛生福利部公告

有關公費疫苗施打計畫,請見疾病管制署官網


產品優勢

  1. 疫苗抗原是基因重組棘蛋白S-2P,技術來自於美國NIH,經過基因修飾的S-2P可維持在融合前三聚體構型(trimeric pre-fusion form),使抗原更加穩定。
  2. 疫苗佐劑採用美國Dynavax藥廠的CpG 1018佐劑與鋁鹽佐劑。

最新進度

  • 從2020年底高端新冠肺炎疫苗展開擴大第二期臨床試驗,在3個月內完成3,015名受試者收案。
  • 2021/6/10 由獨立科學專家組成的IDMC獨立數據監測委員會進行期間分析解盲。數據顯示,高端新冠肺炎疫苗安全性與耐受性良好,所有受試者未出現疫苗相關嚴重不良反應。
  • 2021/7/19 取得台灣專案製造核准(EUA)。
  • 2021/10/27 獲選為WHO團結試驗疫苗,於哥倫比亞、馬利及菲律賓三個國家,展開全球萬人規模、多國多中心、多疫苗、適應性、共享安慰劑的第三期臨床試驗。
  • 2022/2/14 取得巴拉圭專案製造核准(EUA)。

新冠肺炎疫苗

藥物開發/臨床前 第一期臨床試驗 第二期臨床試驗 第三期臨床試驗 上市銷售

公開發表文獻

Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in adolescents in Taiwan: A double-blind, randomized, placebo-controlled phase 2 trial

15 March 2022|MedRxiv

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The reactogenicity and immunogenicity of a booster dose after the second dose of a protein subunit vaccine MVC-COV1901: An extension to an open-label, dose-escalation, and non-randomized phase 1 study

4 January 2022|MedRxiv

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Evaluating the Neutralizing Ability of a CpG-Adjuvanted S-2P Subunit Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Variants of Concern

5 November 2021|Clinical Infectious Diseases

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Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan

13 October 2021|The Lancet Respiratory Medicine

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Protection of Hamsters Challenged with SARS-1 CoV-2 Variants of Concern by Two Doses of MVC-COV1901 Vaccine Followed by a Single Dose of Beta Variant Version of MVC-COV1901

29 September 2021|bioRxiv

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Safety and Immunogenicity of CpG 1018 and Aluminium Hydroxide-Adjuvanted SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901: A Large-Scale Double-Blinded, Randomised, Placebo-Controlled Phase 2 Trial

8 August 2021|MedRxiv

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Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVCCOV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study

25 June 2021|EClinicalMedicine

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CpG-adjuvanted stable prefusion SARS-CoV-2 spike protein protected hamsters from SARS-CoV-2 challenge

22 April 2021|Scientific Reports

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Evaluating the neutralizing ability of a CpG-adjuvanted S-2P subunit vaccine against SARS-CoV-2 Variants of Concern

22 March 2021|MedRxiv

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Development of CpG-adjuvanted stable prefusion SARS-CoV-2 spike antigen as a subunit vaccine against COVID-19

18 November 2020|Scientific Reports

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