Introduction

MVC COVID-19 vaccine is a protein subunit vaccine that contains recombinant spike protein of SARS-CoV-2 virus and has been authorized for emergency use by the Taiwan Food and Drug Administration, Ministry of Health and Welfare.

For the Emergency Use Authorization information, please refer to the announcement of the Ministry of Health and Welfare.

For the Government-funded Vaccination, please refer to the official website of the Centers for Disease Control.


Features

  1. The antigen is recombinant spike protein (S-2P) which is licensed from US NIH. The recombinant S-2P protein can maintain the trimeric pre-fusion form to make the antigen more stable.
  2. With adjuvant of aluminum hydroxide and CpG 1018 developed by Dynavax.
  • Indications The MVC COVID-19 vaccine is indicated for active immunization to prevent novel coronavirus disease (COVID-19, also known as severe pneumonia with novel pathogens) in individuals 20 years of age and older.
  • PlatformProtein subunit vaccine
  • Sources of technologyUS National Institutes of Health
  • Dosing and ScheduleInject 0.5 ml of the MVC COVID-19 vaccine into the arm by intramuscular injection. Two doses in total are required. The second dose should be administered 28 days after the first dose.

Progress

  • On 14 February 2022, MVC COVID-19 vaccine has been authorized for emergency use by Paraguay's regulatory authority, Dirección Nacional de Vigilancia Sanitaria (DINAVISA).
  • On 27 October 2021, MVC-COV1901 was selected for WHO COVID-19 Solidarity Trial Vaccines.
  • On 19 July 2021, MVC COVID-19 vaccine has been authorized for emergency use by Taiwan FDA.
  • In June 2021, the independent data monitoring committee (IDMC) conducted an interim analysis of the study. The data showed that MVC COVID-19 vaccine did not elicit serious adverse reactions and is safe and well tolerated.
  • The large-scale Phase II clinical trial for MVC COVID-19 vaccine initiated at the end of 2020, and completed the enrollment of 3,015 subjects within 3 months.

MVC COVID-19 Vaccine

R&D/Preclinical Phase I Phase II Phase III Marketed

Publications

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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