MVC COVID-19 vaccine

Last updated

MVC COVID-19 vaccine
Vaccine description
Target SARS-CoV-2
Vaccine type Protein subunit
Clinical data
Other namesMVC-COV1901
Routes of
Legal status
Legal status
  • Full and emergency authorizations
Full list of MVC vaccine authorizations

The MVC COVID-19 vaccine (Chinese :高端新冠肺炎疫苗; pinyin :Gāoduān xīnguàn fèiyán yìmiáo; Wade–Giles :Kaotuan hsinkuan feiyen yimiao), designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine , is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation in Taiwan, American company Dynavax Technologies and the U.S. National Institute of Health. [1] [2]



This vaccine is made by the recombinant S-2P spike protein. [3] It is adjuvanted with CpG 1018 supplied by Dynavax, which was used in a previously FDA-approved adult hepatitis B vaccine. [3] [4]

Clinical trials

On 16 February 2020, Medigen Vaccine Biologics Corporation (MVC) signed a collaboration agreement with National Institutes of Health (NIH) for COVID-19 vaccine development. The partnership will allow MVC to obtain NIH's COVID-19 vaccine and related biological materials to conduct animal studies in Taiwan. [5] On 23 July 2020, Medigen announced collaboration with Dynavax Technologies to develop COVID-19 vaccine. [4] [6]

On 13 October 2020, MVC received Taiwan's government subsidies for the initiation of Phase 1 Clinical Trial in Taiwan starting early October. The Phase 1 Clinical Trial was held at National Taiwan University Hospital with 45 participants ranging the age of 20–50. [7] [8]

On 25 January 2021, MVC initiated Phase 2 Clinical Trial for its COVID-19 vaccine candidate MVC-COV1901 with the first participant being dosed. The Phase 2 Clinical Trial for the MVC COVID-19 vaccine was a randomized, double-blinded, and multi-center clinical trial, planned to enroll 3,700 participants of any age 20 above. [3] [9] [10]

On 10 June 2021, MVC released its COVID-19 vaccine Phase 2 interim analysis results, which demonstrates good safety profile in participants. The Phase 2 Clinical Trial in the end included 3,800 participants with all participants receiving second dose by 28 April 2021. MVC announced that it will request Emergency Use Authorization (EUA) with the concluding of the Phase 2 Clinical Trial. [11]

Preliminary results from Phase I trials on 77 participants were published in June 2021, indicating what the authors described as "robust" immune system response elicited by the vaccine. The study assessed the humoral immune response by measuring quantities of binding IgG to S protein, and also the cellular immune response by measuring the quantities of IFN-γ and IL-4 secreting T cells. [12]

On 20 July 2021, MVC filed a Phase 3 Clinical Trial IND application with Paraguay's regulatory authority, which was later approved. The Phase 3 Clinical Trial, however, was different from regular Phase 3 Clinical Trial, which uses immune-bridging trial to compare the performance of MVC COVID-19 vaccine with the Oxford-AstraZeneca COVID-19 vaccine. [13] The decision was a controversial announcement as immune-bridging trials were not fully approved or widely accepted by health authorities. In addition, the accuracy of immune-bridging trials were also been questioned for years.[ citation needed ]

Adolescents trial

In July 2021, Medigen commenced phase II trials for adolescents aged 12–18. [14]


On July 19, 2021, MVC COVID-19 vaccine obtained Emergency Use Authorization (EUA) approval from the Taiwanese government after fulfilling EUA requirements set by Taiwanese authority. [15] The EUA, however, was met with controversy due to the lack of efficacy data and Phase 3 Clinical Trial. On August 23, 2021, President Tsai Ing-Wen was among the first Taiwanese to receive a dose of the vaccine. [16]

Tsai Ing-Wen receiving a dose of the vaccine 2021. 08.23 Zong Tong Shi Da Yi Miao  (51396127301).jpg
Tsai Ing-Wen receiving a dose of the vaccine


In May 2021, when Taiwan experienced an outbreak of domestic cases, government announced the vaccine would be available in July despite the result of the phase 2 trial had yet to be announced; in June 2021, the vaccine was still under clinical trial without obtained EUA, but the vaccine was sent to Taiwan FDA for the application of EUA. [17] Seroconversion rate was used as the surrogate endpoint, though there was lack of evidence at that time. Compared to EUA of vaccine issued in the US, both Moderna and BNT/Pfizer vaccine finished interim analysis from Phase 3 study, which Medigen vaccine skipped. [18]

Related Research Articles

H5N1 vaccine clinical trials

H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.

Arcturus Therapeutics is an American RNA medicines biotechnology company focused on the discovery, development and commercialization of therapeutics for rare diseases and infectious diseases. Arcturus has developed a novel, potent, and safe RNA therapeutics platform called LUNAR, a proprietary lipid-enabled delivery system for nucleic acid medicines including small interfering RNA (siRNA), messenger RNA (mRNA), gene editing RNA, DNA, antisense oligonucleotides (ASO), and microRNA.

Valneva SE is a French biotech company headquartered in Saint-Herblain, France, developing and commercializing vaccines for infectious diseases. It has manufacturing sites in Livingston, Scotland; Solna, Sweden and Vienna, Austria, with other offices in France, Canada and the United States.

COVID-19 vaccine Vaccine designed to provide acquired immunity against SARS-CoV-2

A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID‑19). Prior to the COVID‑19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. On 10 January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by 19 March, the global pharmaceutical industry announced a major commitment to address COVID-19. The COVID‑19 vaccines are widely credited for their role in reducing the spread, severity, and death caused by COVID-19.

Convidecia Vaccine against COVID-19

AD5-nCOV, trade-named Convidecia, is a single-dose viral vector vaccine for COVID-19 developed by CanSino Biologics. It conducted its Phase III trials in Argentina, Chile, Mexico, Pakistan, Russia, and Saudi Arabia with 40,000 participants.

Casirivimab/imdevimab Antiviral combination medication

Casirivimab/imdevimab, sold under the brand name REGEN-COV among others, is a combination medicine used for the treatment and prevention of COVID-19. It consists of two human monoclonal antibodies, casirivimab and imdevimab that must be mixed together. The combination of two antibodies is intended to prevent mutational escape. It is also available as a co-formulated product. It was developed by the American biotechnology company Regeneron Pharmaceuticals.

Valneva COVID-19 vaccine Vaccine candidate against COVID-19

Valneva COVID-19 vaccine, also known as the VLA2001 and VLA2101 , is a COVID-19 vaccine candidate developed by French biotechnology company Valneva SE in collaboration with American company Dynavax Technologies.

ZF2001 Vaccine against COVID-19

ZF2001, trade-named Zifivax or ZF-UZ-VAC-2001, is an adjuvanted protein subunit COVID-19 vaccine developed by Anhui Zhifei Longcom in collaboration with the Institute of Microbiology at the Chinese Academy of Sciences. The vaccine candidate is in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan, and Uzbekistan.

Janssen COVID-19 vaccine Vaccine against COVID-19

The Janssen COVID-19 vaccine or Johnson & Johnson COVID-19 vaccine is a COVID-19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands, and its Belgian parent company Janssen Pharmaceuticals, subsidiary of American company Johnson & Johnson.

CoVLP COVID-19 vaccine candidate produced in a plant

CoVLP is a COVID-19 vaccine candidate developed by Medicago and GlaxoSmithKline (GSK). It is a coronavirus virus-like particle vaccine grown in the Australian weed, Nicotiana benthamiana.

ZyCoV-D Vaccine candidate against COVID-19

ZyCoV-D is a DNA plasmid-based COVID-19 vaccine developed by Indian pharmaceutical company Cadila Healthcare, with support from the Biotechnology Industry Research Assistance Council. It is approved for emergency use in India.

SCB-2019 Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

Sanofi–GSK COVID-19 vaccine Vaccine candidate against COVID-19

The Sanofi–GSK COVID-19 vaccine code-named VAT00002 and VAT00008 is a COVID-19 vaccine candidate developed by Sanofi Pasteur and GSK.

Minhai COVID-19 vaccine Vaccine against COVID-19

Minhai COVID-19 vaccine, trademarked as KCONVAC, is a COVID-19 vaccine developed by Shenzhen Kangtai Biological Products Co. Ltd and its subsidiary, Beijing Minhai Biotechnology Co., Ltd.

V-01 Vaccine candidate against COVID-19

V-01 is a COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc.

COVID-19 vaccination in Japan

COVID-19 vaccination in Japan started later than in most other major economies. The country has frequently been regarded "slow" for its vaccination efforts.

COVID-19 vaccination in Taiwan Plan to immunize against COVID-19

COVID-19 vaccination in Taiwan is an ongoing immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), in response to the ongoing pandemic in the country. Following the approval of the Oxford–AstraZeneca COVID-19 vaccine on 18 March 2021, vaccinations commenced on 22 March 2021, and will continue throughout the year with the goal of vaccinating 70% of the population by late October 2021.

COVID-19 vaccination in mainland China Plan to immunize against COVID-19

COVID-19 vaccination in mainland China is an ongoing immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in mainland China, in response to the ongoing pandemic in the region.

COVAX-19 Vaccine candidate against COVID-19

COVAX-19 is a recombinant protein-based COVID-19 vaccine developed by South Australian based biotech company Vaxine. It is under clinical trial in collaboration with the Iranian company CinnaGen.

COVID-19 vaccine clinical research

COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness and safety. 24 vaccines are authorized for use by national governments, including six approved for emergency or full use by at least one WHO-recognised stringent regulatory authority; while five are in Phase IV. 204 vaccines are undergoing clinical trials that have yet to be authorized. Nine clinical trials consider heterologous vaccination courses.


  1. "Dynavax and Medigen Announce Collaboration to Develop a Novel Adjuvanted COVID-19 Vaccine Candidate". GlobeNewswire. 23 July 2020. Retrieved 7 June 2021.
  2. 黃驛淵 (10 June 2021). "【獨家】【國產疫苗解盲1】高端實體疫苗針劑首曝光 「每天9萬劑」生產基地直擊" (in Chinese). Mirror Media.
  3. 1 2 3 "Medigen Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax's CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in Taiwan". Retrieved 7 August 2021.
  4. 1 2 "Medigen Collaborates with Dynavax to Develop Novel Adjuvanted COVID-19 Vaccine Candidate". Retrieved 7 August 2021.
  5. "MVC and NIH Collaborate to Develop COVID-19 Vaccine". Retrieved 7 August 2021.
  6. "MVC Signed an License Agreement with NIH on COVID-19 Vaccine". Medigen. 5 May 2020. Retrieved 27 July 2021.
  7. "Medigen's COVID-19 Vaccine Combined with Dynavax's CpG 1018 Adjuvant Receives Taiwan Government Subsidy with First Participant Dosed in Early October". Retrieved 7 August 2021.
  8. "A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult (COVID-19)". United States National Library of Medicine. Retrieved 11 March 2021.
  9. "A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19". United States National Library of Medicine. Retrieved 11 March 2021.
  10. "A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults". United States National Library of Medicine. 28 March 2021. Retrieved 3 April 2021.
  11. "MVC Released COVID-19 Vaccine Phase 2 Interim Analysis Result". Retrieved 7 August 2021.
  12. Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, Chen C, Janssen R, Shih SR, Huang CG, Tai IC, Chang SC (25 June 2021). "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". EClinicalMedicine. 38: 100989. doi:10.1016/j.eclinm.2021.100989. ISSN   2589-5370. PMC   8233066 . PMID   34222848.
  13. "MVC Announces Paraguay Approval of IND Application for Phase 3 Clinical Trial". Retrieved 7 August 2021.
  14. "A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents". United States National Library of Medicine. 6 July 2021. Retrieved 6 July 2021.
  15. "MVC COVID-19 Vaccine Obtains Taiwan EUA Approval". Retrieved 7 August 2021.
  16. Taiwan begins contested rollout of new Medigen domestic vaccine, Nikkei Asia, Erin Hale, August 23, 2021
  17. "立委質疑國產疫苗合約不平等 陳時中:國內外一樣 | 政治 | 中央社 CNA". (in Chinese). Retrieved 12 September 2021.
  18. 聯合新聞網 (18 June 2021). "缺三期試驗 國產疫苗EUA遭質疑 | 聯合新聞網:最懂你的新聞網站". 聯合新聞網 (in Chinese). Retrieved 12 September 2021.