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
administration
Intramuscular
Legal status
Legal status
  • Full and emergency authorizations
Full list of MVC vaccine authorizations
Identifiers
DrugBank

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]

Contents

Technology

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]

Authorization

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

Controversies

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]

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References

  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". www.medigenvac.com. Retrieved 7 August 2021.
  4. 1 2 "Medigen Collaborates with Dynavax to Develop Novel Adjuvanted COVID-19 Vaccine Candidate". www.medigenvac.com. Retrieved 7 August 2021.
  5. "MVC and NIH Collaborate to Develop COVID-19 Vaccine". www.medigenvac.com. 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". www.medigenvac.com. Retrieved 7 August 2021.
  8. "A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult (COVID-19)". clinicaltrials.gov. 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". clinicaltrials.gov. United States National Library of Medicine. Retrieved 11 March 2021.
  10. "A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults". clinicaltrials.gov. United States National Library of Medicine. 28 March 2021. Retrieved 3 April 2021.
  11. "MVC Released COVID-19 Vaccine Phase 2 Interim Analysis Result". www.medigenvac.com. 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". www.medigenvac.com. Retrieved 7 August 2021.
  14. "A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents". clinicaltrials.gov. United States National Library of Medicine. 6 July 2021. Retrieved 6 July 2021.
  15. "MVC COVID-19 Vaccine Obtains Taiwan EUA Approval". www.medigenvac.com. 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". www.cna.com.tw (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.