Vaccine Info

Medigen COVID-19 Vaccine

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Last reviewed
January 17, 2022
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Medigen COVID-19 Vaccine Description

Medigen Vaccine Biologics Corp. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 (ISS-1018) supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S. National Institutes of Health (NIH). The recombinant S-2P protein can maintain the trimeric pre-fusion form to make the antigen more stable.

Medigen has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at the NIH. California-based Dynavax developed the adjuvant of aluminum hydroxide and CpG 1018.

The Taiwan Food and Drug Administration approved the manufacture of high-end vaccines in accordance with "Pharmaceutical Affairs Law Article 48-2." Based on Medigen MVC's preclinical, Phase 1, and Phase 2 clinical study data, MVC-COV1901 has shown robust safety and favorable immunogenicity responses. It was granted an EUA in Taiwan.

An interim analysis of a phase two study published by The Lancet on October 13, 2021, showed that the MVC-COV1901 vaccine has a good safety profile and elicits promising neutralizing antibody titers. Compared with other vaccines that have received emergency use authorization, MVC-COV1901 is safe, well-tolerated, and rarely causes febrile reactions in both young and older adults, said the Company.

The WHO Solidarity Trial Vaccines (STv) study selected MVC's vaccine candidate on October 26, 2021, as one of two included in the global trial. "We are seeing promising results thus far; we hope that the international trial conducted by WHO and participating countries will assist in curbing the escalation of cases," said Charles Chen, Vice Chairman & CEO, Medigen Vaccine Biologics Corp, in a press release.

Drug Bank: DB15854

Medigen Vaccine Biologics Corp. is located in Taipei, Taiwan, and is a biopharmaceutical company using cell-based technologies to develop novel vaccines and biosimilars. For more information, visit www.medigenvac.com.

Medigen MVC-COV1901 COVID-19 Vaccine Indication

The MVC COVID-19 vaccine is indicated for adults over 18 years old to prevent COVID-19 disease, which is caused by the infection of the SARS-CoV-2 betacoronavirus.

Medigen MVC-COV1901 COVID-19 Vaccine Dosage

MVC-COV1901 COVID-19 vaccine is indicated and is administered in two vaccine doses 28 days apart.

Medigen MVC-COV1901 COVID-19 Vaccine Side effects

As of May 8, 2021, there are no vaccine-related SAE (Serious Adverse Reaction), AESI (Adverse Events of Special Interest), and VAED (Vaccine-associated Enhanced Disease) were observed. Therefore, at the Interim IDMC meeting, the committee concluded no significant safety issues and agreed to initiate a new clinical trial for adolescents (12~18 years old) following TFDA regulations. 

Medigen MVC-COV1901 COVID-19 Vaccine Storage

The MVC COVID-19 vaccine requires 2 ~ 8 °C refrigerated storage.

Medigen MVC-COV1901 COVID-19 Vaccine News

December 6, 2021 - The participants in the Phase 3 clinical trial of the Medigen COVID-19 vaccine in Paraguay have now received two shots of either the Medigen or AstraZeneca.

November 30, 2021 - Belize MOHW Approved Entry for Persons with the Taiwanese Medigen Jab.

November 22, 2021 - Grand Pacific CRO Australia (on behalf of Medigen Vaccine Biologics Corp) was granted Provisional Determination by Australia's Therapeutic Goods Administration.

November 11, 2021 - MVC-COV1901 is one of two current vaccine candidates included in WHO’s Solidarity Trial Vaccines, a multi-center, multi vaccine, adaptive, shared placebo, event-driven, individually randomized controlled Phase 3 clinical trial. Recruitment began at 40 sites across three countries, Colombia, Mali, and the Philippines.

October 27, 2021 - Medigen Vaccine Biologics Corp's MVC-COV1901 COVID-19 vaccine candidate has been recommended by an independent vaccine prioritization advisory group to be included in the World Health Organisation Solidarity Trial Vaccines.

October 26, 2021 - The WHO and the Ministries of Health of Colombia, Mali, and the Philippines announced the launch of the co-sponsored Solidarity Trial Vaccines, which invited MVC-COV1901 to participate.

October 26, 2021 - The Company announced it was invited to participate in the WHO new crown vaccine meeting for the sixth time held on 10/25/2021. Dr. Lien Jiaen reported the safety tracking and monitoring data of large-scale use of the high-end new coronary pneumonia vaccine after the administration.

October 20, 2021 - The Company announced the third phase of the clinical trial of the new crown pneumonia vaccine in Paraguay officially launched on 10/13/21. One week after the trial started, more than 300 people have registered and completed the first dose of nearly a hundred subjects. 

October 13, 2021 - The Lancet published interim results of the large-scale phase 2 trial in Taiwan. The study shows MVC-COV1901 has a good safety profile and elicits promising immunogenicity responses. These data support MVC-COV1901 to enter phase 3 efficacy trials.

August 23, 2021 - Medigen announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week in Taiwan. Ryan Spencer, CEO of Dynavax, commented, "We are pleased that Medigen's vaccine is now available for the people of Taiwan. In addition, we are very excited for this first, of hopefully multiple EUAs and approvals for COVID-19 vaccines that include CpG 1018 adjuvant. Considering the limitations of current vaccines and the global vaccine shortage, we believe adjuvanted vaccines can contribute significantly to current vaccination efforts."

August 8, 2021 - A non-peer-reviewed study was published 'Safety and Immunogenicity of CpG 1018 and Aluminium Hydroxide-Adjuvanted SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901: A Large-Scale Double-Blind, Randomised, Placebo-Controlled Phase 2 Trial.' Interpretation: MVC-COV1901 shows good safety profiles and promising immunogenicity responses. The current data supports MVC-COV1901 to enter phase 3 efficacy trials and enable regulatory considerations for Emergency Use Authorisation.

August 1, 2021 - The Lancet published a Research Paper: 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. Interpretation - The MVC COV1901 vaccine was well tolerated, elicited robust immune responses, and was suitable for further development.

July 20, 2021 - Medigen Vaccine Biologics Corp. filed a Phase 3 Clinical Trial IND application with Paraguay's regulatory authority, Dirección Nacional de Vigilancia Sanitaria (DINAVISA), on July 6th for the MVC-COV1901 vaccine. DINAVISA has, as of today, approved MVC's application and has given the authorization to initiate subject recruitment.

July 19, 2021 - Medigen Vaccine Biologics Corp. announced it obtained Taiwan EUA approval because MVC's COVID-19 vaccine has fulfilled EUA standards set by Taiwan's regulatory agencies.

June 25, 2021 - The Lancet published a study that concluded 'article is the first clinical report of a subunit protein vaccine using S-2P antigen, adjuvanted with Th1-skewing CpG and aluminum hydroxide that demonstrates good tolerability and immunogenicity, and support further clinical development of S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide.'

Medigen MVC-COV1901 COVID-19 Vaccine Clinical Trials

Medigen MVC-COV1901 is currently involved in 9 clinical trials to Evaluate the Safety, Tolerability, and Immunogenicity of this COVID-19 vaccine.

MVC-COV1901 vaccine's Phase 1 and 3,815-participant Phase 2 clinical study data has shown robust safety and promising immunogenicity responses and, as a result, obtained Taiwan's EUA approval on July 19th, 2021. MVC will continue to collaborate with international partners for phase 3 clinical trial development and assist the global community in its fight against the COVID-19 pandemic. 

WHO and the Ministries of Health of Colombia, Mali, and the Philippines announced the co-sponsored Solidarity Trial Vaccines launch, which includes MVC-COV1901. This is an international, randomized clinical trial platform designed to rapidly evaluate promising new candidate vaccines selected by an independent vaccine prioritization advisory group composed of leading scientists and experts.