MVC-COV1901 COVID-19 Vaccine Description
Medigen Vaccine Biologics Corp. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 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. NIH. The recombinant S-2P protein can maintain the trimeric pre-fusion form to make the antigen more stable.
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."
On August 23, 2021, Charles Chen, CEO at Medigen, commented, "Medigen is honored to be able to serve the people of Taiwan and participate in the global response to this pandemic. We were grateful to have received emergency use authorization from the Taiwan FDA and greatly appreciate the time and effort of both the TFDA staff and the experts that participated in the risk and benefit analysis meeting. In addition, it is heartening to see a productive outcome from the dedicated effort from the team at Medigen."
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.
MVC-COV1901 COVID-19 Vaccine Indication
The MVC COVID-19 vaccine is indicated for adults over 20 years old to prevent COVID-19 disease, which is caused by the infection of the SARS-CoV-2 betacoronavirus.
MVC-COV1901 COVID-19 Vaccine Dosage
MVC-COV1901 COVID-19 vaccine is indicated and is administered in two vaccine doses 28 days apart.
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) are observed. And the Interim IDMC meeting, the committee concluded that there are no major safety issues and has agreed to initiate a new clinical trial for adolescents (12~18 years old) following TFDA regulations.
MVC-COV1901 COVID-19 Vaccine Storage
The MVC COVID-19 vaccine requires 2 ~ 8 °C refrigerated storage.
MVC-COV1901 COVID-19 Vaccine News
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 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.'
MVC-COV1901 COVID-19 Vaccine Clinical Trials
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.
Phase 2 study - ClinicalTrials.gov Identifier: NCT04822025
Phase 2 study - ClinicalTrials.gov Identifier: NCT04951388