Medigen COVID-19 Vaccine
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.
Taiwan-based Medigen obtained a global technology license for S-2P from the U.S. Vaccine Research Center at the U.S. NIH. And 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 June 25, 2021, The Lancet published phase 1 study results that concluded the MVC COV1901 vaccine was well tolerated and elicited robust immune responses. 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 on July 19, 2021.
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 of Medigen Vaccine Biologics Corp, in a press release.
On January 4, 2022, a non-peer-reviewed study of 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, showed that three doses of MVC-COV1901-induced antibodies were still effective, albeit lowered neutralizing titers, against the SARS-CoV-2 virus Omicron variant. A clinical trial (June 21, 2022) found the Medigen COVID vaccine had an efficacy level of about 84% and that there were "no vaccine‐related Serious Adverse Reactions."
On August 1, 2023, the National University of Asunción shared the phase 3 analysis data: Seropositive participants neutralizing antibodies: the seroconversion rate of the MVC group is 98.6% (versus 90.0% in AZD1222), and the MVC's neutralizing antibody GMT is equivalent to 1.7 times more than AZD1222; Seronegative participants neutralizing antibodies: the seroconversion rate of the MVC group is 100% (versus 94.9% in AZD1222), and the MVC's neutralizing antibody GMT equivalent to 4.8 times more than AZD1222.
As of August 2023, Medigen's COVID-19 vaccine had seen more than three million doses administered across seven countries.
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. Drug Bank: DB15854. Vaccine availability as of March 17, 2022. Clinical trial listing as of March 18, 2022.
Medigen Omicron BA.x Variant
Medigen announced on January 24, 2022, that for the SARS-CoV-2 Omicron variant strain, the neutralizing antibody concentration of three doses of high-end vaccines was completed. Compared with the neutralization data of the Wuhan prototype strain, the decrease in the neutralizing antibody against Omicron was similar to that of the existing three-dose mRNA vaccine. The serum of the vaccine can still neutralize Omicron, indicating that the third dose of the high-end vaccine is expected to provide a considerable degree of protection against Omicron.
Medigen - BlueWillow Intranasal COVID-19 Booster (BW-1019)
The intranasal COVID-19 booster combines BlueWillow's proprietary nanoemulsion technology, which acts as an efficient antigen delivery and adjuvant, with Medigen's U.S. National Institutes of Health-licensed SARS-CoV-2 spike protein. The platform is unique among intranasal solutions in that it does not rely on an adenovirus vector but rather utilizes the adjuvant that is proven to be safe in humans. BW-1019 elicits mucosal immunity, stopping the spread at the entry of the virus. Intranasal booster following the primary intramuscular vaccine series has shown to be a successful follow-on solution.
As of 2023, the Medigen vaccine was authorized in Somaliland, Taiwan, Paraguay, Australia, and Thailand.
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 beta coronavirus.
MVC-COV1901 COVID-19 vaccine is indicated and is administered in two vaccine doses 28 days apart. Inject 0.5 ml of the MVC COVID-19 vaccine into the arm by intramuscular injection. The second dose should be administered 28 days after the first dose.
Medigen Side effects
As of May 8, 2021, there are no vaccine-related Serious Adverse Reactions, Adverse Events of Special Interest, and Vaccine-associated Enhanced Disease were observed. Therefore, the committee concluded no significant safety issues at the Interim IDMC meeting and agreed to initiate a new clinical trial for adolescents (12 -18 years old) following TFDA regulations.
The MVC COVID-19 vaccine requires 2 ~ 8 °C refrigerated storage.
Medigen MVC-COV1901 COVID-19 Vaccine News
August 2, 2023 - The research team from the National University of Asunción (UNA) shared the analysis results from the local laboratory. For both seropositive subjects infected with SARS-CoV-2 and uninfected seronegative subjects, MVC COVID-19 Vaccine is superior to AZD1222.
June 21, 2022 - The journal MDPI published: Immune Response to SARS-CoV-2 Vaccines. In this review, we have compiled the immune response to SARS-CoV-2 infection and, followed by the mechanism of action of various vaccine platforms such as mRNA, Adenoviral vector, inactivated virus, subunit vaccines, and have also summarized various adjuvants used in the COVID-19 vaccine formulation.
June 7, 2022 - Medigen Vaccine Biologics Corp. applied to the Australian medicines regulator for provisional approval of its COVID-19 vaccine.
April 21, 2022 - The journal Vaccines published: An Immunobridging Study to Evaluate the Neutralizing Antibody Titer in Adults Immunized with Two Doses of Either ChAdOx1-nCov-19 (AstraZeneca) or MVC-COV1901. The GMT ratio and sero-response rate exceeded the criteria established by the Taiwan regulatory authority, leading to EUA approval of MVC-COV1901 in Taiwan.
May 15, 2022 - Eligible recipients can choose a full dose of the Medigen vaccine.
March 2, 2022 - Medigen Vaccine Biologics and BlueWillow Biologics, Inc. announced the intranasal COVID-19 booster (BW-1019) provided protection and boosted immune response when administered following an intramuscular vaccine series in preclinical studies.
February 15, 2022 - CNA reported that Medigen Vaccine Biologics Corp. announced the WHO's Phase 3 Solidarity Trial Vaccines program of its COVID-19 vaccine could be unblinded in March 2022. As of Dec. 22, 2021, over 11,500 people registered to participate in the project, WHO data showed.
February 14, 2022 - The National Directorate of Sanitary Surveillance of the Republic of Paraguay granted the emergency authorization to the MVC-COV1901 vaccine for application in adults from 18 years of age.
February 10, 2022 - CNA reported that 1,278,614 people had made online appointments to receive a booster dose. The CECC is offering AstraZeneca, Moderna, Pfizer-BioNTech, and the locally produced Medigen over one week, Feb. 14-20, at designated hospitals, clinics, and other sites spokesperson Chuang Jen-hsiang said at a press briefing.
February 2, 2022 - Taiwan News reported future COVID-19 booster shots in Taipei City would use BioNTech and Medigen doses. Taiwan's Central Epidemic Command Center announced 72 new confirmed cases of COVID-19, of which 40 are local and 32 are imported, and no deaths, on Feb. 5, 2022.
January 26, 2022 - Taiwan's Central Epidemic Command Center reopened the Vaccine Appointment Platform for the public to make an appointment for the third injection.
January 25, 2022 - According to the results of different animal tests, it is confirmed that a next-generation vaccine can effectively neutralize high-interest mutants such as Alpha, Beta, Gamma, Delta, and Omicron, showing the potential to effectively combat different virus mutations. This development project will apply to the Food and Drug Administration for human trials to conduct exploratory research on the next-generation vaccine. At present, the high-end next-generation broad-acting vaccine (Beta) has completed process scale-up and experimental vaccine production.
January 24, 2022 - Medigen announced relevant research data on the high-end third-injection supplement shows that regardless of whether the first two doses of high-end or AZ vaccine are administered, the third-injection high-end can increase the concentration of neutralizing antibodies, thereby enhancing the protection against highly concerned variant strains.
January 11, 2022 - The Medigen vaccine was added to a list of eight previously recognized vaccines that enable people to visit Thailand under its new tourism sandbox plan, according to the Thailand foreign ministry's Department of Consular Affairs.
January 4, 2022 - A limited study found neutralizing antibodies remained detectable on day 209 at 59.4, 79.4, and 113.2 (IU/mL) for low dose (LD), middle dose (MD), and high dose (HD) groups, respectively. At four weeks after the booster dose, neutralizing titers increased to 1719.6, 818.3, and 1345.6 for LD, MD, and HD groups, respectively.
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.
December 2, 2021 - Medigen Vaccine Biologics Corp. received a US$ 2.3 million grant from CEPI to fund trials of its COVID-19 vaccine as a potential booster.
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.
November 5, 2021 - A peer-reviewed study: Evaluating the Neutralizing Ability of a CpG-Adjuvanted S-2P Subunit Vaccine Against SARS-CoV-2 Variants of Concern - Two doses of MVC-COV1901 were able to elicit neutralizing antibodies against SARS-CoV-2 variants with an overall tendency of inducing higher immune response at a higher dose level. The neutralizing titers to the Beta variant in rats and humans were lower than those for WT and the Alpha variant. An additional third dose in rats was able to partially compensate for the reduction in neutralization against the Beta variant.
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 clinical trials to Evaluate the Safety, Tolerability, and Immunogenicity of this COVID-19 vaccine.
As of early December 2021, the participants in a Phase 3 clinical trial of Medigen Vaccine Biologics Corp.'s COVID-19 vaccine in Paraguay had received two shots of either the Medigen or AstraZeneca vaccine. The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of anti-S IgG as well as the potential efficacy of MVC-COV1901 in preventing COVID-19. - last updated on January 14, 2022.
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.