Benzinga | Aug 23, 2021 08:02AM EDT

Medigen Vaccine Biologics, Dynavax Highlight Rollout Of Its COVID-19 Vaccine, MVC-COV1901; ~600K People Expected To Receive The Medigen Vaccine This Week

- Approximately 600,000 people are anticipated to receive the Medigen

vaccine this week

- MVC-COV1901 is a subunit vaccine comprised of recombinant SARS-CoV-2 S-2P

antigen adjuvanted with CpG 1018(R) adjuvant

- Medigen received Taiwan Emergency Use Authorization and approval for

inclusion in Taiwan's COVID-19 vaccine immunization program in July

PR Newswire

TAIPEI, Taiwan and EMERYVILLE, Calif., Aug. 23, 2021

TAIPEI, Taiwan and EMERYVILLE, Calif., Aug. 23, 2021 /PRNewswire/ -- Medigen

Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical

company focusing on the development and production of vaccines and

biologics, and Dynavax Technologies Corporation (NASDAQ:DVAX), a

biopharmaceutical company focused on developing and commercializing novel

vaccines, today announced the rollout of its COVID-19 vaccine, MVC-COV1901.

Approximately 600,000 people are anticipated to receive the Medigen vaccine

this week.

Charles Chen, Chief Executive Officer 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. It is heartening to see a productive

outcome from the dedicated effort from the team at Medigen."

Ryan Spencer, Chief Executive Officer of Dynavax commented, "We are pleased

that Medigen's vaccine is now available for the people of Taiwan. 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."

In July, MVC received Taiwan Emergency Use Authorization and approval for

inclusion in Taiwan's COVID-19 vaccine immunization program, MVC-COV1901.

MVC COVID-19 vaccine is indicated for adults over 20 years old and is

administered in two doses 28 days apart for prevention of COVID-19. The

Advisory Committee recommended that MVC should submit safety monitoring

report monthly during the declared EUA period and should submit a vaccine

effectiveness report within one year after obtaining EUA approval.

About MVC-COV1901

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. MVC has obtained a global technology license for S-2P from the

U.S. Vaccine Research Center at National Institutes of Health (NIH).

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.