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.
About Medigen Vaccine Biologics Corporation (MVC)
MVC
is a biopharmaceutical company using cell-based technologies to
develop novel vaccines and biosimilars. MVC's pipeline includes
EV71 vaccine, dengue vaccine, quadrivalent influenza vaccine and
COVID-19 vaccine which all have entered late clinical stage. MVC's
large-scale production facility is state-of-the-art and adherent to
international PIC/s GMP requirements. For more information,
visit www.medigenvac.com.
About CpG 1018 Adjuvant
CpG 1018 is the adjuvant used in HEPLISAV-B. Dynavax developed CpG
1018 to provide an increased vaccine immune response, which has
been demonstrated in HEPLISAV-B. CpG 1018 adjuvant provides a
well-developed technology and a significant safety database,
potentially accelerating the development and large-scale
manufacturing of a COVID-19 vaccine.
About Dynavax
Dynavax is a commercial stage biopharmaceutical company developing
and commercializing novel vaccines. The Company's first commercial
product, HEPLISAV-B® [Hepatitis B Vaccine
(Recombinant), Adjuvanted], is approved in the U.S. and the
European Union for prevention of infection caused by all known
subtypes of hepatitis B virus in adults age 18 years and
older. Dynavax is also advancing CpG 1018 adjuvant as a premier
vaccine adjuvant through research collaborations and partnerships.
Current collaborations are focused on adjuvanted vaccines for
COVID-19, pertussis, and universal influenza. For more information,
visit www.dynavax.com and follow the company
on LinkedIn.
MVC's Forward Looking Statements
This press release
contains certain forward-looking statements relating to the
business of Medigen Vaccine Biologics Corporation (MVC, TPEx:
6547.TWO) including with respect to the progress, timing and
completion of research, development and clinical trials for MVC's
COVID 19 vaccine candidate, MVC-COV1901, and the ability to
manufacture, market, commercialize and achieve market acceptance
thereof. These forward-looking statements are based largely on the
current expectations of MVC as applicable, as of the date of this
press release and are subject to a number of known and unknown
risks and uncertainties and other factors that may cause actual
results, performance or achievements to be materially different
from any future results, performance or achievement expressed or
implied by these forward-looking statements. In particular, such
could be affected by, among other things, uncertainties involved in
the development and manufacture of MVC's COVID19 vaccines,
unexpected clinical trial results, unexpected regulatory actions or
delays, competition in general, currency fluctuations, changes in
global financial markets and the ability to obtain or maintain
patent or other proprietary intellectual property protection. In
light of these risks and uncertainties, there can be no assurance
that such forward-looking statements will in fact be realized. MVC
and is providing the information in this press release as the date
hereof, and disclaim any intention or obligation to publicly update
or revise any forward-looking statements, whether as a result of
new information, future events, or otherwise.
Dynavax Forward-Looking Statements
This press release
contains "forward-looking" statements, including statements
regarding the potential to develop and manufacture a COVID-19
vaccine containing CpG 1018 adjuvant, potential for other
collaborators to receive EUAs for their vaccine candidates
and recombinant subunit protein vaccines' potential
contribution to global vaccination efforts. Actual results may
differ materially from those set forth in this press release due to
the risks and uncertainties inherent in vaccine research and
development, including the timing of completing development or
receiving EUAs, whether CpG 1018 adjuvant plus aluminum combined
with MVC's subunit vaccine will prove to be safe and efficacious in
remaining clinical trials and ongoing monitoring, whether and when
any vaccine will receive final approval for use, and whether
sufficient quantities of CpG 1018 adjuvant will be able to be
manufactured, as well as other risks detailed in the "Risk Factors"
section of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2020, as well as
discussions of potential risks, uncertainties and other important
factors in our other filings with the U.S. Securities and Exchange
Commission. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the
future, even if new information becomes available. Information on
Dynavax's website at www.dynavax.com is not incorporated by
reference in our current periodic reports with the SEC.
Medigen Contact:
Paul Torkehagen
Director, International Business Development
paul@medigenvac.com
Dynavax Contacts:
Nicole Arndt, Senior Manager,
Investor Relations
narndt@dynavax.com
510-665-7264
Derek Cole, President
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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SOURCE Dynavax Technologies