Full Press Release Details
European Commission Announces That
Tomorrow It Will Authorize the Agreement with CureVac for the Supply of up to 405 Million Doses of mRNA-Based COVID-19 Vaccine
Germany/ BOSTON, USA - November 16, 2020 - CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company
developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reports the
European Commission's announcement that tomorrow it will authorize an Advanced Purchase Agreement for CureVac s
mRNA-based COVID-19 vaccine candidate, CVnCoV.
Once finalized, the contract
with the European Commission will provide member states of the European Union with up to 225 million doses of the vaccine and includes
the option for an additional purchase of 180 million doses. The mRNA vaccine will be supplied once it has proven to be safe and
effective against COVID-19. CureVac will receive an upfront payment to support the advanced clinical development of CVnCoV and
the current ramp-up of its manufacturing network, as well as market launch and supply preparations.
"CureVac is leveraging
20 years of expertise in mRNA technology to develop a COVID-19 vaccine that can contribute to the end of the COVID-19 pandemic
and to potentially allow all of us to return to an unrestricted life, where we are free again to engage in all activities we enjoy
doing," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "As an important step toward that goal, we
are proud to potentially supply our COVID-19 vaccine to citizens of the European Union. Beyond the European Union, we are actively
engaging with governments and multilateral organizations across the globe to ensure broad and equitable access to our COVID-19
CureVac is currently expanding
manufacturing capacities for the large-scale manufacturing of CVnCoV. Vaccine doses are expected to be produced both at CureVac's
in-house, GMP-certified manufacturing site in Germany and across a broad European manufacturing network.
CureVac began development
of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding
the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. The Phase 1 clinical study of CVnCoV began in June
2020 at clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovation
(CEPI). At the end of September 2020, CVnCoV entered into a Phase 2a clinical trial in Peru and Panama, extending clinical studies
into older adults and regions with high-incidence of COVID-19 infections. Phase 1 interim data reported in November 2020, showed
that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first
indication of T cell activation. The quality of immune response was found to be comparable to recovered COVID-19 patients,
closely mimicking the immune response after natural COVID-19 infection. The data support the decision to advance a 12 g dose
in the upcoming pivotal Phase 2b/3 study.
CureVac plans to initiate
the pivotal Phase 2b/3 clinical study before end of 2020. Clinical trial material is provided by the company's production
capacities for mRNA vaccines at its headquarters in T bingen supported by the current expansion of those manufacturing capacities
to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
CureVac is a global biopharmaceutical company active in the field of messenger RNA (mRNA) technology, with more than 20 years of
expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary
technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins
capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline
across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had
its initial public offering on the New York Nasdaq in August 2020. It is headquartered in T bingen, Germany, and employs more
than 500 people at its sites in T bingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.
CureVac Media Contact
Thorsten Sch ller, Vice
President Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1577
CureVac Investor Relations
Dr. Sarah Fakih, Vice President
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
Forward-Looking Statements
This press release contains statements that constitute "forward looking statements"
as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express
the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac (the "company") regarding
future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the
company's strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking
statements by terminology such as "anticipate," "intend," "believe," "estimate,"
"plan," "seek," "project," or "expect," "may," "will,"
"would," "could," "potential," "intend," or "should," the negative
of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions
and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's
performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks,
uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility
in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical
trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability
to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects
of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel,
reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due
to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers
are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and
could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included
in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation
to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events
or developments, except as required by law.
For further information, please reference the company's
reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting
EDGAR on the SEC website at www.sec.gov.