A Study to Determine the Safety and Efficacy of SARS-CoV-2 mRNA Vaccine CVnCoV in Adults for COVID-19

Inclusion Criteria:

- Male or female participants 18 years of age or older.

- Be willing and able to provide written informed consent prior to initiation of any
trial procedures.

- Expected compliance with protocol procedures and availability for clinical follow-up
through the last planned visit.

- Females of non-childbearing potential defined as follows: surgically sterile (history
of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or
postmenopausal {defined as amenorrhea for ≥12 consecutive months prior to screening
(Day 1) without an alternative medical cause}. A follicle-stimulating hormone (FSH)
level may be measured at the discretion of the Investigator to confirm postmenopausal
status.

- Females of childbearing potential: negative pregnancy test (human chorionic
gonadotropin [hCG]) within 24 hours prior to each trial vaccination on Day 1 and Day
29.

- Females of childbearing potential must use highly effective methods of birth control
from 2 weeks before the first administration of the trial vaccine until 3 months
following the last administration. The following methods of birth control are
considered highly effective when used consistently and correctly:

- Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal or transdermal);

- Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable or implantable);

- Intrauterine devices;

- Intrauterine hormone-releasing systems;

- Bilateral tubal ligation;

- Vasectomized or infertile partner;

- Sexual abstinence

- {periodic abstinence (e.g., calendar, ovulation, symptothermal and post-ovulation
methods) and withdrawal are not acceptable}.

Exclusion Criteria:

- History of virologically-confirmed COVID-19 illness.

- For females: pregnancy or lactation.

- Use of any investigational or non-registered product (vaccine or drug) within 28 days
preceding the administration of trial vaccine or planned use during the trial.

- Receipt of any licensed vaccines within 28 days (for live vaccines) or 14 days (for
inactivated or any other vaccines) prior to administration of the first trial vaccine.

- Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus
(SARS-CoV, Middle East Respiratory Syndrome-CoV) vaccine or planned used during the
trial.

- Any treatment with immunosuppressants or other immune-modifying drugs (including but
not limited to anabolic steroids, corticosteroids, biologicals and methotrexate) for >
14 days total within 6 months preceding the administration of trial vaccine or planned
use during the trial. For corticosteroid use, this means prednisone or equivalent, 0.5
mg/kg/day for 14 days or more. The use of inhaled, topical, or localized injections of
corticosteroids (e.g., for joint pain/inflammation) is permitted.

- Any medically diagnosed or suspected immunosuppressive or immunodeficient condition
based on medical history and physical examination including known infection with human
immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV);
current diagnosis of or treatment for cancer including leukemia, lymphoma, Hodgkin
disease, multiple myeloma or generalized malignancy; chronic renal failure or
nephrotic syndrome; and receipt of an organ or bone marrow transplant.

- History of angioedema (hereditary or idiopathic) or history of any anaphylactic
reaction.

- History of potential immune-mediated disease (pIMD).

- History of allergy to any component of CVnCoV.

- Administration of immunoglobulins or any blood products within 3 months prior to the
administration of trial vaccine or planned receipt during the trial.

- Participants with a significant acute or chronic medical or psychiatric illness that,
in the opinion of the Investigator, precludes trial participation (e.g., may increase
the risk of trial participation, render the participant unable to meet the
requirements of the trial, or may interfere with the participant's trial evaluations).
These include severe and/or uncontrolled cardiovascular disease, gastrointestinal
disease, liver disease, renal disease, respiratory disease, endocrine disorder, and
neurological and psychiatric illnesses. However, those with controlled and stable
cases can be included in the trial.

- Participants with impaired coagulation or any bleeding disorder in whom an IM
injection or a blood draw is contraindicated.

- Foreseeable non-compliance with the trial procedure as judged by the Investigator.

Roll-over Criteria for the Open-label Phase:

- Participants must have received at least 1 dose of CVnCoV during the randomized
observer blinded phase.

- Participants must provide additional written informed consent to be eligible for the
open label phase.