August 12, 2021
ModernaTX, Inc.
Attention: Ms. Carlota Vinals
200 Technology Square
Cambridge, MA 02139
Dear Ms. Vinals:
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health
emergency that has a significant potential to affect national security or the health and security of
United States citizens living abroad, and that involves the virus that causes Coronavirus Disease
2019 (COVID-19). 1 On the basis of such determination, the Secretary of HHS on March 27,
2020, declared that circumstances exist justifying the authorization of emergency use of drugs
and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (the
FD&C Act or the Act) (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under
that section. 2
On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use
Authorization (EUA) for emergency use of Moderna COVID‑19 Vaccine for the prevention of
COVID-19 for individuals 18 years of age and older, pursuant to Section 564 of the Act. FDA
reissued the letter of authorization twice: February 25, 2021 3 and July 7, 2021. 4
On August 12, 2021, having concluded that revising this EUA is appropriate to protect the public
health or safety under section 564(g)(2) of the Act, FDA again is reissuing the letter in its
entirety with revisions incorporated to authorize for emergency use a third dose of the Moderna
COVID-19 vaccine administered at least 28 days following the two dose regimen of this vaccine
in individuals 18 years of age or older who have undergone solid organ transplantation, or
individuals 18 years of age or older who are diagnosed with conditions that are considered to
have an equivalent level of immunocompromise.
1
U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration
that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020.
2
U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations
Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250
(April 1, 2020).
3
In the February 25, 2021 revision, FDA allowed flexibility on the date of submission of monthly periodic safety
reports and revised the requirements for reporting of vaccine administration errors by ModernaTX, Inc.
4
In the July 7, 2021 revision, , FDA clarified terms and conditions that relate to export of Moderna COVID‑19
Vaccine from the United States.
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Moderna COVID‑19 Vaccine is for use for active immunization to prevent COVID-19 caused by
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age
and older. The vaccine contains a nucleoside-modified messenger RNA encoding the viral spike
(S) glycoprotein of SARS-CoV-2 formulated in lipid particles. It is an investigational vaccine
not licensed for any indication.
FDA reviewed safety and efficacy data from an ongoing phase 3 trial in approximately 30,000
participants randomized 1:1 to receive Moderna COVID‑19 Vaccine or saline control. The trial
has enrolled participants 18 years of age and older.
FDA’s review of the available safety data from 30,351 participants 18 years of age and older,
who were followed for a median of 7 weeks after receiving the second dose, did not identify
specific safety concerns that would preclude issuance of an EUA. Review of additional safety
data from these participants with a median of 9 weeks of follow-up after receipt of the second
dose did not change FDA’s assessment of safety of the vaccine.
FDA’s analysis of the efficacy data from 28,207 participants 18 years of age and older without
evidence of SARS-CoV-2 infection prior to dose 1 confirms the vaccine was 94.1% effective
(95% confidence interval (CI) 89.3, 96.8) in preventing COVID-19 occurring at least 14 days
after the second dose (with 11 COVID-19 cases in the vaccine group compared to 185 COVID-
19 cases in the placebo group). In this final scheduled analysis participants had been followed for
a median of 9 weeks following the second dose. This result is consistent with that obtained from
an interim analysis of efficacy conducted after these participants had been followed for a median
of 7 weeks after the second dose (vaccine efficacy 94.5%, 95% CI: 86.5, 97.8).
Based on the safety and effectiveness data, and review of manufacturing information regarding
product quality and consistency, it is reasonable to believe that Moderna COVID‑19 Vaccine
may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific
evidence available, that the known and potential benefits of Moderna COVID‑19 Vaccine
outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in
individuals 18 years of age and older. Finally, on December 17, 2020, the Vaccines and Related
Biological Products Advisory Committee voted in agreement with this conclusion.
For the August 12, 2021 authorization of a third dose of the Moderna COVID-19 vaccine in
individuals 18 years of age or older who have undergone solid organ transplantation, or
individuals 18 years of age or older who are diagnosed with conditions that are considered to
have an equivalent level of immunocompromise, FDA reviewed safety and effectiveness data
reported in two manuscripts on solid organ transplant recipients. The first study was a double-
blind, randomized-controlled study conducted in 120 individuals who had undergone various
solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) a median
of 3.57 years earlier (range 1.99-6.75 years). A third dose of the Moderna COVID-19 vaccine
was administered to 60 individuals approximately 2 months after they had received a second
dose (i.e., doses at 0, 1 and 3 months); saline placebo was given to 60 individuals for
comparison. The primary outcome was anti-RBD antibody at 4 months greater than 100 U/mL.
This titer was selected based on NHP challenge studies as well as a large clinical cohort study to
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indicate this antibody titer was possibly protective. Secondary outcome was based on a virus
neutralization assay polyfunctional T cell responses. Baseline characteristics were comparable
between the two study arms as were pre-intervention anti-RBD titer and neutralizing antibodies.
Levels of SARS-CoV-2 antibodiesindicative of a significant response occurred four weeks after
the third dose in 33/60 (55.0%) of the Moderna COVID-19 vaccinated group and 10/57 (17.5%)
of the placebo individuals. In the 60 individuals who received a third vaccine dose, the adverse
event profile was similar to that after the second dose and no grade 3 or grade 4 adverse events
were reported. A supportive secondary study describes a single arm study conducted in 101
individuals who had undergone various solid organ transplant procedures (heart, kidney, liver,
lung, pancreas) a median of 97±8 months earlier. A third dose of a similar mRNA COVID-19
vaccine, Pfizer-BioNTech COVID-19, was administered to 99 of these individuals
approximately 2 months after they had received a second dose. Levels of SARS-CoV-2
antibodies meeting the pre-identified criteria for success occurred four weeks after the third dose
in 26/59 (44.0%) of those who were initially considered to be seronegative and received a third
dose of the Pfizer-BioNTech COVID-19 vaccine; 67/99 (68%) of the entire group receiving a
third vaccination had an increase in antibody titers that the investigators considered significant.
In those who received a third vaccine dose, the adverse event profile was similar to that after the
second dose and no grade 3 or grade 4 events were reported. Despite the moderate enhancement
in antibody titers, the totality of data (including the supportive paper by Kamar et al. and
demonstrated efficacy of the product in the elderly and persons with co-morbidities) supports the
conclusion that a third dose of the Moderna COVID-19 vaccine may be effective in this
population, and that the known and potential benefit of a third dose of Moderna COVID-19
vaccine outweigh the known and potential risks of the vaccine for immunocompromised
individuals at least 18 years of age who have received two doses of the Moderna COVID-19
vaccine and who have undergone solid organ transplantation, or who are diagnosed with
conditions that are considered to have an equivalent level of immunocompromise.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of Moderna COVID-19 Vaccine for the
prevention of COVID-19, as described in the Scope of Authorization section of this letter
(Section II) and subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of
COVID-19 when administered as described in the Scope of Authorization (Section II) meets the
criteria for issuance of an authorization under Section 564(c) of the Act, because:
A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus;
B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19, and that,
when used under the conditions described in this authorization, the known and
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potential benefits of Moderna COVID‑19 Vaccine when used to prevent COVID-19
outweigh its known and potential risks; and
C. There is no adequate, approved, and available alternative to the emergency use of
Moderna COVID-19 Vaccine to prevent COVID-19. 5
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited as follows:
• ModernaTX, Inc. will supply Moderna COVID‑19 Vaccine either directly or
through authorized distributor(s) 6 to emergency response stakeholders 7 as
directed by the U.S. government, including the Centers for Disease Control and
Prevention (CDC) and/or other designee, for use consistent with the terms and
conditions of this EUA;
• The Moderna COVID‑19 Vaccine covered by this authorization will be
administered by vaccination providers 8 and used only to prevent COVID-19 in
individuals ages 18 and older; and
5
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
6
“Authorized Distributor(s)” are identified by ModernaTX, Inc. or, if applicable, by a U.S. government entity, such
as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to
distribute authorized Moderna COVID‑19 Vaccine.
7
For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that
have legal responsibility and authority for responding to an incident, based on political or geographical boundary
lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health
range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases
(e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there
might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination
providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an
official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases,
it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination
providers will all be met.
8
For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider
licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare
professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health
officer) to administer or provide vaccination services in accordance with the applicable emergency response
stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC
COVID-19 Vaccination Program. If the vaccine is exported from the United States, a “vaccination provider” is a
provider that is authorized to administer this vaccine in accordance with the laws of the country in which it is
administered. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S.
Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures
against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and
State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth
Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).
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• The Moderna COVID‑19 Vaccine may be administered by a vaccination provider
without an individual prescription for each vaccine recipient.
Product Description
The Moderna COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials.. The
Moderna COVID-19 Vaccine does not contain a preservative.
Each 0.5 mL dose of the Moderna COVID-19 Vaccine contains 100 mcg of a nucleoside-
modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose
of the Moderna COVID-19 Vaccine also includes the following ingredients: lipids (SM-102; 1,2-
dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG]; cholesterol; and
1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine
hydrochloride, acetic acid, sodium acetate, and sucrose.
The dosing regimen is two doses of 0.5 mL each, one month apart. A third dose may be
administered at least 28 days following the second dose of the two dose regimen of this vaccine
to individuals 18 years of age or older who have undergone solid organ transplantation, or
individuals 18 and older who are diagnosed with conditions that are considered to have an
equivalent level of immunocompromise.
The manufacture of the authorized Moderna COVID‑19 Vaccine is limited to those facilities
identified and agreed upon in the ModernaTX, Inc. request for authorization.
The Moderna COVID-19 Vaccine vial label and carton labels are clearly marked for
“Emergency Use Authorization.” The Moderna COVID‑19 Vaccine is authorized to be
distributed, stored, further redistributed, and administered by emergency response stakeholders
when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the
fact that the vial and carton labels may not contain information that otherwise would be required
under the FD&C Act.
The Moderna COVID‑19 Vaccine is authorized for emergency use with the following product-
specific information required to be made available to vaccination providers and recipients,
respectively (referred to as “authorized labeling”):
• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers):
Emergency Use Authorization (EUA) of the Moderna COVID‑19 Vaccine to Prevent
Coronavirus Disease 2019 (COVID-19)
• Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the
Moderna COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in
Individuals 18 Years of Age and Older
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits of Moderna COVID‑19 Vaccine, when used to prevent
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COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its
known and potential risks.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that Moderna COVID‑19 Vaccine may
be effective in preventing COVID-19 when used in accordance with this Scope of Authorization
(Section II), pursuant to Section 564(c)(2)(A) of the Act.
Having reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I above, I have concluded that Moderna
COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set
forth in Section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of Moderna COVID‑19 Vaccine under this EUA must be consistent with, and
may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II)
and the Conditions of Authorization (Section III). Subject to the terms of this EUA and under the
circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C)
described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1),
Moderna COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals 18 years of age and
older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it
does not meet certain requirements otherwise required by applicable federal law.
III. Conditions of Authorization
Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization:
ModernaTX, Inc. and Authorized Distributor(s)
A. ModernaTX, Inc. and authorized distributor(s) will ensure that the authorized
Moderna COVID‑19 Vaccine is distributed, as directed by the U.S. government,
including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets)
will be made available to vaccination providers, recipients, and caregivers consistent
with the terms of this letter.
B. ModernaTX, Inc. and authorized distributor(s) will ensure that appropriate storage
and cold chain is maintained until delivered to emergency response stakeholders’
receipt sites.
C. ModernaTX, Inc. will ensure that the terms of this EUA are made available to all
relevant stakeholders (e.g., emergency response stakeholders, authorized distributors,
and vaccination providers) involved in distributing or receiving authorized Moderna
COVID‑19 Vaccine. ModernaTX, Inc. will provide to all relevant stakeholders a
copy of this letter of authorization and communicate any subsequent amendments that
might be made to this letter of authorization and its authorized labeling.
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D. ModernaTX, Inc. may develop and disseminate instructional and educational
materials (e.g., video regarding vaccine handling, storage/cold-chain management,
preparation, disposal) that are consistent with the authorized emergency use of the
vaccine as described in the letter of authorization and authorized labeling, without
FDA’s review and concurrence, when necessary to meet public health needs during
an emergency. Any instructional and educational materials that are inconsistent with
the authorized labeling are prohibited.
E. ModernaTX, Inc. may request changes to this authorization, including to the
authorized Fact Sheets for Moderna COVID‑19 Vaccine. Any request for changes to
this EUA must be submitted to Office of Vaccines Research and Review
(OVRR)/Center for Biologics Evaluation and Research (CBER). Such changes
require appropriate authorization prior to implementation9.
F. ModernaTX, Inc. will report to Vaccine Adverse Event Reporting System (VAERS):
• Serious adverse events (irrespective of attribution to vaccination);
• Cases of Multisystem Inflammatory Syndrome in adults; and
• Cases of COVID-19 that result in hospitalization or death, that are reported to
ModernaTX, Inc.
These reports should be submitted to VAERS as soon as possible but no later than
15 calendar days from initial receipt of the information by ModernaTX, Inc.
G. ModernaTX, Inc. must submit to Investigational New Drug application (IND)
number 19745 periodic safety reports at monthly intervals, in accordance with a due
date agreed upon with the Office of Biostatistics and Epidemiology (OBE),
beginning after the first full calendar month after authorization. Each periodic safety
report is required to contain descriptive information which includes:
• A narrative summary and analysis of adverse events submitted during the
reporting interval, including interval and cumulative counts by age groups, special
populations (e.g., pregnant women), and adverse events of special interest;
• A narrative summary and analysis of vaccine administration errors, whether or
not associated with an adverse event, that were identified since the last reporting
interval;
• Newly identified safety concerns in the interval; and
• Actions taken since the last report because of adverse experiences (for example,
changes made to Healthcare Providers Administering Vaccine (Vaccination
Providers) Fact Sheet, changes made to studies or studies initiated).
9
The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized
labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new
fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing
processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to
require data collection or study. For changes to the authorization, including the authorized labeling, of the type listed
in (3), (6), or (7), review and concurrence is required from the Preparedness and Response Team (PREP)/Office of
the Center Director (OD)/CBER and the Office of Counterterrorism and Emerging Threats (OCET)/Office of the
Chief Scientist (OCS).
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H. No changes will be implemented to the description of the product, manufacturing
process, facilities, or equipment without notification to and concurrence by the
Agency.
I. All manufacturing facilities will comply with Current Good Manufacturing Practice
requirements.
J. ModernaTX, Inc. will submit to the EUA file Certificates of Analysis (CoA) for each
drug product lot at least 48 hours prior to vaccine distribution. The CoA will include
the established specifications and specific results for each quality control test
performed on the final drug product lot.
K. ModernaTX, Inc. will submit to the EUA file quarterly manufacturing reports, staring
in July 2021, that include a listing of all Drug Substance and Drug Product lots
produced after issuance of this authorization. This report must include lot number,
manufacturing site, date of manufacture, and lot disposition, including those lots that
were quarantined for investigation or those lots that were rejected. Information on the
reasons for lot quarantine or rejection must be included in the report.
L. ModernaTX, Inc. and authorized distributor(s) will maintain records regarding release
of Moderna COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity, release
date).
M. ModernaTX, Inc. and authorized distributor(s) will make available to FDA upon
request any records maintained in connection with this EUA.
N. ModernaTX, Inc. will conduct post-authorization observational studies to evaluate
the association between Moderna COVID-19 Vaccine and a pre-specified list of
adverse events of special interest, along with deaths and hospitalizations, and severe
COVID-19. The study population should include individuals administered the
authorized Moderna COVID-19 Vaccine under this EUA in the general U.S.
population (18 years of age and older), populations of interest such as healthcare
workers, pregnant women, immunocompromised individuals, subpopulations with
specific comorbidities. The studies should be conducted in large scale databases with
an active comparator. ModernaTX, Inc. will provide protocols and status update
reports to the IND 19745 with agreed-upon study designs and milestone dates.
O. ModernaTX, Inc., working with its contract research organization, will continue to
monitor the performance of its clinical investigators in ongoing clinical studies of its
vaccine and will report to FDA promptly any significant deviations from the
protocols.
Emergency Response Stakeholders
P. Emergency response stakeholders will identify vaccination sites to receive authorized
Moderna COVID‑19 Vaccine and ensure its distribution and administration,
consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.
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Q. Emergency response stakeholders will ensure that vaccination providers within their
jurisdictions are aware of this letter of authorization, and the terms herein and any
subsequent amendments that might be made to the letter of authorization, instruct
them about the means through which they are to obtain and administer the vaccine
under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare
Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for
Recipients and Caregivers] is made available to vaccination providers through
appropriate means (e.g., e-mail, website).
R. Emergency response stakeholders receiving authorized Moderna COVID‑19 Vaccine
will ensure that appropriate storage and cold chain is maintained.
Vaccination Providers
S. Vaccination providers will administer the vaccine in accordance with the
authorization and will participate and comply with the terms and training required by
CDC’s COVID-19 Vaccination Program.
T. Vaccination providers will provide the Fact Sheet for Recipients and Caregivers to
each individual receiving vaccination and provide the necessary information for
receiving their second dose.
U. Vaccination providers administering Moderna COVID‑19 Vaccine must report the
following information associated with the administration of Moderna COVID‑19
Vaccine of which they become aware to VAERS in accordance with the Fact Sheet
for Healthcare Providers Administering Vaccine (Vaccination Providers):
• Vaccine administration errors whether or not associated with an adverse event
• Serious adverse events (irrespective of attribution to vaccination)
• Cases of Multisystem Inflammatory Syndrome in adults
• Cases of COVID-19 that result in hospitalization or death
Complete and submit reports to VAERS online at
https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the
words “ Moderna COVID‑19 Vaccine EUA” in the description section of the
report. More information is available at vaers.hhs.gov or by calling 1-800-822-
7967. To the extent feasible, report to ModernaTX, Inc., by contacting 1-866-663-
3762, by providing a copy of the VAERS form to ModernaTX, Inc., Fax: 1-866-
599-1342 or by email;
[email protected].
V. Vaccination providers will conduct any follow-up requested by the U.S
government, including CDC, FDA, or other designee, regarding adverse events to
the extent feasible given the emergency circumstances.
W. Vaccination providers will monitor and comply with CDC and/or emergency
response stakeholder vaccine management requirements (e.g., requirements
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concerning obtaining, tracking, and handling vaccine) and with requirements
concerning reporting of vaccine administration data to CDC.
X. Vaccination providers will ensure that any records associated with this EUA are
maintained until notified by FDA. Such records will be made available to CDC
and FDA for inspection upon request.
Conditions Related to Printed Matter, Advertising, and Promotion
Y. All descriptive printed matter, advertising, and promotional material relating to the
use of the Moderna COVID‑19 Vaccine shall be consistent with the authorized
labeling, as well as the terms set forth in this EUA, and meet the requirements set
forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Z. All descriptive printed matter, advertising, and promotional material relating to the
use of the Moderna COVID‑19 Vaccine clearly and conspicuously shall state that:
• This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 18 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
Condition Related to Export
AA. If the product is exported from the United States, conditions C, D, and P through Z
do not apply, but export is permitted only if 1) the regulatory authorities of the
country in which the vaccine will be used are fully informed that this vaccine is
subject to an EUA and is not approved or licensed by FDA and 2) the intended use of
the vaccine will comply in all respects with the laws of the country in which the
product will be used. The requirement in this letter that the authorized labeling (i.e.,
Fact Sheets) be made available to vaccination providers, recipients, and caregivers in
condition A will not apply if the authorized labeling (i.e., Fact Sheets) are made
available to the regulatory authorities of the country in which the vaccine will be
used.
IV. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products during the COVID-19
pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section
564(g) of the Act.
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Sincerely,
--/S/--
____________________________
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration
Enclosure
