HomeMy WebLinkAbout11.22.21 Board Correspondence - FW_ Informed Consent (2)
From:Paulsen, Shaina
To:Pickett, Andy; Ring, Brian; Alpert, Bruce
Cc:Valencia, Shyanne; Reaster, Kayla
Subject:Board Correspondence - FW: Informed Consent
Date:Monday, November 22, 2021 7:55:02 AM
Attachments:vaccination_clinic_06162021-2.pdf
FYI - This was sent to the full board.
Shaina Paulsen
Associate Clerk of The Board
Butte County Administration
25 County Center Drive, Suite 200, Oroville, CA 95965
T: 530.552.3304 | F: 530.538.7120
From: lance dreiss <lancedreiss@att.net>
Sent: Saturday, November 20, 2021 10:11 AM
To: Connelly, Bill <BConnelly@buttecounty.net>; Lucero, Debra <DLucero@buttecounty.net>; Kimmelshue, Tod
<TKimmelshue@buttecounty.net>; Ritter, Tami <TRitter@buttecounty.net>; District Attorney <District_Attorney@buttecounty.net>;
Waugh, Melanie <mwaugh@buttecounty.net>; Teeter, Doug <DTeeter@buttecounty.net>; Clerk of the Board
<clerkoftheboard@buttecounty.net>
Subject: Informed Consent
.ATTENTION: This message originated from outside Butte County. Please exercise judgment before opening attachments, clicking on
links, or replying..
Board of Supervisors, Clerk of the Board, Public Record, Sheriff Honea, DA Ramsey:
Vital information for Board of Supervisors, Butte County Public Health, and anyone promoting mobile vaccine units going to schools,
vaccinating ANY child, and informed consent.
Thank you,
Diana Dreiss
https://urldefense.com/v3/__https://ca.childrenshealthdefense.org/wp-content/uploads/vaccination_clinic_06162021-
2.pdf__;!!KNMwiTCp4spf!TCxx0kTEmNEMUVDY7W9ogHuwuVTWXzzU3rFcrm8V13pVzigzfMZccerIACpWAYmUmGb26mlhvGE$
Sent from my iPad
May 10, 2021
Pfizer Inc.
Attention: Ms. Elisa Harkins
500 Arcola Road
Collegeville, PA 19426
Dear Ms. Harkins:
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
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2019 (COVID-19).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-19pandemic, pursuant to Section 564 of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3), subject to
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terms of any authorization issued under that section.
On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use
Authorization (EUA) for emergency use of Pfizer-
prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the
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Act. FDA reissued the letter of authorization twice: December 23, 2020and February 25, 2021.
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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.
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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).
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In the December 23, 2020 revision, FDAremovedreference to the number of doses per vial after dilution from the
letter of authorization, clarified the instructions for vaccination providersreporting to VAERS, and made other
technical corrections. FDA also revised the Fact Sheet for Healthcare Providers Administering Vaccine
(Vaccination Providers) to clarify the number of doses of vaccine per vial after dilution and the instructions for
reporting to VAERS. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination
Providers) and the Fact Sheet for Recipients and Caregivers were revised to include additional information on safety
monitoring and to clarify information about the availability of other COVID-19 vaccines.
Ѝ
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 Pfizer Inc. The Fact Sheet for
Health Care Providers Administering Vaccine (Vaccination Providers) was revised to provide an update to the
storage and transportation temperature for frozen vials, direct the provider to the correct CDC website for
information on monitoring vaccine recipients for the occurrence of immediate adverse reactions, to include data
from a developmental toxicity study, and add adverse reactions that have been identified during post authorization
use. The Fact Sheet for Recipients and Caregivers was revised to add adverse reactions that have been identified
during post authorization use.
Page 2Pfizer Inc.
On May 10, 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 to authorize emergency use of Pfizer-
of COVID-19 for individuals 12 through 15 years of age, as well as for individuals 16 years of
age and older.With authorization of Pfizer-
COVID-19 in individuals 12 through 15 years of age, the Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) is being revised to include the following
vaccines, in particular in adolescents. Procedures should be in place to avoid injury from
recipients or their caregivers to tell the vaccination provider about fainting in association with a
previous injection.
Pfizer-is for use for active immunization to prevent COVID-19
caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)in individuals 12
years of age and older.The vaccine contains a nucleoside-modified messenger RNA (modRNA)
encoding the viral spike (S) glycoprotein of SARS-CoV-2formulated in lipidparticles. It is an
investigational vaccine not licensed for any indication.
For the December 11, 2020 authorization for individuals 16 years of age and older, FDA
reviewed safety and efficacy data from an ongoing phase 1/2/3trial in approximately 44,000
participants randomized 1:1to receive Pfizer-BioNTech accine or saline control.
at that time
considered the safety and effectiveness data as they relate to the request for emergency use
authorization in individuals 16 years of age and older. review of the available safety data
from 37,586 of the participants 16 years of age and older,who were followed for a median of
two months after receiving the second dose,did not identify specific safety concerns that would
preclude issuance of an EUA. analysis of the available efficacy data from 36,523
participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days
after dose 2 confirmedthe vaccine was 95% effective (95% credible interval 90.3, 97.6) in
preventing COVID-19 occurring at least 7 days after the second dose (with 8 COVID-19 cases in
the vaccine group compared to 162 COVID-19 cases in the placebo group). Based on these data,
and review of manufacturing information regarding product quality and consistency, FDA
concluded that it is reasonable to believe that Pfizer-may be
effective. Additionally, FDA determined it is reasonable to conclude,based on the totality of the
scientific evidence available, thatthe known and potential benefits of Pfizer-BioNTech
outweigh the known and potential risks of the vaccine,for the prevention of
COVID-19in individuals 16 years of age and older.Finally, on December 10, 2020, the
Vaccines and Related Biological Products Advisory Committee voted in agreement with this
conclusion.
For the May 10, 2021 authorization for individuals 12 through 15 years of age, FDA reviewed
safety and effectiveness data from the above-referenced, ongoing Phase 1/2/3 trial that has
enrolled approximately 46,000 participants, including 2,260 participants 12 through 15 years of
age. Trial participants were randomized 1:1 to receive Pfizer-BioNTech COVID-19 Vaccine or
Page 3Pfizer Inc.
ailable safety data from 2,260 participants 12 through 15
years of age, who were followed for a median of 2 months after receiving the second dose, did
SARS-CoV-2 50% neutralizing antibody titers 1 month after the second dose of Pfizer-
BioNTech COVID-19 Vaccine in a subset of participants who had no serological or virological
evidence of past SARS-CoV-2 infection confirm the geometric mean antibody titer in
participants 12 through 15 years of age was non-inferior to the geometric mean antibody titer in
descriptive efficacy data
from 1,983 participants 12 through 15 years of age without evidence of SARS-CoV-2 infection
prior to 7 days after dose 2 confirm thatthe vaccine was 100% effective (95% confidence
interval 75.3, 100.0) in preventing COVID-19 occurring at least 7 days after the second dose
(with no COVID-19 cases in the vaccine group compared to 16 COVID-19 cases in the placebo
group). Based on these data, FDA concluded that it is reasonable to believe that Pfizer-BioNTech
FDA determined it is reasonable to conclude, based on the totality of the scientific evidence
available, that the known and potential benefits of Pfizer-
outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in
individuals 12 through 15 years of age.
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 Pfizer-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 Pfizer-ccine for the
prevention of COVID-19when administered as described in the Scope of Authorization (Section
II) meetsthe criteria for issuance of an authorization under Section 564(c) of the Act, because:
1.SARS-CoV-2 can cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus;
2.Based on the totality of scientific evidence available to FDA, it is reasonable to believe
thatPfizer-may be effective in preventing COVID-19,
and that, when used under the conditions described in this authorization, the known and
potential benefits of Pfizer-when used to prevent
COVID-19outweigh itsknown and potential risks; and
3.There is no adequate, approved, and available alternative to the emergency use of
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Pfizer-to prevent COVID-19.
II.Scope of Authorization
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No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
Page 4Pfizer Inc.
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited as follows:
Pfizer Inc. will supply Pfizer-either directly or
67
throughauthorized distributor(s),toemergency response stakeholdersas
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;
ThePfizer-covered by this authorization will be
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administered by vaccination providersand used only to prevent COVID-19in
individuals ages 12and older; and
Pfizer-maybe administered by a vaccination
provider without an individual prescription for each vaccine recipient.
Product Description
The Pfizer-BioNTech COVID-19 Vaccine issupplied as a frozen suspension in multiple dose
vials; each vial must be diluted with1.8 mL of sterile 0.9% Sodium Chloride Injection, USP
prior to useto form the vaccine. The Pfizer-BioNTech COVID-19 Vaccine does not contain a
preservative.
Each 0.3mLdose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside-
modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
6
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 Pfizer-
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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
-19 vaccination response organization and plans), there
alth 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.
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,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
-19 vaccination and emergency response plan(s) and who is enrolled in the CDC
COVID-
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).
Page 5Pfizer Inc.
Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients:
lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg
2\[(polyethylene glycol)-2000\]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3-
phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic
potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate,
and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection) contributes an additional 2.16
mg sodium chloride per dose.
The dosing regimen is two doses of 0.3 mL each,3 weeks apart.
Themanufacture of the authorized Pfizer-islimited to those
facilities identified and agreed upon authorization.
The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for
ThePfizer-Vaccine is authorized to be
distributed,stored,further redistributed, and administered by emergency response stakeholders
when packaged in the authorized manufacturer packaging (i.e.,vialsand cartons), despite the
fact that the vial and carton labels may not contain information that otherwise would be required
under theFD&C Act.
Pfizer-is authorized foremergency use with the following
product-specific information required to be made available tovaccination providers and
recipients,respectively :
Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers):
Emergency Use Authorization (EUA) of Pfizer-toPrevent
Coronavirus Disease 2019 (COVID-19)
Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of
Pfizer-toPrevent Coronavirus Disease 2019 (COVID-19)
inIndividuals 12Years of Age and Older
Ihave concluded,pursuant toSection 564(d)(2) ofthe Act, that it isreasonable tobelieve that
the known and potential benefits ofPfizer-,when used toprevent
COVID-19and used in accordance with this Scope ofAuthorization (Section II), outweigh its
known and potential risks.
I have concluded, pursuant toSection 564(d)(3) ofthe Act, based onthe totality ofscientific
evidence available toFDA, that itisreasonable tobelieve that Pfizer-BioNTech
Vaccine maybeeffective inpreventingCOVID-19 when used in accordance with this Scope of
Authorization (Section II), pursuant toSection 564(c)(2)(A) ofthe Act.
Having reviewed the scientific information available toFDA, including theinformation
supporting the conclusions described inSection I above, I have concluded that Pfizer-BioNTech
(as described in this Scope ofAuthorization (Section II)) meets the criteria set
forth in Section 564(c) of the Act concerning safety and potential effectiveness.
Page 6Pfizer Inc.
The emergency use ofPfizer-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), Pfizer-is authorized toprevent COVID-19in individuals
12years 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:
Pfizer Inc. and Authorized Distributor(s)
A.Pfizer Inc.and authorized distributor(s)will ensure that the authorized Pfizer-
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.Pfizer Inc. and authorized distributor(s)will ensure that appropriate storage and cold
chain is maintained until delivered to.
C.Pfizer 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 Pfizer-
.Pfizer 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.
D.Pfizer 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,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.Pfizer Inc. mayrequest changes to this authorization, including to the authorized Fact
Sheets for the Pfizer COVID-19 Vaccine. Any request for changes to this EUA must
be submitted to Office of Vaccines Research and Review (OVRR)/Center for
Page 7Pfizer Inc.
Biologics Evaluation and Research (CBER). Such changes require appropriate
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authorization prior to implementation.
F.Pfizer Inc. will report to Vaccine Adverse Event Reporting System (VAERS):
Serious adverse events (irrespective of attribution to vaccination);
Cases of Multisystem Inflammatory Syndrome in children and adults; and
Cases of COVID-19 that result in hospitalization or death, that are reported to
Pfizer Inc.
These reports should be submitted to VAERS as soon as possible but no later than
15 calendar days frominitial receipt of the information by Pfizer Inc.
G.Pfizer Inc. must submit to Investigational New Drug application (IND) number
19736periodic safety reports at monthly intervals in accordance with a due date
agreed upon with the Office of Biostatistics and Epidemiology (OBE)/CBER
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
notassociated 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).
H.No changes will beimplementedto 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.Pfizer 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.
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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).
Page 8Pfizer Inc.
K.PfizerInc. will submit to the EUA file quarterly manufacturing reports 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.The first report is due July
2021.
L.Pfizer Inc.and authorized distributor(s)will maintain records regarding release of
Pfizer-BioNTech for distribution (i.e., lot numbers, quantity,
release date).
M.Pfizer Inc. and authorized distributor(s)will make available to FDA upon request any
records maintained in connection with this EUA.
N.Pfizer Inc. will conduct post-authorization observational studies to evaluate the
association between Pfizer-BioNTech 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 Pfizer-BioNTech COVID-19 Vaccine under this EUA in the general U.S.
population (12years 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. Pfizer Inc. will provide protocols and status update reports to
the IND 19736with agreed-upon study designs and milestone dates.
Emergency Response Stakeholders
O.Emergency response stakeholders will identify vaccination sites to receiveauthorized
Pfizer-and ensure its distribution and administration,
consistent with the terms of this letter -19 Vaccination Program.
P.Emergency response stakeholders will ensure that vaccination providers within their
jurisdictions are aware of thisletter 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 \[i.e.,Fact Sheet for Healthcare
Providers Administering Vaccine(Vaccination Providers) and Fact Sheet for
Recipients andCaregivers\]ismade available to vaccination providers through
appropriate means (e.g., e-mail, website).
Q.Emergency response stakeholders receiving authorized Pfizer-
Vaccine will ensure that appropriate storage and cold chain is maintained.
Vaccination Providers
Page 9Pfizer Inc.
R.Vaccination providers will administer the vaccine in accordance with the
authorization and will participate and comply with the terms and training required by
-19 Vaccination Program.
S.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.
T.Vaccination providers administering Pfizer-must
report the following information associated with the administration of Pfizer-
of which they become aware to VAERS in
accordance with the Fact Sheet for Healthcare Providers Administering Vaccine
(Vaccination Providers):
Vaccineadministration errors whether or not associated with an adverse event
Serious adverse events (irrespective of attribution to vaccination)
Cases of Multisystem Inflammatory Syndrome in children and 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
Pfizer-
the report. More information is available at vaers.hhs.gov or by calling 1-800-822-
7967.To the extent feasible, report to Pfizer Inc. by contacting 1-800-438-1985or
by providing a copy of the VAERS form to Pfizer Inc.; Fax: 1-866-635-8337.
U.Vaccination providers will conduct any follow-up requested by theU.S
government, including CDC, FDA,orother designee, regarding adverse events to
the extent feasible given the emergency circumstances.
V.Vaccination providers will monitor and comply withCDC and/or emergency
response stakeholder vaccine management requirements (e.g., requirements
concerning obtaining, tracking, and handling vaccine) and withrequirements
concerning reporting ofvaccine administration data to CDC.
W.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.
Page 10Pfizer Inc.
Conditions Related to Printed Matter, Advertising,and Promotion
X.All descriptive printed matter, advertising,and promotional material, relating to the
use of the Pfizer-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.
Y.All descriptive printed matter, advertising,and promotional material relating to the
use of the Pfizer-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 12years 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.
IV.Duration of Authorization
This EUA will be effectiveuntil the declaration thatcircumstancesexist justifyingthe
authorization of theemergencyuseofdrugs and biological products during the COVID-19
pandemic is terminated underSection 564(b)(2)oftheAct or theEUA is revoked underSection
564(g)ofthe Act.
Sincerely,
--/S/--
____________________________
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration
Enclosures