Burk Declaration
- Date
- 2021-12-17
Summary
Document 40-6 in Case 2:21-cv-00702-CLM, filed December 17, 2021 in the U.S. District Court, N.D. of Alabama, is Exhibit 6 to the Burk Declaration. It reproduces an October 29, 2021 letter from the Food and Drug Administration to Pfizer Inc. reissuing the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine. The letter recounts earlier authorizations and revisions beginning December 11, 2020, and states that this revision authorizes use for children 5 through 11 years of age and an additional formulation using Tris buffer. It summarizes FDA's review of trial safety and effectiveness data, including an analysis of 36,523 participants showing 95% effectiveness. The 20-page exhibit closes with the duration of authorization and is signed by the FDA's Acting Chief Scientist.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Full text
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 1 of 20 FILED
2021 Dec-17 PM 01:27
U.S. DISTRICT COURT
N.D. OF ALABAMA
Burk Declaration
Exhibit 6
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 2 of 20
October 29, 2021
Pfizer Inc.
Attention: Mr. Amit Patel
235 East 42nd St
New York, NY 10017
Dear Mr. Patel:
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act or 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 (21 U.S.C. 360bbb-3), subject to terms
of any authorization issued under that section. 2
On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use
Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the
prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the
Act. FDA reissued the letter of authorization on: December 23, 2020, 3 February 25, 2021, 4 May
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 FD&C 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 December 23, 2020 revision, FDA removed reference to the number of doses per vial after dilution from the
letter of authorization, clarified the instructions for vaccination providers reporting 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.
4
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.
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 3 of 20
Page 2 – Pfizer Inc.
10, 2021, 5 June 25, 2021, 6 and August 12, 2021. 7 On August 23, 2021, FDA approved
COMIRNATY (COVID-19 Vaccine, mRNA) 8 and reissued the letter in its entirety for both
Pfizer-BioNTech COVID‑19 Vaccine and certain uses of COMIRNATY (COVID-19 Vaccine,
mRNA). 9 Subsequently, FDA reissued the letter of authorization on September 22, 2021 10
and October 20, 2021. 11
5
In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in
individuals 12 through 15 years of age, as well as for individuals 16 years of age and older. In addition, FDA
revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include the
following Warning: “Syncope (fainting) may occur in association with administration of injectable vaccines, in
particular in adolescents. Procedures should be in place to avoid injury from fainting.” In addition, the Fact Sheet
for Recipients and Caregivers was revised to instruct vaccine recipients or their caregivers to tell the vaccination
provider about fainting in association with a previous injection.
6
In the June 25, 2021 revision, FDA clarified terms and conditions that relate to export of Pfizer-BioNTech
COVID‑19 Vaccine from the United States. In addition, the Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) was revised to include a Warning about myocarditis and pericarditis following
administration of the Pfizer-BioNTech COVID-19 Vaccine. The Fact Sheet for Recipients and Caregivers was
updated to include information about myocarditis and pericarditis following administration of the Pfizer-BioNTech
COVID‑19 Vaccine.
7
In the August 12, 2021 revision, FDA authorized a third dose of the Pfizer-BioNTech COVID-19 Vaccine
administered at least 28 days following the two dose regimen of this vaccine in individuals 12 years of age or older
who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with
conditions that are considered to have an equivalent level of immunocompromise.
8
COMIRNATY (COVID-19 Vaccine, mRNA) was approved for active immunization to prevent COVID-19 caused
by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
9
In the August 23, 2021 revision, FDA clarified that, subsequent to the FDA approval of COMIRNATY (COVID-
19 Vaccine, mRNA) for the prevention of COVID-19 for individuals 16 years of age and older, this EUA would
remain in place for the Pfizer-BioNTech COVID-19 Vaccine for the previously-authorized indication and uses. It
also authorized COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included
in the approved biologics license application (BLA). In addition, the Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the
authorized Pfizer-BioNTech COVID-19 Vaccine and updated language regarding warnings and precautions related
to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine
Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-
BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19
Vaccine, mRNA).
10
In the September 22, 2021 revision, FDA authorized the administration of a single booster dose of COMIRNATY
(COVID-19 Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine at least 6 months after completing the
primary series of this vaccine in individuals: 65 years of age and older; 18 through 64 years of age at high risk of
severe COVID-19; and 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-
CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
11
In the October 20, 2021 revision, FDA clarified eligibility for the booster dose of COMIRNATY (COVID-19
Vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine and authorized the administration of a single booster
dose of Pfizer-BioNTech COVID‑19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) as a heterologous
booster dose following completion of primary vaccination with another authorized COVID-19 vaccine. The eligible
population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster
dose of the vaccine used for primary vaccination.
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 4 of 20
Page 3 – Pfizer Inc.
On October 29, 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 is again reissuing the October
20, 2021 letter of authorization in its entirety with revisions incorporated to:
1) authorize the use of Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11
years of age; and
2) authorize a manufacturing change to include an additional formulation of the Pfizer-
BioNTech COVID-19 Vaccine that uses tromethamine (Tris) buffer instead of phosphate
buffered saline (PBS) used in the originally authorized Pfizer-BioNTech COVID-19
Vaccine.
The formulation of the Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer is authorized
in two presentations: 12
1) Multiple dose vials, with gray caps and labels with a gray border, formulated to
provide, without need for dilution, doses (each 0.3 mL dose containing 30 µg nucleoside-
modified messenger RNA (modRNA)) for individuals 12 years of age and older; and
2) Multiple dose vials, with orange caps and labels with an orange border, formulated to
provide, after dilution, doses (each 0.2 mL dose containing 10 µg modRNA) for
individuals 5 through 11 years of age. 13
The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19
Vaccine, mRNA) have the same formulation. The products are legally distinct with certain
differences that do not impact safety or effectiveness. Accordingly, under this EUA, the Pfizer-
BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19 Vaccine,
mRNA) can be used interchangeably to provide doses for primary vaccination in individuals 12
years of age and older, or to provide a single booster dose in the adult populations described in
Section II of this letter of authorization, without presenting any safety or effectiveness concerns.
The Pfizer-BioNTech COVID-19 Vaccine formulations that use Tris and PBS buffers, and which
are authorized for use in individuals 12 years of age and older, contain the same modRNA and
lipids, and the same quantity of these ingredients, per 0.3 mL dose. The two formulations differ
with respect to certain inactive ingredients only and have been shown to be analytically
comparable. 14
12
The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer is available in multiple dose vials with purple
caps, and is formulated to provide, after dilution, doses (each 0.3mL containing 30 µg modRNA) for individuals 12
years of age and older. The formulation that uses PBS buffer is not authorized for use in children 5 through 11 years
of age.
13
The Pfizer-BioNTech COVID-19 Vaccine (0.2 mL dose containing 10 µg modRNA) that uses Tris buffer and is
available in multiple dose vials with orange caps and labels with an orange border is the only formulation that is
authorized for use in individuals 5 through 11 years of age.
14
Analytical comparability assessments use laboratory testing to demonstrate that a change in product formulation
does not impact a product's safety or effectiveness. For the Pfizer-BioNTech COVID-19 Vaccine, multiple different
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 5 of 20
Page 4 – Pfizer Inc.
Accordingly, under this EUA, for individuals 12 years of age and older, COMIRNATY
(COVID-19 Vaccine, mRNA) and these two formulations of the Pfizer-BioNTech COVID-19
Vaccine, when prepared according to their respective instructions for use, can be used
interchangeably without presenting any safety or effectiveness concerns.
Therefore, for individuals 12 years of age and older, COMIRNATY (COVID-19 Vaccine,
mRNA) is authorized to complete the primary regimen or provide a booster dose for individuals
who received their initial primary dose(s) with the Pfizer-BioNTech COVID-19 Vaccine
(whether the PBS formulation or Tris formulation), and the Pfizer-BioNTech COVID-19
Vaccine (whether the PBS formulation or Tris formulation) is authorized to complete the
primary regimen or provide a booster for individuals who received their initial primary dose(s)
with COMIRNATY (COVID-19 Vaccine, mRNA).
For the December 11, 2020 authorization for individuals 16 years of age and older, FDA
reviewed safety and effectiveness data from an ongoing Phase 1/2/3 trial in approximately
44,000 participants randomized 1:1 to receive Pfizer-BioNTech COVID‑19 Vaccine or saline
control. The trial enrolled participants 12 years of age and older. FDA’s review 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. FDA’s 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. FDA’s 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 confirmed that the 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-BioNTech COVID‑19 Vaccine may be
effective. Additionally, FDA determined it is reasonable to conclude, based on the totality of the
scientific evidence available, that the known and potential benefits of Pfizer-BioNTech
COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of
COVID-19 in 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 enrolled
approximately 46,000 participants, including 2,260 participants 12 through 15 years of age.
release parameters were evaluated to assess the comparability of the modified formulation (the formulation with the
Tris buffer) to the originally-authorized formulation (the formulation with the PBS buffer). These release
parameters ranged from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the
product. Additionally, characterization testing was performed to evaluate product composition and purity, including
characteristics of the modRNA, as these are characteristics associated with the activity of the vaccine. The
combination of release testing and characterization testing demonstrated that the modified formulation is analytically
comparable to the original formulation.
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 6 of 20
Page 5 – Pfizer Inc.
Trial participants were randomized 1:1 to receive Pfizer-BioNTech COVID-19 Vaccine or saline
control. FDA’s review of the available 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 not
identify specific safety concerns that would preclude issuance of an EUA. FDA’s analysis of
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 that the geometric mean antibody titer in
participants 12 through 15 years of age was non-inferior to the geometric mean antibody titer in
participants 16 through 25 years of age. FDA’s analysis of available 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 that the 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 COVID‑19 Vaccine may be effective in individuals 12 through 15 years of age.
Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific
evidence available, that the known and potential benefits of Pfizer-BioNTech COVID‑19
Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19
in individuals 12 through 15 years of age.
For the August 12, 2021 authorization of a third primary series dose in individuals 12 years of
age or older who have undergone solid organ transplantation, or individuals 12 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 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 the Pfizer-BioNTech COVID-
19 Vaccine was administered to 99 of these individuals approximately 2 months after they had
received a second dose. Levels of total SARS-CoV-2 binding antibodies meeting the pre-
specified 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
were subsequently considered to have levels of antibodies indicative of a significant response. 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. A supportive secondary study
describes 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 a similar
messenger RNA vaccine (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 indicate this antibody titer was protective.
Secondary outcomes were based on a virus neutralization assay and 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 total SARS-CoV-2 binding
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 7 of 20
Page 6 – Pfizer Inc.
antibodies indicative 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.
Despite the moderate enhancement in antibody titers, the totality of data (i.e., supportive paper
by Hall et al. demonstrated efficacy of the product in the elderly and persons with co-
morbidities) supports the conclusion that a third dose of the Pfizer-BioNTech COVID-19
Vaccine may be effective in this population, and that the known and potential benefits of a third
dose of Pfizer-BioNTech COVID-19 Vaccine outweigh the known and potential risks of the
vaccine for immunocompromised individuals at least 12 years of age who have received two
doses of the Pfizer-BioNTech 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.
For the September 22, 2021 authorization of a single booster dose administered at least 6 months
after completing the primary series in individuals: 65 years of age and older; 18 through 64 years
of age at high risk of severe COVID-19; and 18 through 64 years of age whose frequent
institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious
complications of COVID-19 including severe COVID-19, FDA reviewed safety and
effectiveness data from the above-referenced, ongoing Phase 1/2/3 trial in which 329 participants
18 through 75 years of age received a booster dose of the Pfizer-BioNTech COVID-19 Vaccine
approximately 6 months (range 4.8 to 8.8 months) after completion of the primary series. FDA’s
review of the available safety data from 329 participants 18 through 75 years of age, who had
been followed for a median of 2.6 months after receiving the booster dose, did not identify
specific safety concerns that would preclude issuance of an EUA. The effectiveness of the
booster dose of the Pfizer-BioNTech COVID-19 Vaccine is based on an assessment of 50%
neutralizing antibody titers (NT50) against SARS-CoV-2 (USA_WA1/2020). FDA’s analysis of
SARS-CoV-2 NT50 one month after the booster dose compared to 1 month after the primary
series in study participants 18 through 55 years of age who had no serological or virological
evidence of past SARS-CoV-2 infection up to 1 month after the booster dose confirmed
noninferiority for both geometric mean ratio and difference in seroresponse rates. Based on the
totality of the scientific evidence available, including data from the above-referenced clinical
trial, FDA concluded that a booster dose the Pfizer-BioNTech COVID-19 Vaccine may be
effective, and that the known and potential benefits of a single booster dose at least 6 months
after completing the primary series outweigh the known and potential risks for individuals 65
years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19;
and individuals 18 through 64 years of age whose frequent institutional or occupational exposure
to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe
COVID-19.
For the October 20, 2021 authorization of a single booster dose as a heterologous booster dose
following completion of primary vaccination with another authorized COVID-19 vaccine, FDA
reviewed data from an ongoing Phase1/2 clinical trial in participants 19-85 years of age. In this
trial, adults who had completed primary vaccination with a Moderna COVID-19 Vaccine 2-dose
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 8 of 20
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series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech
COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks prior to enrollment and who
reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of
one of three vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-
BioNTech COVID-19 Vaccine. Adverse events were assessed through 28 days after the booster
dose. An overall review of adverse reactions reported following the Pfizer-BioNTech COVID-
19 Vaccine heterologous booster dose did not identify any new safety concerns, as compared
with adverse reactions reported following Pfizer-BioNTech COVID-19 Vaccine primary series
doses or homologous booster dose. Neutralizing antibody titers, as measured by a pseudovirus
neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein with D614G
mutation, were assessed on Day 1 prior to administration of the booster dose and on Day 15 after
the booster dose. A booster response to the Pfizer-BioNTech COVID-19 Vaccine was
demonstrated regardless of primary vaccination. Based on the on the totality of the scientific
evidence available, including data from the above-referenced clinical trial, FDA concluded that a
heterologous booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be effective, and
that the known and potential benefits of a heterologous booster dose of the Pfizer-BioNTech
COVID-19 Vaccine following completion of primary vaccination with another authorized
COVID-19 vaccine outweigh the known and potential risks.
For the October 29, 2021 authorization for the Pfizer-BioNTech COVID-19 Vaccine that uses
Tris buffer for individuals 5 through 11 years of age, FDA reviewed safety and effectiveness data
from an ongoing Phase 1/2/3 trial that has enrolled 4,695 participants 5 through 11 years of age,
of whom 3,109 participants received PfizerBioNTech COVID19 Vaccine (containing 10 µg
modRNA) formulated using PBS buffer and approximately 1,538 participants received saline
control in Phase 2/3. FDA’s review of the available safety data from 3,109 participants 5
through 11 years of age who received Pfizer-BioNTech COVID-19 Vaccine (containing 10 µg
modRNA), including 1,444 who were followed for at least 2 months after receiving the second
dose, did not identify specific safety concerns that would preclude issuance of an EUA. SARS-
CoV-2 50% neutralizing antibody titers 1 month after the second dose were compared between a
subset of participants 5 through 11 years of age who received Pfizer-BioNTech COVID-19
Vaccine (containing 10 µg modRNA) and a subset of participants 16 through 25 years of age
who received Pfizer-BioNTech COVID-19 Vaccine (containing 30 µg modRNA) in the above-
referenced ongoing Phase 1/2/3 trial that enrolled approximately 46,000 participants.
Immunobridging analyses included a subset of participants from each study who had no
serological or virological evidence of past SARS-CoV-2 infection. FDA’s analyses confirm that
immunobridging criteria were met for both geometric mean antibody titers and seroresponse
rates. FDA’s analysis of available descriptive efficacy data from 1,968 participants 5 through 11
years of age without evidence of SARS-CoV-2 infection prior to 7 days after dose 2 confirm that
the vaccine was 90.7% effective (95% confidence interval 67.7, 98.3) in preventing COVID-19
occurring at least 7 days after the second dose (with 3 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 COVID‑19 Vaccine may be effective in
individuals 5 through 11 years of age. Additionally, FDA determined it is reasonable to
conclude, based on the totality of the scientific evidence available, that the known and potential
benefits of Pfizer-BioNTech COVID‑19 Vaccine outweigh the known and potential risks of the
vaccine, for the prevention of COVID-19 in individuals 5 through 11 years of age. Finally, on
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Page 8 – Pfizer Inc.
October 26, 2021, the Vaccines and Related Biological Products Advisory Committee voted in
agreement with this conclusion.
For the October 29, 2021 authorization of the manufacturing change to include an additional
formulation of the Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer instead of PBS
buffer used in the originally authorized Pfizer-BioNTech COVID-19 Vaccine, FDA reviewed
data on analytical comparability, which uses laboratory testing to demonstrate that a change in
product formulation is not expected to impact safety or effectiveness. In the case of Pfizer-
BioNTech COVID-19 Vaccine, multiple different release parameters were evaluated, ranging
from product appearance to size of the lipid-nanoparticle to the integrity of the modRNA in the
product. Characterization testing included looking at product composition and purity including
characteristics of the modRNA, and strength including the lipid-nanoparticle size distribution
and shape, as these are characteristics associated with the activity of the vaccine. In this case,
analytical comparability to the current PBS formulation of the Pfizer-BioNTech COVID-19
Vaccine was demonstrated for the Tris formulation of the Pfizer-BioNTech COVID-19 Vaccine
through a combination of release and characterization testing.
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-BioNTech COVID‑19 Vaccine 15 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. Additionally, as specified in
subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under
this EUA as described in the Scope of Authorization section of this letter (Section II).
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine 16 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 Pfizer-BioNTech COVID‑19 Vaccine 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-BioNTech COVID‑19 Vaccine when used to prevent
COVID-19 outweigh its known and potential risks; and
15
Reference to the Pfizer-BioNTech COVID-19 Vaccine hereinafter refers to both the PBS and Tris formulations,
unless specifically delineated otherwise.
16
In this section (Section I), references to Pfizer-BioNTech COVID‑19 Vaccine also apply to COMIRNATY
(COVID-19 Vaccine, mRNA).
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C. There is no adequate, approved, and available alternative 17 Pfizer-BioNTech
COVID‑19 Vaccine to prevent COVID-19. 18
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:
• Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through
authorized distributor(s), 19 to emergency response stakeholders 20 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;
• Pfizer-BioNTech COVID‑19 Vaccine may be administered by a vaccination provider 21
without an individual prescription for each vaccine recipient.
17
Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years
of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at
the time of reissuance of this EUA. Additionally, there are no COVID-19 vaccines that are approved to provide:
COVID-19 vaccination in individuals 5 through 15 years of age; a third primary series dose to certain
immunocompromised populations described in this EUA; a homologous booster dose to the authorized population
described in this EUA; or a heterologous booster dose following completion of primary vaccination with another
authorized COVID-19 vaccine.
18
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
19
“Authorized Distributor(s)” are identified by Pfizer 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-BioNTech COVID‑19 Vaccine.
20
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.
21
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).
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 11 of 20
Page 10 – Pfizer Inc.
For use in individuals 12 years of age and older
• The Pfizer-BioNTech COVID-19 Vaccine formulations that use Tris and PBS buffers
(each 0.3 mL dose containing 30 µg modRNA) covered by this authorization will be
administered by vaccination providers and used only to prevent COVID-19 in individuals
12 years of age and older with a two-dose primary regimen (3 weeks apart) and to
provide:
o a third primary series dose at least 28 days following the second dose to
individuals 12 years of age or older who have undergone solid organ
transplantation, or who are diagnosed with conditions that are considered to have
an equivalent level of immunocompromise;
o a single booster dose at least 6 months after completion of a primary series of the
vaccine to individuals: 65 years of age or older; 18 through 64 years of age at high
risk of severe COVID-19; and 18 through 64 years of age with frequent
institutional or occupational exposure to SARS-CoV-2;
o a single booster dose as a heterologous booster dose following completion of
primary vaccination with another authorized COVID-19 vaccine, where the
eligible population(s) and dosing interval for the heterologous booster dose are
the same as those authorized for a booster dose of the vaccine used for primary
vaccination; and
For use in individuals 5 through 11 years of age
• The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer (each 0.2 mL dose
containing 10 µg modRNA) covered by this authorization will be administered by
vaccination providers and used only to prevent COVID-19 in individuals 5 through 11
years of age with a two-dose primary regimen (3 weeks apart).
For use in individuals who are 11 years old at the time of the first dose, and turn 12 years old
before the second dose:
• Notwithstanding the age limitations for use of the different formulations and
presentations described above, individuals who will turn from 11 years to 12 years of age
between their first and second dose in the primary regimen may receive, for either dose,
either: (1) the Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer (each 0.2 mL
dose containing 10 µg modRNA) covered by this authorization; or (2) the Pfizer-
BioNTech COVID-19 Vaccine and COMIRNATY formulations provided in one of the
presentations for individuals 12 years of age and older (each 0.3 mL dose containing 30
µg modRNA) covered by this authorization.
• The vaccine will be administered by vaccination providers and used only to prevent
COVID-19 with a two-dose primary regimen (3 weeks apart).
This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine,
mRNA) product when used to provide: (1) a two-dose primary regimen (0.3 mL each, 3 weeks
apart) for individuals 12 through 15 years of age; (2) a third primary series dose at least 28 days
following the second dose to individuals 12 years of age or older who have undergone solid
organ transplantation or who are diagnosed with conditions that are considered to have an
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 12 of 20
Page 11 – Pfizer Inc.
equivalent level of immunocompromise; (3) a single booster dose (0.3 mL) at least 6 months
after completion of the primary series to individuals 65 years of age and older, 18 through 64
years of age at high risk of severe COVID-19, and 18 through 64 years of age with frequent
institutional or occupational exposure to SARS-CoV-2; and (4) a single booster dose (0.3 mL) as
a heterologous booster dose following completion of primary vaccination with another
authorized COVID-19 vaccine, where the eligible population(s) and dosing interval for the
heterologous booster dose are the same as those authorized for a booster dose of the vaccine used
for primary vaccination.
Product Description 22
The Pfizer-BioNTech COVID-19 Vaccine, supplied in two formulations, is provided in three
different vials:
For use in individuals 12 years of age and older
• The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer is available in multiple
dose vials with purple caps. It is formulated to provide, after dilution, 0.3 mL doses
(each containing 30 µg modRNA) and can be used for all authorized indications in
individuals 12 years of age and older.
• The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer, and is available in
multiple dose vials with gray caps and labels with gray borders, is formulated to provide,
after dilution, 0.3 mL doses (each containing 30 µg modRNA) and can be used for all
authorized indications in individuals 12 years of age and older.
For use in individuals 5 through 11 years of age
• The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer, and is available in
multiple dose vials with orange caps and labels with orange borders, is formulated to
provide, after dilution, 0.2 mL doses (each containing 10 µg modRNA) and can be used
for administration to individuals 5 through 11 years of age.
For use in individuals 12 years of age and older
The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer (supplied in multiple dose vials
with purple caps) is supplied as a frozen suspension; each vial must be diluted with 1.8 mL of
sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. The Pfizer-
BioNTech COVID-19 Vaccine does not contain a preservative. Each 0.3 mL dose of the Pfizer-
BioNTech COVID-19 Vaccine contains 30 µg of modRNA encoding the viral spike (S)
glycoprotein of SARS-CoV-2. 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[(polyethylee 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
For COMIRNATY (COVID-19 Vaccine, mRNA) product description, please see the COMIRNATY (COVID-19
22
Vaccine, mRNA) prescribing information, found here: https://www.fda.gov/media/151707/download.
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 13 of 20
Page 12 – Pfizer Inc.
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 Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer and that is supplied in multiple
dose vials with gray caps is supplied as a frozen suspension and should not be diluted. The
Pfizer-BioNTech COVID-19 Vaccine does not contain a preservative. Each 0.3 mL dose of the
Pfizer-BioNTech COVID-19 Vaccine contains 30 µg of a modRNA encoding the viral spike (S)
glycoprotein of SARS-CoV-2. 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 0.19 mg cholesterol), 0.06 mg
tromethamine, 0.4 mg tromethamine hydrochloride, and 31 mg sucrose.
For use in individuals 5 through 11 years of age
The Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer and that is supplied in multiple
dose vials with orange caps is supplied as a frozen suspension; each vial must be diluted with
1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each
dose of the Pfizer-BioNTech COVID-19 Vaccine contains 10 µg of a modRNA encoding the
viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19
Vaccine also includes the following ingredients: lipids (0.14 mg (4-
hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene
glycol)-2000]-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine,
and 0.06 mg cholesterol), 10.3 mg sucrose, 0.02 mg tromethamine, and 0.13 mg tromethamine
hydrochloride. The diluent (0.9% Sodium Chloride Injection, USP) contributes 0.9 mg sodium
chloride per dose.
The manufacture of the authorized Pfizer-BioNTech COVID‑19 Vaccine is limited to those
facilities identified and agreed upon in Pfizer’s request for authorization.
The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for
“Emergency Use Authorization.” The Pfizer-BioNTech 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.
Pfizer-BioNTech 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 Pfizer-BioNTech COVID‑19 Vaccine to Prevent
Coronavirus Disease 2019 (COVID-19) - For 12 Years of Age and Older Dilute Before
Use)
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 14 of 20
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• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers):
Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent
Coronavirus Disease 2019 (COVID-19) - For 12 Years of Age and Older Do Not Dilute
• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers):
Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent
Coronavirus Disease 2019 (COVID-19) - For 5 Through 11 Years of Age Dilute Prior To
Use
• Vaccine Information Fact Sheet for Recipients and Caregivers About COMIRNATY
(COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent
Coronavirus Disease (COVID-19) For Use Use in Individuals 12 Years of Age and Older
• Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-
BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease (COVID-19) for Use in
Individuals 5 Through 11 Years of Age
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 Pfizer-BioNTech COVID‑19 Vaccine,23 when used to
prevent 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 Pfizer-BioNTech 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 Pfizer-BioNTech
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 Pfizer-BioNTech 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), Pfizer-BioNTech COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals
5 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:
23
The conclusions supporting authorization stated in this section (Section II) also apply to COMIRNATY (COVID-
19 Vaccine, mRNA).
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 15 of 20
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Pfizer Inc. and Authorized Distributor(s)
A. Pfizer Inc. and authorized distributor(s) will ensure that the authorized Pfizer-
BioNTech 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. Pfizer Inc. and authorized distributor(s) will ensure that appropriate storage and cold
chain is maintained until delivered to emergency response stakeholders’ receipt sites.
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-
BioNTech COVID‑19 Vaccine. 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, 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. Pfizer Inc. may request changes to this authorization, including to the authorized Fact
Sheets for the 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
implementation.24
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.
24
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).
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 16 of 20
Page 15 – Pfizer 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 Pfizer Inc.
G. Pfizer Inc. must submit to Investigational New Drug application (IND) number
19736 periodic 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
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).
H. No changes will be implemented to the description of the product, manufacturing
process, facilities, or equipment without notification to and concurrence by FDA.
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.
K. Pfizer Inc. will submit to the EUA file quarterly manufacturing reports, starting 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. Pfizer Inc. and authorized distributor(s) will maintain records regarding release of
Pfizer-BioNTech COVID‑19 Vaccine 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
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 17 of 20
Page 16 – Pfizer Inc.
adverse events of special interest, including myocarditis and pericarditis, 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 (5 years of age and older),
individuals who receive a booster dose, 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 19736 with agreed-upon study designs and milestone dates.
Emergency Response Stakeholders
O. Emergency response stakeholders will identify vaccination sites to receive authorized
Pfizer-BioNTech COVID‑19 Vaccine and ensure its distribution and administration,
consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.
P. 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 Vaccine Information
Fact Sheet for Recipients and Caregivers] is made available to vaccination providers
through appropriate means (e.g., e-mail, website).
Q. Emergency response stakeholders receiving authorized Pfizer-BioNTech COVID‑19
Vaccine will ensure that appropriate storage and cold chain is maintained.
Vaccination Providers
R. 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.
S. Vaccination providers will provide the Vaccine Information Fact Sheet for Recipients
and Caregivers to each individual receiving vaccination and provide the necessary
information for receiving their second dose and/or third dose.
T. Vaccination providers administering the vaccine must report the following
information associated with the administration of the 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 children and adults
• Cases of COVID-19 that result in hospitalization or death
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Complete and submit reports to VAERS online at
https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the
words “Pfizer-BioNTech 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 Pfizer Inc. by contacting 1-800-438-1985 or
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 the U.S
government, including CDC, FDA, or other designee, regarding adverse events to
the extent feasible given the emergency circumstances.
V. Vaccination providers will monitor and comply with CDC and/or emergency
response stakeholder vaccine management requirements (e.g., requirements
concerning obtaining, tracking, and handling vaccine) and with requirements
concerning reporting of vaccine 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.
Conditions Related to Printed Matter, Advertising, and Promotion
X. All descriptive printed matter, advertising, and promotional material, relating to the
use of the Pfizer-BioNTech 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.
Y. All descriptive printed matter, advertising, and promotional material relating to the
use of the Pfizer-BioNTech 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 either in individuals 12 years of age and older, or in
individuals 5 through 11 years of age, as appropriate; 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
Z. If the Pfizer-BioNTech COVID‑19 Vaccine is exported from the United States,
conditions C, D, and O through Y 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
Case 2:21-cv-00702-CLM Document 40-6 Filed 12/17/21 Page 19 of 20
Page 18 – Pfizer Inc.
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.
Conditions With Respect to Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is licensed for individuals 16 years of
age and older. There remains, however, a significant amount of Pfizer-BioNTech
COVID-19 Vaccine that was manufactured and labeled in accordance with this
emergency use authorization. The authorization remains in place with respect to the
Pfizer-BioNTech COVID-19 Vaccine for this population.
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19
Vaccine, mRNA) product when used to provide: (1) a two-dose primary regimen for
individuals 12 through 15 years of age; 25 (2) a third primary series dose to individuals
12 years of age or older who have undergone solid organ transplantation or who are
diagnosed with conditions that are considered to have an equivalent level of
immunocompromise; (3) a single booster dose at least 6 months after completing the
primary series to individuals 65 years of age or older, 18 through 64 years of age at
high risk of severe COVID-19, and 18 through 64 years of age with frequent
institutional or occupational exposure to SARS-CoV-2; and (4) a heterologous
booster dose to certain individuals who have completed primary vaccination with a
different authorized COVID-19 vaccine as described in the Scope of Authorization
(Section II) under this EUA. Conditions A through W in this letter apply when
COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in
this subsection III.BB., except that product manufactured and labeled in accordance
with the approved BLA is deemed to satisfy the manufacturing, labeling, and
distribution requirements of this authorization.
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.
25
As noted above, this includes the first dose of a two-dose primary regimen for individuals who are 11 years old
and will turn 12 years of age between their first and second dose in the primary regimen.
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Sincerely,
--/S/--
____________________________
Jacqueline A. O'Shaughnessy, Ph.D.
Acting Chief Scientist
Food and Drug Administration
Enclosures
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