Marks Declaration
- Date
- 2021-12-17
Summary
Marks Declaration Exhibit 2, filed December 17, 2021 as Document 41-2 in Case 2:21-cv-00702-CLM in the U.S. District Court, N.D. of Alabama. The 21-page exhibit is a Food and Drug Administration letter to Pfizer Inc. dated December 16, 2021, reissuing the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine and certain uses of COMIRNATY (COVID-19 Vaccine, mRNA). The letter recounts the authorization first issued December 11, 2020 and its later revisions, and it summarizes FDA's review of trial safety and effectiveness data for several authorized age groups. It states that the Tris buffer formulations of the two vaccines can be used interchangeably and extends the expiration date of the Tris buffer formulation from 6 months to 9 months. The letter closes with conditions of authorization and its duration, signed by the FDA Acting Chief Scientist.
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Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 1 of 21 FILED
2021 Dec-17 PM 01:50
U.S. DISTRICT COURT
N.D. OF ALABAMA
Marks Declaration
Exhibit 2
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 2 of 21
December 16, 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 41-2 Filed 12/17/21 Page 3 of 21
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
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.
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 4 of 21
Page 3 – Pfizer Inc.
October 20, 2021, 11 October 29, 2021, 12 November 19, 2021, 13 and December 9, 2021. 14
On December 16, 2021, FDA approved a supplement to the COMIRNATY (COVID-19
Vaccine, mRNA) BLA to include a new 30 microgram dose formulation of COMIRNATY
(COVID-19 Vaccine, mRNA) that uses Tris buffer in addition to the PBS buffer used in the
originally approved vaccine.
On December 16, 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 December
13, 2021 letter of authorization in its entirety with revisions incorporated to amend the EUA for
COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to
clarify that the Pfizer-BioNTech COVID-19 Vaccine that uses Tris buffer and COMIRNATY
(COVID-19 Vaccine, mRNA) that uses the Tris buffer have the same formulation and can be
used interchangeably. In addition, FDA is: extending the expiration date of the Pfizer-BioNTech
COVID-19 Vaccine that uses the Tris buffer from 6 months to 9 months when held at -90 °C to -
60 °C; revising the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination
Providers) to include information on the updated expiration dating of the formulation of the
Pfizer-BioNTech COVID-19 Vaccine that uses the Tris buffer; and updating the Fact Sheet for
Recipients and Caregivers to provide information on the formulation of COMIRNATY (COVID-
19 Vaccine, mRNA) that uses the Tris buffer. The authorized uses, as well as the two
formulations that have three presentations, are described in the Scope of Authorization section of
this letter (Section II).
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.
12
In the October 29, 2021 revision, FDA authorized: 1) the use of Pfizer-BioNTech COVID-19 Vaccine for children
5 through 11 years of age; and 2) 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 was authorized in two presentations: 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
mg 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. The formulation that uses Tris
buffer is the only formulation that is authorized for use in individuals 5 through 11 years of age.
13
In the November 19, 2021 revision, FDA authorized the use of COMIRNATY (COVID-19 Vaccine, mRNA) and
the Pfizer-BioNTech COVID-19 Vaccine as a single booster dose in individuals 18 years of age or older at least 6
months after completing the primary series of this vaccine (i.e., as a homologous booster dose), and as a single
booster dose following completion of primary vaccination with another authorized COVID-19 vaccine (i.e., as a
heterologous booster dose) in individuals 18 years of age or older. The dosing interval for the heterologous booster
dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.
14
In the December 9, 2021 revision, FDA authorized the use of the vaccine as a single booster dose in individuals
16 and 17 years of age, at least 6 months after completing the primary series of this vaccine (i.e., as a homologous
booster dose).
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 5 of 21
Page 4 – Pfizer Inc.
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.
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.
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 6 of 21
Page 5 – Pfizer Inc.
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
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
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 7 of 21
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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
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
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 8 of 21
Page 7 – Pfizer Inc.
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 Pfizer-BioNTech COVID-19 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
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. Release and characterization tests include tests for purity, composition, and critical
attributes of mRNA 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.
For the November 19, 2021 authorization expanding the eligible population for the homologous
and heterologous booster doses to individuals 18 years of age and older, FDA reviewed data
provided by the sponsor and other data available to FDA, including real world evidence. Data
previously reviewed to support the September 22, 2021 authorization of a homologous booster
dose, together with new real-world data indicating increasing COVID-19 cases in the United
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 9 of 21
Page 8 – Pfizer Inc.
States, including among vaccinated individuals, and suggesting a decreased risk of myocarditis
following mRNA COVID-19 vaccine booster doses compared with second primary series doses,
support expansion of the population eligible for a Pfizer-BioNTech COVID-19 vaccine
homologous booster dose to include all individuals 18 years of age and older who completed the
primary series at least 6 months previously. Data previously reviewed to support the October 20,
2021 authorization of a heterologous booster dose, together with data and information to support
authorization of the EUA amendment to expand the eligible population for a homologous booster
dose of the Moderna COVID-19 Vaccine, support a revision to the Pfizer-BioNTech COVID-19
Vaccine EUA such that the eligible population for a heterologous booster dose of the Pfizer-
BioNTech COVID-19 Vaccine is all adults 18 years of age and older who completed primary
vaccination with another authorized COVID-19 vaccine. Based on the totality of the scientific
evidence available, FDA concludes that a homologous or heterologous booster dose of the
Pfizer-BioNTech COVID-19 Vaccine may be effective, and that the known and potential
benefits of the booster dose of the Pfizer-BioNTech Vaccine following completion of primary
vaccination with Pfizer-BioNTech COVID-19 Vaccine or another authorized COVID-19
vaccine, outweigh the known and potential risks in individuals 18 years of age and older.
For the December 9, 2021 authorization expanding the eligible population for the homologous
booster doses to individuals 16 years of age and older, FDA reviewed: data submitted previously
by the sponsor to support the September 22, 2021 and November 19, 2021 authorization of a
homologous booster dose under EUA; real-world data, which includes data that indicates
increasing COVID-19 cases in the United States amongst vaccinated and unvaccinated
individuals, and data suggesting a decreased risk of myocarditis following administration of
Pfizer-BioNTech COVID-19 Vaccine booster doses compared with second primary series doses
among vaccinated individuals; and a benefit-risk assessment from the sponsor, to support the
expansion of the population eligible for a Pfizer-BioNTech COVID-19 Vaccine homologous
booster dose to include all individuals 16 years of age and older who completed the primary
series at least 6 months previously. Based on the totality of the scientific evidence available,
FDA concludes that a homologous booster dose of the Pfizer-BioNTech COVID-19 Vaccine
may be effective, and that the known and potential benefits of the booster dose of the Pfizer-
BioNTech COVID-19 Vaccine following completion of primary vaccination with Pfizer-
BioNTech COVID-19 Vaccine outweigh the known and potential risks in individuals 16 years of
age and older.
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) 16 under
this EUA as described in the Scope of Authorization section of this letter (Section II).
15
Reference to the Pfizer-BioNTech COVID-19 Vaccine hereinafter refers to both the formulations that use the PBS
and Tris buffers, unless specifically delineated otherwise.
16
Reference to COMIRNATY (COVID-19 Vaccine, mRNA) hereinafter refers to both the formulations that use the
PBS and Tris buffers, unless specifically delineated otherwise.
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 10 of 21
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I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Pfizer-BioNTech COVID‑19 Vaccine 17 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
C. There is no adequate, approved, and available alternative 18 Pfizer-BioNTech
COVID‑19 Vaccine to prevent COVID-19. 19
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), 20 to emergency response stakeholders 21 as directed by the U.S.
17
In this section (Section I), references to Pfizer-BioNTech COVID‑19 Vaccine also apply to COMIRNATY
(COVID-19 Vaccine, mRNA).
18
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.
19
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
20
“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.
21
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
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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; and
• Pfizer-BioNTech COVID‑19 Vaccine may be administered by a vaccination provider 22
without an individual prescription for each vaccine recipient.
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), as described in more detail under
Product Description below, 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 16 years of age or older; and
o a single booster dose as a heterologous booster dose following completion of
primary vaccination with another authorized COVID-19 vaccine in individuals 18
years of age and older, where the dosing interval for the heterologous booster
dose is the same as that authorized for a booster dose of the vaccine used for
primary vaccination.
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), as described in more detail under Product Description
below, 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).
cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and
vaccination providers will all be met.
22
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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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 (COVID-19 Vaccine, mRNA)
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
equivalent level of immunocompromise; (3) a single booster dose (0.3 mL) at least 6 months
after completion of the primary series to individuals 16 years of age and older; 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 in individuals 18 years of age and older,
where the dosing interval for the heterologous booster dose is the same as that authorized for a
booster dose of the vaccine used for primary vaccination.
The Pfizer-BioNTech COVID-19 Vaccine that uses PBS buffer and COMIRNATY (COVID-19
Vaccine, mRNA) that uses PBS buffer have the same formulation. Additionally, the Pfizer-
BioNTech COVID-19 Vaccine that uses Tris buffer and COMIRNATY (COVID-19 Vaccine,
mRNA) that uses Tris buffer 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) that uses PBS buffer can be used interchangeably, and the Pfizer-BioNTech
COVID-19 Vaccine that uses Tris buffer and COMIRNATY (COVID-19 Vaccine, mRNA) that
uses Tris buffer can be used interchangeably, as described above, without presenting any safety
or effectiveness concerns.As described below under Product Description, the formulations that
use Tris and PBS buffers, which are covered by this authorization 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. 23 Accordingly, under this
23
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
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. Release and characterization tests include tests for purity, composition, and critical attributes of mRNA
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 13 of 21
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EUA, for individuals 12 years of age and older, the two formulations of COMIRNATY
(COVID-19 Vaccine, mRNA) and the 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, and the
Pfizer-BioNTech COVID-19 Vaccine 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).
Product Description 24
The Pfizer-BioNTech COVID-19 Vaccine, supplied in two formulations, is provided in three
different color-coded multiple dose vials:
Vials with purple caps Vials with gray caps Vials with orange caps
and labels with gray and labels with orange
borders borders
Authorized 12 years of age and 12 years of age and 5 through 11 years of
age older older age
Formulated 0.3 mL doses, after 0.3 mL doses 0.2 mL doses, after
to provide dilution (each containing 30 µg dilution
(each containing 30 µg modRNA) (each containing 10 µg
modRNA) modRNA)
Buffer used PBS Tris Tris
Dilution Dilute with 1.8 mL of Not to be diluted Dilute with 1.3 mL of
sterile 0.9% Sodium sterile 0.9% Sodium
Chloride Injection, USP Chloride Injection, USP
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.
24
For COMIRNATY (COVID-19 Vaccine, mRNA) that uses the PBS buffer product description, please see the
COMIRNATY (COVID-19 Vaccine, mRNA) prescribing information, found here:
https://www.fda.gov/media/151707/download; for COMIRNATY (COVID-19 Vaccine, mRNA) that uses the Tris
buffer product description, please see the COMIRNATY (COVID-19 Vaccine, mRNA) prescribing information,
found here: https://www.fda.gov/media/154834/download.
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Multiple dose vials with purple caps
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[(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 Pfizer-BioNTech COVID-19 Vaccine does
not contain a preservative. The diluent (0.9% Sodium Chloride Injection) contributes an
additional 2.16 mg sodium chloride per dose.
Multiple dose vials with gray caps and labels with gray borders
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. The Pfizer-BioNTech COVID-19
Vaccine does not contain a preservative.
Multiple dose vials with orange caps and labels with orange borders
Each 0.2 mL 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 Pfizer-BioNTech COVID-
19 Vaccine does not contain a preservative. 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.
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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
• 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 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,25 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 as described in
25
The conclusions supporting authorization stated in this section (Section II) also apply to COMIRNATY (COVID-
19 Vaccine, mRNA).
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Page 15 – Pfizer Inc.
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-
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.26
26
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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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 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).
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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, 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
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Page 18 – Pfizer Inc.
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
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.
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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
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; 27 (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 after completing the primary series to
individuals 16 years of age or older; and (4) a heterologous booster dose in
individuals 18 years of age and older 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.
27
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.
Case 2:21-cv-00702-CLM Document 41-2 Filed 12/17/21 Page 21 of 21
Page 20 – Pfizer Inc.
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.
Sincerely,
--/S/--
____________________________
Jacqueline A. O'Shaughnessy, Ph.D.
Acting Chief Scientist
Food and Drug Administration
Enclosures
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