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COVID -19 Vaccine (BNT162, PF -07302048)
BB-IND 19736
1.12.4 Request for Comments and Advice
PFIZER CONFIDENTIAL
Page 1COVID -19 Vaccine (BNT162, PF -07302048)
Request for Comments and Advice
sBLA Booster Dose for
Children 12 Through 15 Years of A ge
March 2022
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FDA-CBER-2022-5812-0235609
COVID -19 Vaccine (BNT162, PF -07302048)
BB-IND 19736
1.12.4 Request for Comments and Advice
PFIZER CONFIDENTIAL
Page 21.INTRODUCTION
Reference is made to BB-IND 19736 for the COVID -19 Vaccine ( BNT162 ; PF-07302048),
which Pfizer and BioNTech are developing for the indication of active immunization to
prevent coronavirus disease 2019 (COVID -19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS -CoV-2). Reference is alsomade to the Emergency Use Authorization
(EUA 27034) for Pfizer -BioNTech COVID -19 Vaccine most recentl y re-issued on 3 January
2022 extending the licensure to include :1) booster dose for adolescents 12 through 15 years
of age ; 2) r educed interval between the completion of primary vaccination and a booster dose
to at least 5 months; 3) a third primary series dose for certain immunocompromised children
5 through 11yearsof age .
Reference is made to the Biologics License Application (BLA) 125742 for COMI RNATY
(COVID -19 Vaccine , mRNA ) approved 23 August 2021 for the prevention of COVID -19
caused b ySARS -CoV -2 in individuals 16 y ears of age and older. Additional reference is
made to the supplemental BLA (sBLA) to extend licensure of COMIRNATY to adolescents
12 through 15 years of age submitted on 16 December 2021 ( Sequence 0211) with a
proposed indication ofactive immunization to prevent COVID -19 caused by SARS -CoV -2
in individuals 12 y ears of age and older .
As communicated with the United States (US) Food and Drug Administration (FDA),
Pfizer /BioNTech plan to submit the sBL A to add a booster dose for individuals ≥ 16 years old
with 6 months safety data post -Dose 3 and FDA agreement has been reached on the dat a
requirements to support review of the application in an email correspondence from Dr.
Ramachandra Naik (CBER) to Ms. Elis aHarkins Tull (Pfizer I nc.)on 20 Jan uary 2022.
The purpose of this communication is to request feedback from FDA on the acceptabil ity of
apply ing for licensure of a booster dose for adolescents 12 t hrough 15 years of agein the
same sBLA planned to apply for licensure of a booster dose for individuals 16years of age
and older asa single submission.
Specificall y, we intend to submit the following to support approval of a booster dose for
adolescents 12 through 15 y ears of age:
A summary of real-world safet y and effectiveness data available forthis age group,
including recent data from the Centers for Disease Control and Prevention and our site at
Kaiser Permanente Southern California. These data will be used to inform a benefit -risk
assessment for use of a booster dose among children 12 through 15 years of age.
A cumulative review of post-authorization adverse event report s following administration
of a booster dose in adolescents 12through 15 years of age will be included , to be
provided together with the cumulative review already agreed covering the individuals
≥16 yearswho received a b ooster dose .
A booster dose of BNT162b2 is currentl y being studied in individuals 12through 17 years of
age(randomized to receive either 10 µg or 30 µg) in Subs tudy C of Study C459 1031 . It is
planned to randomize approximately 600participants in this ag e group but due to emergency
use authorization of a booster dose for adolescents 12through 15 years of age being granted
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COVID -19 Vaccine (BNT162, PF -07302048)
BB-IND 19736
1.12.4 Request for Comments and Advice
PFIZER CONFIDENTIAL
Page 3in January 2022 ,enrollment (which started in December 2021 )is lagging significantly . As of
11March 2022, 132 participants have been randomized (about half of whom will have
received 30 µg).
Since the immune response after the first 2 doses of BNT162b2 30 µg in adolescents
12through 15 years of age was greater than in individuals 16through 25 years of age , there
is no reason to expec t that the immune response to a booster dose would be any different. In
light of the wide spread availability of the booster dose under the EUA, and the resultant
challenges to enrolling such individuals into a clinical study , Pfizer/BioNTech propose to
submit descriptive safet y and immunogenicit y data from approximately 200 randomized
participants from Substudy C of Study C4591031 as a post approval commitment. The
protocol allows for conduct of non -prespecified analy ses if required for regulatory purposes .
We respectfull y request Agency ’s feedback b y 22March 2022.
2. QUESTIONS FOR THE AG ENCY
2.1.Sponsor Question 1
Does CBER agree that Pfizer/BioNTech submit a single sBLA supported by clinical trial
data forindividuals 16 years and older and supplemented with real world data for adolescents
12 through 15 years of age to obtain approval of a booster dose for individuals 12 years of
age and older?
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Document Approval Record
Document Name:
Document Title:
Signed By: Date(GMT) Signing Capacity
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