125742 S16 M1 ped studies deferral req

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COVID -19Vaccine (BNT162 ,PF-07302048 )
BB-IND 019736
Agreed Pediatric Study Plan
PFIZER CONFIDENTIAL
Page 1ATTACHMENT A—DEFERRAL REQUEST
Product Name COVID -19 Vaccine (BNT162, PF -07302048)
IND number 019736
Applicant BioNTech
Proposed Initial Indication Active immunization against COVI D-19 in 
individuals ≥16years of age
Future Supplemental Indications Active immunization against COVI D-19 in children 
and adolescents 12through 15 years of age; Active 
immunization against COVID -19 in children and 
infants <12years of age .
1.Pediatric age group sfor whom
deferrals are requestedAdolescents, children ,and infants 15 y ears of age 
and y ounger
2.Reason for requesting deferral of
pediatric studies (address each
age group separately  and for
each group choose all that
apply ):Adeferral of the evaluation of the COVID -
19 
vaccine in individuals ≤15 years of age is requested 
based on the following Criteria for Deferral 
(Section 505B(a)(4)(A)(i)(I) of the Act): “Pediatric 
studies should be delay ed until additional safety  or 
effectiveness data have been collected” and “The 
drug or biological product will be read y for approval 
for use in adults before pediatric studies are 
complete. ”
Adequate evidence of safety  and efficacy  has been 
established in the pivotal study  C4591001 in 
individuals ≥16 y ears of age to allow Emergency  
Use Authorization in that age group. 
Study C4591001 includes subject s12 through 
17years of age.  It was appro priate to defer studies
in children 6 months to <12years of age until 
adequate safet y and immunogenicity  information 
wasavailable in 12 -through 15- year-old children 
and adolescents. I t would then be appropriate to 
defer further age -de-escalation to <6 months until 
adequate safet y data is available in 6 month through 
11-year-old children.
090177e197a0846f\Approved\Approved On: 22-Jul-2021 20:39 (GMT)
FDA-CBER-2021-5683-0950091
COVID -19Vaccine (BNT162 ,PF-07302048 )
BB-IND 019736
Agreed Pediatric Study Plan
PFIZER CONFIDENTIAL
Page 23. Pediatric age group(s) not 
included in the deferral requestChildren and adolescents 16 through 17 years of age
4. Reason for not including the 
pediatric age group(s) listed in 
number 3 in the deferral request Study  C4591001 includes subjects 16 through 17 
years of age
5. Has a pediatric plan been 
submitted to the Agency .Yes
6. Suggested deferred date for 
initiation and submission of 
studi esThe initiation date for Study C4591007, a safet y and 
effectiveness stud y in children <12 years of age , was 
24 March 2021. The estimated initiation date for 
Study  C4591023, a dose -finding safet y and 
effectiveness stud y in infants less than 6 months of 
age, is 31 January  2022.
090177e197a0846f\Approved\Approved On: 22-Jul-2021 20:39 (GMT)
FDA-CBER-2021-5683-0950092
Document Approval Record
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090177e197a0846f\Approved\Approved On: 22-Jul-2021 20:39 (GMT)
FDA-CBER-2021-5683-0950093