125742 S16 M1 ped studies deferral track change

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COVID-19 Vaccine (BNT162, PF-07302048) 
BB-IND 019736 
Agreed Initial Pediatric Study Plan 
 
PFIZER CONFIDENTIAL 
Page 1  
  
ATTACHMENT A — DEFERRAL REQUEST 
 
Product Name COVID-19 Vaccine (BNT162, PF-07302048) 
IND number 019736 Applicant  BioNTech Proposed Initial Indication  Ac tive immunization against COVID- 19 in 
individuals ≥16 years of age 
Future Supplemental Indications  Active immunization against COV ID-19 in children 
and adolescents 12 through 15 years of age; Active 
immunization against COV ID-19 in children and 
infants <12 years of age.
1.  Pediatric age g roups for whom 
deferrals are requested Adolescents, children, an d infants 15 years of age 
and younger 
2.  Reason for requesting deferral of 
pediatric studies (address each age group separately and for each group choose all that apply): A deferral of the evalu ation of the COVID-19 
vaccine in individuals ≤15 y ears 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 delayed until additional safety or 
effectiveness data have b een collected” and “The 
drug or biological product will  be ready for approval 
for use in adults before p ediatric studies are 
complete.” 
Adequate evidence of saf ety and efficacy has been 
established in the pivotal study C4591001 in 
individuals ≥16 years of a ge to allow Emergency 
Use Authorization in that age group. Study C4591001 includes subjects 12 through 17 years of age.  It wasis  appropriate to defer studies in 
children 6 months5  to <1211 years of age until 
adequate safety and imm unogenicity information 
wasis  available in 12- through 15-year-old children 
and adolescents.  It woul d then be appropriate to 
defer further age-de-escalation to <6 months until 
adequate safety data is available in 6 
month5  through 11-year-old children.   
090177e197a0bec0\Approved\Approved On: 22-Jul-2021 22:30 (GMT)
FDA-CBER-2021-5683-0651247
COVID-19 Vaccine (BNT162, PF-07302048) 
BB-IND 019736 
Agreed Initial Pediatric Study Plan 
 
PFIZER CONFIDENTIAL 
Page 2  
 3.  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 studies The estimated initiation date f or Study C4591007, a 
safety and effectiven ess study in children <11<12 
years of age, was 24 Marchis no later than April  
2021. The estimated initia tion date for Study 
C4591023, a dose-finding safety and effectiveness 
study in infants less th an 6 months of age, is 
31 January 2022. 
  
090177e197a0bec0\Approved\Approved On: 22-Jul-2021 22:30 (GMT)
FDA-CBER-2021-5683-0651248