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BNT162b 2
Module 1.12.5 Waiver Request for FDA Designated Suffix for B iologics
PFIZER CONFIDENTIAL
Page 1BLA 125742
COVID -19 mRNA Vaccine (nucleoside modified)
WAIVER REQUEST FOR FDA
-DESIGNATED SUFFIX FO R BIOLOGICS
MARCH 2020
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BNT162b 2
Module 1.12.5 Waiver Request for FDA Designated Suffix for B iologics
PFIZER CONFIDENTIAL
Page 2TABLE OF CONTENTS
1. INTRODUCTION ................................ ................................ ................................ ................. 3
2. EXI STING METHODS TO ENSURE SAFE DISPENSING AND OPTIMAL
PHARMACOVIGILANCE OF VACCINES ................................ ................................ .......3
2.1. VACCI NATION RECORD KEEPI NG METHODS ................................ ............... 3
2.2. VACCI NE SAFETY MONITORING SYSTEMS ................................ ................... 4
3. CONCLUSION ................................ ................................ ................................ ...................... 4
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Module 1.12.5 Waiver Request for FDA Designated Suffix for B iologics
PFIZER CONFIDENTIAL
Page 31.INTRODUCTION
Reference is made to BLA 125 742for BNT162b2 [Proposed Proprietary Name
“COMI RNATY”; Proposed Non proprietary Name “ COVID -19 mRNA Vaccine (nucleoside
modified)”]. BNT162b2 is a prophy lactic vaccine developed by BioNTech and Pfizer to
prevent C oronavirus Disease 2019 (COVID -19) caused by SARS -CoV -2 infection. The
proposed indication that is the subject of this initial BLA application isactive immunization
to prevent corona virus disease 2019 (COVID -19) caused b y severe acute respiratory
syndrome coronavirus 2 (SARS -CoV -2)in individuals 16 y ears of age and older .
Further reference is made to the draft Guidance for Industry “Nonproprietary Naming of
Biological Products: Update (March 2019 )”. As outlined in this guidance, the purpose of the
suffix is to ensure safe dispensing and optimal pharmacovigilance of biologic products
approved under section 351 of the Public Health Service Act (PHS) that do not contain an
FDA designated suffix. Further to this the guidance also states that “Vaccines are currently
within the scope of the naming convention described in the Naming Guidance. However,
“FDA is reconsider ing that approach and is evaluating whether the currently available
identification systems associated with the administration of vaccines are sufficiently robust to
ensure safe dispensing practices and optimal pharmacovigilance without requiring
distinguishable proper names”. Pfizer believes that an additional suffix for COVID -19
mRNA Vaccine (nucleoside modified) would be burdensome and redundant as the US
Department of Health and Human Services (HHS) has existing methods to ensure safe
dispensing and opt imal pharmacovigilance of vaccines. These methods include existing
vaccination record keeping practices and vaccine safet y and monitoring s ystems. Further to
this, the addition of a suffix may be redundant and lead to confusion in dispensing and
administra tionof the vaccine .
2.EXISTING METHODS TO ENSURE SAFE DISPENSI NG AND OPTIMAL
PHARMACOVIGILANCE OF VACCINES
As noted above there are several methodologies currentl y used to ensure the safe use of
vaccines. These methods ensure robust adverse event reporting, monitoring and tracking of
vaccine administration . These methods combined are robust and support the fact that the
addition of a suffix would not be necessary for vaccines.
2.1. VACCINATION RECORD KEEPING METHODS
Existing vaccination record keeping methods include;
oThe National Childhood Vaccine Injury Act which requires Health Care
Professionals to provide a vaccine information statement (VIS) to
patients/guardians prior to administration as well as to report adv erse events to
the V accine Adverse Event Reporting System (VAERS)
oImmunization I nformation Sy stems consolidate vaccination histories to help
assure timely vaccination scheduling and provides aggregate vaccination data
for use in surveillance s ystems as wel l as to inform on public health decisions
and goals related to vaccines.
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BNT162b 2
Module 1.12.5 Waiver Request for FDA Designated Suffix for B iologics
PFIZER CONFIDENTIAL
Page 42.2.VACCINE SAFETY MONITORING SYSTEMS
Vaccine safety monitoring s ystems include;
oVaccine Adverse Event Reporting S ystem (VAERS) is designed to detect
safet y concerns with vaccines. HCPs a nd manufactures are required to report
adverse events to VAERS. Consumers can also report to this sy stem and
further reporting may be burdensome and discouraging.
oVaccine Safet y Datalink (VSD) which utilizes data from doctors’ offices,
urgent care visits, emergency department visits, and hospital stays to monitors
vaccine safet y and conduct studies on rare and serious side effects of vaccines.
These studies also include concerns raised in literature. The VSD also submits
their reports to VAERS.
oThe Post-Licensu re Rapid I mmunization Monitoring S ystem (PRI SM) is y et
another means b y which vaccine safet y is evaluated. As part of the Agency ’s
Sentinel sy stem , PRI SM is linked to statewide registries and is being used to
develop signal detection tools for evaluat ion of adverse events .
3.CONCLUSION
As outlined above, t here are adequate policies and sy stems in place to ensure the safe
dispensing and optimal pharmacovigilance of vaccines which COVID -19 will be subject to.
Additional requirements such as a designated suffix may be redundant and burdensome.
Toward that end, werespectfully request a waiver from the requirement for anFDA
designated suffix for COVID -19mRNA Vaccine (nucleoside modified) , the subject of this
BLA application .
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