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From: Marion Gruber, PhD, Director, Office of Vaccines Research and Review, Center for
Biologics Evaluation and Research
To: BLA STN 125742 /0
Date: August 17, 2021
Subject: Rationale for designat ion of a nonproprietary name for COVID -19 Vaccine, mRNA
(Comirnaty ) that does not include a distinguishing suffix
Introduction: BioNTech Manufacturing GmbH has submitted a Biologics License Application for a COVID -
19 vaccine (STN 125742 , Action Due Date January 16 , 2022). The proposed indication and usage
statement from the draft package insert is as follows: “COMIRNATY is a vaccine indicated for active
immunization to prevent coronavirus disease 2019 (COVID -19) caused by severe acute r espiratory
syndrome coronavirus 2 (SARS CoV 2) in individuals 16 years of age and older. ”
This memorandum documents the justification for and my supervisory concurrence with the decision to
depart from the recommendations in the Guidance for Industry: Nonproprietary Naming of Biological
Products (January 2017) (“ Naming Guidance ”) in approving a non -proprietary name without a suffix for
this product.1
Summary:
I have concluded that the existing mechanisms to track this product are sufficient to ensure safety and
pharmacovigilance and a suffix on the nonproprietary name is not necessary for the safe use of this
vaccine.
The issue of whether to designate the nonproprietary name s of vaccine s without a distinguishing suffix
was discussed with the FDA Biosimilar Policy Council on April 10, 2019.2 The Council, including Dr.
Marks and Dr. Woodcock, agreed with OVRR that a distinguishing suffix was not needed for vaccines and
further recommended that if we designate a proper name without a distinguishing suffix for a vaccine,
we should document this departure from the Naming Guidance. As Director of OVRR, I am the
supervisor to OVRR staff who reviewed this BLA. This memo documents my concurrence with the
decision to depart from the Naming Guidance.
1 See 21 C.F.R. § 10.115(d)(3) (“Although guidance documents do not legally bind FDA, they represent the agency’s
current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate
justification and supervisory concurrence.” )
2 The FDA Biosimilar Policy Council is a cross -center workgroup within FDA that discusses issues regarding the
implementation of the BPCI Act.
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The fundamental question for this memo is whether the inclusion of the suffix in the proper name for
Comirnaty is necessary for safe use, or whether other measures are in place to that are sufficient to
ensure safe use and pharmacovigilance .
This memo describes unique vaccine administration recording requirements and safety monitoring
programs for U.S. -licensed vaccines , including requirements for vaccines subject to the National Vaccine
Compensation Injury Program. The totality of circumstan ces associated with the administration of
vaccines, including the unique recordkeeping requirements, monitoring systems, and public health
considerations, supports the review team recommendation and my decision to depart from the Naming
Guidance and to des ignate a proper name without a distinguishing suffix for this vaccine.
1. Vaccination Records
Unique recordkeeping requirements associated with the administration of vaccines in the U.S., including
those associated with the National Childhood Vaccine Injury Act and Immunization Information Systems,
provide for the identification of most vaccines by their manufacturer (and potentially by lot number),
without the need for a distinguishable suffix .
National Childhood Vaccine Injury Ac t: Most US -licensed vaccin es are subject to The National
Childhood Vaccine Injury Act of 1986 . Covered vaccines are those recommended for routine
administration to children or pregnant women by the CDC, subject to an excise tax by federal law and added to the Vaccine Injury Com pensation Table by the Secretary for HHS.
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For vaccines included in the “Vaccine Injury Table ” (which include most of the US -licensed vaccines)
there are additional recordkeeping require ment s that permit the identification of the vaccine
administered without a suffix. For those vaccines included in the “Vaccine Injury Table” the National
Childhood Vaccine Injury Act of 1986 requires each healthcare provider (HCP) who administers a vaccine
included in the “Vaccine Injury Table” to record in the vaccinee’s permanent medical record 1) the date
of administration of the vaccine, 2) the vaccine manufacturer and lot number, and 3) the name and
address and, if appropriate the title of the HCP administering the vaccine.4 This requirement is unique
for vaccines. This Act applies to any vaccine for which there is a routine recommendation to children or
pregnant women , even if many or most doses of the vaccine are administered to adults in general (e.g .,
influenza vaccine).
For those vaccines that are not included on the Vaccine Injury Table , the Advisory Committee on
Immunization Practices recommends that “This information should be kept for all vaccines, not just for
those required by the Act.”( https://www.cdc.gov/vaccines/hcp/acip -recs/general -recs/records.html ).
3 Covered vaccines: Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b, Hepatitis A, Hepatitis B, Human
papillomavirus, Seasonal Influenza, Measles, Mumps, and Rubella, Meningococcal, Pneumococcal conjugate, Polio,
Rotavirus, and Varicella, in any combination.
4 https://www.hrsa.gov/sites/default/files/hrsa/vaccine -compensation/vaccine -injury- table.pdf
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Immunization Information Systems : Unlike records associated with other drugs or biologics ,
vaccination records are required for childcare , school, summer camps and international travel. These
records are retained by the clinic or HCP office in a patient’s chart. To facilitate retrieval of records , all
states have an Immunization Information System ( IIS). IIS are centralized population- based repositories
of immunization related information. They receive and share data on individual clients/patients with a
number of other systems, including Electronic Health Record systems (EHR -S). One of the goals of the
IIS is to promote vaccine safety in public and private provider settings and enable the identification of
vaccine recipients by vaccine lot, manufacturer, provider, and/or time frame – consistent with the
NCVIA of 1986 but not limited to vaccines subject to the Act .
Participation in IIS is widespread and supported by the federal government. One of the national Healthy
People objectives for 2020 was 95% participation of children aged <6 years in a fully operational
population -based IIS (participating in an IIS means having two or more vaccinations recorded in the IIS).
IIS data from 2012 indic ate that approximately 86% of children aged <6 years with two or more
vaccinations were participating in IISs (CDC. Progress in immunization information systems – United
States, 2012. MMWR Morb Mortal Wkly Rep. 2013;62(49):1005- 1008. Mangione -Smith R, DeC ristofaro
AH, Setodji CM, et al. The quality of ambulatory care delivered to children in the United States. N Engl J Med. 2007;357(15):1515 -1523. DOI: 10.1056/NEJMsa064637) . From 2013 to 2016 the percentage of
children with ≥2 immunizations recorded in IIS s increased from 90% to 94%, approaching the Healthy
People 2020 objective of ≥95%. (CDC. Progress in childhood vaccination data in immunization
information systems – United States, 201 3-2016. MMWR Morb Mortal Wkly Rep. 2017;66(43):1 178-
1181).
Nationally, 57.8 million U.S. adults aged 19 years or older participated in an IIS in 2012 (CDC. Progress in
immunization information systems – United States, 2012. MMWR Morb Mortal Wkly Rep.
2013;62(49):1005- 1008.). This number reflects adults who may have had childhood vaccines entered
during childhood and now have aged to adults. In 2013, 32% of U.S. adults had a record in the IIS and at
least one vaccination administered during adulthood.
The National Vaccine Advisory Committee (established to comply with Section 2105 of the Public Health
Service Act) recommends that public health departments work toward including adults in all state IISs,
reduce barriers to including adult vaccination records in IISs, and ensure that IISs meet new standards of
EHR in teroperability to track and maintain adult vaccination records.
For vaccines administered to the military each branch records and tracks immunizations (https://www.health.mil/Military -Healt
h-Topics/Health -Readiness/Immunization -
Healthcare/Immunization -Tracking -Systems ).
2. Vacci ne Safety Monitoring Systems
The Vaccine Adverse Reporting System:
VAERS is a national program managed by the FDA and CDC to monitor the safety of all vaccines licensed
for use in the US. FDA and CDC conduct safety surveillance for vaccine -associated safety concerns
utilizing VAERS. This system is valuable for signal detection , and it has unique characteristics that
differentiate it from other adverse event surveillance systems . As a preliminary matter, in addition to
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mandatory reporting of adverse events by manufacturers that is common to all drugs and biologics, for
vaccines covered by the National Childhood Vaccine Injury Act, there is mandatory reporting for healthcare providers for any event list ed by the vaccine manufacturer as a contraindication t o
subsequent doses of the vaccine and any adverse event found in the “Reportable Events table” that
occurs within the specified time after vaccination .
The form that is used for VAERS, which mirrors the information required to be collected under the
NCVIA, further permits the accurate identification of the event and the vaccine administered. VAERS
requires the vaccine name (“type and brand name”), manufacturer, and lot number. The form permits
the user to enter the vaccine type/brand name manually or to select a specific vaccine identified by
abbreviation/disease and proprietary name from a “pick list.”
(https://vaers.hhs.gov/pdf/VAERSForm Mar2021.pdf ). While it may be possible for the FAER S sys
tem
that covers other biologics and drugs to adopt a similar format, at this time, this format is unique to
VAERS and is permitted, in part, because of the limited scope of products covered by the reporting system.
The Vaccine Safety Datalink : The Vac
cine Safety Datalink (VSD) project is a collaboration between the
National Immunization Program of the CDC and several HMOs. The project began in 1990 with the
purpose of rigorously evaluating concerns about the safety of vaccines. According to the CD C, the VSD
generates rapid, important safety assessments for both routine vaccinations and emergency vaccination campaigns.
5 To accomplish this, t he VSD uses electronic health data from each participating site that
includes information on vaccine type, v accine manufacturer, vaccine lot number, date of vaccination,
and other vaccinations given on the same day. Participating healthcare organizations cover more than
9.1 million people nationwide (over 3% of the US population).
3. Additional considerations for vaccines:
The four -letter suffix will likely be interpreted by some individuals to refer to an unintended and non -
specific attribute to the product. Some individuals may believe this refers to an unidentified ingredient,
a new adjuvant or an abbreviat ion for a chemical. This may cause confusion and concern regarding the
safety of the vaccine. This confusion is particularly concerning given increased public concerns about the
safety of vaccination and rising levels of refusals to vaccinate. Decreased confidence in vaccine safety
does not just affect the health of patients who refuse to vaccinate, as is the case with decreased
confidence in therapeutic biologic products. C onfusion surrounding vaccine safety could undermine the
effectiveness of the vacc ine program overall and, ultimately, lead to negative public health effects,
including outbreaks of preventable diseases.
5 Vaccine 32 (2014) 5390– 5398
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