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sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϭŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology
3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW
Completed by Reviewer
Product Name
Manufacturer
STN #
DCC Login ID #
Submission Type PAER PSUR
PBRER PADER
Submission Format ELECTRONIC
PAPER
Reporting Period FROM
TO
Date Received by FDA
Date Routed to Reviewer
Regulatory Information Specialist (RIS) - Name
Reviewer - Name
Reviewer Signature
(electronic signature)
COMMENTSPfizer-BioNTech COVID-19 Vaccine
Pfizer-BioNTech
19736.453
August 16, 2021
August 16, 2021
Laura Gottschalk
Deborah Thompson
This is the 8th Summary Monthly Safety Report for the Pfizer-BioNTech COVID-19
Vaccine (Comirnaty).✔
✔
July 1, 2021
July 31, 2021
Deborah L.
Thompson -SDig tal y signed by Deborah L Thompson S
DN: c=US o=U S Government ou=HHS ou=FDA ou=People 0 9 2342 19200300 100 1 1=2002552931 cn=Deborah L Thompson S Date: 2021 08 26 15:27:43 04'00'
FDA-CBER-2021-5683-1150410
Reference Documents (X:\DE\MEDICAL OFFICER\Guidance Documents):
1. E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs 1996
2. Addendum to E2C Safety Data Management: Periodic Safety Update Reports for Marketed Drugs 2004
sϰͺϮϬϭϵϭϭϬϳͺ>, WĂŐĞϮŽĨϮOffice of Biostatistics and Epidemiology/Division of Epidemiology
3HULRGLF 6DIHW\ 5HSRUW 5HYLHZ &KHFNOLVW
1. Countries where the product is licensed or authorized for distribution:
Not Reported US Worldwide
2. Estimated number of doses distributed by reporting period/cumulative:
Not5eported US
WorldwideNot Applicable
3. Does this report describe any actions taken by the manufacturer or other regulatory agency for
this product (e.g. labeling changes)? Yes No
4. Have there been any new safety issues identified by the reviewer in this PSUR? Yes No
If YES, please provide pertinent information below AND notify/discuss safety issues with the Team Lead
and/or Branch Chief.
Conclusions:
The contents of this PSUR/PAER do not i ndicate a need for further regulatory action.
Please see the following comments and recommendations:During the reporting period, the European Medicines Agency (EMA) and other Health Authorities requested label updates and Direct Healthcare Professional Communications to address findings on
myocarditis and pericarditis following vaccination with BNT162b2. The U.S. Pharmacovigilance Plan was also updated in July to include myocarditis and pericarditis as important identified risks.
In addition, the following safety signals were addressed or are under evaluation: erythema multiforme, glomerulonephritis and nephrotic syndrome are under evaluation; thrombosis with thrombocytopenia
syndrome (TTS) is an ongoing review topic - the sponsor reports that an updated review does not support a causal association with the vaccine; immune thrombocytopenia (ITP) has been reviewedpreviously and will be reviewed again in PSUR#1 (Dec 19, 2020 through June 18, 2021) - the sponsor reports that the totality of data do not support the ITP signal as a risk.
The sponsor also provided safety evaluations for the following topics: systemic capillary leak syndrome, transverse myelitis, multisystem inflammatory syndrome (MIS), disseminated intravascular
coagulation, dizziness, deafness, tinnitis, blindness/visual disturbances, cerebral hemorrhage and cerebrovascular accident, TTS, and menstrual disorders or post-menopausal hemorrhages. No newsafety signals were identified.
The sponsor also provided observed/expected (O/E) analyses for adverse events of special interest (AESI). In the primary O/E analysis, the following AESIs had the upper limit of the 95% CI >1: acute
disseminated encephalomyelitis (ADEM), MIS, myasthenia gravis, polyneuropathy, rhabdomyolysis, and transverse myelitis (TM). In age-stratified analyses, the following AESIs had an O/E >1 for at leastone age group: Guillain-Barre syndrome, ischemic stroke, MIS, narcolepsy, and TM; for some AESIs the low numbers of events contributed to variability in the O/E across age groups. The sponsor willcontinue to monitor these events and will provide additional evaluation in the next SMSR.
A separate O/E analysis was performed for myocarditis, including by sex and dose using low, mid, and high background rates as well as a 14- and 21-day risk window. The highest O/E ratios were seen in
younger age males and post-2nd dose.
In addition, the O/E analysis for anaphylaxis showed an O/E of 3.795 (95% CI 3.690-3.903), which has continued to decline from previous O/E analyses.
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period / cum
217,960,099 period / 1,090,385,631 cum
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1150411