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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)
COMMENTSCOVID-19 vaccine, mRNA (BNT162b2)
Pfizer
19736.491
Process track #907079
September 15, 2021
September 15, 2021
Laura Gottschalk
Deborah Thompson
This is the 9th Summary Monthly Safety Report for Comirnaty (COVID-19 mRNA
Vaccine).✔
✔
August 1, 2021
August 31, 2021
Deborah L.
Thompson -SD gitally signed by Deborah L Thompson S
DN: c=US o=U S Government ou=HHS ou=FDA ou=Peop e 0 9 2342 19200300 100 1 1=2002552931 cn=Deborah L Thompson S Date: 2021 09 29 08:11:36 04 00
FDA-CBER-2021-5683-1150412
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 current reporting period (August 12, 2021) an EUA was granted in the U.S. for a third dose of BNT162b2 administered at least 28 days following the two dose regimen
in individuals 12 years and older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered an equival ent level of
immunocompromise. There were no actions taken for safety reasons during the reporting period.
The following signals were addressed or are under evaluation by the sponsor during the reporting period: uveitis is under evaluation; thrombosis with thrombocytopenic syndrome
(TTS) underwent an updated review and the sponsor concluded the available data do not support a causal association with the vaccine; per the sponsor, available data do notsupport a risk for erythema multiforme, glomerulonephritis and nephrotic syndrome, myasthenia gravis, hypoesthesia/paraesthesia, and rhabdomyolysis.
The sponsor provided safety evaluation reports, including individual case reviews, observed to expected (O/E) analyses as applicable, and literature searches, for
hypoesthesia/paraesthesia, rhabdomyolysis, rheumatoid arthritis, menstrual disorders, post-menopausal hemorrhages, myasthenia gravis, acute disseminated encephalopathy(ADEM), Guillain-Barre syndrome (GBS), capillary leak syndrome (CLS), and TTS. No new safety signals were identified based on the totality of data presented in the safetyevaluation reports. Topics will continue to be monitored.
The sponsor is evaluating a new safety topic of uveitis based on a literature report that described a prospective multicenter study that investigated efficacy and safety of the
2-dose BNT162b2 regimen in adults with autoimmune inflammatory rheumatic diseases (AIIRD; n=686) compared to controls (n=121); two cases of uveitis were reported inAIIRD patients. An IR was sent asking the sponsor in the next SMSR to provide a descriptive summary of reports, literature search, O/E analysis, and assessment of causalityand safety for the occurrence of uveitis following vaccination with Comirnaty.
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FDA-CBER-2021-5683-1150413