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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)
COMMENTSHuman Coronavirus mRNA vaccine in lipid nanoparticles
Pfizer-BioNTech
19736/289
Process Track ID: 528778
April 15, 2021
April 15, 2021
Ramachandra Naik
Deborah Thompson✔
March 1, 2021
March 31, 2021
Deborah L.
Thompson -SDigital 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 04 27 13:44:06 04 00
FDA-CBER-2021-5683-1150402
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:The reference safety information (RSI) was updated on March 2, 2021 with the following safety-related changes: diarrhea, pain in extremity (arm), an d
vomiting (added as adverse reactions in Section 4.8 Undesirable Effects).
Reviewer comment: Section 6.2 of he EUA product labeling was updated with the terms diarrhea, pain in extremity (arm), and vomiting.In addition, the following safety topics and signals were addressed by the sponsor in his reporting period and will be added to the RSI and proposed loc al
labels "in due course" per labeling and regulatory processes: vaccine stress-related responses, including dizziness, paraesthesia, and tachycar dia.
Evaluation of hepa ic events, herpes zoster, and seizure is ongoing. The sponsor evaluated the following events and determined hey are not a risk/no ta
validated signal: delayed skin reactions, extensive swelling of vaccinated limb, reactions associated wi h dermal fillers, thromboembolic event s (including
those with thrombocytopenia), anosmia, ageusia, arrhythmia, dysphagia, hoarseness, hypertension, hypoglycemia, meningitis, myasthenia gravis, peripheral
neuropathy, and transverse myeli is.
The company investigated reports of vials with leakages in Hong Kong (26 vials all from one batch). The root cause of leakage was the combination of the
container closure process (crimping) and specific transport conditions . A total of
batches were affected and were quarantined. The company excluded any influence on batches that are on market anywhere ou ong Kong andMacau. No batches are currently distributed; .
✔✔
✔✔ ✔
current / cumulative
120,917,940 current / 243,145,305
cumulative
(b) (4)
(b) (4)
(b) (4)
(b) (4)
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(b) (4)
FDA-CBER-2021-5683-1150403