{"id":6779,"date":"2024-03-13T14:21:40","date_gmt":"2024-03-13T14:21:40","guid":{"rendered":"https:\/\/www.ghr.agency\/?page_id=6779"},"modified":"2024-10-21T09:13:13","modified_gmt":"2024-10-21T09:13:13","slug":"international-health-regulations-duplicate-1-2","status":"publish","type":"page","link":"https:\/\/www.ghr.agency\/?page_id=6779","title":{"rendered":"PSUR"},"content":{"rendered":"\t\t
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PSUR-DATA for Covid-19 vaccines \u2013 the most comprehensive global pharmacovigilance data available here<\/h1>

According to EU law, Periodic Safety Update Reports (PSURs)<\/a> must be submitted by the marketing authorisation holder, i.e. the pharmaceutical company, if the safety of the medicinal product still requires further examination. These reports contain the most comprehensive globally available pharmacovigilance data for a specific time frame, mostly 6 months. The Pharmacovigilance Risk Assessment Committee (PRAC)<\/a> of the European Medicines Agency (EMA) then evaluates these data in a separate Assessment Report (AR PRAC) for a positive risk-benefit ratio and potential safety signals.
<\/strong><\/p>

Until 2023, these important Covid-19 vaccine pharmacoviligance data were confidential. In order to obtain EMA’s safety data on Covid vaccines, more than 130 European doctors interested in pharmacovigiliance joined forces across borders and founded the PSUR4doctors initative to request these data sets from EMA according to EU transparency laws. The GHRA provided to the PSUR4ddoctors initative the legal background support and was the common voice to speak to EMA. Since then, Covid-19 vaccine pharmacovigilance data are continuously dispatched. As a result of this unique legal campaign, EMA agreed to the PSUR4doctors‘ request and\u00a0 makes since then the PSURs and accompanying PRAC AR publicly available for download on the respective EMA product page for Covid vaccines.<\/p>

Below are all data officially released so far by EMA are made accessible and will be further updated on a continuing basis. Please check regularly for updates.<\/p>

PSUR-DATENARCHIV<\/h2>

Periodische Sicherheitsberichte (PSUR) m\u00fcssen von den Zulassungsinhabern, also den Pharmafirmen, in besonderen F\u00e4llen, in denen die Sicherheit des Arzneimittels noch eingehender Pr\u00fcfung bedarf, erstellt werden. Diese Berichte enthalten alle global verf\u00fcgbaren Pharmakovigilanzdaten des betreffenden Arzneimittels f\u00fcr einen bestimmten Zeitraum (meist 6 Monate), die in einem umfangreichen Rohdatensatz angeh\u00e4ngt sind.<\/strong><\/p>

Dieser PSUR wird dem Ausschuss f\u00fcr Risikobewertung im Bereich der Pharmakovigilanz der Europ\u00e4ischen Arzneimittelbeh\u00f6rde (kurz PRAC) vorgelegt, der in einem Beurteilungsbericht (kurz AR PRAC) das positive Risiko-Nutzen Verh\u00e4ltnis \u00fcberpr\u00fcft. Im negativen Beurteilungsfall m\u00fcsste das Arzneimittel vom Markt genommen werden.<\/p>

Um die Sicherheitsdaten der EMA betreffend Covid-Impfstoffe zu erhalten, haben sich Anfang 2023 \u00fcber 130 europ\u00e4ische \u00c4rztinnen und \u00c4rzte \u00fcber die Grenzen hinweg zusammengeschlossen und diese Datens\u00e4tze bei der EMA beantragt. Dabei wurde die Initative von der GHRA rechtlich unterst\u00fctzt. Seither werden diese laufend \u00fcbermittelt und auf TKP in einem durchsuchbaren OCR Format zur Verf\u00fcgung gestellt sowie unterstehend verlinkt. Aufgrund dieser Aktion hat sich die EMA im Sommer 2023 bereit erkl\u00e4rt, die PSURs and PRAC AR auf der jeweiligen EMA-Produktseite der Covid-Impfstoffe \u00f6ffentlich zum Download bereit zu stellen.<\/p>

Untenstehend finden Sie alle bisher \u00fcbermittelten Daten zum download – die Sammlung wird laufend erweitert.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Biontech\/Pfizer<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1. PSUR Comirnaty\/Biontech (2020\/12\/19-2021\/06\/18)<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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1.PSUR Comirnaty\/Biontech (pp. 1-286)<\/span><\/span><\/a> – EMA-PRAC AR of 1.PSUR Biontech (still missing)<\/span>
<\/span><\/span><\/span><\/p>

\u00a0<\/p>

Appendix 1: Reference Information (19 May 2021) 287
Appendix 1.1: Safety Related Changes to RSI 328
Appendix 1.2: Core Data Sheet (12 February 2021) 343
Appendix 1.3: Core Data Sheet (02 March 2021) 363
Appendix 1.4: Core Data Sheet (20 April 2021) 384
Appendix 1.5: Combined EUA Fact Sheet for Healthcare Providers and Full EUA Prescribing Information (11 December 2020) 407
Appendix 1.6: Combined EUA Fact Sheet for Healthcare Providers and Full EUA Prescribing Information (23 December 2020) 436
Appendix 1.7: Combined EUA Fact Sheet for Healthcare Providers and Full EUA Prescribing Information (05 January 2021) 466
Appendix 1.8: Combined EUA Fact Sheet for Healthcare Providers and Full EUA Prescribing Information (25 January 2021) 496
Appendix 1.9: EU-SmPC (21 December 2020) 526
Appendix 1.10: EU-SmPC (08 January 2021) 558
Appendix 1.11: EU-SmPC (28 January 2021) 593
Appendix 2.1: Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials 626
Appendix 2.1.1: Cumulative Summary Tabulation of Serious Adverse Events from Non-Pfizer (Licensing Partner) Clinical Trials 653
Appendix 2.2: Cumulative and Interval Summary Tabulation of Serious and
Non-Serious Adverse Reactions from Post-Marketing Data Sources 655
Appendix 2.3: Cumulative Clinical Trial Exposure with Demographic Data 884
Appendix 2.3B: Cumulative Clinical Trial Exposure with Demographic Data from Biontech Development Programs 886
Appendix 2.3C: Cumulative Clinical Trial Exposure with Demographic Data from Fosun Development Programs 887
Appendix 2.3.1: Cumulative Clinical Trial Exposure with Demographic Data from Other Pfizer Development Programs 888, <\/span>Appendix 3: Tabular Summary of Safety Signals 889
Appendix 3.1: Signal Evaluation No Data
<\/span>
all Appendices 1-2.3.1 available here<\/a><\/p>

Appendix 3: Tabular Summary of Safety Signals 889
Appendix 3.1: Signal Evaluation No Data
Appendix 4.1: Listing of Completed (Concluded with Final Clinical Study Report) Interventional Safety Studies No Data
<\/span>Appendix 4.2 Listing of Ongoing (Started or Concluded with No Final Clinical Study Reports) Interventional Safety Studies
Appendix 4.3 Listing of Completed (Concluded with Final Clinical Study Report) Non-Interventional Safety Studies No Data
Appendix 4.4 Listing of Ongoing (Started or Concluded with No Final Clinical Study Reports) Non-Interventional Safety Studies 904
Appendix 5 List of Sources of Information Used to Prepare the PSUR No Data
Appendix 6A Regulatory Authorities Request(s) Following Review of SMSR (Not Considered as a Signal) 906
Appendix 6A.1 Lymphopenia Cumulative Review 908
Appendix 6A.2 Hypoglycaemia Cumulative Review 914
Appendix 6A.3 Serious Hypertension Cumulative Review 920
Appendix 6A.4 Haemophagocytic Syndrome Cumulative Review 926
Appendix 6B Regulatory Authorities Request(s) Following Review of SMSR 933
Appendix 6B.1 Immune Thrombocytopenia 935
Appendix 6B.2-1 Hearing Loss (Serious Cases) 955
Appendix 6B.2-2 Tinnitus 966
Appendix 6B.3 Serious Arrhythmias 984
Appendix 6B.4 Pancreatitis 990
Appendix 6B.5 Acquired Haemophilia 1000
Appendix 6B.6 Menstrual Disorders 1011
Appendix 6C Observed Versus Expected Analyses for Adverse Events of Special Interest 1029
Appendix 6D.1 Interval Summary Tabulation of Fatal Reports 1058
Appendix 6D.2 Cumulative Summary Tabulation of Fatal Reports 1088
Appendix 6E Safety Effects of Mixed Schedule No Data
Appendix 6.1 Proposed Product Information (Regional Appendix) No Data
Appendix 6.2 Proposed Additional Pharmacovigilance and Risk Minimisation Activities (Regional Appendix) No Data
Appendix 6.3 Summary of Ongoing Safety Concerns (Regional Appendix) No Data
Appendix 6.4 Reporting of Results from Post-Authorisation Safety Studies (Regional Appendix) No Data
Appendix 6.5 Effectiveness of Risk Minimisation (Regional Appendix) No Data
Appendix 7 Cumulative Marketing Authorisation Status No Data
Appendix 8 Characterisation of Important Risks No Data<\/p>

all Appendices 3-8 available here<\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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2. PSUR Comirnaty\/Biontech (2021\/06\/20 - 2021\/12\/18)<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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2.PSUR Comirnaty\/Biontech (pp 1-352)<\/a> \u2013 <\/span>EMA PRAC AR 2.PSUR Biontech<\/span><\/a><\/p>

Appendix 1 Reference Information (02 December 2021) 353
Appendix 1.1 Safety Related Changes to RSI 417
Appendix 1.2 Core Data Sheet (19 May 2021) 435
Appendix 1.3 Core Data Sheet (14 July 2021) 476
Appendix 1.4 Core Data Sheet (11 August 2021) 518
Appendix 1.5 Core Data Sheet (08 September 2021) 560
Appendix 1.6 Core Data Sheet (19 October 2021) 607
Appendix 2.1 Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials, pp. 671-709
Appendix 2.1.1 Cumulative Summary Tabulation of Serious Adverse Events from Non-Pfizer (Licensing Partner) Clinical Trials 710
Appendix 2.2 Cumulative and Interval Summary Tabulation of Serious and Non-Serious Adverse Reactions from Post-Marketing Data Sources, pp. 714-1050
Appendix 2.3 Cumulative Clinical Trial Exposure with Demographic Data 1051
Appendix 2.3B Cumulative Clinical Trial Exposure with Demographic Data from Biontech Development Programs 1053
Appendix 2.3C Cumulative Clinical Trial Exposure with Demographic Data from Fosun Development Programs 1054
Appendix 2.3.1 Cumulative Clinical Trial Exposure with Demographic Data from Other Pfizer Development Programs 1055
Appendix 3 Tabular Summary of Safety Signals 1056
Appendix 3.1 Signal Evaluation No Data
Appendix 4.1 Listing of Completed (Concluded with Final Clinical Study Report) Interventional Safety Studies No Data
Appendix 4.2 Listing of Ongoing (Started or Concluded with No Final Clinical Study Reports) Interventional Safety Studies 1078
Appendix 4.3 Listing of Completed (Concluded with Final Clinical Study Report) Non-Interventional Safety Studies No Data
Appendix 4.4 Listing of Ongoing (Started or Concluded with No Final Clinical Study Reports) Non-Interventional Safety Studies 1080
Appendix 5 List of Sources of Information Used to Prepare the PSUR (Literature Abstracts) 1085
Appendix 6A List of Regulatory Authorities Request(s) 1136
Appendix 6A.1 Exacerbation (Flare-Up) of Pre-Existing AI\/Inflammatory Disorders 1170
Appendix 6A.2 Chronic Urticaria\/Worsening of Pre-Existing Chronic Urticaria 1213
Appendix 6A.3 Polymyalgia Rheumatica Cumulative Review 1224
Appendix 6A.4 Glomerulonephritis and Nephrotic Syndrome Cumulative Review 1282
Appendix 6A.5 MIS-C \/ MIS-A 1299
Appendix 6B Observed Versus Expected Analyses for Adverse Events of Special Interest 1309
Appendix 6C.1 Interval Summary Tabulation of Fatal Reports 1354
Appendix 6C.2 Cumulative Summary Tabulation of Fatal Reports 1406<\/p>

all Appendices pp. 352-1406 here<\/a><\/p>

Appendix 6.1 Proposed Product Information (Regional Appendix) No Data
Appendix 6.2 Proposed Additional Pharmacovigilance and Risk Minimisation Activities (Regional Appendix) No Data
Appendix 6.3 Summary of Ongoing Safety Concerns (Regional Appendix) No Data
Appendix 6.4 Reporting of Results from Post-Authorisation Safety Studies (Regional Appendix) No Data
Appendix 6.5 Effectiveness of Risk Minimisation (Regional Appendix) No Data
Appendix 7 Cumulative Marketing Authorisation Status No Data
Appendix 8 Characterisation of Important Risks No Data<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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3. PSUR Comirnaty\/Biontech (2021\/12\/19-2022\/06\/18)<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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3.PSUR Biontech (1-622)<\/a> \u2013<\/span>EMA-PRAC Assessment Report of 3. PSUR Biontech<\/span> <\/a><\/p>\n

Appendix 1 Reference information (10 May 2022), p. 397
Appendix 1.1 Safety related changes to RSI, p. 474
Appendix 1.2 Core data sheet (02 December 2021), p. 494
Appendix 1.3 Core data sheet (21 December 2021), p. 558
Appendix 1.4 Core data sheet (14 January 2022), p. 626
Appendix 1.5 Core data sheet (23 March 2022), p. 697<\/p>\n

all Appendices 1-1.5 pp 397-768 here
<\/a>
Appendix 2.1 Cumulative summary tabulation of serious adverse events from clinical trials
<\/p>\n

Appendix 2.1 pp. 769\u2013815 available here<\/a><\/p>

Appendix 2.1.1 Cumulative summary tabulation of serious adverse events from non-Pfizer (licensing partner) clinical trials<\/p>\n

Appendix 2.1.1. pp. 816-820 available here
<\/a><\/p>\n

Appendix 2.2 Cumulative and interval summary tabulation of serious and non-serious adverse reactions from post-marketing data sources <\/p>\n

Appendix 2.2. pp. 821-1213 available here<\/a><\/p>\n

Appendix 2.3 Cumulative clinical trial exposure with demographic data, p. 1214
Appendix 2.3B Cumulative clinical trial exposure with demographic data from Biontech development programs, p. 1217
Appendix 2.3C Cumulative clinical trial exposure with demographic data from Fosun development programs, p. 1218
Appendix 2.3.1 Cumulative clinical trial exposure with demographic data from other Pfizer development programs, p. 1219
Appendix 3 Tabular summary of safety signals, p. 1220
Appendix 3.1 Signal evaluation (no data)
Appendix 4.1 Listing of completed (concluded with final clinical study report) interventional safety studies (no data)
Appendix 4.2 Listing of ongoing (started or concluded with no final clinical study reports) interventional safety studies, p. 1235
Appendix 4.3 Listing of completed (concluded with final clinical study report) non-interventional safety studies (no data)
Appendix 4.4 Listing of ongoing (started or concluded with no final clinical study reports) non-interventional safety studies, p. 1237
Appendix 5 List of sources of information used to prepare the PSUR (literature abstracts), p. 1243
Appendix 6A List of regulatory authorities request(s), p. 1251
Appendix 6A.1 Dizziness cumulative review, p. 1261
Appendix 6A.2 Acquired haemophilia cumulative review
Appendix 6A.3 Hearing loss and tinnitus cumulative review, p. 1289
Appendix 6A.4 Multisystem inflammatory syndrome, p. 1318
Appendix 6A.5 Autoimmune hepatitis cumulative review, p. 1345
Appendix 6B Observed versus expected analyses for adverse events of special interest, p. 1400
Appendix 6C.1 Interval summary tabulation of fatal reports, p. 1470<\/p>\n

Appendices 2.3-6C.1 pp. 1214-1515 available here<\/a><\/p>\n

Appendix 6C.2 Cumulative summary tabulation of fatal reports<\/p>\n

Appendices 6C.1 pp. 1516 -1598 available here <\/a><\/p>\n

Appendix 6D Tables supporting clinical reactogenicity data on individuals previously exposed or not to SARS-CoV-2, p. 1599
Appendix 6.1 Proposed product information (regional appendix) (no data)
Appendix 6.2 Proposed additional pharmacovigilance and risk minimisation activities (regional appendix) (no data)
Appendix 6.3 Summary of ongoing safety concerns (regional appendix) (no data)
Appendix 6.4 Reporting of results from post-authorisation safety studies (regional appendix) (no data)
Appendix 6.5 Effectiveness of risk minimisation (regional appendix) (no data)
Appendix 7 Cumulative marketing authorisation status (no data)
Appendix 8 Characterisation of important risks, p. 1658<\/p>\n

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4. PSUR Comirnaty\/Biontech - 2022\/06\/19-2022\/12\/18<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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4.PSUR Biontech (pp. 1-335) – EMA-PRAC Assessment Report of 3. PSUR Biontech (pp.336-504) one document\u00a0<\/span><\/a> <\/strong>
<\/span><\/p>

All Appendices requested at EMA,\u00a0 still pending
<\/span><\/p>

APPENDIX 1 REFERENCE INFORMATION (05 DECEMBER 2022) 334
APPENDIX 1.1 SAFETY RELATED CHANGES TO RSI 474
APPENDIX 1.2 CORE DATA SHEET (10 MAY 2022) 572
APPENDIX 1.3 CORE DATA SHEET (26 JULY 2022) 649
APPENDIX 1.4 CORE DATA SHEET (31 AUGUST 2022) 754
APPENDIX 1.5 CORE DATA SHEET (08 SEPTEMBER 2022) 880
APPENDIX 1.6 CORE DATA SHEET (06 OCTOBER 2022) 1006
APPENDIX 2.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM CLINICAL TRIALS 1145
APPENDIX 2.1.1 CUMULATIVE SUMMARY TABULATION OF SERIOUS ADVERSE EVENTS FROM NON-PFIZER (LICENSING PARTNER) CLINICAL TRIALS 1200
APPENDIX 2.2 CUMULATIVE AND INTERVAL SUMMARY TABULATION OF
SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 1206
APPENDIX 2.2.1 BNT162B2 ORIGINAL CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 1621
APPENDIX 2.2.2 BNT162B2 ORIGINAL\/OMICRON BA.1 CUMULATIVE AND
INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS
ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 2035
APPENDIX 2.2.3 BNT162B2 ORIGINAL\/OMICRON BA.4\/BA.5 CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS
ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 2081
APPENDIX 2.2.4 BNT162B2 ORIGINAL\/OMICRON CUMULATIVE AND INTERVAL SUMMARY TABULATION OF SERIOUS AND NON-SERIOUS ADVERSE REACTIONS FROM POST-MARKETING DATA SOURCES 2138
APPENDIX 2.2.5 INCREMENTAL DEMOGRAPHY SUMMARY 2139
APPENDIX 2.3 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA 2146
APPENDIX 2.3B CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM BIONTECH DEVELOPMENT PROGRAMS 2151
APPENDIX 2.3C
CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM FOSUN DEVELOPMENT PROGRAMS 2153
APPENDIX 2.3.1 CUMULATIVE CLINICAL TRIAL EXPOSURE WITH DEMOGRAPHIC DATA FROM OTHER PFIZER DEVELOPMENT PROGRAMS 2154
APPENDIX 3 TABULAR SUMMARY OF SAFETY SIGNALS 2156
APPENDIX 3.1 SIGNAL EVALUATION NO DATA<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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  1. PSUR Spikevax\/Moderna (01\/01\/2022 \u2013 18\/06\/2022)<\/strong><\/li><\/ol>

    3.PSUR Spikevax\/Moderna<\/a> <\/span>\u2013 AR 3.PSUR Spikevax\/Moderna<\/p>

    (EMA provided a set of documents which does not follow the original numbering)<\/i><\/p>

    Appendix 1 Reference Safety Information 567
    Appendix 2 Cumulative Summary Tabulations of Serious Adverse Events from Clinical Trials 568
    Appendix 3 Cumulative and Interval Summary Tabulations of Serious and Non-Serious Adverse Reactions from Post-marketing Data Sources 569
    Appendix 4.1 Tabular Summary of Safety Signals 570,     pp. 566-914<\/a>
    Appendix 4.2 Signal Evaluation Reports 583, EMA only sent Appendix 4.2f: Signal Evaluation report: Corneal graft rejection,\u00a0     pp. <\/span><\/a>915-1298.<\/span>
    Appendix 5 Listing of all MAH-Sponsored Interventional Trials with the Primary Aim of Identifying, Characterising, or Quantifying a Safety Hazard or Confirming the Safety Profile of the Medicinal Product 591
    Appendix 6 Listing of all the MAH-sponsored Non-interventional Studies with the Primary Aim of Identifying, Characterising, or Quantifying a Safety Hazard; Confirming the Safety Profile of the Medicinal Product; or Measuring the Effectiveness of Risk Management Measures 611
    Appendix 7 List of the Sources of Information Used to Prepare the PBRER (if desired by the MAH) 616
    Appendix 8 EU Regional Appendices 639
    Appendix 9 US Regional Appendices 641
    Appendix 10 Canada Regional appendix 642
    Appendix 11 Other Appendices Supporting PBRER 647, EMA sent Appendix 11.5a, Appendix 11.5a Myocarditis\/Pericarditis: Patients < 40 years of age after Dose 2 and Dose 3: Case Listings,
    Appendix 12 Literature search strategies 791
    pp. 667(1269)-1568,
    <\/a>    in addition: 1569-1868<\/a>, 1869-2268<\/a>, 2269-2734,<\/a> 2735-3034<\/a>,
    (3035-3417 coming soon).<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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    3. PSUR Vaxzevria\/AstraZeneca (29\/12\/2021-28\/06\/2022)<\/strong><\/p>

    3. PSUR Vaxzevria\/AZ (pp. 141-711) and EMA-PRAC Assessment Report of 3. PSUR <\/strong>Vaxzevria\/AZ\u00a0<\/strong> (pp. 1-124)
    <\/strong><\/p>

    Appendix 1 Reference Information (AstraZeneca Core Data Sheet)<\/span><\/p>

    Appendix 2 Cumulative Summary Tabulation of Serious Adverse Events from Clinical Trials + Interval\/Cumulative Summary Tabulations of Serious and Non-Serious Adverse Reactions from Marketed Experience<\/span><\/p>

    Appendix 3 Tabular Summary of Validated Safety Signals<\/span><\/p>

    Appendix 4 Listings of All Post-Authorisation Safety Studies<\/span><\/p>

    Appendix 5 List of the Sources of Information Used to Prepare the PBRER (Not produced as not considered necessary for this report)<\/span><\/p>

    Appendix 6 Post-marketing Exposure Data<\/span><\/p>

    Appendix 7 Standardised MedDRA Queries (SMQ) and MedDRA search \u00a0<\/span>term (MST) lists used for Adverse Events of Special Interest (AESIs) and Safety Concerns in the VAXZEVRIA Risk Management Plan (RMP)<\/span><\/p>

    Appendix 8 Observed versus Expected Analyses<\/span><\/p>

    Appendix 9 Observed versus Expected Analyses Supporting Information<\/span><\/p>

    Appendix 10 Lot Analysis (Not produced as not applicable\/Not produced as<\/span><\/p>

    no information to report)<\/span><\/p>

    Additional<\/span> <\/i>Appendix 11 Cases with reported Vaccination error and case level outcome of fatal<\/span><\/p>

    Additional Appendix 12 Listing of Myocarditis case reports with Vaxzevria<\/span><\/p>

    Additional Appendix 13 Listing of Rhabdomyolysis<\/span><\/p>

    Additional Appendix 14 EMA LEG O\/E: Incidence rates<\/span><\/p>

    Additional Appendix 15 EMA LEG: Sex and age differences, exclusion of previous cases and VTE definition in VTE studies<\/span><\/p>

    Additional Appendix 16 Evaluation of Cutaneous vasculitis<\/span><\/p>

    Additional Appendix 17 AZ sponsored observational study in relation to Thrombosis with Thrombocytopenic syndrome, request from Health Canada.<\/span><\/p>

    Additional Appendix 18 Thrombosis in combination with thrombocytopenia \/Thrombosis with Thrombocytopenic syndrome Tables related to evaluation of new information<\/span><\/p>

    Additional Appendix 19 Listings of Medically Confirmed Subacute thyroiditis case reports with VAXZEVRIA<\/span><\/p>

    Additional Appendix 20 GBS Signal Evaluation and Supporting Document for CDS Changes<\/span><\/p>

    Regional Appendices are relevant for submission as follows<\/span><\/b><\/p>

    European Union (EU)<\/span><\/p>

    Regional Appendix R1 Proposed Product Information<\/span><\/p>

    Regional Appendix R2 Proposed Additional Pharmacovigilance and Risk Minimisation Activities (Not produced as no proposals to report)<\/span><\/p>

    Regional Appendix R3 Summary of Ongoing Safety Concerns in the European Union<\/span><\/p>

    Regional Appendix R4<\/span><\/p>

    Reporting of Results from Post-Authorisation Safety Studies<\/span><\/p>

    (Not produced as no information to report)<\/span><\/p>

    Regional Appendix R5 Effectiveness of Risk Minimisation (Not produced as not applicable)<\/span><\/p>

    The following Regional Appendices are not required for submission in EU<\/span><\/p>

    Regional Appendix R6 Individual Case Safety Reports<\/span><\/p>

    Regional Appendix R7 US Prescribing Information<\/span><\/p>

    Regional Appendix R8 Combination Product Five-day and Malfunction Report Analysis<\/span><\/p>