Ministry of Health and population I Sully davall 5g Assistant Minister for Public Health eg pla Casi yj sll sole Projects and Initiatives datalt dawall cil jstiag CaUBilaally Ayaucall Cy pictll Ay yrta og pide / BI jgll eS )osLud cvs yh as GA Si SLi AS yo Goa Oy abl Ley ASN Faye 2 sae Gol) LAY yal) alld aSialyal path og) clay 1 F¥) Gplacaiall 9 (2022 Une 28 iil) Fea ya Liga Wj) sil CU CDE Guay adhe de 1 shediiall Al ga GJ i} Salguciy 5 5 96a) Ayadball Gy jl) Lig eds any Aad de -2 Tsdlan a 95 ab ARE Mla Al) UE LS fl AS yds Ga oy Lad Ue Ay Le Sislun daual gf i pth Las ntegly Lal Lis ay 3) a) CL cds Gian Lacs all Jaf 4yadlaall bi all say Adal G15 e NMo00S | 3 1-4-2022 1| _NM0006 _ 3-4-2022 2 NM0218 19-4-2022 4 ACB6256 30-6-2022 5 ‘ACB6800_ 30-6-2022 | 6 Pw40179 30-6-2022 1 ACC1399 30-6-2022 8 __Pwaoi0 31-7-2022 9 |__ Pw40103 31-7-2022 10, PW40210 31-7-2022 u ceil al URE uu Juslb 5 a6 Jy si6all spall Yaga gua — 27953192 -: csSb—3 AUN) cial) palill — 11516 -: ot Va — Gal) Galas G3National Institute for Public Health and the Environment Ministry of Health, Welfare and Sport EU OFFICIAL CONTROL AUTHORITY BATCH RELEASE CERTIFICATE, FOR IMMUNOLOGICAL PRODUCTS Health Protection, PO Box 1, 3720 BA, Bilthoven, The Netherlands RIVM, Centre f Finished Produ EUIEEA OFFICIAL CONTROL AUTHORITY BATCH RELEAS Examined under Article 114 of Directive 2001/83VEC as amended by Directive 200427/EC (Immunological Medicinal Products) and in accondance with the Administative Procedure for Official Control Authority Bateh Release. Vaxzevria (previously COVID-19 Vaccine AstraZeneca) Trade name: International non-proprietary Name Ph. Bur. Pandemie COVID-19 Vaccine (Non-Replicating name / common name: Adenavirus-Vectored Vaccine) Batch numbers appearing on package and other) INMOBTENN2337, {dentiication numbers associated with this butch: ‘Type of container: vial ‘Total numberof containers i tis batch: 3osi20 Number of doses per container: 10 dose Date of start of period of validity 19-10-2021 BU/2is290 Marketing authorisation nun AstraZeneca Nimegen B.V. Lagelandsewep 78 {6545 CG Nijmegen The Netherlands Name and address of manufaet Name and address of marketing authorisation AstraZeneca AB holder: Astrallén SE-IS1 85 SSdertilje Sweden ‘This batch has been examined using documented procedures which form part of a quality system whieh i in ‘accordance with the ISO/IEC 17025 siandavd. This examination is based on the relevant EU OCABR guideline For this product. fad down in the relevant European ‘This batch is in compliance with the approved specification nd is released Pharmacopocia monographs and the above marketing authorisation Signed Brysie Dr. MAW. Bruysters, an authorized signatory [Name and function of signatory: 15-12-2021, Date of issue: Cextiicate Number: 212108 Version: |National Institute for Public Health and the Environment Ministry of Health, Welfare and Sport EU OFFICIAL CONTROL AUTHORITY BATCH RELEASE CERTIFICATE FOR IMMUNOLOGICAL PRODUCTS RIVM, Centre for Health Protestion, PO Box 1, 3720 BA, Bilthoven, The Netherlands EU/EEA OFFICIAL CONTROL AUTHORITY BATCH RELEASE - Finished Product Examined under Article 114 of Dieeotive 2001/83VEC as amended by Directive 2004/27/EC (Immunological Medicinal Products) and in accordance with the Administra fe Procedure for Official Control Authority Bate Release, ‘Trade name: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) International non-proprietary Name Parsdemie COVID-19 Vaccine (Non-Replicaing name / common ame: Adenovirus-Vectored Vaccine) Batch numbers appearing on package and other identitieation numbers associated with this batch: | Acpot43, ACBSS15 Marketing authorisat a [26-04-2002 TT eUnris90R Name and address of manufacturer: AstraZeneca Nijmegen BLY. Lagelandseweg 78 66545 CG Nijmegen The Netherlands Name and address of marketing authorisation holder: AstraZeneca AB Astraallén SE-151 85 SSdertlje Sweden aceonlance withthe ISOMEC 17025 for this produc ‘This batch has boen examined using documented procedures which form part of quality system wich i in lard. This examination i based on the relevant EU OCABR guideline ‘This batch is in compliance with the approved specifications laid down in the relevant European Pharmacopoeia monographs and the above marketing authorisation and is released. Signe Fl|— [Name andl function of signatory: Dr. B. de Vries, an authorized signatory Date of is 17-12-2021 Certificate Number: 212157 Version: 1National Institute for Public Health and the Environment Ministry of Health, Welfare and Sport EU OFFICIAL CONTROL AUTHORITY BATCH RELEASE CERTIFICATE FOR IMMUNOLOGICAL PRODUCTS RIVM, Cente for Health Protection, PO Box 1, 3720 BA, Bilthoven, The Netherlands SE - Finished Product EU/REA OFFICIAL CONTROL AUTHORITY BATCH REI Examined under Atticle 114 of Directive 2001/83/EC as amended by Directive 2004/27/EC (Immunological Mecicinal Products) and in aevordance withthe Administrative Procedure for Official Comtol Authority Batch Release Trade name: Vaxzevria (previously COVID-I9 Vaccine AstraZeneca) International non-proprietary Name/ Ph. Bur. Pandemie COVID-19 Vaccine (Non-Replicating name / common name: Adenovirus-Vectored Vaccine) Batch numbers appearing on package and other | NMO00S, NM2769) {dentiication numbers assoctated with this bateh: Type of container: vial ‘Total number of containers in tis batch 243460 Number of doses per container: LO dose 01-10-2021 Date of start of period of validity: BU//avis29002 Marketing authorisation AstraZeneca Nijmegen BV, Lagelandseweg 78 6545 CG Nijmegen The Netherlands [Name and adress of ms Name and address of marketing authorisation AstraZeneca AB Astraallén holder: SE-51 85 Siertije Sweden ‘This batch has been examined using documented procedures which form part ofa quality system which is in sccordance with the ISOMEC 17025 standard This examination is based on the relevant EU OCABR guideline for this product, ‘This batch isin compliance with the approved specifications laid dovn in the rekvant European Pharmacopoeia monographs and the above marketing authorisation and i released. Signed: Detorte., [Name and function of signatory: Dr. ing. D. de Haan - de Costa, an authorized signatory 08-12-2021 Date of issue: Certificate Number: 211995 Version: |Fee Notional institute for Public Heath E8249) and the Environment ‘Ministry of Health, Welfare and Sport EU OFFICIAL CONTROL AUTHORITY BATCH RELEASE CERTIFICATE FOR IMMUNOLOGICAL PRODUCTS RIVM, Centee for Health Protection, PO Box 1, 3720 BA, Bilthoven, The Netherlands EU/EEA OFFICIAL CONTROL AUTHORITY BATCH RELEASE - Finished Product Examined under Article 114 of Directive 2001/83/EC as amended by Directive 2004/27/EC (Immunological Medicinal Products) and in accordance with the Administeative Procedute for Official Control Authority Bateh Release Trade name! Vaxzevta (previously COVID-19 Vaccine AstraZeneca) International non-proprietary Name / Ph. Bur. Pandemic COVID-19 Vaccine (Non-Replicating ume / common name: Adenovirus-Vectored Vaccine) Batch numbers appearing on package and other || Nurgoas, nt2869 ‘dlenifcation numbers assoclated ith this batch: Rasputin joss ‘Marketing athorton number (ued by Bunraisz90 raeaseee a {6545 CG Nijmegen The Netherlands Name and address of marketing author AstraZeneca AB holder: Asteaallén SE-1S1 85 Side ‘This batch has been examined using documented procedures which form part of a quality system which isin accordance with the ISO/IEC 17025 standard, This examination is based on the relevant EU OCABR guideline for this product ‘This batch is in compliance with the approved spectfications laid down inthe relevant European ‘Pharmacopoeia monographs and the above marketing authorisation and is released. Signed: {+ Name aad function of signatory: Dr. Bde Vries, an authorized signatory Date of issue: 06-12-2021 Certificate Number: 211996 Version: 1AstraZeneca Vaxzevria (AZD1222) Batch by Batch Extension Egypt As of January 27' 2022 Astrazeneca is using real time data to extend the shelf life of certain lots of AZD1222 (Vaxzevria] when a request is made by a Government or Regulatory Authority. The switch from extrapolation (shelf life model) to real time data is due to the increased number of results from batches achieving 9-Months of age while under study in the official stability programs, At this time, AstraZeneca is being very conservative with shelf life extension. The approved, registered specifications for A2D1222 were designed to achieve a 6-month shelf life for Vaxzevria DP. All batches that are manufactured, tested and released to this specification are expected to maintain product quality for 6-months from date of manufacture. Infectivity Analysis The specification calls for batches to be released with an infectivity result of 2 7.0 x 10° ifu/mL to achieve a 6-month shelf life. The infectivity stability specification is > 5.0 x 10° ifu/ml, To determine the infectivity required for a batch to attain a 9-month shelf life while also accounting for the inherent variability in the cell based infectivity assay, all available infectivity data was analyzed and a cut off was set. As such, an interim 1.2 x 10° ifu/mL cut off is proposed for shelf life extensions until the appropriate filing is made to establish a 9-month shelf life for all AZ01222. Viral Particle Concentration A review of the stability data has shown that viral particle concentration is decreasing over time. An interim 0.9 x 10" vp/mL cut off is proposed for shelf life extensions until the appropriate filing is made to establish an extended shelf life for all AZD1222. For a batch to attain 8-Months shelf life, a limit of 1.1 x 10° ifu/mL can be applied. Conclusion ‘A commitment was made to evaluate the ability to extend certain batches of DP in Egypt and Astrazeneca can meet that commitment, The parameters for deciding to extend a particular batch of AZD1222 is infectivity and viral particle concentration of the lot at release. An infectivity of 1.2 x 10° fu/ml. and a viral particle concentration of 0.9 x 10" vp/ml is required, at this time, to confidentially assure that the material will remain within specification for the duration of the 3 month extension. The maximum total shelf life of any AZD1222 extension is 9-Months unless additional re-testing has been carried out after the expiry of the lot. See Appendix 1 for a list of batches that can be extended, Callum Chapman, Associate Director, Product Quality DateAstraZeneca Appendix 1-Extension Analysis EYG-EXT-0001 Viral Particle Original | Proposed Batch | Manufacturer aaa Concentration | SEMenson | Expiry | Expiry i (vp/mt) pes Date Date "| Catalent ; * March 31 ames? | ACB6256 | fanagri__| 145%10" | 1.0x20 Yes ae aralent ; a March aT ane cpss00 | ier 15x10? | 10x10) Yes | ton March 31 . 1 Wockhardt | 12x10? | 1.0x10! Yes ae ap Yes : 30 neeizeg | HEME aa | oox10" | emontns | Pt Anagni 2022 Only : : ‘April 30 | Pwaot01 | Wockhardt | 1.3% 10 1.0% 10 Yes 2022 April 30 ° 0 pwaoi03 | Wockhardt | 1.4.x 10! 10x10 Yes aa | PW40210 | Wockhardt | 14x10? | 1.0x 10" Yes oso co 2022Certificate Of Completion Envelope Ic: FF03C274C8BB41209724A5ECAZ76N6C Subject Please DocuSign: Egypt Extension Memo (Simple). doce Source Envelope: Documant Pages: 2 Certificate Pages: 2 ‘AutoNav: Disabled Envelopeld Stamping: Disabled Signatures: Initials: 0 Time Zone: (UTC+01:00) Brussels, Copenhagen, Madrid, Paris Record Tracking ‘Status: Original 28-Mar-22 | 10:48 Signer Events Callum Chapman callum.chapman@astrazeneca.com ‘Associate Dir. Product Quality Astrazeneca Security Leve (None) Email, Account Authentication Electronic Record and Signature Disclosure: ‘Accepted: 20-May-21 [21:47 ID: 10e5t@73-c6b0-4791-ab09-1816477223e0 In Person Signer Events Editor Delivery Events Agent Delivery Events Intermediary Delivery Events Certified Delivery Events Carbon Copy Events Witness Events Notary Events Envelope Summary Events Envelope Sent Certified Delivered Signing Complete Completed Payment Events Holder: Callum Chapman callum.chapman@astrazeneca.com Signature ‘Signature Adoption: Uploaded Signature Image Using IP Address: 147.161.166.181 Signature Status Status Status Status Status Signature Signature Status Hashedinorypted Security Checked Securily Checked Securty Checked Status Electronic Record and Signature Disclosure Docu status: Completed Envelope Originator Callum Chapman Puerta de Hiewo Guadelajara, Jalisco 45116 callum.chapman@astrazeneca.com IP Addvess: 147.161.166.181 Location: Docusign Timestamp Sont: 28-Mar-22 | 10:46 Viewed: 26-Mar-22 | 10:47 Signed: 28-Mar-22 | 10:47 Freeform Signing Timestamp Timestamp Timestamp Timestamp Timestamp Timestamp Timestamp Timestamp Timestamps 28-Mar-22 | 10:48 28-Mar-22 | 10:87 28-Mar-22 | 10:47 28-Mar-22 | 10:47 jestampsElectric Record and Signature Disclosure created on: O7-Maye24 | 12:57 Patties agreed to: Callum Chapman Thereby consent to that AstraZeneca Worldwide https://vww.astrazeneca.com may disclose personal information such as; full name, email address, and any other information you may supply on the electronie form to AstraZeneca affiliates and third party service providers throughout the world in relation to the handling and administration of the Electronic Signature Service solution. 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