= = Dares CNBG [rug Name] (Common Name: SFR HA KIEAE CVero HEIR) Trade Name: COVILO English Name: COVID-19 Vaccine (Vero Cel), Inactivated (Chinese Phonetic Alphabet: Xinxing Guanzhuang Bingda Miehvoyiriao (Vero Xibao} [composition) ‘The COVID-19 Vaccine (Vero Cell), Inactivated is made from the SARS- CoV.2, 19nCoV.CDC-Tan- HI strain which, cells for culturing, harvesting, B:propiolacione ‘and purification, then flowed by adsorption adjuvant to form the liquid vaccine, The vaccine i fee of atibiotes and preservatives ‘etve Compostn: SARS-CoV2, SxCWN:CDC Tan HBO? stain in sctvated) ‘Adjuvant: Aluminium hydroxide Exeipients: Disodium hydrogen phosphs dihydrogen phosphate Sodium chloride, Sodium Uappearance) ‘The products semi-transparent suspension with slight white colo, ‘which could be layered due to precipitation. and the preepitation can be casly dispersed by shaking, [Therapeutic tndieation} This products for active immunization t prevent COVID-19 caused by ‘SARS. CoV-2 vrusin individuals 3 years of age and olde. ‘The vaccine efficacy ofthis product for adults in 18-59-year-ld cohort ive been shown based on the interim tepor of the international Phase T clnial tral in which, the proportion of alder adults (260 years old) ‘was low (2.01%). The acquired data demonstrates that cerain level of neuvalzing anibody can be indced after vaccination among 3-17 and 2 60 years of ape [Pharmacodynamic Properties] ‘The antibodies against the SARS.CoV-2 can be produced after vaccine tion, to prevent the COVID-19 disease caused by SARS-CoV? virus This products conditionally approved based on the resus of protective ef 26) eported in interim analyse of Ue inerational Phase Il linia il “The present experience with the vaccine froma Phase Wl trial up to 90 ays pst last vaceination und the second inl data in approximately 30,000 healthy adults aged 18 years and oker in UAF Uereseotation) Each via contains 28 mL of product for five times of administration, ‘ach administration requires 0 mL as one dose, each dase contains 49-104 units of inactivated SARS-CoV? antigen and 0-3-0 6 mg/ml. aluminium hydroxide adjuvant [immunization Regimen and Dosage] ‘Two dose regimen a an interval of 21-28 days, each dose is O Smt The recommended adminisrabon is through intramuscular route, the injec {ion ito a muscle wil be preferably performed in he upper par of te am Toe ned for boos immunization with ths product aa not been dete Adverse Reactions) The safety ofthis product is evaluated through the Chins and iternation- al cinical sal The Chita Phase Ul clinical trials are randomized, Jov- This package insert was last revised in 08/2021 COVID-19 Vaccine (Vero Cell), Inactivated ‘This product is conditional approval, Please read the instructions carefully and use under the guidance of a physician ble-blinded and placebo parallel controlled to preliminarily evaluate the safety and immunogenicity ofthis product for adults 18 years and older. The interational Phase Il! clinical tral is an intemational multi-center, randomized, double blinded, placebo parallel controlled to evaluate the protective efficacy, safety and immunogenicity of this product Invest ators actively follow up the safety dats of (21/28 days ater exch vac~ ination to observe the cocurrence of adverse events and pay atlention to the serous adverse events occurred witht 12 months aftr full-course vaccination atthe same tine The incidence for Adverse Reactions (ARs) (CIOMS recommendation) can be presented as: Very common (210%), common (I-10%, including 1%), uneommon (0.1-1%, including 0 1%), rare (001-0 1%, including (0.01%), very rare (<0 01%) Summarize the safety data of this product in the Phase Ul and Phase It clinical tals LARS atthe Injection Site Very common: P Uncommon: Redness, swelling, induration, rash, pruritus, Rare: Erythema 2Systemic ARS ‘ery common: Headache Common: Fever, atgue, myalgia, arth diacthes, praitus, ‘Uncommon: Dizziness, anorexia, vomiting, oropharyngeal pain, dyspha- gia, running nose, constipation, hypersensitivity Rare: Acute allergic reaction, lethargy, drowsiness, difficulty falling asleep, sneezing, aasopharyngitis, nasal congestion, dry throat, influenza, hypoesthesia, limb pain, palpitations, abdominal pan, rash, abnormal skin mucose, acne, ophthalmodynia, ear discomfort, lymphadenopathy; Very rare: Chills taste dysfunction, loss of taste, paresthesia, remor, attention disorder, epistaxs, ashi, throat initaticn, tonsil, physical discomfort, neck pain jaw pain, neck lump, mouth ulcers, toowache, esophagus disorders, gastits, fecal discoloration, blurred vison, eye i= tation, earache, tension, hypertension, hypotension, urinary incontinence, delayed menstruation cough. dyspnea, nausea, Severity of ARS “The severity of ARs for this product observed in clinical tials is mainly trade | (mild), and the incidence of grade 3 and above solicited ARS is 0'54%, ao grade 4 ARS related to this product are reported. The grade 3 [ARS atthe injection ste reported in lineal rials inlude: pain, rash, peu- Fitus; the grade 3 systemic ARS include: fever, fatigue, headache, myal fia anbralgia, cough, dyspnea, nausea, vomiting, dlarthes, constipation, dysphag 4 Serious Adverse Event (SAE) [As the date of December 31°, 2020, among all observed SAEs during the international Phase Il cinieal trials one subject with serious nausea, vomiting and other symptoms was confimed to be related to the vacck- nation of this produc, this subject was hospitalized and cured. Another Subject with "ight upper limb weakress an cannot speak clearly’ was ‘diagnosed a¢ ‘inflammatory demyelination syndrome, multiple sclerosis (MS), clinical isolated syndrome (C18), and acute disseminated encepha- lommyeltis (ADEM)" by hospital, Whether this case is related tothe vacei- nation could not be determined [Contraindications) 1 Individuals who ar allergic to any component (including excipients)of this product. 2, Individuals who have allerge reactions with vaccines before (acute allerpie reacton, angioneurouc edema, dyspnea, ec) 3. Individuals with uncontolied eplepsy or other progressive nervous system diseases, and with history of Gullan-Barre syndrome. lspci Warnn nd Precio “Phe prostatic of tis product 2.5 mb for five umes of sdin- israton Fort ovacernatesbjecs with 2 ml of vaccine at ove fame, Please pay sennon tothe tformation for mul dose o single tne on he wl abel before ute. 2. Please use he oped vse unmediatly. Fo dose (2.5 mL ‘a shoul be sored arom tempers or 2°C °C according 10 The actual staon afer fiat dose withdrawal. Use the il 2 000 ‘recticaly possible and wai 6 hours (sore at 2°C-8°) or within 1 Foe (oore room temperate 3, Disifet the surface ofthe ruber stopper before vaccination, and ‘ros-contammation should be suicly avoided darng vaccination, ‘The vaccination eror (ee or eater than OS. fr section) that {nny be caused by mull exactions should be minimized. Where & {all05 ta dose cannot be extracted, he remaining volume should be ‘carded Don ool exes vacin rom mole ii 4, Longtem peristece of protection sty sl ongong, no data in ths repard fe avaiable at presen the recommendations are bated on term dat, 5 -At prevents he evidence ofthe protectuve efficacy of this product ‘on people ged 3-17 and > 60 has not been obtained, 6 Belore we carefully hock the racine colin, label, appearance and expiration dt. there are cack, spas, Sais, Sratches, bred inbel on the conte, voce exp or abnormal epperence Served, the vcrine shall ot be wed. 7 Invaselarnochon is stnely prohibited There sno safety and ‘ficacy data of the vaceine though subcutaneous and nadermal ‘om 8 Drugs and equipment such as epephnne should be availble for tevergency teatent the evel of an ocasonal vee alee r= Schou The vacrnce chou be observed for at lest 15 minutes er ‘> Use with caution patents with acute diseases, acute onset of chron te unas and fever; Delay the vacetnation afc the doctor's evan tonnes. 10.Use with eau in patents who have diabetes and those witha sory o family history of eonvalsions, elepey,encepalopaty ot tren tne ‘Use wi eautonn patents who have decrease platelets or cloting Aieorders Because of the risk of Hlcding which may occu ding {ncumesclardmaistaton ofthe vaccine 12,Use wih caution m palin th impaired mane function (uch as ‘malignant tumor, nephrotic syndrome, AIDS patients, te) beens Safety end effcny dats have ot been Sind hee indvual 13, People meted wih nmunoplobuln should be vacated wit is rod atleast month apr 0 snot affect he nme efacy 14. Chneal tals of ts vac ted in combination withthe vores fave not yet been conduced. 15. Is probit Yo se hs prod gun if any adverse nervous system ‘eacon occured afer vecemition 16. Tere eno entdeace of protective efficacy ofthis product for SARS- CoV? infeed persons 17 Like all ace, dh product may ot have 100% preven efficacy forte vaconee [Vaccination for Special Population) a Trmted éxpenence cxsts with use of COVID-19 Vaccine (Vero (Cal), Inactvated i ‘wornen. Animal studies do not indicate iret or mdirect harmful effects with respect to pregnancy, embryo! foetal development, partution or post-natal development. Admins- ‘tation of COVID-19 Vaccine (Vero Celt, Inactivated in pregnancy should only be considered when the potenual benefits outweigh any ‘Potential risks forthe motber and foots Bresstfoeding Unknown is whether COVID-19 Vaccine (Vero Cel), Inacvate is, cexereted in human milk + Ferny ‘Animal studies do not indicate director murect harmful eects wath respect to reproductive toxicity [Drug Interaction} 1. The concomitant chnical tnals on this vaceine i combination wath other vaccines have not yet been conducted, therefore no data te- sarding the interaction between ths vaccine with other vaccines are svable 2 Combination use with other drugs: Combination use with smmuno- suppressive drug, such as immunosuppressive agents, chemotherapy drugs, ant-metabohe drugs, alkylating agents, cytoioxc drugs, cortco- ‘eros, ec. may reduce the body's unmune response to this product. any vaceies or drugs are being taken or recently taken, please mnfrm the physician in time to avoid dug interaction, [ctinica! Wake) ‘The Phase Ill climecal trial a muli-center, randomized, double-binded, and placebo parallel controlled design and twas conducted m the United ‘Arab Emirates (Abu Dhabi, Sharjah), Kungdomn of Bara, and many ‘other counines/egions, At ieat 45,000 healthy subjects agod 1 years and above were randomized to reoeive candidate vaccine | (his product), fandhdate vaccine 2 or placebo with two-dose regimen (0,21 (+7) days) tera ie vi ey, fey and mgm, The omy sudy hypothesis was thatthe fower lit of the 95% confidence interval (@S%CI) of the vaccine efficacy (VE) calculated from 14 days after of the 2° immunization of this product was greater than 30% in individuals aged 18 years and above. The intenm analysis results of the {merational Phase Il clinical mals ae as following “The pnmary endpoint of the Phase Ill climcal tnal 1s the incidence of COVID-19 case calculated from 14 days after 2 doses, and the ealeul tion method for vaccine efficacy based on person-year incidence 2 the main analysis method for vaccine efficacy. During the inten analysis, all effective endpornt cases (114 cases) of infection during the monitoring Period were confirmed by the Endpoint Assessment Commutiee (EAC) “The interim analysts data showed that following the two-done vacination regimen wih 21 (7) days apart, the vaccine efficacy against COVID-19 was 78.89% (IS%CT: 65.79%-8697%) from 14 days after fll-course vaccination, which achieved the hypothesis of the vaccine efficacy for ‘ccond interim analysis. The median duration of paricrpants follow-up at {he te of data lock was 112 days [storage] Store and transport ina refngerate (2°C-8°C) cond protect from light. Do not freze. EShettife] 24 months [Packaging Configuration} Middle borosilicate glass vil, film-coated Inalogeated butyl rubber stopper, I vallbox, 3 vialvtox, 10 nalfbox (Executed Standard} YBS00352021 Uiimergency Use Approval No.) WKZ[2020)55 (Marketing Authorization Holder) Name. Beying Insitute of| Products Co, Lid ‘Address: Rootn 205, Second Floor, Building 4, No.9 Bo"sang 2™ Road, Economic-Technological Development Area, Beijing, PR. China (Manufacturer) (Name. Beying Insitute of Biologeal Products Co , Ld ‘Address: No. 689 Bo"xing 2" Road, Economie: Technological Develop- ‘ment Area, Bejing, PR. China Post Code: 100175 “Telephone: 0086 10 87220568 Fax: 0086 10 87220568