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SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 1 NAME OFTHE MEDICINAL PRODUCT Trade/Brand Name: COVOVAX™ SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 mL) contains 5 micrograms of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M1. Adjuvant Matrix-M1 containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponariaMolina extract. * SARS-CoV-2 recombinant spike protein is produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species. For the full list of excipients, see section 6.1. Both COVOVAX™ (manufactured by Serum Institute of India Pvt Ltd) and Nuvaxovid (manufactured by Novavax) are SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccines. 3 PHARMACEUTICAL FORM Dispersionfor injection(injection). COVOVAX™ is colourless to slightly yellow, clear to mildly opalescent, free to practically free from visible particles. SIIPL Version 7.0 Page 1of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 4 CLINICAL PARTICULARS 4.1 Therapeuticindications COVOVAX™ is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The vaccine is approved for restricted use in emergency situation that may prevent COVID- 19 disease. 4.2 Posology and method of administration Posology Individuals 12years of age and older COVOVAX™ is administered intramuscularly as a course of 2 doses of 0.5mL each. It is recommended to administer the second dose 3weeks after the first dose, see section 5.1. It is recommended that individuals who receive a first dose of COVOVAX™, complete the vaccination course with COVOVAX™. Paediatric population The safety and efficacy of SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine in children aged less than 12 years have not yet been established. No data are available. Elderly population No dose adjustment 65 years of age. Method of administration COVOVAX™ is intended for Intramuscular (IM) injection only, preferably in the deltoid muscle. For instructions on administration,see section 6.6. 4.3 Contraindications Hypersensitivitytothe activesubstance orto anyof theexcipients listedinsection 6.1. 4.4 Special warnings and precautions foruse Hypersensitivity and anaphylaxis Events of anaphylaxis have been reported with COVID-19 vaccines. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. SIIPL Version 7.0 Page 2of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Close observation for at least 15minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of COVOVAX™. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or on with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur at the injection site following an intramuscular administration in these individuals. Immunocompromised individuals The efficacy, safety, and immunogenicity of the SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine has been assessed in a limited number of immunocompromised individuals. The efficacy of COVOVAX™may be lower in immunosuppressed individuals. Duration of protection The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. Limitations of vaccine effectiveness Individuals may not be fully protected until 7days after their second dose. As with all vaccines, vaccination with COVOVAX™may not protect all vaccine recipients. Excipients Sodium This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. SIIPL Version 7.0 Page 3of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Potassium This vaccine contains potassium, less than 1mmol (39mg) per 0.5mL, that is to say, essentially ‘potassium-free’. 4.5 Interaction with othermedicinal products and otherforms of interaction Co-administration of SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. The clinical significance of this is unknown. Concomitant administration of SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine with other vaccines has not been studied. 4.6 Fertility,pregnancy and lactation Pregnancy There is limited experience with use of SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccinein pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, or post-natal development, see section 5.3. Administration of COVOVAX™in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Breast-feeding It is unknown whether COVOVAX™is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to COVOVAX™is negligible. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3. SIIPL Version 7.0 Page 4of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 4.7 Effects on abilitytodriveand usemachines COVOVAX™ has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. 4.8 Undesirableeffects Overall summary of the safety profile from the Overseas studies: Clinical trial data for the age group : The safety of Nuvaxovid [Novovax SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine]was evaluated from an interim analysis of pooled data from 5 ongoing clinical trials conducted in Australia, South Africa, the United Kingdom, the United States and Mexico. At the time of the analysis, a total of 49,950 participants age 18years and older received at least one dose of Nuvaxovid (n=30,058) or placebo (n=19,892). At the time of vaccination, the median age was 48years (range 18 to 95years). The median duration of follow-up was 70days post-Dose2, with 32,993 (66%) participants completing more than 2months follow-up post-Dose2. Of the pooled reactogenicity data, which includes participants age 18 years and older enrolled in the two phase 3 studies who received at least one dose of Nuvaxovid (n = 19,898) or placebo (n = 10,454), the most frequent adverse reactions were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (15%). Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2days for local events and less than or equal to 1day for systemic events following vaccination. Overall, there was a higher incidence of adverse reactions in younger age groups: the incidence of injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting was higher in adults aged 18 to less than 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose2 than after Dose 1. Licensed inactivated seasonal influenza vaccines were co-administered to participants on the same day as Dose1 of Nuvaxovid(n=217) or placebo (n=214) in the opposite deltoid muscle SIIPL Version 7.0 Page 5of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine of the arm in 431 participants enrolled in an exploratoryPhase3 (2019nCoV-302) sub-study. The frequency of local and systemic adverse reactions in the influenza sub-study population was higher than in the main study population following Dose 1 in both Nuvaxovid and placebo recipients. Tabulated list of adverse reactions Very rare (< 1/10,000), Not known (cannot be estimated from the available data). Table1: Adverse reactions from Nuvaxovid Clinical Trials MedDRA SOC Frequency Adverse reactions General disorders and Very common Injection site paina,injection site administration site tendernessa,fatiguea, malaisea, b conditions Common Injection site rednessa, c, injection site swellinga, pyrexiaa, chills, pain in extremity Uncommon Injection site pruritis Nervous system disorders Very common Headache Musculoskeletal and Very common Myalgiaa, arthralgiaa connective tissue disorders Gastrointestinal system Very common Nausea or vomitinga disorders Skin and subcutaneous Uncommon Rash, erythema, pruritus, urticaria tissue disorders Blood and lymphatic Uncommon Lymphadenopathy system disorders a Higher frequencies of these events were observed after the second dose. b This term also included events reported as influenza-like illness. c This term includes both injection site redness and injection site erythema (common). SIIPL Version 7.0 Page 6of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Clinical trial data for the age group 12 to < 18 Years: The safety of Nuvaxovid [Novavax SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine] was evaluated in a Phase 3, multinational, multicenter, randomized, observer- blinded, placebo-controlled study evaluating the efficacy, safety, and immunogenicity of es (US) and Mexico with a pediatric expansion in adolescents 12 to < 18 years of age conducted in the US only (Study 2019nCoV-301). At the time of the analysis, a total of 2,232 adolescent participants received at least one dose of Nuvaxovid (n=1487) or placebo (n=745). At the time of vaccination, the median age was 14 years (range 12to 17years). Median duration of the safety follow-up period after first and second vaccinations were 94 and 71 days, respectively, in the Nuvaxovid group and 93 and 71 days, respectively, in the placebo group. Nuvaxovid was well tolerated with an acceptable safety profile. Reactogenic events were mostly of mild to moderate severity and of a median duration of 1 to 2 days. Tenderness (65.3%) and pain (61%) were the most frequent solicited local adverse events. Muscle pain (34%), headache (30.3%), fatigue (24.2%), and malaise(14.8%) were the most frequent solicited systemic adverse events. Overall, the safety profile of Nuvaxovidwas similar to that seen with placebo, with higher frequencies of unsolicited treatment-related Treatment Emergent Adverse Events (TEAEs) in the Nuvaxovid group, primarily with events consistent with a reactogenic response. Most participants in the 2 treatment groups reported unsolicited TEAEs that were mild in severity. Table 2: Adverse reactions from Nuvaxovid adolescent Clinical Trial (age group 12 to < 18 Years) MedDRA SOC Frequency Adverse reactions General disorders and Very common Injection site pain, injection sitetenderness, administration site fatigue, malaise conditions Common Injection site erythema, injection site swelling, pyrexia Rare Chills Nervous system disorders Very common Headache Musculoskeletal and Very common Myalgia connective tissue Common Arthralgia disorders Gastrointestinal system Very common Nausea or vomiting SIIPL Version 7.0 Page 7of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine MedDRA SOC Frequency Adverse reactions disorders Rare Diarrhoea Metabolism and nutrition Rare Decreased appetite disorders Blood and lymphatic Uncommon Lymphadenopathy system disorders Overall summary of the safety profile from the Indian study: Adult cohort : COVOVAX™ was safe and well tolerated in the phase 2/3 clinical trial in India. In the Phase 2 part (n=200), 200 adults received COVOVAX™ or Placebo in 3:1 ratio. During 14 day follow up post-second dose, there were no causally related serious adverse events (SAEs) reported. In the Phase 3 part (n=1396), participants received COVOVAX™ or Novavax SARS-CoV-2 rS Protein Nanoparticle Vaccine (Novavax vaccine) in 3:1 ratio [1046 in COVOVAX™ group and 350 in Novavax SARS-CoV-2 rS Protein Nanoparticle Vaccine (Novavax vaccine) group]. All 1396 participants received the first dose while 1375 participants received the second dose. An interim analysis included data collected until Day 36 visit (14 days after second dose) of all 1396 participants. Demographic characteristics were generally similar among participants across both the groups. Overall, the incidence of solicited reactions (injection site reactions: pain, tenderness, erythema, swelling and induration; and systemic reactions: fever, headache, fatigue, malaise, arthralgia, myalgia, nausea and vomiting), unsolicited adverse events and serious adverse events (SAEs) was comparable in the study and control groups. Among 1396 participants who received the first dose, a total of 5 SAEs in 5 (0.4 %) participants were reported; in 3(0.3%) participants in COVOVAX™group and in 2(0.6%) participants in Novavax vaccine group. The SAEs in the COVOVAX™ group included pyrexia, limb crushing injury, and joint effusion (1 participant each). The SAEs in the Novavax vaccine group included dengue fever and retinal vein occlusion reported in 1 participant each. All SAEs were assessed as not related to study vaccine. All SAEs resolved without any sequelae except for event of limb crushing injury which was ongoing at the time of data cut off. Table 3: Adverse drug reactions from COVOVAX™ study in India (Data until Day 36 visit) MedDRA SOC Frequency Adverse reactions Gastrointestinal disorders Common Nausea Uncommon Vomiting General disorders and Very common Injection site pain, pyrexia SIIPL Version 7.0 Page 8of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine administration site conditions Common Injection site tenderness,injection site erythema, injection site swelling, injection site induration, fatigue,pain, malaise Uncommon Asthenia, chills,injection site pruritus, injection site rash Musculoskeletal and Common Myalgia, arthralgia connective tissue disorders Uncommon Pain in extremity, back pain Nervous system disorders Very common Headache Rare Dizziness, somnolence Skin and subcutaneous tissue Rare Pruritus disorders Pediatric cohort (12 to 17 yearsof age): This is a Phase 2/3, observer-blind, randomized, controlled study in Indian children 2 to 17 years of age, to evaluate the safety and immunogenicity of COVOVAX. A total of 460 children of 12 to 17 years of age received the first dose of study vaccine (346 COVOVAX and 114 Placebo) and 445 received the second dose of study vaccine (335 COVOVAX and 110 Placebo). Demographic characteristics were generally similar among participants across both the groups. COVOVAX was well tolerated with an acceptable safety profile. The local and systemic solicited events were mostly of mild severity with median duration of 1 to 2 days. Pain (36.4%) and tenderness (11.3%) were the most frequent solicited local adverse events. Fever (22.5%), headache (18.8%), fatigue (14.2%), and malaise (9.2%) and were the most frequent solicited systemic adverse events. Table 4: Adverse drug reactions in pediatric cohort (12 to 17 years of age) from COVOVAX™study in India (Data until Day 36 visit) MedDRA SOC Frequency Adverse reactions General disorders and Very common Injection site pain, injection sitetenderness, administration site conditions fatigue, pyrexia Common Injection site erythema, injection site swelling, injection site induration,malaise Nervous system disorders Very common Headache Musculoskeletal and connective Common Myalgia,Arthralgia tissue disorders Gastrointestinal system disorders Common Nausea,vomiting SIIPL Version 7.0 Page 9of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 4.9 Overdose No case of overdose has been reported. In the event of an overdose, monitoring of vital functions and possible symptomatic treatmentis recommended. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamicproperties Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX03 Mechanism of action COVOVAX™ is composed of purified full-length SARS-CoV-2 recombinant spike (S) protein that is stabilised in its prefusion conformation. The addition of the saponin-based Matrix-M1 adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. Efficacy data from the Overseas studies: The clinical efficacy, safety, and immunogenicity of Nuvaxovid [Novovax SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine] is being evaluated in two pivotal, placebo- controlled, Phase3 studies, Study1 (2019nCoV-301) conducted in North America and Study2 (2019nCoV-302) conducted in the United Kingdom, and a Phase 2a/b study, Study 3, conducted in South Africa. Study1 (2019nCoV-301) Study1 is an ongoing Phase3, multicentre, randomised, observer-blinded, placebo- controlled study in participants 18 years of age and older in United States and Mexico. Upon enrolment, participants were stratified by age (18to 64 65 years) and assigned in a 2:1 ratio to receive Nuvaxovid or placebo. The study excluded participants who were significantly immunocompromised due to immunodeficiency disease; active cancer on chemotherapy; received chronic immunosuppressive therapy or received immunoglobulin or blood-derived products within 90days; were pregnant or breastfeeding; or had a history of laboratory-confirmed diagnosed COVID-19. Participants with clinically stable underlying comorbidity were included as were participants with well-controlled HIV infection. Enrolment of adults completed in February 2021. Participants will be followed for up to SIIPL Version 7.0 Page 10of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 24months after the second dose for assessments of safety, and efficacy against COVID-19. Following collection of sufficient safety data to support application for emergency use authorisation, initial recipients of placebo were invited to receive two injections of Nuvaxovid 21 days apart and initial recipients of Nuvaxovid to receive two injections of placebo 21 days apart (“blinded crossover”). All participants were offered the opportunity to continue to be followed in the study. The primary efficacy analysis population (referred to as the Per-Protocol Efficacy [PP- EFF] analysis set) included 25,452 participants who received either Nuvaxovid (n=17,312) or placebo (n=8,140), received two doses (Dose 1 on day0; Dose2 at days 21, median 21 days[IQR 21-23]. Range 14-60), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7days after the second dose. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and those who received placebo. In the PP-EFF analysis set for participants who received Nuvaxovid, the median age was 47years (range: 18 to 95years); 88% (n=15,264) were 18 to 64years old and 12% (n=2,048) were aged 65 and older; 48% were female; 94% were from the United States and 6% were from Mexico; 76% were White, 11% were Black or African American, 6% were American Indian (including Native Americans) or Alaskan Native, and 4% were Asian; 22% were Hispanic or Latino. At least one pre-existing comorbidity or lifestyle characteristic associated with an increased risk of severe COVID-19 was present in 16,493 (95%) participants. Comorbidities included: obesity (body mass in 30 kg/m2); chronic lung disease; diabetes mellitus type2, cardiovascular disease; chronic kidney disease; or human immunodeficiency virus (HIV). Other high-risk years with or without comorbidities or age <65 years with comorbidities and/or living or working conditions involving known frequent exposure to SARS-CoV-2 or to densely populated circumstances. COVID-19 cases were confirmed by polymerase chain reaction (PCR) through a central laboratory. Vaccine efficacy is presented in Table 5. SIIPL Version 7.0 Page 11of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Table 5: Vaccine efficacy against PCR-confirmed COVID-19 with onset from 7days after second vaccination1 -PP-EFF analysis set; Study 2019nCoV-301 Nuvaxovid Placebo Incidence Incidence % Rate Per Rate Per Vaccine Partici- COVID- Year Per Partici- COVID- Year Per Efficacy Subgroup pants 19 cases 1,000 pants 19 cases 1,000 N n (%)2 People2 n (%)3 People2 (95% CI) N Primary efficacy endpoint All 17,312 14 (0.1) 3.26 8,140 63 (0.8) 34.01 90.4% participants (82.9, 94.6)3,4 1VE evaluated in participants without major protocol deviation who are seronegative(for SARS-CoV-2)at baselineand do not have a laboratory confirmed current SARS-CoV-2 infection with symptom onset up to 6 days after the second dose, and who have received the full prescribed regimen of trial vaccine. 2 Mean disease incidence rate per year in 1,000 people. 3 Based on log-linear model of PCR-confirmed COVID-19 infection incidence rate using Poisson regression with treatment group and age strataas fixed effects and robust error variance, where VE=100×(1 –relative risk) (Zou 2004). 4 Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30% at the planned primary confirmatory analysis Vaccine efficacy of Nuvaxovid to prevent the onset of COVID-19 from seven days after Dose2 was 90.4% (95% CI 82.9 – 94.6). No cases of severe COVID-19 were reported in the 17,312 Nuvaxovid participants compared with 4cases of severe COVID-19 reported in the 8,140 placebo recipients in the PP-EFF analysis set. Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates for male and female participants and racial groups, and across participants with medical comorbidities associated with high risk of severe COVID-19. There were no meaningful differences in overall vaccine efficacy in participants who were at increased risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. 30kg/m2, chronic lung disease, diabetes mellitus type2, cardiovascular disease, and chronic kidney disease). Efficacy results reflect enrolment that occurred during the time period when strains classified as Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. Sequencing data were available for 61 of the 77 endpoint cases (79%). Of these, 48 out of 61 (79%) were identified as Variants of Concern or Variants of Interest. The most common Variants of Concern identified were: Alpha with 31/61 cases (51%), Beta (2/61, 4%) and Gamma (2/61, 4%), while the most common Variants of Interest were Iota with 8/61 cases (13%), and Epsilon (3/61, 5%). SIIPL Version 7.0 Page 12of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Study1 (2019nCoV-301), Pediatric Expansion The pediatric expansion of Phase 3 study in USA (reported above) in adolescent participants 12 to < 18 years of age randomized in a 2:1 ratio to receive 2 intramuscular (IM) injections of Nuvaxovid (5 µg SARS-CoV-2 rS co formulated with 50 µg Matrix M1 adjuvant) or placebo (normal saline) 21 days apart. All participants completed their initial vaccination period. A planned analysis of efficacy, safety, and immunogenicity (including effectiveness) results was conducted after all pediatric participants were followed for a median of 60 days after second vaccination. A two-dose regimen of Nuvaxovid, administered 21 (+7 days) days apart, markedly increased serum anti-S IgG antibodies, hACE2 receptor binding inhibition antibodies, and neutralizing antibody levels relative to placebo at 2 weeks following second vaccination. The observed vaccine efficacy of Nuvaxovid against PCR-confirmed, symptomatic mild, moderate or severe COVID-19 in the Per-Protocol Efficacy population was 79.54% (95% CI: 46.83, 92.13). Table 6: Vaccine Efficacy against PCR-Confirmed Symptomatic COVID 19 with Onset from at Least 7 Days after Second Vaccination in Baseline Serologically Negative/PCR-negative Adolescent Participants (PP EFF Analysis Set) NVX-CoV2373 Placebo Parameter N = 1205 N = 594 Participants with occurrence of event1, n (%) 6 (0.5) 14 (2.4) Log-linear model using modified Poisson regression2 Mean disease incidence rate per year in 100 people 2.90 14.20 95% CI 1.31, 6.46 8.42, 23.93 Vaccine efficacy (%) 79.54 95% CI 46.83, 92.13 Abbreviations: CI = confidence interval; COVID-19 = coronavirus disease 2019; NVX- -CoV-2 rS -M1 adjuvant; PCR= polymerase chain reaction; PP-EFF = Per-Protocol Efficacy; SARS-CoV-2 rS = severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine; VE = vaccine efficacy. 1. Event = first occurrence of PCR-confirmed mild, moderate, or severe COVID-19 with onset of illnessepisode from at least 7 days after second vaccination within the surveillance period. 2. Modified Poisson regression with logarithmic link function, treatment group, and strata as fixed effects and robust error variance [Zou 2004]. Study2 (2019nCoV-302) Study2 is an ongoing Phase3, multicentre, randomised, observer-blinded, placebo-controlled study in participants 18 to 84 years of age in the United Kingdom. Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. The study excluded participants who were significantly immunocompromised due to immunodeficiency disease; current diagnosis or treatment for cancer; autoimmune disease/condition; received chronic SIIPL Version 7.0 Page 13of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine immunosuppressive therapy or received immunoglobulin or blood-derived products within 90days; bleeding disorder or continuous use of anticoagulants; history of allergic reactions and/or anaphylaxis; were pregnant; or had a history of laboratory-confirmed diagnosed COVID-19. Participants with clinically stable disease, defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 4 weeks before enrolment were included. Participants with known stable infection with HIV, hepatitis C virus (HCV), or hepatitis- B virus (HBV) were not excluded from enrolment Enrolment was completed in November 2020. Participants are being followed for up to 12 months after the primary vaccination series for assessments of safety and efficacy against COVID-19. The primary efficacy analysis set (PP-EEF) included 14,039 participants who received either Nuvaxovid (n= 7,020) or placebo (n= 7,019), received two doses (Dose 1 on day0; Dose 2 at median 21days), (IQR 21-23), range 16-45, did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 56.0 years (range: 18 to 84 years); 72% (n=5,067) were 18 to 64 years old and 28% (n=1,953) were aged 65 to 84; 49% were female; 94% were White; 3% were Asian; 1% were multiple races, < 1% were Black or African American; and < 1% were Hispanic or Latino; and 45% had at least one comorbid condition. Table 7: Vaccine efficacy analysis of PCR-confirmed COVID-19 with onset at least 7days after the second vaccination -(PP-EFF population): Study 2 (2019nCoV-302) Nuvaxovid Placebo Incidence Incidence Subgroup Rate Per Rate Per Partici- COVID- Year Per Partici- COVID- Year Per % Vaccine Efficacy pants 19 cases 1,000 pants 19 cases 1,000 People1 (95% CI) N n (%) People1 N n (%) Primary efficacy endpoint All 89.7%(80.2,94.6)2, 7,020 10 (0.1) 6.53 7,019 96 (1.4) 63.43 participants 3 Subgroup analyses of the primary efficacy endpoint 18 to 64 years of 5,067 9 (0.2) 12.30 5,062 87 (1.7) 120.22 89.8%(79.7,94.9)2 age 65 to 84 1,953 1 (0.10)2 --- 1,957 9 (0.9)2 --- 88.9% SIIPL Version 7.0 Page 14of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Nuvaxovid Placebo Incidence Incidence Subgroup Rate Per Rate Per Partici- COVID- Year Per Partici- COVID- Year Per % Vaccine Efficacy pants 19 cases 1,000 pants 19 cases 1,000 People1 (95% CI) N n (%) People1 N n (%) years of (20.2,99.7)4 age 1 Mean disease incidence rate per year in 1000 people. 2 Based on Log-linear model of occurrence using modified Poisson regression with logarithmic link function, treatment group and strata (age-group and pooled region) as fixed effects and robust error variance [Zou 2004]. 3 Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30% efficacy has been confirmed at the interim analysis. 4 Based on the Clopper-Pearson model (due to few events), 95% CIs calculated using the Clopper-Pearson exact binomial method adjusted for the total surveillance time. These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. Identification of the Alpha variant was based on S gene target failure by PCR. Data were available for 95 of the 106 endpoint cases (90%). Of these, 66 out of 95 (69%) were identified as the Alpha variant with the other cases classified as non-Alpha. No cases of severe COVID-19 were reported in the 7,020 Nuvaxovid participants compared with 4 cases of severe COVID-19 reported in the 7,019 placebo recipients in the PP-EFF analysis set. Licensed seasonal influenza vaccine co-administration sub-study Overall, 431 participants were co-vaccinated with inactivated seasonal influenza vaccines; 217 sub-study participants received Nuvaxovid and 214 received placebo. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. In the per-protocol immunogenicity (PP-IMM) analysis set for participants who received Nuvaxovid (n = 191), median age was 40 years (range: 22 to 70 years); 93% (n = 178) were 18 to 64 years old and 7% (n = 13) were aged 65 to 84, 43% were female; 75% were White; 23% were multiracial or from ethnic minorities; and 27% had at least one comorbid condition. Co- administration resulted in no change to influenza vaccine immune responses as measured by hemagglutination inhibition (HAI) assay. A 30% reduction in antibody responses to Nuvaxovid was noted as assessed by an anti-spike IgG assay with seroconversion rates similar to participants who did not receive concomitant influenza vaccine. (see section 4.5 and section 4.8). Study 3 (2019nCoV-501) Study 3 is an ongoing Phase 2a/b, multicentre, randomised, observer-blinded, placebo-controlled study in HIV-negative participants 18 to 84 years of age and people living with HIV (PLWH) 18 to 64 years of age in South Africa. PLWH were medically stable (free of opportunistic infections), receiving highly active and stable antiretroviral therapy, and having an HIV-1 viral load of < 1000 SIIPL Version 7.0 Page 15of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine copies/mL. Enrolment was completed in November 2020. The primary efficacy analysis set (PP-EFF) included 2,770 participants who received either Nuvaxovid (n = 1,408) or placebo (n = 1,362), received two doses (Dose 1 on day 0; Dose 2 on day 21), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 28 years (range: 18 to 84 years); 40% were female; 91% were Black/African American; 2% were White; 3% were multiple races, 1% were Asian; and 2% were Hispanic or Latino; and 5.5%were HIV-positive. These results reflect enrolment that occurred during the time period when the B.1.351 (Beta) variant was circulating in South Africa. Elderly population Nuvaxovid was assessed in individuals 18 years of age and older. The efficacy of Nuvaxovid was consistent betwe 65 years) and younger individuals (18 to 64 years). Immunogenicitydatafrom theIndian study: Adult cohort 18 years of age): This is a Phase 2/3, multicenter, randomized, observer-blinded, placebo-controlled study in participants 18 years of age and older in India. A total of 1596 were enrolled in the study and received at least one dose of the study vaccine. Safety was assessed in all 1596 participants while immunogenicity was assessed in 458 participants. The demographic and baseline characteristics between the groups were comparable. Among 1596 participants, there were 1563participants (97.9%) between 18 to 59 years of age and remaining 33 (2.1%) Of these 954 were males (59.8%) and 642 were females (40.2%). The median age was 33 years with a range of 18 to 81 years, median BMI was 24.2 kg/m2. Of these 1596 participants, 198 participants (12.4%) had comorbidities at baseline. Comorbidities included obesity (BMI 30), diabetes mellitus, hypertension, cardiovascular disorders, dyslipidaemia, hyperthyroidism, hypothyroidism, asthma,chronic obstructive pulmonary disease etc. Geometric Mean ELISA Units (GMEUs) of IgG antibodies against spike (S) protein were comparable between the groups at baseline – Day 1. GMEUs increased significantly after each SIIPL Version 7.0 Page 16of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine dose of vaccine in both the groups and were comparable. There was > 92% seroconversion in both the groups on Day 36 (14 days after second dose). The immunogenicity data indicates that COVOVAX™ is comparable in terms of anti-S IgG antibody titers and seroconversion rates to Novavax vaccine (see Tables 8and 9). Table 8:Summary of anti-S IgG antibodies COVOVAX™ Novavax vaccine Timepoint Statistic (N=340) (N=110) n (%) n (%) Baseline N 340 110 GMEU 2172.3 1708.6 95% CI (1799.8, 2621.8) (1230.7, 2372.2) 21(+7)days after Dose 1 N 340 110 GMEU 38350.9 34603.6 95% CI (33043.7, 44510.4) (26002.6, 46049.5) 14(+7)daysafter Dose 2 N 338 109 GMEU 143506.4 152276.9 95% CI (133203.2, 154606.7) (132441.4, 175083.1) Table 9: Summary of proportion of participants with seroconversion for anti-S IgG antibodies Timepoint Statistic COVOVAX™ Novavax vaccine (N=340) (N=110) n (%) n (%) 21(+7)days after Dose 1 N Evaluated 340 110 Seroconversion, n (%) 281 (82.6) 92 (83.6) 95% CI (78.2, 86.5) (75.4, 90.0) 14(+7)daysafter Dose 2 N Evaluated 338 109 Seroconversion, n (%) 314 (92.9) 105 (96.3) 95% CI (89.6, 95.4) (90.9,99.0) SIIPL Version 7.0 Page 17of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Pediatric cohort (12 to 17 yearsof age): This is a Phase 2/3, observer-blind, randomized, controlled study in Indian children 2 to 17 years of age, to evaluate the safety and immunogenicity of COVOVAX.A total of 460 children of 12 to 17 years of age were enrolled in the study and received at least one dose of the study vaccine. Safety and immunogenicity was assessed in all participants. Of these 241 were males (52.4%) and 219 were females (47.6%). The median age was 14 years with a range of 12 to 17 years, median BMI was 18.7 kg/m2.None of the participants had anycomorbid condition. GMEUs of anti-S IgG antibodies were comparable between the groups at baseline – Day 1. GMEUs increased substantially after each dose of the vaccine in the COVOVAX group and no response was seen in the Placebo group. There was > 98% seroconversion in the COVOVAX group on Day 36 (14 days after the second dose). The immunogenicity data indicates that COVOVAX™ is highly immunogenic in the children of 12 to 17 years of age (see Tables 10 and 11). Table 10: Summary of anti-S IgG antibodies COVOVAX™ Placebo Timepoint Statistic (N=333) (N=108) n (%) n (%) Baseline N 333 108 GMEU 1664.2 1366.6 95% CI (1413.7, 1959.1) (1033.1, 1807.8) 21(+7)days after Dose 1 N 332 108 GMEU 72660.4 1614.6 95% CI (63586.3, 83029.4) (1174.7, 2219.3) 14(+7)daysafter Dose 2 N 330 107 GMEU 170193.6 1480.4 95% CI (157429.7,183992.4) (1110.1, 1974.3) SIIPL Version 7.0 Page 18of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Table 11: Summary of proportion of participants with seroconversion for anti-S IgG antibodies Timepoint Statistic COVOVAX™ Placebo (N=333) (N=108) n (%) n (%) 21(+7)days after Dose 1 N Evaluated 332 108 Seroconversion, n (%) 317(95.5) 4(3.7) 95% CI (92.7, 97.4) (1.0, 9.2) 14(+7)daysafter Dose 2 N Evaluated 330 107 Seroconversion, n (%) 326 (98.8) 3 (2.8) 95% CI (96.9, 99.7) (0.6, 8.0) 5.2 Pharmacokineticproperties Not applicable. 5.3 Preclinical safety data Non-clinical data reveal no special hazards for humans based on conventional studies of repeat dose toxicity, local toleranceand reproductive and developmental toxicity. Genotoxicity and Carcinogenicity: In vitro genotoxicity studies were conducted with the novel Matrix-M1 adjuvant and the adjuvant was shown to be non-genotoxic. Carcinogenicity studies were not performed. Carcinogenicity is not expected. Reproductive toxicity: A developmental and reproductive toxicity study was performed in female rats administered four intramuscular doses (two prior to mating; two during gestation) of 5 µg SARS-CoV-2 rS protein (approximately 200-fold excess relative to the human dose of 5µg on a weight-adjusted basis) with 10 µg Matrix-M1 adjuvant (approximately 40-fold excess relative to the human dose of 50µg on a weight-adjusted basis). No vaccine-related adverse effects on fertility, pregnancy/lactation, or development of the embryo/fetus and offspring through post-natal Day 21 were observed. SIIPL Version 7.0 Page 19of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 6 PHARMACEUTICAL PARTICULARS 6.1 Listof Excipients The excipients used in the manufacturingof COVOVAX™ are listed below: AdjuvantMatrix-M1 Disodium hydrogenphosphate heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride Polysorbate 80 Water for Injections 6.2 Incompatibilities In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products, vaccines or diluted. 6.3 Shelf-life Unopened vial The expiry date of vaccine is indicated on the label and packaging. Once opened (first needle puncture) multi-dose vials should be used as soon as practically possible and within 6 hours when kept between +2ºC and +25ºC.All opened (punctured) multidose vials of COVOVAX™should be discarded at the end of immunization session or six hours afterthefirst needle puncture, whichever comes first. 6.4 Special Precautions forStorage Store in a refrigerator (+2ºC to +8ºC). Do not freeze. Keep vials in outer carton to protect from light. Opened multidose vial (afterthefirst use) For storage conditions afterthefirst opening of the medicinal product, see section 6.3. 6.5 Natureand Contents of Container COVOVAX™is supplied as ready to use liquid in rubber-stoppered single and multidose vial in below listed presentations 1-dose-0.5 mL per vial 2-doses -1.0 mL per vial SIIPL Version 7.0 Page 20of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine 10-doses -5.0 mL per vial 20-doses -10 mL per vial Not all pack sizes may be marketed. 6.6 Instructions forUse,Handlingand Disposal Administration: COVOVAX™ is a Colourless to slightly yellow, clear to mildly opalescent, free to practically free from visible particles. The vaccine should be discarded if particulate matter or differences in the described appearance are observed. Do not shake the vial. Each vaccine dose of 0.5 mLis withdrawn into a syringe for injection to be administered intramuscularly. Use a separate sterile needle and syringe for each individual. It is normal for liquid to remain in the vial after withdrawing the final dose. When low dead volume syringes and/or needles are used, the amount remaining in the vial may be sufficient for an additional dose. Care should be taken to ensure a full 0.5 mLdose is administered. Where a full 0.5 mLdose cannot be extracted, the remaining volume should be discarded. Do not pool excess vaccine from multiple vials. The vaccine does not contain any preservative. Aseptic technique should be used for withdrawing the dose for administration. After the first opening, multi-dose vials should be used as soon as practically possible and within 6 hours when kept between +2ºC and +25ºC. Discard any unused vaccine. To facilitate the traceability of the vaccine, the name and the batch number of the administered product must be recorded for each recipient. Disposal Any unused vaccine or waste material should be disposed of in accordance with local requirements. 7 MARKETINGAUTHORIZATION Manufactured by: Serum Institute of India Pvt. Ltd. 212/2, Hadapsar, Pune 411028, India. Serum Institute of India Pvt. Ltd. S. No. 105-110, Manjari Bk.,Pune 412307, India. SIIPL Version 7.0 Page 21of 22SUMMARY OF PRODUCT CHARACTERISTICS/ PACKAGE INSERT SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine Marketed by: Serum Institute Life Sciences Pvt. Ltd. 401, Sarosh Bhavan, 16-B/1, Dr. Ambedkar Road, Pune -411 001, INDIA 8 MARKETINGAUTHORISATION NUMBER(S) Permission in Form CT-23 (Permission No. MF/BIO/21/000138) for Manjari premises Permission in Form CT-23 (Permission No. MF/BIO/21/000137) for Hadapsarpremises 9 DATE OF FIRST AUTHORISATION/ RENEWAL OFTHE AUTHORISATION 28December 2021 Date Updated: February 2022 SIIPL Version 7.0 Page 22of 22FACT SHEET FOR VACCINE RECIPIENT APPROVED FOR RESTRICTED USE IN EMERGENCY SITUATION OF SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine COVOVAX™ This vaccine has been given restricted use in emergency situation for prevention of COVID-19. It does not have a marketing authorization, however, this approval for the restricted use in emergency situation grants permission for the vaccine to be used for active immunization of individuals aged 12 years and older for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 12 years of age and older. Reporting of side effects As with any new medicine, this vaccine will be closely monitored to allow quick identification of new safety information. You can help by reporting any side effects, you may get after vaccination to the Serum Institute of India Pvt Ltd who is the manufacturer of COVOVAX™ vaccine on 24 x 7 Toll-Free Number: 1800 1200124 or at pharmacovigilance@seruminstitute.com. For more information read this fact sheet carefully. You are being offered the Serum Institute of India Pvt. Ltd. (SIIPL) COVOVAX™ Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of the COVOVAX™ Vaccine, which you may receive because there is currently a pandemic of COVID-19. The COVOVAX™ is a vaccine and may prevent you from getting COVID-19 disease. Read this Fact Sheet for information about the COVOVAX™ Vaccine. Talk to the healthcare provider / doctor if you have questions. It is your choice to receive the COVOVAX™ Vaccine. The COVOVAX™ vaccination course consists of two separate doses of 0.5 mL each. The second dose should be administered at 3 weeks after the first dose. For intramuscular (IM) injection only. The COVOVAX™ may not protect everyone. Version 3.0, 26.02.2022 Page 1 of 7WHAT YOU NEED TO KNOW BEFORE YOU GET THIS VACCINE WHAT IS COVID-19? COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea. WHAT IS THE SIIPL COVOVAX™ VACCINE? The COVOVAX™ vaccine is approved for restricted use in emergency situation that may prevent COVID-19 caused by a coronavirus called SARS-CoV-2 in individuals 12 years of age and older. WHAT SHOULD YOU MENTION TO YOUR HEALTHCARE PROVIDER / DOCTOR BEFORE YOU GET COVOVAX™ VACCINE? Tell the healthcare provider / doctor about all of your medical conditions, including: • If you have ever had a severe allergic reaction (anaphylaxis) after any drug, food, any vaccine or any ingredients of COVOVAX™ vaccine • If you have fever • If you have a problem with bleeding or bruising, or if you are taking a blood thinning medicines (anticoagulant) • If you have a problem with liver related disorder and/or inflammation of the gall bladder • If your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines) • If you are pregnant or plan to become pregnant • If you are breastfeeding • If you have received another COVID-19 vaccine If you have any of the above conditions, you should consult your healthcare provider / doctor before deciding to take the vaccine. Vaccination in patients with bleeding disorders or receiving a blood thinning medicine (anticoagulants): As with other intramuscular injections, COVOVAX™ should be given with caution to individuals with a problem with bleeding or bruising, or those taking a blood thinning medicine (anticoagulant) because bleeding or bruising may occur following an intramuscular injection in these individuals. Version 3.0, 26.02.2022 Page 2 of 7A fine-gauge needle (23-gauge or smaller caliber) should be used for the vaccination in such individuals, followed by firm pressure on the injection site, without rubbing, for at least 2 minutes. If possible, vaccination could be scheduled prior to the use of these medications, so that the patients’ risk of bleeding is not increased by their therapeutic action. Patients with weak immune system or receiving immunosuppressive medicines: Currently limited amount of data are available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. People with weakened immune systems due to other illnesses or medications might be at increased risk for severe COVID -19. They may receive COVOVAX™. However, people with weakened immune systems should also be aware of the potential for reduced immune responses to COVOVAX™, as well as the need to continue following all current guidance to protect themselves against COVID-19 (see below). WHO SHOULD GET THE COVOVAX™ VACCINE? COVOVAX™ Vaccine has been authorized for restricted use in emergency situation in individuals 12 years of age and older caused by SARS-CoV-2. WHO SHOULD NOT GET THE COVOVAX™ VACCINE? You should not get the COVOVAX™ Vaccine if you have ever had a serious allergic reaction (including anaphylaxis) to: o a previous dose of COVOVAX™ o any ingredient of COVOVAX™ (listed below) If you are not sure, talk to your doctor, pharmacist or nurse. Signs of an allergic reaction may include pain at injection site and/or tenderness, fatigue, malaise, swelling at injection site, pyrexia, chills, headache, nausea or vomiting. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. It might get worsen if not treated immediately. People with a history of severe allergic reactions not related to vaccines or injectable medications such as food, pets, environmental, or latex allergies may get vaccinated. People with a history of allergies to oral medications or a family history of severe allergic reactions may also get vaccinated. Version 3.0, 26.02.2022 Page 3 of 7WHAT ARE THE INGREDIENTS IN THE COVOVAX™ VACCINE? The COVOVAX™ Vaccine includes the following ingredients: SARS-CoV-2 rS Protein DS Adjuvant Matrix-M1 Disodium hydrogen phosphate heptahydrate Sodium dihydrogen phosphate monohydrate Sodium chloride Polysorbate 80 Water for injections HOW IS THE COVOVAX™ GIVEN? The COVOVAX™ Vaccine will be given to you as an intramuscular (IM) injection only, preferably in the deltoid muscle. The COVOVAX™ vaccination course consists of two separate doses of 0.5 mL each. If you receive one dose of the COVOVAX™ vaccine, then the second dose should be administered at 3 weeks after the first dose. If you miss your second dose If you forget to go back at the scheduled time, ask your healthcare provider / doctor for advice. It is important that you return for your second dose of COVOVAX™ vaccine. HAS THE COVOVAX™ VACCINE BEEN USED BEFORE? The COVOVAX™ is used in clinical trials, a large number of participants received two doses in clinical studies. WHAT ARE THE BENEFITS OF THE COVOVAX™ VACCINE? In ongoing clinical trials, the COVOVAX™ Vaccine has been shown to prevent COVID-19 following 2 doses given between 3 weeks apart. The duration of protection against COVID-19 disease is currently unknown. Protection against COVID-19 starts from approximately 7 days after the second dose of COVOVAX™. Individuals may not be fully protected until 7 days after the second dose is administered. However, please note that as with any vaccine, COVOVAX™ may not protect everyone who is vaccinated from COVID-19. WHAT ARE THE RISKS OF THE COVOVAX™ VACCINE? Like all medicines, this vaccine can cause side effects, although not everybody gets them. Version 3.0, 26.02.2022 Page 4 of 7Get urgent medical attention from your doctor if you get symptoms of a severe allergic reaction. Such reactions may include a combination of any of the following symptoms: feeling faint or light-headed pain in a muscle or group of muscles physical discomfort swelling and extreme pain at injection site After vaccination, you may have more than one side effect at the same time. If any of your symptoms are persistent, please seek advice from your healthcare provider / doctor. Side effects that have been reported with the COVOVAX™ Vaccine include: Very Common (may affect more than 1 in 10 people) Injection site pain Injection site tenderness Feeling tired (fatigue) Malaise Headache Fever Soreness of muscles Joint pain Nausea or vomiting Common (may affect up to 1 in 10 people) Chills Injection site redness Injection site swelling Injection site induration (hardness) Pain in extremity (legs or arms) Body ache Uncommon (may affect up to 1 in 100 people) Asthenia (weakness or lack of energy) Injection site pruritus (itching) Injection site rash Rash Skin redness Itching Hives Enlarged lymph nodes Back pain Version 3.0, 26.02.2022 Page 5 of 7Rare Dizziness (feeling dizzy) Sleepiness Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local injection site reactions and less than or equal to 1 day for systemic reactions following vaccination. When compared with Dose 1, local and systemic adverse reactions were more frequently reported after Dose 2. In case you need medical advice, kindly consult your healthcare provider / doctor. These may not be all the possible side effects of the COVOVAX™ Vaccine. Serious and unexpected side effects may occur. If you notice any side effects not mentioned in this leaflet, please inform your healthcare provider / doctor. If you experience unusually high or prolonged fever, or other symptoms, alternative causes should be considered and contact your healthcare provider / doctor to seek further medical advice. WHAT SHOULD I DO ABOUT SIDE EFFECTS? If you experience a severe allergic reaction, call or go to the nearest hospital. Call the healthcare provider / doctor if you have any side effects that bother you or do not go away. In addition, you can report side effects after vaccination to Serum Institute of India Pvt Ltd who is the manufacturer of COVOVAX™ vaccine as below: 24x7 Call Center Toll-Free Number (For Reporting of Adverse Events Only): 1800 1200124 pharmacovigilance@seruminstitute.com WHAT IF I DECIDE NOT TO GET THE COVOVAX™ VACCINE? It is your choice to receive or not receive the COVOVAX™ Vaccine. You may prefer to consult your healthcare provider / doctor. CAN I RECEIVE THE COVOVAX™ VACCINE WITH OTHER VACCINES? There is no information on the use of the COVOVAX™ Vaccine with other vaccines. WHAT IF I AM PREGNANT OR BREASTFEEDING? You may discuss your options with the healthcare provider / doctor. Version 3.0, 26.02.2022 Page 6 of 7WILL THE COVOVAX™ VACCINE GIVE ME COVID-19 INFECTION? No. The COVOVAX™ is spike protein based COVID-19 Vaccine, does not contain SARS-CoV-2 virus and cannot give you COVID-19 infection. KEEP YOUR VACCINATION CARD When you get your dose, please discuss with your healthcare provider / doctor regarding the option of your vaccination record on digital platform, if available. AFTER VACCINATION, DO I NEED TO CONTINUE TAKING PRECAUTIONS TO PREVENT COVID-19 INFECTION? People who get vaccinated should continue to follow all current guidance to protect themselves against COVID-19 after they are vaccinated. That means: Wearing a mask Staying at least six feet away from others Avoiding crowds Washing hands with soap and water or using hand sanitizer HOW CAN I LEARN MORE? • Ask the healthcare provider / doctor. • Contact your local or state public health department. Marketing Authorization Holder & Manufactured by: SERUM INSTITUTE OF INDIA PVT. LTD. Pune, INDIA Prepared: 26 February 2022 Trademark under registration Version 3.0, 26.02.2022 Page 7 of 7