8 COVID-19 vaccines approved in the country as on 22.04.2026 2026-Apr-23 536 KB

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1. COVID-19 vaccines approved for Manufacture for Sale or for Distribution in the country No Vaccine Applicant Date of EUA Date of approval Age group Dosing schedule Route & Storage Shelf Life as on 04.10.2022 1 ChAdOx1 nCoV- 19 Corona Virus Vaccine Recombinant (COVISHIELD) M/s Serum Institute of India Pvt. Ltd. 03.01.2021 27.01.2022 ≥ 18 years Two doses, 4 to 6 weeks apart (Overseas Data available for 12weeks) Intramuscular, 2- 8°C 9 months 2 Whole Virion Inactivated SARS-CoV- 2 Vaccine (COVAXIN) M/s Bharat Biotech International Limited 03.01.2021 27.01.2022 ≥ 18 years Two doses, Day 0 & 28 Intramuscular, 2- 8°C 12 months 3 SARS-CoV-2 vaccine containing Receptor Binding Domain (RBD) of SARS-CoV-2 gene (CORBEVAX) M/s Biological E Limited 28.12.2021 01.07.2025 ≥ 12 years Two doses, Day 0 & 28 Intramuscular, 2- 8°C 12 months 4 COVID-19 Vaccine, Adjuvanted (SARS- CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine, (Omicron JN.1 Variant) with Matrix M1 adjuvant (also denoted as Matrix-M)
   (COVOVAX) M/s Serum Institute of India Pvt. Ltd. 28.12.2021 07.04.2026 ≥ 12 years
   Single dose
   Intramuscular, 2- 8°C 12 months Note: COVISHIELD, COVAXIN, CORBEVAX & COVOVAX vaccines were initially approved for Restricted Use in Emergency Situation in the country on 03.01.2021, 03.01.2021 and 28.12.2021 respectively.

onths Note: COVISHIELD, COVAXIN, CORBEVAX & COVOVAX vaccines were initially approved for Restricted Use in Emergency Situation in the country on 03.01.2021, 03.01.2021 and 28.12.2021 respectively.

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2. COVID-19 vaccines approved for Primary vaccination series for Restricted Use in Emergency Situation in the country

Sr. N o Vaccine Applicant Date of approval Age group Dosing schedule Route & Storage Shelf Life as on 04.10.2022 1 Gam COVID Vac (component I & II) (SPUTNIK-V) M/s Dr. Reddy’s Lab. Ltd. (Importer) 12.04.2021 ≥ 18 years Two doses, Day 0 (comp I) & Day 21 (comp II) Intramuscular, -18°C 12 months 2 mRNA-1273COVID-19 vaccine (Moderna vaccine) M/s Cipla Ltd. (Importer) 29.06.2021 ≥ 18 years Two doses, Day 0 & 28 Intramuscular, -25°C to -15°C 7 months 3 Gam COVID Vac (component I & II) (SPUTNIK-V) M/s Panacea Biotec Ltd 02.07.2021 ≥ 18 years Two doses, Day 0 (comp I) & Day 21 (comp II) Intramuscular, -18°C 12 months 4 COVID-19 vaccine (Ad26.COV2-S) [recombinant] (Janssen Vaccine) M/s Johnson & Johnson Pvt. Ltd.

021 ≥ 18 years Two doses, Day 0 (comp I) & Day 21 (comp II) Intramuscular, -18°C 12 months 4 COVID-19 vaccine (Ad26.COV2-S) [recombinant] (Janssen Vaccine) M/s Johnson & Johnson Pvt. Ltd. (Importer) 07.08.2021 ≥ 18 years Single dose Intramuscular, -25°C to - 15°C &2-8°C 6 months 5 COVID-19 vaccine (Ad26.COV2-S) [recombinant] (Janssen Vaccine) M/s Biological E Limited 18.08.2021 ≥ 18 years Single dose Intramuscular, -25°C to -15°C & 2-8°C 6 months 6 Novel Corona Virus-2019- nCov vaccine (rDNA) (ZyCoV-D) M/s Cadila Healthcare Limited 20.08.2021 ≥ 12 years Three doses Day 0, 28 & 56 Intradermal ,2°-8°C 12 months 7 Gam COVID Vac (component I & II) (SPUTNIK-V) M/s Hetero Biopharma Ltd 07.10.2021 ≥ 18 years Two doses, Day 0 (comp I) & Day 21 (comp II) Intramuscular, -18°C 6 months

Sr. No Vaccine Applicant Date of approval Age group Dosing schedule Route & Storage Shelf Life as on 04.10.2022 8 Whole-Virion Inactivated SARS- CoV-2 Vaccine (COVAXIN) M/s Bharat Biotech International Limited 24.12.2021 ≥ 12 to 18 years Two doses, Day 0 & 28 Intramuscular, 2- 8°C 12 months 26.04.2022

6 to <12 years 9 SARS-CoV-2 vaccine containing Receptor Binding Domain (RBD) of SARS-CoV-2 gene (CORBEVAX) M/s Biological E Limited 26.04.2022 ≥5 to < 12 years Two doses, Day 0 & 28 Intramuscular, 2- 8°C 18 months 10 SARS-CoV-2 rS Protein (COVID-

19. recombinant spike protein Nanoparticle Vaccine (COVOVAX) M/s Serum Institute of India Pvt. Ltd.

Two doses, Day 0 & 28 Intramuscular, 2- 8°C 18 months 10 SARS-CoV-2 rS Protein (COVID- 19) recombinant spike protein Nanoparticle Vaccine (COVOVAX) M/s Serum Institute of India Pvt. Ltd. 28.12.2021 ≥ 18 years Two doses, Day 0 & 21 Intramuscular, 2- 8°C 9 months 08.03.2022 ≥ 12 years 28.06.2022 ≥ 7 to < 12 years 11 Recombinant adenoviral vector vaccine containing particles of serotype 26 containing the protein S gene of the SARS-CoV-2 virus (SPUTNIK Light) M/s Dr. Reddy’s Lab. Ltd. (Importer) 05.02.2022 ≥ 18 years Single dose Intramuscular, -18°C 6 months 12 Recombinant adenoviral vector vaccine containing particles of serotype 26 containing the protein S gene of the SARS-CoV-2 virus (SPUTNIK Light) M/s Hetero Biopharma Ltd 16.03.2022 ≥ 18 years Single dose Intramuscular, -18°C 6 months 13 Novel Corona Virus-2019-nCov vaccine (rDNA) (ZyCoV-D) M/s Cadila Healthcare Limited 26.04.2022 ≥ 12 years Two doses, Day 0 & 28 Intradermal, 2-8°C 9 months 14 Lyophilized mRNA Vaccine for Injection (COVID-19) (HGCO- 19) M/s Gennova Biopharmaceuticals Limited 28.06.2022 ≥ 18 years Two doses, Day 0 & 28 Intramuscular, 2- 8°C 6 months 15 ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant COVID-19 Vaccine (iNCOVACC) M/s Bharat Biotech International Limited 06.09.2022 ≥ 18 years Two doses, Day 0 & 28 Intra Nasal 2-8°C 6 Months

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rus Vectored) recombinant COVID-19 Vaccine (iNCOVACC) M/s Bharat Biotech International Limited 06.09.2022 ≥ 18 years Two doses, Day 0 & 28 Intra Nasal 2-8°C 6 Months

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3. COVID-19 vaccines approved for Booster (third) dose vaccination for Restricted Use in Emergency Situation in the country. Sr. No Vaccine Applicant Date of approval Age group Dosing schedule Route & Storage 1 SARS-CoV-2 vaccine containing Receptor Binding Domain (RBD) of SARS-CoV-2 gene (CORBEVAX) M/s Biological E Limited 03.06.2022 ≥18 years Single dose to be administered 6 months after primary vaccination (two doses) with COVAXIN or COVISHIELD. Intramuscular, 2- 8°C 2 SARS-CoV-2 rS Protein (COVID-

19. recombinant spike protein Nanoparticle Vaccine (COVOVAX) M/s Serum Institute of India Pvt. Ltd. 16.01.2023 ≥ 18 years Single dose to be administered 6 months after primary vaccination
    (two doses) with COVAXIN
    or COVISHIELD. Intramuscular, 2-8°C 3 Novel Corona Virus 2019-nCoV M/s Zydus 20.04.2023 ≥ 18 years Single dose booster (third) dose Intradermal, Vaccine (Recombinant) (3 mg, Lifesciences Limited of Novel Corona Virus 2019-nCoV 2-8°C Single dose) (ZyCoV-D) Vaccine (Recombinant) (3mg, Single dose) to individuals aged ≥18 years after 6 months of primary vaccination (of 2 doses) of either COVAXIN or COVISHIELD.

nCoV 2-8°C Single dose) (ZyCoV-D) Vaccine (Recombinant) (3mg, Single dose) to individuals aged ≥18 years after 6 months of primary vaccination (of 2 doses) of either COVAXIN or COVISHIELD. 4 ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus M/s Bharat Biotech International Limited 24.11.2022 ≥ 18 years To administer booster dose (third dose) after 6 months to individuals Intra Nasal, 2-8°C Vectored) recombinant COVID- 19 Vaccine (iNCOVACC) of age >18 years who have already administered primary (two doses) of COVAXIN or COVISHIELD vaccines 5 Lyophilized mRNA Vaccine for Injection (COVID-19) M/s Gennova Biopharmaceuticals 07.07.2023 ≥ 18 years Single booster dose in individuals aged ≥18 years administered at Intradermal, 2-8°C (GEMCOVAC-OM) Ltd. least 4 months after completion of primary vaccination with either COVISHIELD or COVAXIN.

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