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1.

COVID-19 vaccines approved for Manufacture for Sale or for Distribution in the country

No Vaccine Applicant Date of Date of Age group Dosing schedule Route & Shelf Life as on
EUA approval Storage 04.10.2022
1 ChAdOx1 nCoV- M/s Serum Instituteof 03.01.2021 27.01.2022 ≥ 18 years Two doses, 4 to 6 Intramu 9 months
19 Corona Virus India Pvt. Ltd. weeks apart scular,2-
vaccine (Overseas Data 8°C
Recombinant) available for
(COVISHIELD) 12weeks)
2 Whole-Virion M/s Bharat Biotech 03.01.2021 27.01.2022 ≥ 18 years Two doses, Day 0 Intramu 12 months
Inactivated & 28 scular,2-
SARS-CoV-2 8°C
Vaccine
(COVAXIN)
Note: Both COVISHIELD & COVAXIN vaccines were initially approved for Restricted Use in Emergency Situation in the country on 03.01.2021

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

Sr. Vaccine Applicant Date of Age group Dosing schedule Route & Storage Shelf Life as
N approval on
o 04.10.2022
1 Gam COVID Vac (component I & II) M/s Dr. Reddy’s Lab. 12.04.2021 ≥ 18 years Two doses, Intramuscular, 12 months
(SPUTNIK-V) Ltd. (Importer) Day 0 (comp I) & -18°C
Day 21 (comp II)
2 mRNA-1273COVID-19 vaccine M/s Cipla Ltd. 29.06.2021 ≥ 18 years Two doses, Intramuscular, 7 months
(Moderna vaccine) (Importer) Day 0 & 28 -25ºC to -15ºC
3 Gam COVID Vac (component I & II) M/s Panacea Biotec 02.07.2021 ≥ 18 years Two doses, Intramuscular, 12 months
(SPUTNIK-V) Ltd Day 0 (comp I) & -18°C
Day 21 (comp II)
4 COVID-19 vaccine (Ad26.COV2-S) M/s Johnson & 07.08.2021 ≥ 18 years Single dose Intramuscular, 6 months
[recombinant] (Janssen Vaccine) Johnson Pvt. Ltd. -25ºC to 15ºC
(Importer) &2-8°C
5 COVID-19 vaccine (Ad26.COV2-S) M/s Biological E 18.08.2021 ≥ 18 years Single dose Intramuscular, 6 months
[recombinant] (Janssen Vaccine) Limited -25ºC to -15ºC &
2-8°C

6 Novel Corona Virus-2019-nCov M/s Cadila 20.08.2021 ≥ 12 years Three doses Intradermal 12 months
vaccine (rDNA) (ZyCoV-D) Healthcare Limited Day 0, 28 & 56 ,2-8°C

2|P age
Sr. Vaccine Applicant Date of Age group Dosing schedule Route & Storage Shelf Lifeas
No approval on
04.10.2022
7 Gam COVID Vac (component I & II) M/s Hetero 07.10.2021 ≥ 18 years Two doses, Intramuscular, 6 months
(SPUTNIK-V) Biopharma Ltd Day 0 (comp I) & -18°C
Day 21 (comp II)
8 Whole-Virion Inactivated SARS- M/s Bharat Biotech 24.12.2021 ≥ 12 to 18 years Two doses, Day 0 Intramus 12 months
CoV-2 Vaccine (COVAXIN) & 28 cular,2-
26.04.2022 >6 to <12 years
8°C
9 SARS-CoV-2 vaccine containing M/s Biological E 28.12.2021 ≥ 18 years Two doses, Day 0 Intramus 18 months
Receptor Binding Domain (RBD) Limited 21.02.2022 ≥ 12 years & 28 cular,2-
of SARS-CoV-2 gene (CORBEVAX) 26.04.2022 ≥5 to <12 years 8°C
10 SARS-CoV-2 rS Protein (COVID- M/s Serum 28.12.2021 ≥ 18 years Two doses, Day 0 Intramus 9 months
19) recombinant spike protein Institute of India 08.03.2022 ≥ 12 years & 21 cular,2-
Nanoparticle Vaccine (COVOVAX) Pvt. Ltd. 28.06.2022 ≥ 7 to < 12 years 8°C
11 Recombinant adenoviral vector M/s Dr. Reddy’s Lab. 05.02.2022 ≥ 18 years Single dose Intramuscular, 6 months
vaccine containing particles of Ltd. (Importer) -18°C
serotype 26 containing the protein
S gene of the SARS-CoV-2 virus
(SPUTNIK Light)
12 Recombinant adenoviral vector M/s Hetero 16.03.2022 ≥ 18 years Single dose Intramuscular, 6 months
vaccine containing particles of Biopharma Ltd -18°C
serotype 26 containing the protein
S gene of the SARS-CoV-2 virus
(SPUTNIK Light)
13 Novel Corona Virus-2019-nCov M/s Cadila 26.04.2022 ≥ 12 years Two doses, Intradermal, 9 months
vaccine (rDNA) (ZyCoV-D) Healthcare Limited Day 0 & 28 2-8°C
14 Lyophilized mRNA Vaccine for M/s Gennova 28.06.2022 ≥ 18 years Two doses, Intramuscular, 2- 6 months
Injection (COVID-19) (HGCO- Biopharmaceuticals Day 0 & 28 8°C
19) Limited
15 ChAd36-SARS-CoV-S COVID-19 M/s Bharat Biotech 06.09.2022 ≥ 18 years Two doses, Intra 6 Months
(Chimpanzee Adenovirus Day 0 & 28 Nasal
Vectored) recombinant COVID-19 2-8°C
Vaccine (iNCOVACC)
3|P age
3. COVID-19 vaccines approved for Booster (third) dose vaccination for Restricted Use in Emergency Situation in the
country.
Sr. Vaccine Applicant Date Age group Dosing schedule Route & Storage
No of
appro
val
1 SARS-CoV-2 vaccine containing M/s Biological E 03.06.202 ≥ 18 years Single dose to be administered 6 Intramuscular,
Receptor Binding Domain Limited 2 months after primary vaccination 2-8°C
(RBD) of with COVAXIN & COVISHIELD
SARS-CoV-2 gene (CORBEVAX)
2 SARS-CoV-2 rS Protein (COVID- M/s Serum Institute 16.01.202 ≥ 18 years Single dose to be administered 6 Intramuscular,
19) recombinant spike protein of IndiaPvt. Ltd. 3 months after primary vaccination 2-8°C
Nanoparticle Vaccine with COVAXIN & COVISHIELD
[COVOVAX)
3 Novel Corona Virus 2019-nCoV M/s. Zydus 20.04.202 ≥ 18 years Single dose booster (third) dose Intradermal,
Vaccine (Recombinant) (3 mg, Lifesciences Limited 3 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.
4 ChAd36-SARS-CoV-S COVID-19 M/s Bharat Biotech 24.11.202 ≥ 18 years To administer booster dose (third Intra Nasal ,
(Chimpanzee Adenovirus 2 dose) after 6 months to individuals 2-8°C
Vectored) recombinant COVID- of age >18 years who have already
19Vaccine (iNCOVACC) administered primary (two doses)
of COVAXIN or COVISHIELD
vaccines
5 Lyophilized mRNA Vaccine for M/s Gennova 07.07.202 ≥ 18 years Single booster dose in individuals Intradermal,
Injection (COVID-19) Biopharmaceuticals 3 aged ≥18 years administered at 2-8°C
(GEMCOVAC®-OM) Ltd. least 4 months after completion
of primary vaccination with
either COVISHIELD™ or
COVAXIN®.

4|P age

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