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Date: 2023-07-26 Category: Not Applicable State: Union Government Country: India

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Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification lists COVID-19 vaccines approved for manufacture for sale or distribution in the country, as well as those approved for restricted use in emergency situations.
  • It specifies the vaccine name, applicant (manufacturer/importer), date of approval, age group, dosing schedule, route of administration, storage conditions, and shelf life for each vaccine.

Key Changes

  • Two vaccines, COVISHIELD (manufactured by Serum Institute of India) and COVAXIN (manufactured by Bharat Biotech), were initially approved for restricted use in emergency situations on January 3, 2021, and have now been approved for manufacture for sale or distribution as of January 27, 2022.
  • COVISHIELD requires two doses, 4 to 6 weeks apart, administered intramuscularly, and has a shelf life of 9 months when stored at 2-8°C.
  • COVAXIN requires two doses, administered on Day 0 and Day 28, intramuscularly, and has a shelf life of 12 months when stored at 2-8°C.
  • The gazette also lists 14 vaccines approved for restricted use in emergency situation as of July 8, 2022, including Gam COVID Vac (SPUTNIK-V), mRNA-1273 (Moderna), COVID-19 vaccine (Ad26.COV2-S) (Janssen), ZyCoV-D, CORBEVAX, COVOVAX, SPUTNIK Light and HGCO-19.
  • The age group for COVAXIN has been expanded to include children between 6 to 18 years.
  • CORBEVAX is approved for individuals 5 years and older.
  • COVOVAX is approved for individuals 7 years and older.
  • ZyCoV-D is approved for individuals 12 years and older and can be administered in two or three doses depending on the approval date.
  • HGCO-19 is approved for individuals 18 years and older.

Impact Analysis

Manufacturers

  • Action Item: Manufacturers should assess their production and distribution capabilities to meet potential market demand.

Healthcare Providers

  • Action Item: Update vaccination protocols and training materials to reflect the updated approvals and guidelines. Ensure proper storage facilities are available to maintain vaccine integrity.

Citizens

  • Action Item: Citizens should consult with healthcare providers to determine the most suitable vaccine based on their age, health condition, and availability.

Government

  • Action Item: Update national vaccination policies and guidelines to reflect the updated approvals. Ensure adequate supply and distribution of vaccines across the country. Continue public awareness campaigns to promote vaccination.

Key Entities Referenced

M/s Serum Institute of India Pvt. Ltd.: Manufacturer of COVISHIELD vaccine. M/s Bharat Biotech: Manufacturer of COVAXIN vaccine. M/s Dr. Reddy’s Lab. Ltd.: Importer of SPUTNIK-V and SPUTNIK Light vaccines. M/s Cipla Ltd.: Importer of Moderna vaccine. M/s Panacea Biotec Ltd: Manufacturer of SPUTNIK-V vaccine. M/s Johnson & Johnson Pvt. Ltd.: Importer of Janssen Vaccine. M/s Gennova Biopharmaceuticals Limited: Manufacturer of HGCO-19 vaccine. M/s Biological E Limited: Manufacturer of Janssen Vaccine and CORBEVAX vaccine. M/s Cadila Healthcare Limited: Manufacturer of ZyCoV-D vaccine. M/s Hetero Biopharma Ltd: Manufacturer of SPUTNIK-V and SPUTNIK Light vaccines.
Official Source Record View Original Source →
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COVID-19 vaccines approved for Manufacture for Sale or for Distribution in the country No Vaccine Applicant Date of Age group Dosing schedule Route & Storage Shelf Life as approval on 08.07.2022 1 ChAdOx1 nCoV-19 Corona Virus M/s Serum Institute 27.01.2022 ≥ 18 years Two doses, 4 to 6 Intramuscular, 9 months vaccine Recombinant) of India Pvt. Ltd. weeks apart 2-8°C (COVISHIELD) (Overseas Data available for 12 weeks) 2 Whole-Virion Inactivated SARS- M/s Bharat Biotech 27.01.2022 ≥ 18 years Two doses, Day 0 Intramuscular, 12 months CoV-2 Vaccine (COVAXIN) & 28 2-8°C Note: Both COVISHIELD & COVAXIN vaccines were initially approved for Restricted Use in Emergency Situation in the country on 03.01.2021 COVID-19 vaccines approved for Restricted Use in Emergency Situation in the country Sr. Vaccine Applicant Date of Age group Dosing schedule Route & Storage Shelf Life No approval as on 08.07.2022 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 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)Sr. Vaccine Applicant Date of Age group Dosing schedule Route & Storage Shelf Life No approval as on 08.07.2022 8 Whole-Virion Inactivated SARS- M/s Bharat Biotech 24.12.2021 ≥ 12 to 18 years Two doses, Day 0 Intramuscular, 12 months CoV-2 Vaccine (COVAXIN) & 28 2-8°C 26.04.2022 >6 to <12 years 9 SARS-CoV-2 vaccine containing M/s Biological E 28.12.2021 ≥ 18 years Two doses, Day 0 Intramuscular, 12 months Receptor Binding Domain (RBD) Limited 21.02.2022 ≥ 12 years & 28 2-8°C of SARS-CoV-2 gene (CORBEVAX) 26.04.2022 ≥5 to <12 years 10 SARS-CoV-2 rS Protein (COVID- M/s Serum 28.12.2021 ≥ 18 years Two doses, Day Intramuscular, 9 months 19) recombinant spike protein Institute of India 08.03.2022 ≥ 12 years 0 & 21 2-8°C Nanoparticle Vaccine [COVOVAX] Pvt. Ltd. 28.06.2022 ≥ 7 to < 12 years 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, 2-8°C 6 months Injection (COVID-19) [HGCO-19] Biopharmaceuticals Day 0 & 28 Limited

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