COVID 19 vaccines in India

Central Drugs Standard Control Organisation (CDSCO) based on the the recommendations of the Expert Committee has approved the follwoing vaccines  for restricted use in emergency situation in India.

1. Covaxin of M/s Bharat Biotech for age group of 6-12 and 12-18 years
2. Sputinik -V of M/s Dr. Reddy’s Laboratories Ltd.  (Importer)
3. Sputinik -V of M/s Panacea Biotec Ltd
4. Janssen - Johnson & Johnson (Importer)
5. Janssen - M/s Biological E Limited
6. ZyCoV-D of Zydus Cadila - age group >12 years
7. Sputinik -V of M/s Hetero Biopharma Ltd 
8. Corbevax of Biological E. Limited - age groups 5-12, >12 and >18 years
9. Covovax of M/s Serum Institute of India - age groups >12 and >18 years
10. Moderna - M/s Cipla (Importer)
11. SPUTNIK Light of M/s Dr. Reddy’s Lab. Ltd. (Importer) 
12. SPUTNIK Light of  M/s Hetero Biopharma Ltd 
13. Lyophilized mRNA Vaccine for Injection (COVID-19) [HGCO-19] of M/s Gennova Biopharmaceuticals Limited
14. BBV154 (iNCOVACC) -  M/s Bharat Biotech

COVISHIELD and COVAXIN have been accorded approval for Manufacture for Sale or for Distribution in the country.

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

Note: Both COVISHIELD & COVAXIN vaccines were initially approved for Restricted Use in Emergency Situation in the country on 03.01.2021

List of COVID-19 vaccines approved for Restricted Use in Emergency Situation in the country

Source : CDSCO

COVAXIN

COVAXIN^TM, India's indigenous COVID-19 vaccine Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV), from where they received the virus seed strain. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country and globally. This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.

The vaccine received approval from Drug Controller General of India (DCGI) for Phase I, II & III Human Clinical Trials and an Adaptive, Seamless Phase I, Followed by Phase II Randomized, Double blind, Multicentre Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) and a Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity,and Lot-to-Lot consistency of BBV152, a Whole virion Inactivated Vaccine in Adults greater than or equal to 18 Years of Age. .

The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx. 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers across the country and the vaccine has been found to be safe as per the data available till date. 

The vaccine has also received the WHO Emergency Use Listing (EUL).

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended for upgradation of status for the vaccine from restricted use in emergency situations to grant of "Conditional Market Authorization" for the adult population on 19th January 2022. “Conditional Market Authorization” is a new category of market authorization that has emerged during the current global pandemic of COVID19. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

Covaxin for the age group of 2 to 18 years

The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021.

M/s Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.

An expert panel on India’s Central Drugs Standard Control Organisation (CDSCO) recommended granting emergency use authorisation (EUA) to Bharat Biotech’s Covid-19 vaccine, Covaxin, for use in children aged two to 18 years.

For more details, click  here. 

Covishield

M/s Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.

The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%. Further, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.

After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended for upgradation of status for the vaccine from restricted use in emergency situations to grant of "Conditional Market Authorization" for the adult population on 19th January 2022. “Conditional Market Authorization” is a new category of market authorization that has emerged during the current global pandemic of COVID19. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

The vaccine has also received the WHO Emergency Use Listing (EUL).

For more details, click  here. 

ZyCoV-D

M/s Cadila Healthcare Ltd., has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology, the world’s first and India’s indigenously developed DNA based vaccine for COVID-19 to be administered in humans including Children and adults 12 years and above.

Safety in Phase I and II clinical trial of ZyCoV-D in healthy subjects established as endorsed by the independent Data Safety Monitoring Board (DSMB). Zydus commenced Phase III trial.

The firm initiated Phase-I/II clinical trial in India in more than 1000 participants. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. The Phase-III clinical trial in 26000 Indian participants is ongoing.

DCGI has approved ZyCoV-D for restricted use in emergency situation.

For more details, click  here. 

Sputinik V

M/s Dr. Reddy’s Laboratories Ltd. (M/s DRL) and M/s Gamaleya Institute, Russia Gam-COVID-Vac have developed the combined vector vaccine, popularly called Sputnik-V. The Gam-COVID-Vac combined vector vaccine (Component I & Component II) has been developed by National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, Moscow, Russia. 

The National Regulator  - Drugs Controller General of India (DCGI) has granted Permission for Restricted Use in Emergency Situations to Sputnik-V vaccine. 

The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals of ≥ 18 years of age. The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C. The vaccine comprises of two components I & II, which are not interchangeable. M/s DRL will import the vaccine for use in the country.

For more details, click  here. 

Biological E’s novel Covid-19 vaccine

Biological E. Limited has developed the Covid-19 vaccine - Corbevax containing Receptor Binding Domain of SARS-CoV-2 for protection against Covid-19 disease when administered intramuscularly in a two dose schedule (0, 28D). 

DCGI has approved Corbevax for restricted use in emergency situation.

For more details, click  here. 

BBV154 - Intranasal vaccine

Bharat Biotech is conducting Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. BBV154 is an intranasal vaccine stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T cell responses.  Immune responses at the site of infection (in the nasal mucosa) – essential for blocking both infection and transmission of COVID-19.

Phase I Human Clinical Trial of the vaccine is oingoing.

For more details, click  here. 

COVOVAX

Indian Council of Medical Research and Serum Institute of India jointly performing a phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults. 

The vaccine has received the WHO Emergency Use Listing (EUL).

DCGI has approved COVOVAX for restricted use in emergency situation.

For more details, click  here. 

mRNA based vaccine (HGCO19)

Randomized, Phase I/II, Placebo-controlled, Dose-Ranging, study to evaluate the Safety, Tolerability and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy adult subjects. The trial is being conducted by Gennova Biopharmaceuticals Limited.

Phase I/II Human Clinical Trial is ongoing. 

Comparison of COVID-19 vaccines

To view the Comparative Sheet for different COVID-19 vaccines, under Indian Government suppy and their packaging details, Click Here.

Source : ICMR