A COVID-19 candidate inactivated virus vaccine.

Phase of research

Emergency use authorization

How it helps


Drug status


Supporting references
Contradictory references
AI-suggested references
Clinical trials

General information

COVAXIN™ is a COVID-19 candidate vaccine being developed by Bharat Biotech. It is a whole virion inactivated type of candidate vaccine. It is based on the β-propiolactone-inactivated SARS-CoV-2 NIV-2020-770 strain, which carries the D614G mutation. Alum or IMDG (TLR7 and TLR8 agonist) adsorbed onto alum were the adjuvants tested in a phase I/II clinical trials (Ella et al., 2021). In a Syrian hamster model, the formulation with aluminium hydroxide (Algel)-IMDG administered in the form of two 3 μg doses 14 days apart manifested the best immunogenic properties (Mohandas et al., 2021).

On January 3, 2021, COVAXIN™ was granted emergency use authorization in India. 

Marketed as



Supporting references

Link Tested on Impact factor Notes Publication date
Draft landscape of COVID-19 candidate vaccines
healthy adults Jul/28/2020
Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152
Preprint Animal model
mice, rats, rabbits

BBV152 vaccine formulations generated significantly high antigen-binding and neutralizing antibody titers

Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model
Animal model Mixed substance
Syrian hamsters 4.45

The candidate vaccine elicited potent humoral immune response in a Syrian hamster model. In a SARS-CoV-2 challenge, the hamsters were protected from pneumonia and had shortened time to lower respiratory tract viral clearance.

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial
Spike protein Phase II clinical trial Phase I clinical trial Randomized controlled double-blind trial Mixed substance
Healthy adults and adolescents (aged 12–65) 24.45

In the participants of the phase I study, neutralising antibody response was still present 3 months after the second dose administration. In the phase II study, the individuals vaccinated with 6 μg doses adjuvanted with Algel-IMDG had higher neutralizing antibody titres and seroconversion rates compared to the “3 μg” group. The T cell response in the vaccinated subjects was Th1-biased. The solicited adverse events were mild of moderate, the vaccine was generally well tolerated. Sample size: 184 (“3 μg” group) + 177 (“6 μg” group). Dosage: 2 doses 28 days apart (3 μg each, with Algel-IMDG (phase I and II); 6 μg each, with Algel-IMDG (phase I and II); or 6 μg each, with Algel (phase I) (+ Algel-only control in phase I)). Primary outcomes: Neutralising antibody titres and seroconversion rates at 4 weeks post second dose (phase II).

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
Phase I clinical trial Randomized controlled double-blind trial Mixed substance
Healthy adults; SARS-CoV-2 NIV-2020-770 strain (inactivated) 24.45

No serious (only temporary mild and moderate) adverse events causally associated with the vaccine were noted. The vaccination elicited anti-Spike, RBD, and Nucleocapsid IgG responses which were Th1 biased. After the second dose, seroconversion (MNT50) was observed in 82.8% (6 μg Algel (alum) group) to 91.2% (6 μg Algel-IMDG group).  Seroconversion (PRNT50) ranged from 86.4% (6 μg Algel-IMDG group) to 93.4% (3 μg Algel-IMDG group). In some of the Algel-IMDG group patients' blood samples but almost none of the Algel/Algel control group samples there were CD3+, CD4+, and CD8+ T-cell responses (with IFN-γ) observed. Sample size: 99 (3 μg Algel-IMDG group) + 99 (6 μg Algel-IMDG) + 93 (6 μg Algel) + 73 control. Dosage: Two IM doses of 3 μg with Algel-IMDG or 6 μg with Algel-IMDG, or 6 μg with Algel 14 days apart. Endpoints: Safety (primary outcome), seroconversion, and cell-mediated responses.

Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques
Animal model Mixed substance
rhesus macaques; SARS-CoV-2 strain P-3, NIV-2020770 12.12

The best outcomes were observed in animals vaccinated with 3 μg doses (adjuvanted with Algel 2) (“group III”). SARS-CoV-2-challenged (14 days after the second vaccine dose) rhesus macaques were protected from interstitial pneumonia. By day 7 post viral challenge, viral genomic RNA was detectable in none of the vaccinated animals. No clinical or radiographic abnormalities were observed in animals from the group III. RBD-specific IgGs were detectable in the vaccinated macaques from the third week after the first immunization and were high at 28th day after immunization and 7th day post viral challenge. The presence of neutralizing antibodies positively correlated with the IgGs. Compared to placebo, significantly lower levels of IL-6 and higher levels of IL-8 were observed in group III.

Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B 1.1.7 variant of SARS-CoV-2
In vitro Mixed substance
Sera of vaccinated individuals; Vero CCL-81 cells; SARS-CoV-2 strains hCoV-19/India/2020770, hCoV19/India/20203522, and hCoV-19/India/2020Q111 7.09

In vitro, the sera of individuals vaccinated with two doses of the vaccine (collected 4 weeks after the second dose) potently neutralized a SARS-CoV-2 strain carrying the B.1.1.7 hallmark mutations.


AI-suggested references

Link Publication date
Letter of concern regarding >>Reduction in COVID-19 infection using surgical facial masks outside the healthcare system<<.
Booster dose of the inactivated COVID-19 vaccine BBV152 (Covaxin) enhances the neutralizing antibody response against alpha, Beta, Delta and omicron variants of concern.
Neutralization of Beta and Delta variant with sera of COVID-19 recovered cases and vaccinees of inactivated COVID-19 vaccine BBV152/Covaxin
Comparable neutralization of SARS-CoV-2 Delta AY.1 and Delta with individuals sera vaccinated with BBV152
Antibody response after first and second-dose of ChAdOx1-nCOV (CovishieldTM ) and BBV-152 (CovaxinTM ) among health care workers in India: The final results of cross-sectional coronavirus vaccine-induced antibody titre (COVAT) study.
Humoral Immune Response of SARS-CoV-2 Infection and Anti-SARS-CoV-2 Vaccination in Renal Transplant Recipients
Effectiveness of COVID-19 vaccine (Covaxin) against breakthrough SARS-CoV-2 infection in India
High-Titer Neutralizing Antibodies against the SARS-CoV-2 Delta Variant Induced by Alhydroxyquim-II-Adjuvanted Trimeric Spike Antigens
Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial
Th1 skewed immune response of whole virion inactivated SARS CoV 2 vaccine and its safety evaluation.
Neutralization of B.1.1.28 P2 variant with sera of natural SARS-CoV-2 infection and recipients of inactivated COVID-19 vaccine Covaxin
Safety of the ChAdOx1 nCoV-19 and the BBV152 vaccines in 724 patients with rheumatic diseases: a post-vaccination cross-sectional survey
Novel antiviral effects of chloroquine, hydroxychloroquine, and green tea catechins against SARS-CoV-2 main protease and 3C-like protease for COVID-19 treatment
Prime-Boost Vaccination With Covaxin/BBV152 Induces Heightened Systemic Cytokine and Chemokine Responses
SARS-CoV-2 Reinfection Rate and Estimated Effectiveness of the Inactivated Whole Virion Vaccine BBV152 Against Reinfection Among Health Care Workers in New Delhi, India
Drug repurposing for COVID-19 using computational screening: Is Fostamatinib/R406 a potential candidate?
Insight into the Advances in Clinical Trials of SARS-CoV-2 Vaccines
Immunogenic and reactogenic efficacy of Covaxin and Covishield: a comparative review
Implication of in silico studies in the search for novel inhibitors against SARS-CoV-2
Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study.
Sub-optimal neutralisation of omicron (B.1.1.529) variant by antibodies induced by vaccine alone or SARS-CoV-2 Infection plus vaccine (hybrid immunity) post 6-months
Persistence of Antibodies Against Spike Glycoprotein of SARS-CoV-2 in Healthcare Workers Post Double Dose of BBV-152 and AZD1222 Vaccines
Comparison of the immunogenicity & protective efficacy of various SARS-CoV-2 vaccine candidates in non-human primates
Humoral antibody kinetics with ChAdOx1-nCOV (Covishield ) and BBV-152 (Covaxin ) vaccine among Indian Healthcare workers: A 6-month longitudinal cross-sectional Coronavirus Vaccine-induced antibody titre (COVAT) study
Immunogenicity and safety of a heterologous prime-boost COVID-19 vaccine schedule: ChAdOx1 vaccine Covishield followed by BBV152 Covaxin
Antibody responses to the BBV152 vaccine in individuals previously infected with SARS-CoV-2: A pilot study
Locally harvested Covid-19 convalescent plasma could probably help combat the geographically determined SARS-CoV-2 viral variants

Clinical trials

ID Title Status Phase Start date Completion date
NCT04834869 COVID-19 Vaccines Safety Tracking (CoVaST) Recruiting Apr/01/2021 Jan/31/2022
  • Alternative id - CoVaST
  • Interventions - Biological: BNT162b2|Biological: mRNA-1273|Biological: AZD1222|Biological: CoronaVac|Biological: Sinopharm|Biological: Gam-COVID-Vac|Biological: JNJ-78436735|Biological: CVnCoV|Biological: NVX-CoV2373|Biological: BBV152
  • Study type - Observational
  • Study results - No Results Available
  • Locations - American College of Physicians, Philadelphia, Pennsylvania, United States|McMaster University, Hamilton, Ontario, Canada|University of Split, Split, Croatia|Masaryk University, Brno, Czechia|University of Tartu, Tartu, Estonia|Jimma University, Jimma, Ethiopia|Justus-Liebig University Giessen, Giessen, Germany|University of Ghana, Accra, Ghana|Sinaloa's Pediatric Hospital, Culiacán, Mexico|Medical University of Silesia, Katowice, Poland|Nursing School of Coimbra, Coimbra, Portugal|Irkutsk Scientific Center of Siberian Branch of Russian Academy of Sciences, Irkutsk, Russian Federation|University of Belgrade, Belgrade, Serbia|University of Ljubljana, Ljubljana, Slovenia
  • Study designs - Observational Model: Other|Time Perspective: Prospective
  • Enrollment - 30000
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Local Side Effects|Systemic Side Effects|Unrecognized Side Effects
NCT04471519 Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers Active, not recruiting Phase 1|Phase 2 Jul/15/2020 Jun/30/2021
  • Alternative id - BBIL/BBV152-A/2020|Protocol No:BBIL/BBV152-A/2020
  • Interventions - Biological: BBV152A - Phase I|Biological: BBV152B - Phase I|Biological: BBV152C - Phase I|Biological: Placebo - Phase I|Biological: BBV152A - Phase II|Biological: BBV152B - Phase II
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - King George Hospital, Visakhapatnam, Andhra Pradesh, India|All India Institute of Medical Sciences, Patna, Bihar, India|Pt BD SHARMA,PGIMS/UHS, Rohtak, Haryana, India|Jeevan Rekha Hospital, Belgaum, Karnataka, India|Gillukar Multispeciality Hospital, Nagpur, Maharastra, India|All India Institute of Medical Sciences, Delhi, New Delhi, India|Institute of Medical Sciences and SUM Hospital, Bhubaneswar, Orissa, India|SRM Hospital & Research center, Chennai, Tamilnadu, India|Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India|Rana Hospital and Trauma Center, Gorakhpur, Uttar Pradesh, India|Prakhar Hospital, Kanpur, Uttar Pradesh, India|Redkar Hospital and Research Centre, Goa, India
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 755
  • Age - 12 Years to 65 Years   (Child, Adult, Older Adult)
  • Outcome measures - Phase 1: Occurrence of adverse events and Serious Adverse events|Phase 2: Evaluation of Neutralizing Antibody Titers|Phase 1: Evaluation of Neutralizing Antibody Titers|Phase 2: Occurrence of adverse events and Serious Adverse events
NCT05258669 Immuno-bridging and Broadening Study of a Whole, Inactivated COVID-19 Vaccine BBV152 in Healthy Adults Active, not recruiting Phase 2|Phase 3 Feb/20/2022 Oct/31/2023
  • Alternative id - OCU-002
  • Interventions - Biological: BBV152
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - IACT Health, Columbus, Georgia, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 400
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Compare immune response measured by serum neutralizing antibodies against Wild-Type SARS-CoV-2 in US-based participants and age-matched controls participants who participated in the Phase 3 efficacy trial in India.|Evaluate the change over time in immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.|Evaluate the immunogenicity of two doses of BBV152 measured by MNT neutralizing antibodies.|Evaluate the serious adverse events (SAEs)|Evaluate response rate of anti-SARS-CoV-2 IgG antibody seroconversion from negative to positive following 28 days of BBV152 administration|Evaluate the immunogenicity of the single dose of BBV152.|Evaluate immune-broadening, as measured by MNT neutralizing antibodies, compare the sera taken from previously mRNA or viral vector vaccinated US-based participants with sera taken from previously mRNA or Viral Vector vaccinated placebo controls.|Evaluate the medically attended adverse events (MAAEs).|Evaluate potential immune-mediated medical conditions (PIMMCs).|Evaluate the adverse events of special interest (AESI).|Evaluate the unsolicited adverse events.|Evaluate the solicited adverse events.
NCT04641481 An Efficacy and Safety Clinical Trial of an Investigational COVID-19 Vaccine (BBV152) in Adult Volunteers Active, not recruiting Phase 3 Nov/16/2020 Dec/01/2022
  • Alternative id - BBIL/BBV152-C/2020
  • Interventions - Biological: BBV152|Biological: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Pt BD SHARMA,PGIMS/UHS, Rohtak, Haryana, India
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
  • Enrollment - 25800
  • Age - 18 Years to 99 Years   (Adult, Older Adult)
  • Outcome measures - First occurrence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19.|First occurence of Virologically confirmed (RT-PCR positive) symptomatic cases of COVID-19 based on the case definition for the secondary efficacy symptomatic endpoint.|Virologically confirmed (RT-PCR positive) severe cases of COVID-19|Virologically confirmed COVID-19 cases of any severity occurring among participants 18 through 59 years of age and ≥60 years of age.|Virologically confirmed COVID-19 asymptomatic and symptomatic cases occurring from two weeks after the second vaccination.|Reactogenicity and Safety|The occurrence of enhanced respiratory disease episodes.|Immunogenicity: Lot-to-Lot consistency of three consecutive GMP Lots|Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)