Drugs / BBV-152 ANTIGEN ADJUVATED WITH ALGEL-IMDG
BBV-152 ANTIGEN ADJUVATED WITH ALGEL-IMDG
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | COVAXIN | COVID-19 | 2022-04-12 | “the U.S. Food and Drug Administration (FDA) that the agency placed its Phase 2/3 immuno-bridging and broadening study for COVAXIN™ (BBV152), OCU-002, on clinical hold.” ocugen.com ↗ |
| Clinical hold | US (FDA) | — | COVID-19 | 2021-11-26 | “clinical hold on the Company’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States.” ocugen.com ↗ |
| Filed | Other | COVAXIN | COVID-19 | — | “COVAXIN™ (BBV152), the company’s COVID-19 vaccine candidate, which was submitted to Health Canada for regulatory review” ocugen.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05639998 | Sep 2021 → Mar 2022 | COVID-19 | Bharat Biotech International Limited | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04918797 | May → Aug 2021 | COVID-19 | Bharat Biotech International Limited | Completed | Met primary |
| Phase 41 trial · 1 missed | ||||||
| Phase 4 | NCT05142319 | Oct 2021 → Jun 2023 | COVID-19 | Tan Tock Seng Hospital | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT05522335 Comparator | Apr → Jul 2022 | COVID-19 | Bharat Biotech International Limited | Unknown | No outcome recorded |
| Phase 3 | NCT05567471 Comparator | Feb → May 2022 | COVID-19 | Bharat Biotech International Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2023-01-09 | Bharat Biotech International Limited | Results COVAXIN® successfully completes clinical trials in Phase 2/3 in the US bharatbiotech.com ↗
Study met both co-primary endpoints with robust immune responses |
| 2023-01-09 | Ocugen | Results Ocugen Announces Positive Top-Line Data for COVID-19 Vaccine Candidate COVAXIN™ (BBV152) in Phase 2/3 Immuno-bridging and Broadening Study: Both Co-primary Endpoints Met ocugen.com ↗
Study met both co-primary endpoints with robust immune responses |
| 2022-09-14 | Ocugen | Results Ocugen Announces Publication of a Comprehensive Review of BBV152 in Frontiers in Immunology ocugen.com ↗
Additionally, BBV152 has a broader impact on public health, as it induces high neutralization efficacy against different SARS-CoV-2 variants of concern. |
| 2022-07-20 | Bharat Biotech International Limited | Results COVAXIN® demonstrates Persistence of immunity and impact of third dose of inactivated COVID-19 vaccine against emerging variants bharatbiotech.com ↗
Administration of a third dose, after 6 months of two dose vaccination, dramatically increased neutralizing antibody responses against both homologous and heterologous strains (Alpha, Beta, Delta, Delta Plus and Omicron) and showed increased memory B cell response. |
| 2022-06-21 | Ocugen | Results Ocugen Announces Publication of Positive Results of COVID-19 Vaccine Trial for Children 2-18 in The Lancet Infectious Diseases ocugen.com ↗
Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for the COVID-19 vaccine COVAXIN™ (BBV152) in The Lancet Infectious Diseases (“The Lancet”) . |
| 2022-06-17 | Bharat Biotech International Limited | Results COVAXIN® demonstrates robust safety and immunogenicity in children 2-18 years bharatbiotech.com ↗
Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study. |
| 2022-05-23 | Ocugen | Regulatory Ocugen Announces FDA Removes Clinical Hold on Phase 2/3 Clinical Trial for COVAXIN™ (BBV152) ocugen.com ↗
Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the Company’s Phase 2/3 clinical trial, OCU-002, for COVAXIN™ (BBV152). |
| 2022-04-26 | Bharat Biotech International Limited | Regulatory COVAXIN® for Children: India approves COVAXIN® in Children 6-12 years bharatbiotech.com ↗ |
| 2022-04-12 | Ocugen | Regulatory Ocugen, Inc. Provides Update on its Phase 2/3 Study of COVAXIN™ (BBV152) ocugen.com ↗
Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines, announced that the Company was informed by the U.S. Food and Drug Administration (FDA) that the agency placed its Phase 2/3 immuno-bridging and broadening study for COVAXIN™ (BBV152), OCU-002, on clinical hold. |
| 2022-02-18 | Ocugen | Regulatory Ocugen, Inc. Announces U.S. FDA Lifts Clinical Hold on the Submission of Its Investigational New Drug Application for Its COVID-19 Vaccine Candidate COVAXIN™ (BBV152) ocugen.com ↗ |
| 2022-01-12 | Bharat Biotech International Limited | Results COVAXIN® (BBV152) Booster Shown to Neutralize Both Omicron and Delta Variants of SARS-CoV-2 bharatbiotech.com ↗
Sera samples from individuals who received a booster of COVAXIN® (BBV152) were observed to be effective in neutralizing Omicron and Delta variants on a live virus neutralization assay. |
| 2022-01-12 | Ocugen | Results COVAXIN™ (BBV152) Booster Shown to Neutralize Both Omicron and Delta Variants of SARS-CoV-2 ocugen.com ↗
Sera samples from individuals who received a booster of COVAXIN™ (BBV152) were observed to be effective in neutralizing Omicron and Delta variants on a live virus neutralization assay. |
| 2022-01-08 | Bharat Biotech International Limited | Results COVAXIN® (BBV152) booster dose study shows promising results bharatbiotech.com ↗
COVAXIN® (BBV152) booster dose study shows Promising Results |
| 2022-01-08 | Ocugen | Results COVAXIN™ (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety ocugen.com ↗
The analysis found that participants receiving a booster dose saw a significant increase in neutralizing titers, an important predictor of vaccine efficacy. |
| 2021-12-30 | Bharat Biotech International Limited | Results COVAXIN® for Children: Study demonstrates robust safety and immunogenicity in 2-18 Volunteers bharatbiotech.com ↗
today announced that BBV152 (COVAXIN), its whole -virion inactivated COVID -19 vaccine candidate, has proven to be safe, well -tolerated, and immunogenic in paediatric subjects in phase II/III study. |
| 2021-12-30 | Ocugen | Results Ocugen Partner, Bharat Biotech, Announces Positive Immunogenicity and Safety Data From COVAXIN™ (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS ocugen.com ↗
Using a two-dose regimen administered 28-days apart, antibody responses in subjects were comparable to adult data from a previous phase 3 study. |
| 2021-12-15 | Ocugen | Results New Data Suggest COVAXIN™ (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination ocugen.com ↗
The study found that COVAXIN™ (BBV152) generated a robust immune memory against spike and nucleoprotein that was comparable to that following natural COVID-19 infection for the levels of antibodies, memory B cells and memory CD4+ T cells. |
| 2021-11-26 | Ocugen | Regulatory Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152) ocugen.com ↗ |
| 2021-11-12 | Bharat Biotech International Limited | Results Bharat Biotech's COVAXIN® Phase III data published in The Lancet bharatbiotech.com ↗
Bharat Biotech, a global leader in vaccine development and innovation, announced today that the safety and efficacy analysis data from Phase III clinical trials of COVAXIN® is peer reviewed and published in The Lancet. |
| 2021-11-11 | Ocugen | Results Ocugen Statement Regarding Publication of COVAXIN™ (BBV152) Phase 3 Study Results in The Lancet ocugen.com ↗
We are pleased that The Lancet , a trusted source of clinical, public health and global health knowledge, published Phase 3 data showing the COVID-19 vaccine candidate, COVAXIN™ (BBV152), has 93.4% efficacy against severe COVID-19 disease. |
| 2021-11-05 | Ocugen | Regulatory Ocugen, Inc. Announces Submission of Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years ocugen.com ↗ |
| 2021-11-03 | Bharat Biotech International Limited | Regulatory Bharat Biotech's COVAXIN® Authorized for Emergency Use by the World Health Organization bharatbiotech.com ↗
Bharat Biotech, a global leader in vaccine development and innovation, today announced that COVAXIN®, India’s first indigenous Covid-19 vaccine, has been granted Emergency Use Listing by the World Health Organization (WHO). |
| 2021-11-03 | Ocugen | Regulatory Ocugen Statement Regarding WHO Emergency Use Listing Announcement ocugen.com ↗
We are pleased that WHO has recognized the potential value of COVAXIN™ (BBV152), a differentiated broad-spectrum vaccine candidate, developed by our partner, Bharat Biotech. |
| 2021-10-27 | Ocugen | Regulatory Ocugen, Inc. Announces Submission of Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152) ocugen.com ↗
Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States. |
| 2021-07-03 | Bharat Biotech International Limited | Results Bharat Biotech Concludes Final Analysis for COVAXIN® Efficacy from Phase 3 Clinical Trials bharatbiotech.com ↗
Bharat Biotech, a global leader in vaccine development and innovation, announced today safety and efficacy analysis data from Phase III clinical trials of COVAXIN®, a whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with ICMR and NIV Pune. |
| 2021-04-21 | Bharat Biotech International Limited | Results Bharat Biotech and ICMR Announce Interim Results from Phase 3 trials of COVAXIN®; Demonstrates overall Interim Clinical Efficacy of 78% and 100% efficacy against Severe COVID-19 disease bharatbiotech.com ↗
Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. |
| 2021-03-03 | Bharat Biotech International Limited | Results Bharat Biotech Announces Phase 3 Results of COVAXIN®: India's First COVID-19 Vaccine Demonstrates Interim Clinical Efficacy of 81% bharatbiotech.com ↗
The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial. |
| 2021-01-03 | Bharat Biotech International Limited | Regulatory Bharat Biotech's COVAXINTM Emergency Use Authorization Approval by DCGI-CDSCO, MoH&FW bharatbiotech.com ↗
The approval of COVAXIN™ for emergency use is a giant leap for Innovation and novel product development in India. |
| 2020-06-29 | Bharat Biotech International Limited | Regulatory India's 1st COVID-19 Vaccine - COVAXINTM, Developed by Bharat Biotech gets DCGI approval for Phase I & II Human Clinical Trials bharatbiotech.com ↗
The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. |
All press releases naming this drug 33 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BBV-152 ANTIGEN ADJUVATED WITH ALGEL-IMDG | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802199 ↗ |
| Known as | BBV152 | “125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.” NCT05567471 ↗3“BBV152 (Covaxin™) is a whole-virion inactivated SARS-CoV-2 vaccine mixed with an immune adjuvant.” PMID 39241318 ↗ Sep 2024 “an inactivated COVID-19 vaccine, BBV152 (COVAXIN; Bharat Biotech International, Hyderabad, India)” PMID 35717995 ↗ Jun 2022 “BBV152 (COVAXIN®) With BBV154 (Adenoviral Intranasal COVID-19 Vaccine)” NCT05639998 ↗ |
| Known as | covaxin | “Group 2 (COVAXIN®): In this group, 160 participants will be recruited and administered with COVAXIN® vaccine on day 0 and on day 28 via intramuscular route.” NCT05522335 ↗6“either intranasal adenoviral vectored SARS-CoV-2 vaccine (BBV154) or licensed intramuscular vaccine, Covaxin®” PMID 37596281 ↗ Aug 2023 “BBV152 (Covaxin™) is a whole-virion inactivated SARS-CoV-2 vaccine mixed with an immune adjuvant.” PMID 39241318 ↗ Sep 2024 |
| Modality | Vaccine | “Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)” NCT04918797 ↗ |
| Route | Intramuscular | “administered with adult formulation of BBV152 as two 0·5 mL intramuscular doses” PMID 35717995 ↗ Jun 2022 |