Drugs / BBV152
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04641481 | Nov 2020 → Jan 2021 | COVID-19 | Bharat Biotech International Limited | Unknown | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT05541289 | — | COVID-19 | Ocugen | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT05258669 Comparator | Feb 2022 → Sep 2023 | COVID-19 | Ocugen | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| 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 ↗ |
| 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 ↗
This review by Dotiwala and Upadhyay provides a detailed analysis of the immunogenicity, safety, and efficacy of BBV152—a whole virus inactivated vaccine and an important tool in the fight to control the COVID-19 pandemic. |
| 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 ↗ |
| 2022-04-26 | Bharat Biotech International Limited | Regulatory COVAXIN® for Children: India approves COVAXIN® in Children 6-12 years bharatbiotech.com ↗
today announced that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine candidate, has received emergency use approval in children 6-12 years of age. |
| 2022-04-12 | Ocugen | Regulatory Ocugen, Inc. Provides Update on its Phase 2/3 Study of COVAXIN™ (BBV152) ocugen.com ↗
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 ↗
More than 90% of all individuals boosted with COVAXIN® (BBV152) showed neutralizing antibodies. |
| 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 ↗
The phase 2, double -blind, randomised controlled COVAXIN® trial demonstrated long-term safety with no serious adverse events. |
| 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 ↗
Whole-Virion inactivated SARS-CoV-2 Vaccine (BBV152) 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 ↗
The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies. |
| 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. |
| 2021-11-09 | Ocugen | Regulatory Ocugen Provides Business Update and Third Quarter 2021 Financial Results ocugen.com ↗
The submission of COVAXIN for Emergency Use Authorization for pediatrics is another example of Ocugen contributing to public health efforts to curb the pandemic, giving parents another option for protecting their children. |
| 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 ↗
MALVERN, Pa., Nov. 05, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of Ocugen’s COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside of the U.S., for pediatric use. |
| 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. |
| 2021-03-03 | 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. |
All press releases naming this drug 24 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BBV152 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05258669 ↗ |
| Modality | Vaccine | “a whole virion inactivated SARS-CoV-2 vaccine” NCT04641481 ↗ |
| Route | Intramuscular | “two intramuscular doses of vaccine or placebo administered 4 weeks apart” PMID 34774196 ↗ Nov 2021 |