iNCOVACC
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | Viral vector |
| Clinical data | |
| Trade names | iNCOVACC |
| Routes of administration | Intranasal |
| ATC code |
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| Part of a series on the |
| COVID-19 pandemic |
|---|
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|
.svg){kind=small} COVID-19 portal |
iNCOVACC (codenamed BBV154)[1] is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech,[2][3] American company Precision Virologics[4][5] and the Washington University School of Medicine in St Louis, Missouri, United States.[6][7]
History
[edit]Clinical trials
[edit]Phase I trials
[edit]On recommendation by the Subject Expert Committee (SEC) under the Indian drug regulator, the company conducted phase 1 clinical trials using 75 volunteers and submit safety and immunogenicity data for the committee's consideration before it proceeds to the second phase of the trial.[8]
Phase II and III trials
[edit]On 12 August 2021, after evaluating the results of phase I trial data, the drug regulator approved for phase II/III randomized trials that involves evaluation of the immunogenicity and safety of Covaxin with BBV154 in healthy volunteers.[9]
Authorizations
[edit]India
[edit]On 24 December 2022, the Government of India approved the intranasal vaccine for inclusion in the vaccination programme as a booster dose for those above 18 years of age.[10][11]
References
[edit]- ^ "Intranasal Covid vaccine by Bharat Biotech gets approval for booster dose". mint. 28 November 2022.
- ^ Clinical trial number NCT04751682 for "Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19" at ClinicalTrials.gov
- ^ "Intranasal Vaccine For Covid-19". Bharat Biotech. Retrieved 5 March 2021.
- ^ "St. Louis-based Precision Virologics and India's Biotech leader Bharat Biotech obtain rights to intranasal COVID-19 vaccine technology". www.biostl.org. Retrieved 29 August 2021.
- ^ Hassan AO, Kafai NM, Dmitriev IP, Fox JM, Smith BK, Harvey IB, et al. (October 2020). "A Single-Dose Intranasal ChAd Vaccine Protects Upper and Lower Respiratory Tracts against SARS-CoV-2". Cell. 183 (1): 169–184.e13. doi:10.1016/j.cell.2020.08.026. PMC 7437481. PMID 32931734.
- ^ "Bharat Biotech to make a billion doses of an intranasal adenovirus vaccine". The Indian Express. 23 September 2020. Archived from the original on 3 May 2021. Retrieved 23 September 2020.
- ^ "Bharat Biotech Partners With US University For Covid Intranasal Vaccine". NDTV.com. Archived from the original on 3 May 2021. Retrieved 23 September 2020.
- ^ Raghavan P (30 January 2021). "Explained: Understanding BBV154, Bharat Biotech's single-dose intranasal Covid-19 vaccine". The Indian Express.
- ^ Gaurav K (13 August 2021). "First nasal vaccine developed by Bharat Biotech gets nod for Phase 2/3 trial". Hindustan Times.
- ^ "Intranasal vaccine gets clearance as booster option in Covid fight". The Indian Express. 24 December 2022.
- ^ "World's first intranasal covid vaccine to be available in India as booster dose from today". The Tribune. 24 December 2022.
External links
[edit]
Scholia has a profile for BBV154 (Q106309712).
- Bharat Biotech's Intranasal Vaccine for COVID-19: Everything we know so far about BBV154 firstpost.com
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