Biology:iNCOVACC
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | viral |
| Clinical data | |
| Trade names | iNCOVACC |
| Routes of administration | Intranasal |
| ATC code |
|
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
Clinical trials
Phase I trials
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
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
India
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
- ↑ "Intranasal Covid vaccine by Bharat Biotech gets approval for booster dose" (in en). mint. 28 November 2022. https://www.livemint.com/news/world/worlds-first-nasal-covid-vaccine-by-bharat-biotech-gets-approval-but-no-efficacy-data-yet-11669641320191.html.
- ↑ 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. https://www.bharatbiotech.com/intranasal-vaccine.html.
- ↑ "St. Louis-based Precision Virologics and India's Biotech leader Bharat Biotech obtain rights to intranasal COVID-19 vaccine technology" (in en). www.biostl.org. https://www.biostl.org/news-and-media/home/st-louis-based-precision-virologics-and-indias-biotech-leader-bharat-biotech-obtain-rights-to-intranasal-covid-19-vaccine-technology.
- ↑ "A Single-Dose Intranasal ChAd Vaccine Protects Upper and Lower Respiratory Tracts against SARS-CoV-2". Cell 183 (1): 169–184.e13. October 2020. doi:10.1016/j.cell.2020.08.026. PMID 32931734.
- ↑ "Bharat Biotech to make a billion doses of an intranasal adenovirus vaccine" (in en). The Indian Express. 23 September 2020. https://indianexpress.com/article/india/bharat-biotech-to-manufacture-a-billion-doses-of-nasal-spray-covid-19-vaccine-6607305/.
- ↑ "Bharat Biotech Partners With US University For Covid Intranasal Vaccine". NDTV.com. https://www.ndtv.com/india-news/bharat-biotech-partners-with-us-university-for-covid-intranasal-vaccine-2299947.
- ↑ "Explained: Understanding BBV154, Bharat Biotech's single-dose intranasal Covid-19 vaccine" (in en). The Indian Express. 30 January 2021. https://indianexpress.com/article/explained/explained-understanding-bbv154-bharat-biotechs-single-dose-intranasal-covid-19-vaccine-7160945/.
- ↑ "First nasal vaccine developed by Bharat Biotech gets nod for Phase 2/3 trial" (in en). Hindustan Times. 13 August 2021. https://www.hindustantimes.com/india-news/first-nasal-vaccine-developed-by-bharat-biotech-gets-nod-for-phase-2-3-trial-101628860078002.html.
- ↑ "Intranasal vaccine gets clearance as booster option in Covid fight" (in en). The Indian Express. 24 December 2022. https://indianexpress.com/article/india/intranasal-vaccine-gets-clearance-as-booster-option-in-covid-fight-8341377/.
- ↑ "World's first intranasal covid vaccine to be available in India as booster dose from today" (in en). The Tribune. 24 December 2022. https://www.tribuneindia.com/news/nation/govt-approves-bharat-biotechs-needle-free-intranasal-covid-vaccine-as-booster-dose-for-those-above-18-463791.
External links
- Bharat Biotech's Intranasal Vaccine for COVID-19: Everything we know so far about BBV154 firstpost.com
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