iNCOVACC

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]

See also: BBV152

INCOVACC
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesiNCOVACC
Routes of
administration		Intranasal
ATC code
  • None
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History

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
See also: List of COVID-19 vaccine authorizations § iNCOVACC

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
  1. "Intranasal Covid vaccine by Bharat Biotech gets approval for booster dose". mint. 28 November 2022.
  2. Clinical trial number NCT04751682 for "Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19" at ClinicalTrials.gov
  3. "Intranasal Vaccine For Covid-19". Bharat Biotech. Retrieved 5 March 2021.
  4. "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.
  5. 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.
  6. "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.
  7. "Bharat Biotech Partners With US University For Covid Intranasal Vaccine". NDTV.com. Archived from the original on 3 May 2021. Retrieved 23 September 2020.
  8. Raghavan P (30 January 2021). "Explained: Understanding BBV154, Bharat Biotech's single-dose intranasal Covid-19 vaccine". The Indian Express.
  9. Gaurav K (13 August 2021). "First nasal vaccine developed by Bharat Biotech gets nod for Phase 2/3 trial". Hindustan Times.
  10. "Intranasal vaccine gets clearance as booster option in Covid fight". The Indian Express. 24 December 2022.
  11. "World's first intranasal covid vaccine to be available in India as booster dose from today". The Tribune. 24 December 2022.
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