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

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

  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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