BBV154

Last updated

BBV154
Vaccine description
Target SARS-CoV-2
Vaccine type Viral vector
Clinical data
Routes of
administration
Intranasal
ATC code
  • None

BBV154 is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech, [1] [2] American company Precision Virologics [3] [4] and the Washington University School of Medicine in St Louis, Missouri ,United States. [5] [6]

Contents

Clinical trials

Phase I trials

On recommendation by the Subject Expert Committee (SEC) under the Indian drug regulator, the company is going to conduct 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. [7]

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. [8]

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References

  1. Clinical trial number NCT04751682 for "Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19" at ClinicalTrials.gov
  2. "Intranasal Vaccine For Covid-19". Bharat Biotech. Retrieved 5 March 2021.
  3. "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.
  4. Hassan, AO; Kafai, NM; Dmitriev, IP; Fox, JM; Smith, BK; Harvey, IB; Chen, RE; Winkler, ES; Wessel, AW; Case, JB; Kashentseva, E; McCune, BT; Bailey, AL; Zhao, H; VanBlargan, LA; Dai, YN; Ma, M; Adams, LJ; Shrihari, S; Danis, JE; Gralinski, LE; Hou, YJ; Schäfer, A; Kim, AS; Keeler, SP; Weiskopf, D; Baric, RS; Holtzman, MJ; Fremont, DH; Curiel, DT; Diamond, MS (1 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.
  5. "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.
  6. "Bharat Biotech Partners With US University For Covid Intranasal Vaccine". NDTV.com. Archived from the original on 3 May 2021. Retrieved 23 September 2020.
  7. Raghavan P (30 January 2021). "Explained: Understanding BBV154, Bharat Biotech's single-dose intranasal Covid-19 vaccine". The Indian Express.
  8. Gaurav, Kunal (13 August 2021). "First nasal vaccine developed by Bharat Biotech gets nod for Phase 2/3 trial". Hindustan Times.