Bio E COVID-19
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | Protein subunit |
| Clinical data | |
| Other names | BECOV2D |
| Routes of administration | Intramuscular |
| ATC code |
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| Part of a series on the |
| COVID-19 pandemic |
|---|
 |
|
.svg){kind=small} COVID-19 portal |
Bio E COVID-19 is a COVID-19 vaccine candidate developed by Biological E. Limited, Baylor College of Medicine and Dynavax Technologies[1][2][3][4]
Clinical research[edit]
Phase I and II trials[edit]
In phase I clinical trial was carried to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants.[4]The phase II concluded in April 2021.[5][6]
Phase III trials[edit]
In April 2021, the Drugs Controller General of India permitted the vaccine candidate to start phase III clinical trials. A total of 1,268 healthy participants between the age of 18 and 80 years to be selected from 15 sites across India for the trial and intended to be part of a larger global Phase III study.[6]
Manufacturing[edit]
In April 2021, the U.S. International Development Finance Corporation (DFC) announced to fund in expansion of the manufacturing capability the Biological E. Limited in India. It will ramp up to produce at least 1 billion doses of vaccines by end of 2022.[7]
References[edit]
- ^ "A prospective open label randomised phase-I seamlessly followed by phase-II study to assess the safety, reactogenicity and immunogenicity of Biological E's novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 for protection against Covid-19 disease when administered intramuscularly in a two dose schedule (0, 28D) to healthy volunteers". ctri.nic.in. Clinical Trials Registry India. 13 January 2021. CTRI/2020/11/029032. Archived from the original on 12 November 2020.
- ^ "CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate". cepi.net. CEPI. Retrieved 5 March 2021.
- ^ Chui M (16 November 2020). "Biological E. Limited and Baylor COVID-19 vaccine begins clinical trial in India". Baylor College of Medicine.
- ^ a b Leo L (16 November 2020). "Biological E initiates human trials of vaccine". Mint.
- ^ "Coronavirus | Biological E gets nod to start Phase III trials of COVID-19 vaccine". The Hindu. 24 April 2021.
- ^ a b Leo, Leroy (24 April 2021). "Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3". mint.
- ^ Basu, Nayanima (25 April 2021). "US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan". ThePrint.
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Scholia has a profile for Bio E COVID-19 (Q106350062). |
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