Corbevax

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Corbevax
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Trade namesCorbevax
Other namesBECOV2D
Routes of
administration
Intramuscular
ATC code
  • None

Corbevax[1] or BioE COVID-19, is a COVID-19 vaccine candidate developed by Indian biopharmacutical firm Biological E. Limited (BioE), the Baylor College of Medicine in Houston, United States, and American company Dynavax Technologies. It is a protein subunit vaccine.[2][3][4][5]

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.[5]The phase II concluded in April 2021.[6][7]

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.[8][7]

Manufacturing and Orders[edit]

In April 2021, the U.S. International Development Finance Corporation (DFC) announced that it would fund the expansion of BioE's manufacturing capabilities, so that it could produce at least 1 billion doses by end of 2022.[9]

On 3 June, India's Ministry of Health and Family Welfare pre-ordered 300 million doses of Corbevax.[10]

References[edit]

  1. ^ Bharadwaj, Swati (3 June 2021). "Telangana: Biological E starts at risk manufacturing of Corbevax". The Times of India. Retrieved 3 June 2021.
  2. ^ "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 and some amount of sperm in its drug 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.
  3. ^ "CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate". cepi.net. CEPI. Retrieved 5 March 2021.
  4. ^ Chui M (16 November 2020). "Biological E. Limited and Baylor COVID-19 vaccine begins clinical trial in India". Baylor College of Medicine.
  5. ^ a b Leo L (16 November 2020). "Biological E initiates human trials of vaccine". Mint.
  6. ^ "Coronavirus | Biological E gets nod to start Phase III trials of COVID-19 vaccine". The Hindu. 24 April 2021.
  7. ^ a b Leo, Leroy (24 April 2021). "Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3". mint.
  8. ^ "A Prospective, multicentre, Phase II Seamlessly Followed by Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological E's CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to COVID-19-Negative Adult Subjects". ctri.nic.in. Clinical Trials Registry India. 5 June 2021. CTRI/2021/06/034014.
  9. ^ Basu, Nayanima (25 April 2021). "US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan". ThePrint.
  10. ^ "Health ministry buys 300 mn doses of Biological-E's Covid vaccine in advance". Hindustan Times. 3 June 2021. Retrieved 4 June 2021.

External links[edit]