Corbevax

Corbevax
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Trade namesCorbevax
Other namesBECOV2D, BioE COVID-19
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status

Corbevax is a protein subunit COVID-19 vaccine[1][2][3][4] developed by Texas Children's Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas and Dynavax technologies based in Emeryville California.[5] It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production.[6][7]

Technology

The vaccine consists of a version of the receptor binding domain (RBD) of the SARS‑CoV‑2 spike protein, together with the adjuvants aluminium hydroxide gel and CpG 1018.[2] The protein is produced by the yeast Pichia pastoris; the process is similar to that of existing Hepatitis B vaccines.[2]

Manufacturing

In April 2021, the U.S. International Development Finance Corporation (DFC) announced that it would fund the expansion of BioE's (Biological E Ltd, India) manufacturing capabilities, so that it could produce at least 1 billion doses by end of 2022.[8]

History

Clinical trials

A phase I clinical trial was carried out to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants.[4] The phase II concluded in April 2021.[9][10]

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.[11][10] As of December 2021, Biological E announced positive results, but some experts criticized the lack of public data from phase III trials.[12]

Society and culture

On 28 December 2021, India approved the vaccine for emergency use.[13]

Economics

The development of the vaccine was financed with $7 million from mostly private investors, including a $1 million donation by Tito's Vodka.[14][15] The vaccine technology is given patent-free to manufacturers, although Baylor College receives a fee.[12][16][17]

On 3 June 2021, India's Ministry of Health and Family Welfare pre-ordered 300 million doses of Corbevax.[18]

The BioE company estimated the vaccine to be priced at ₹250 (around $3) per dose and may even be priced below ₹400 (around $5) for two doses in India.[19]

The vaccine is planned for use in low-income countries to increase vaccine access and equity, and thus is designed to be easily storable and manufactured with traditional processes. The vaccine is not patented and is planned to be openly licensed under COVAX.[12][20]

In January 2022 the scientists developing Corbevax have declared no G7 countries were yet funding the open source vaccine and reiterated their plea to the US federal government and G7 countries to provide funding for the mass production and distribution of Corbevax, arguing Moderna had received much more support.[21]

References

  1. ↑ "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.
  2. 1 2 3 "CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate". cepi.net. CEPI. 29 December 2020. Archived from the original on 29 December 2020. Retrieved 5 March 2021.
  3. ↑ Chui M (16 November 2020). "Biological E. Limited and Baylor COVID-19 vaccine begins clinical trial in India". Baylor College of Medicine.
  4. 1 2 Leo L (16 November 2020). "Biological E initiates human trials of vaccine". Mint.
  5. ↑ "Covovax and Corbevax: What we know about India's new Covid vaccines". BBC News. 28 December 2021.
  6. ↑ Raghavan P (10 June 2021). "Explained: How is Biological E's Corbevax different?". The Indian Express. Retrieved 29 December 2021.
  7. ↑ "Covovax and Corbevax: What we know about India's new Covid vaccines". BBC News. 28 December 2021.
  8. ↑ Basu N (25 April 2021). "US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan". ThePrint.
  9. ↑ "Coronavirus | Biological E gets nod to start Phase III trials of COVID-19 vaccine". The Hindu. 24 April 2021.
  10. 1 2 Leo L (24 April 2021). "Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3". mint.
  11. ↑ "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. Archived from the original on 5 June 2021.
  12. 1 2 3 "A new coronavirus vaccine heading to India was developed by a small team in Texas. It expects nothing in return". The Washington Post. 30 December 2021. Archived from the original on 1 January 2022.
  13. ↑ Achom D (28 December 2021). "India Clears 2 New Vaccines And Merck's Covid Pill". NDTV.com.
  14. ↑ Pathak, Dipali (13 May 2020). "Tito's Handmade Vodka gives $1M grant for COVID-19 vaccine". Baylor College of Medicine. Retrieved 29 January 2022.
  15. ↑ "Supporting COVID-19 Research". Tito's Vodka. 13 May 2020. Retrieved 29 January 2022.
  16. ↑ "A Texas team comes up with a COVID vaccine that could be a global game changer". NPR.org. Retrieved 15 January 2022.
  17. ↑ "Texas scientists' new Covid-19 vaccine is cheaper, easier to make and patent-free". the Guardian. 15 January 2022. Retrieved 15 January 2022.
  18. ↑ "Health ministry buys 300 mn doses of Biological-E's Covid vaccine in advance". Hindustan Times. 3 June 2021. Retrieved 4 June 2021.
  19. ↑ Bharadwaj S (5 June 2021). "Bio E's Corbevax may be India's cheapest vaccine at Rs 250 per dose". The Times of India.
  20. ↑ Hotez, Peter J.; Bottazzi, Maria Elena (30 December 2021). "A COVID Vaccine for All". Scientific American. Archived from the original on 30 December 2021. Retrieved 2 January 2022.
  21. ↑ "Open-Source Vaccines Got More Funding From Tito's Vodka Than the Government". www.vice.com. Retrieved 25 January 2022.
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