Corbevax

Last updated

Corbevax
Vaccine description
Target SARS-CoV-2
Vaccine type Protein subunit
Clinical data
Trade names Corbevax
Other namesBECOV2D, Biological E 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] [6] It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production. [7] [8]

Contents

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] As the RBD protein is poorly immunogenic alone, adjuvantation is essential for a RBD-based vaccine immunogenicity. [9] Researchers at the Precision Vaccine Program at Boston Children's Hospital and Harvard Medical School, in Boston, Massachusetts, in collaboration with Texas Children's Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas, undertook a screening process that compared multiple molecules head-to-head in different combinations. [10] Two adjuvants — aluminum hydroxide and CpG—proved to be the most successful combination when added to the RBD protein, [9] especially in models of older populations. 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 Biological E's manufacturing capabilities, so that it could produce at least 1 billion doses by the end of 2022. [11]

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. [12] [13] [14]

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. [15] [13] On 3 June 2021, India's Ministry of Health and Family Welfare pre-ordered 300 million doses. [16]

As of December 2021, Biological E announced positive results, but some experts criticized the lack of public data from phase III trials. [17] The developer specifically claimed the vaccine appeared to be over 90% effective against the original variant based on antibody levels. [18] On 28 December 2021, India approved the vaccine for emergency use. [19]

2022

In January 2022, the developers declared that no G7 countries had funded the project and reiterated their plea for funding for mass production and distribution, arguing that Moderna had received much more support. [20]

As of August, 70 million doses had been administered to adolescents in India. It was also approved by the Botswana Medicines Regulator Authority. [21] A study reported that the heterologous (Corbevax plus Zycov-D) vaccine was effective against Omicron in India. [22]

Financing

Vaccine development was partly financed with $7 million from mostly private investors, including a $1 million donation by Tito's Vodka. [23] [24] The vaccine technology, for antigen production and use, is given patent-free to manufacturers, although Baylor College receives a fee. [17] [25] [26]

The evaluation of adjuvant components for use in a RBD based vaccine was partially enabled by NIH funding [27] along with prior funding to support development of the CpG adjvuant for use in vaccines. [28]

The BioE company planned to priced the shot at ₹250 (around $3) per dose. [29]

Licensing

The vaccine is not patented and is planned to be openly licensed under COVAX. [17] [30]

See also

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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. ↑ Hotez PJ, Bottazzi ME (January 2022). "Whole Inactivated Virus and Protein-Based COVID-19 Vaccines". Annual Review of Medicine. 73 (1): 55–64. doi: 10.1146/annurev-med-042420-113212 . PMID   34637324. S2CID   238747462.
  6. ↑ "Covovax and Corbevax: What we know about India's new Covid vaccines". BBC News. 28 December 2021.
  7. ↑ Raghavan P (10 June 2021). "Explained: How is Biological E's Corbevax different?". The Indian Express. Retrieved 29 December 2021.
  8. ↑ "Covovax and Corbevax: What we know about India's new Covid vaccines". BBC News. 28 December 2021.
  9. 1 2 Nanishi E, Borriello F, O'Meara TR, McGrath ME, Saito Y, Haupt RE, et al. (January 2022). "An aluminum hydroxide:CpG adjuvant enhances protection elicited by a SARS-CoV-2 receptor binding domain vaccine in aged mice". Science Translational Medicine. 14 (629): eabj5305. doi:10.1126/scitranslmed.abj5305. PMC   10176044 . PMID   34783582.
  10. ↑ Fliesler N (6 January 2022). "Another Angle of Attack". Harvard Medical School. Retrieved 23 June 2024.
  11. ↑ Basu N (25 April 2021). "US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan". ThePrint.
  12. ↑ "Coronavirus | Biological E gets nod to start Phase III trials of COVID-19 vaccine". The Hindu. 24 April 2021.
  13. 1 2 Leo L (24 April 2021). "Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3". mint.
  14. ↑ Thuluva S, Paradkar V, Gunneri SR, Yerroju V, Mogulla R, Turaga K, et al. (August 2022). "Evaluation of safety and immunogenicity of receptor-binding domain-based COVID-19 vaccine (Corbevax) to select the optimum formulation in open-label, multicentre, and randomised phase-1/2 and phase-2 clinical trials". eBioMedicine. 83: 104217. doi:10.1016/j.ebiom.2022.104217. PMC   9372721 . PMID   35970020.
  15. ↑ "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.
  16. ↑ "Health ministry buys 300 mn doses of Biological-E's Covid vaccine in advance". Hindustan Times. 3 June 2021. Retrieved 4 June 2021.
  17. 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.
  18. ↑ Prakash S (April 2022). "Development of COVID 19 vaccine: A summarized review on global trials, efficacy, and effectiveness on variants". Diabetes & Metabolic Syndrome. 16 (4). Elsevier BV: 102482. doi:10.1016/j.dsx.2022.102482. PMC   8990436 . PMID   35427915. As per company claim, Corbevax showed over 90% effective (Table 1) against the original SARS CoV2 variant based on antibodies produced by the people who received the vaccine.
  19. ↑ Achom D (28 December 2021). "India Clears 2 New Vaccines And Merck's Covid Pill". NDTV.com.
  20. ↑ "Open-Source Vaccines Got More Funding From Tito's Vodka Than the Government". www.vice.com. 11 January 2022. Retrieved 25 January 2022.
  21. ↑ Palca J (31 August 2022). "Whatever happened to the new no patent covid vaccine touted as a global game changer".
  22. ↑ "Corbevax as heterologous booster along wth[sic] Covishield more effective against Covid-19 variants: Research". Deccan Herald. 25 December 2022. Retrieved 19 June 2023.
  23. ↑ Pathak D (13 May 2020). "Tito's Handmade Vodka gives $1M grant for COVID-19 vaccine". Baylor College of Medicine . Retrieved 29 January 2022.
  24. ↑ "Supporting COVID-19 Research". Tito's Vodka. 13 May 2020. Retrieved 29 January 2022.
  25. ↑ "A Texas team comes up with a COVID vaccine that could be a global game changer". NPR.org. Retrieved 15 January 2022.
  26. ↑ Salam E (15 January 2022). "Texas scientists' new Covid-19 vaccine is cheaper, easier to make and patent-free". the Guardian. Retrieved 13 August 2022.
  27. ↑ Dowling DJ, Levy O (August 2022). "A Precision Adjuvant Approach to Enhance Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccines Optimized for Immunologically Distinct Vulnerable Populations". Clinical Infectious Diseases. 75 (Suppl 1): S30–S36. doi:10.1093/cid/ciac342. PMC   9129145 . PMID   35512145.
  28. ↑ "Dynavax Awarded $17 Million Contract from National Institutes of Health" (Press release). Dynavax. 29 September 2008.
  29. ↑ Bharadwaj S (5 June 2021). "Bio E's Corbevax may be India's cheapest vaccine at Rs 250 per dose". The Times of India.
  30. ↑ Hotez PJ, Bottazzi ME (30 December 2021). "A COVID Vaccine for All". Scientific American. Archived from the original on 30 December 2021. Retrieved 2 January 2022.
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