Protein subunit vaccine against COVID-19
Pharmaceutical compound
Corbevax is aprotein subunit COVID-19 vaccine [ 1] [ 2] [ 3] [ 4] Texas Children's Hospital Center for Vaccine Development andBaylor College of Medicine inHouston, Texas and Dynavax technologies based in Emeryville, California.[ 5] [ 6] Biological E. Limited (BioE) for development and production.[ 7] [ 8]
The vaccine consists of a version of thereceptor binding domain (RBD) of theSARS‑CoV‑2 spike protein , together with theadjuvants aluminium hydroxide gel andCpG 1018.[ 2] [ 9] Boston Children's Hospital andHarvard Medical School , inBoston, Massachusetts , in collaboration withTexas Children's Hospital Center for Vaccine Development andBaylor College of Medicine inHouston, Texas , undertook a screening process that compared multiple molecules head-to-head in different combinations.[ 10] [ 9] yeast Pichia pastoris ; the process is similar to that of existingHepatitis B vaccines .[ 2]
In April 2021, theU.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]
A phase I clinical trial was carried out to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants.[ 4] [ 12] [ 13] [ 14]
In April 2021, theDrugs 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] 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] [ 18] [ 19]
In January 2022, the developers declared that noG7 countries had funded the project and reiterated their plea for funding for mass production and distribution, arguing thatModerna 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] Zycov-D ) vaccine was effective againstOmicron in India.[ 22]
Vaccine development was partly financed with $7 million from mostly private investors, including a $1 million donation byTito's Vodka .[ 23] [ 24] [ 17] [ 25] [ 26]
The evaluation of adjuvant components for use in a RBD based vaccine was partially enabled by NIH funding[ 27] [ 28]
The BioE company planned to priced the shot at ₹250 (around $3) per dose.[ 29]
The vaccine is not patented and is planned to be openly licensed underCOVAX .[ 17] [ 30]
^ "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.^a b c "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. Retrieved5 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 . ^ 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 . ^ "Covovax and Corbevax: What we know about India's new Covid vaccines" .BBC News . 28 December 2021.^ Raghavan P (10 June 2021)."Explained: How is Biological E's Corbevax different?" .The Indian Express . Retrieved29 December 2021 . ^ "Covovax and Corbevax: What we know about India's new Covid vaccines" .BBC News . 28 December 2021.^a b 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 . ^ Fliesler N (6 January 2022)."Another Angle of Attack" . Harvard Medical School. Retrieved23 June 2024 . ^ Basu N (25 April 2021)."US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan" .ThePrint . ^ "Coronavirus | Biological E gets nod to start Phase III trials of COVID-19 vaccine" .The Hindu . 24 April 2021.^a b Leo L (24 April 2021)."Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3" .mint . ^ 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 . ^ "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.^ "Health ministry buys 300 mn doses of Biological-E's Covid vaccine in advance" .Hindustan Times . 3 June 2021. Retrieved4 June 2021 .^a b c "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 fromthe original on 1 January 2022.^ 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. ^ Achom D (28 December 2021)."India Clears 2 New Vaccines And Merck's Covid Pill" .NDTV.com . ^ "Open-Source Vaccines Got More Funding From Tito's Vodka Than the Government" .www.vice.com . 11 January 2022. Retrieved25 January 2022 .^ Palca J (31 August 2022)."Whatever happened to the new no patent covid vaccine touted as a global game changer" . ^ "Corbevax as heterologous booster along wth [sic ] Covishield more effective against Covid-19 variants: Research" .Deccan Herald . 25 December 2022. Retrieved19 June 2023 .^ Pathak D (13 May 2020)."Tito's Handmade Vodka gives $1M grant for COVID-19 vaccine" .Baylor College of Medicine . Retrieved29 January 2022 . ^ "Supporting COVID-19 Research" .Tito's Vodka . 13 May 2020. Retrieved29 January 2022 .^ "A Texas team comes up with a COVID vaccine that could be a global game changer" .NPR.org . Retrieved15 January 2022 .^ Salam E (15 January 2022)."Texas scientists' new Covid-19 vaccine is cheaper, easier to make and patent-free" .the Guardian . Retrieved13 August 2022 . ^ 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 . ^ "Dynavax Awarded $17 Million Contract from National Institutes of Health" (Press release). Dynavax. 29 September 2008.^ Bharadwaj S (5 June 2021)."Bio E's Corbevax may be India's cheapest vaccine at Rs 250 per dose" .The Times of India . ^ Hotez PJ, Bottazzi ME (30 December 2021)."A COVID Vaccine for All" .Scientific American .Archived from the original on 30 December 2021. Retrieved2 January 2022 .
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