Corbevax

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. As the RBD protein is poorly immunogenic alone, adjuvantation is essential for a RBD-based vaccine immunogenicity.{{cite journal | vauthors = Nanishi E, Borriello F, O'Meara TR, McGrath ME, Saito Y, Haupt RE, Seo HS, van Haren SD, Cavazzoni CB, Brook B, Barman S, Chen J, Diray-Arce J, Doss-Gollin S, De Leon M, Prevost-Reilly A, Chew K, Menon M, Song K, Xu AZ, Caradonna TM, Feldman J, Hauser BM, Schmidt AG, Sherman AC, Baden LR, Ernst RK, Dillen C, Weston SM, Johnson RM, Hammond HL, Mayer R, Burke A, Bottazzi ME, Hotez PJ, Strych U, Chang A, Yu J, Sage PT, Barouch DH, Dhe-Paganon S, Zanoni I, Ozonoff A, Frieman MB, Levy O, Dowling DJ | title = An aluminum hydroxide:CpG adjuvant enhances protection elicited by a SARS-CoV-2 receptor binding domain vaccine in aged mice | journal = Science Translational Medicine | volume = 14 | issue = 629 | pages = eabj5305 | date = January 2022 | pmid = 34783582 | pmc = 10176044 | doi = 10.1126/scitranslmed.abj5305 }} 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.{{Cite web | vauthors = Fliesler N |url=https://hms.harvard.edu/news/another-angle-attack |title=Another Angle of Attack |date=6 January 2022 |access-date=23 June 2024 |publisher=Harvard Medical School}} Two adjuvants — aluminum hydroxide and CpG—proved to be the most successful combination when added to the RBD protein, 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.

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.{{cite news | vauthors = Basu N |title=US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan |url=https://theprint.in/diplomacy/us-assures-export-of-raw-materials-to-india-for-covid-vaccines-as-doval-speaks-to-sullivan/646030/ |work=ThePrint |date=25 April 2021 }}

A phase I clinical trial was carried out to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants. The phase II concluded in April 2021.{{cite news |title=Coronavirus {{!}} Biological E gets nod to start Phase III trials of COVID-19 vaccine |url=https://www.thehindu.com/business/biological-e-gets-nod-to-start-phase-iii-trials-of-covid-19-vaccine/article34400287.ece |work=The Hindu |date=24 April 2021 }}{{cite news | vauthors = Leo L |title=Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3 |url=https://www.livemint.com/news/india/biological-e-completes-phase-2-covid-vaccine-trial-gets-sec-nod-for-phase3-11619261685348.html |work=mint |date=24 April 2021 }}{{cite journal | vauthors = Thuluva S, Paradkar V, Gunneri SR, Yerroju V, Mogulla R, Turaga K, Kyasani M, Manoharan SK, Medigeshi G, Singh J, Shaman H, Singh C, Rao AV | title = 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 | journal = eBioMedicine | volume = 83 | issue = | pages = 104217 | date = August 2022 | pmid = 35970020 | doi = 10.1016/j.ebiom.2022.104217 | pmc = 9372721 }}

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.{{cite web|website=ctri.nic.in|publisher=Clinical Trials Registry India|title=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.|id=CTRI/2021/06/034014 |url=http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56379|url-status=live|date=5 June 2021|archive-url=https://web.archive.org/web/20210605032027/http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56379 |archive-date=5 June 2021 }} On 3 June 2021, India's Ministry of Health and Family Welfare pre-ordered 300 million doses.{{Cite web |date=3 June 2021 |title=Health ministry buys 300 mn doses of Biological-E's Covid vaccine in advance |url=https://www.hindustantimes.com/india-news/health-ministry-buys-300-mn-doses-of-biological-e-s-covid-vaccine-in-advance-101622691849144.html |access-date=4 June 2021 |website=Hindustan Times}}

As of December 2021, Biological E announced positive results, but some experts criticized the lack of public data from phase III trials. The developer specifically claimed the vaccine appeared to be over 90% effective against the original variant based on antibody levels.{{cite journal | vauthors = Prakash S | title = Development of COVID 19 vaccine: A summarized review on global trials, efficacy, and effectiveness on variants | journal = Diabetes & Metabolic Syndrome | volume = 16 | issue = 4 | pages = 102482 | date = April 2022 | pmid = 35427915 | pmc = 8990436 | doi = 10.1016/j.dsx.2022.102482 | publisher = Elsevier BV | quote = "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." }} On 28 December 2021, India approved the vaccine for emergency use.{{cite news |date=28 December 2021 |title=India Clears 2 New Vaccines And Merck's Covid Pill |work=NDTV.com |url=https://www.ndtv.com/india-news/coronavirus-2-more-vaccines-covovax-and-corbevax-and-anti-viral-drug-molnupiravir-cleared-in-india-2675170 |vauthors=Achom D}}

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.{{Cite web |title=Open-Source Vaccines Got More Funding From Tito's Vodka Than the Government |url=https://www.vice.com/en/article/open-source-vaccines-got-more-funding-from-titos-vodka-than-the-government/ |access-date=25 January 2022 |website=Vice.com |date=11 January 2022 |language=en}}

As of August, 70 million doses had been administered to adolescents in India. It was also approved by the Botswana Medicines Regulator Authority.{{Cite news | vauthors = Palca J |date=31 August 2022 |title=Whatever happened to the new no patent covid vaccine touted as a global game changer |url=https://www.npr.org/sections/goatsandsoda/2022/08/31/1119947342/whatever-happened-to-the-new-no-patent-covid-vaccine-touted-as-a-global-game-cha}} A study reported that the heterologous (Corbevax plus Zycov-D) vaccine was effective against Omicron in India.{{Cite web |date=25 December 2022 |title=Corbevax as heterologous booster along {{sic|nolink=y|reason=error in source|wth}} Covishield more effective against Covid-19 variants: Research |url=https://www.deccanherald.com/science-and-environment/corbevax-as-heterologous-booster-along-wth-covishield-more-effective-against-covid-19-variants-research-1174903.html |access-date=19 June 2023 |website=Deccan Herald |language=en}}

Vaccine development was partly financed with $7 million from mostly private investors, including a $1 million donation by Tito's Vodka.{{cite web | url=https://www.bcm.edu/news/titos-handmade-vodka-gives-1m-grant-for-covid-19-vaccine | title=Tito's Handmade Vodka gives $1M grant for COVID-19 vaccine | publisher=Baylor College of Medicine | date=13 May 2020 | vauthors = Pathak D | access-date=29 January 2022}}{{cite web | publisher=Tito's Vodka | title=Supporting COVID-19 Research | url=https://www.titosvodka.com/stories/supporting-covid-19-research/ | date=13 May 2020 | access-date=29 January 2022}} The vaccine technology, for antigen production and use, is given patent-free to manufacturers, although Baylor College receives a fee.{{Cite news|date=30 December 2021|title=A new coronavirus vaccine heading to India was developed by a small team in Texas. It expects nothing in return.|newspaper=The Washington Post|url=https://www.washingtonpost.com/world/2021/12/30/corbevax-texas-childrens-covid-vaccine/|archive-url=https://archive.today/20220101164442/https://www.washingtonpost.com/world/2021/12/30/corbevax-texas-childrens-covid-vaccine/|archive-date=1 January 2022}}{{Cite news|title=A Texas team comes up with a COVID vaccine that could be a global game changer|language=en|work=NPR.org|url=https://www.npr.org/sections/goatsandsoda/2022/01/05/1070046189/a-texas-team-comes-up-with-a-covid-vaccine-that-could-be-a-global-game-changer|access-date=15 January 2022}}{{cite web | vauthors = Salam E | title=Texas scientists' new Covid-19 vaccine is cheaper, easier to make and patent-free | website=the Guardian | date=15 January 2022 | url=https://www.theguardian.com/us-news/2022/jan/15/corbevax-covid-vaccine-texas-scientists | access-date=13 August 2022}}

The evaluation of adjuvant components for use in a RBD based vaccine was partially enabled by NIH funding{{cite journal | vauthors = Dowling DJ, Levy O | title = A Precision Adjuvant Approach to Enhance Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccines Optimized for Immunologically Distinct Vulnerable Populations | journal = Clinical Infectious Diseases | volume = 75 | issue = Suppl 1 | pages = S30–S36 | date = August 2022 | pmid = 35512145 | pmc = 9129145 | doi = 10.1093/cid/ciac342 }} along with prior funding to support development of the CpG adjvuant for use in vaccines.{{Cite press release |date=29 September 2008 |title=Dynavax Awarded $17 Million Contract from National Institutes of Health |url=https://investors.dynavax.com/news-releases/news-release-details/dynavax-awarded-17-million-contract-national-institutes-health |publisher=Dynavax}}

The BioE company planned to priced the shot at ₹250 (around $3) per dose.{{cite news | vauthors = Bharadwaj S |title=Bio E's Corbevax may be India's cheapest vaccine at Rs 250 per dose |url=https://timesofindia.indiatimes.com/india/bio-es-corbevax-may-be-indias-cheapest-vaccine-at-rs-250-per-dose/articleshow/83249282.cms |work=The Times of India |date=5 June 2021 }}

The vaccine is not patented and is planned to be openly licensed under COVAX.{{cite web| vauthors = Hotez PJ, Bottazzi ME |date=30 December 2021|title=A COVID Vaccine for All|url=https://www.scientificamerican.com/article/a-covid-vaccine-for-all/|url-status=live|access-date=2 January 2022|website=Scientific American|archive-url=https://web.archive.org/web/20211230172714/https://www.scientificamerican.com/article/a-covid-vaccine-for-all/ |archive-date=30 December 2021 }}

• Sanofi–GSK COVID-19 vaccine

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• {{cite news |title=What Is Biological E Vaccine? Can It Be The Most 'Affordable' Jab? Know Here |url=https://www.outlookindia.com/website/story/india-news-what-is-biological-e-vaccine-can-it-be-the-most-affordable-jab-know-here/382732 |work=Outlook India}}
• {{cite news |title=Explained: How Corbevax is different |url=https://indianexpress.com/article/explained/corbevax-vaccine-biological-e-india/ |work=The Indian Express }}

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