Corbevax is a

protein subunit In structural biology, a protein subunit is a polypeptide chain or single protein molecule that assembles (or "''coassembles''") with others to form a protein complex. Large assemblies of proteins such as viruses often use a small number of ty ...

COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...

developed by

Texas Children's Hospital Texas Children's Hospital is a nationally ranked, freestanding 973-bed, acute care women's and children's hospital located in Houston, Texas. It is the primary pediatric teaching hospital affiliated with Baylor College of Medicine and is located wit ...

Center for Vaccine Development and

Baylor College of Medicine Baylor College of Medicine (BCM) is a medical school and research center in Houston, Texas, within the Texas Medical Center, the world's largest medical center. BCM is composed of four academic components: the School of Medicine, the Graduate Sc ...

Houston, Texas Houston (; ) is the most populous city in Texas, the most populous city in the Southern United States, the fourth-most populous city in the United States, and the sixth-most populous city in North America, with a population of 2,304,580 in ...

and Dynavax technologies based in Emeryville, California. It is licensed to Indian biopharmaceutical firm

Biological E. Limited Biological E Limited (also known as BioE) is an Indian biotechnology and biopharmaceutical company based in Hyderabad, Telangana. It specialises in the areas of low-cost vaccine production. __TOC__ History The company was founded by Dr. D.V.K. ...

(BioE) for development and production.

Technology

The vaccine consists of a version of the receptor binding domain (RBD) of the

SARS‑CoV‑2 Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a p ...

spike protein In virology, a spike protein or peplomer protein is a protein that forms a large structure known as a spike or peplomer projecting from the surface of an enveloped virus. as cited in The proteins are usually glycoproteins that form dimers or ...

, together with the

adjuvants In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analgesi ...

aluminium hydroxide Aluminium hydroxide, Al(OH)3, is found in nature as the mineral gibbsite (also known as hydrargillite) and its three much rarer polymorphs: bayerite, doyleite, and nordstrandite. Aluminium hydroxide is amphoteric, i.e., it has both basic and ...

gel and CpG 1018. The protein is produced by the

yeast Yeasts are eukaryotic, single-celled microorganisms classified as members of the fungus kingdom. The first yeast originated hundreds of millions of years ago, and at least 1,500 species are currently recognized. They are estimated to constitut ...

Pichia pastoris ''Pichia pastoris'' is a species of methylotrophic yeast. It was found in the 1960s, with its feature of using methanol as a source of carbon and energy. After years of study, ''P. pastoris'' was widely used in biochemical research and biotech i ...

''; the process is similar to that of existing

Hepatitis B vaccine Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and th ...

Manufacturing

In April 2021, the

U.S. International Development Finance Corporation The United States International Development Finance Corporation (DFC) is a development finance institution and agency of the United States federal government. DFC invests in development projects primarily in lower and middle-income countries. Fi ...

(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.

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. The phase II concluded in April 2021. In April 2021, the

Drugs Controller General of India Drugs Controller General of India (DCGI) is the head of department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood p ...

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. 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.

Society and culture

Legal status

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

Economics

The development of the vaccine was financed with $7 million from mostly private investors, including a $1 million donation by

Tito's Vodka Tito's Handmade Vodka is a vodka brand made by Fifth Generation, founded by Tito Beveridge in 1997 in Austin, Texas – specializing in vodka made from yellow corn, rather than potatoes or wheat. It is distilled 6 times and unaged. Marketing i ...

. The vaccine technology is given patent-free to manufacturers, although Baylor College receives a fee. On 3 June 2021, India's

Ministry of Health and Family Welfare The Ministry of Health and Family Welfare is an Indian government ministry charged with health policy in India. It is also responsible for all government programs relating to family planning in India. The Minister of Health and Family Welfare ...

pre-ordered 300 million doses of Corbevax. 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. 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 COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Hea ...

. In January 2022, the scientists developing Corbevax have declared that 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 that Moderna had received much more support.

References

External links

* * {{Portal bar , Medicine , Viruses , COVID-19 Clinical trials Indian COVID-19 vaccines Science and technology in India Protein subunit vaccines Products introduced in 2021