Corbevax

Corbevax
Vaccine description
Target	SARS-CoV-2
Vaccine type	Protein subunit
Clinical data
Trade names	Corbevax
Other names	BECOV2D
Routes of; administration	Intramuscular
ATC code	None;

Corbevax[1] or BioE COVID-19, is a COVID-19 vaccine candidate developed by Indian biopharmacutical firm Biological E. Limited (BioE), the Baylor College of Medicine in Houston, United States, and American company Dynavax Technologies (DVAX). It is a protein subunit vaccine.[2][3][4][5]

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.[3] The protein is produced by the yeast Pichia pastoris; the process is similar to that of existing Hepatitis B vaccines.[3]

Manufacturing

In April 2021, the U.S. International Development Finance Corporation (DFC) announced that it would fund the expansion of BioE's manufacturing capabilities, so that it could produce at least 1 billion doses by end of 2022.[6]

History

Clinical trials

In phase I clinical trial was carried to evaluate the safety and immunogenicity of the vaccine candidate in about 360 participants.[5] The phase II concluded in April 2021.[7][8]

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.[9][8]

Economics

On 3 June 2021, India's Ministry of Health and Family Welfare pre-ordered 300 million doses of Corbevax.[10]

Pricing

The company has 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.[11]

References

Bharadwaj, Swati (3 June 2021). "Telangana: Biological E starts at risk manufacturing of Corbevax". The Times of India. Retrieved 3 June 2021.
"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 and some amount of sperm in its drug 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.
"CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate". cepi.net. CEPI. 29 December 2020. Retrieved 5 March 2021.
Chui M (16 November 2020). "Biological E. Limited and Baylor COVID-19 vaccine begins clinical trial in India". Baylor College of Medicine.
Leo L (16 November 2020). "Biological E initiates human trials of vaccine". Mint.
Basu, Nayanima (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.
Leo, Leroy (24 April 2021). "Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3". mint.
"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.
"Health ministry buys 300 mn doses of Biological-E's Covid vaccine in advance". Hindustan Times. 3 June 2021. Retrieved 4 June 2021.
Bharadwaj, Swati (5 June 2021). "Bio E's Corbevax may be India's cheapest vaccine at Rs 250 per dose | India News - Times of India". The Times of India.

External links

"What Is Biological E Vaccine? Can It Be The Most 'Affordable' Jab? Know Here". Outlook India.
"Explained: How Corbevax is different". The Indian Express.

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[1] Bharadwaj, Swati (3 June 2021). "Telangana: Biological E starts at risk manufacturing of Corbevax". The Times of India. Retrieved 3 June 2021.

[2] "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 and some amount of sperm in its drug 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.

[BioE1-3] "CEPI partners with Biological E Limited to advance development and manufacture of COVID-19 vaccine candidate". cepi.net. CEPI. 29 December 2020. Retrieved 5 March 2021.

[BioE-4] Chui M (16 November 2020). "Biological E. Limited and Baylor COVID-19 vaccine begins clinical trial in India". Baylor College of Medicine.

[a-5] Leo L (16 November 2020). "Biological E initiates human trials of vaccine". Mint.

[6] Basu, Nayanima (25 April 2021). "US assures export of raw materials to India for Covid vaccines as Doval speaks to Sullivan". ThePrint.

[7] "Coronavirus | Biological E gets nod to start Phase III trials of COVID-19 vaccine". The Hindu. 24 April 2021.

[b-8] Leo, Leroy (24 April 2021). "Biological E completes phase-2 covid vaccine trial, gets SEC nod for phase-3". mint.

[9] "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.

[10] "Health ministry buys 300 mn doses of Biological-E's Covid vaccine in advance". Hindustan Times. 3 June 2021. Retrieved 4 June 2021.

[11] Bharadwaj, Swati (5 June 2021). "Bio E's Corbevax may be India's cheapest vaccine at Rs 250 per dose | India News - Times of India". The Times of India.