Corbevax

Last updated

Corbevax
Vaccine description
Target SARS-CoV-2
Vaccine type Protein subunit
Clinical data
Trade names Corbevax
Other namesBECOV2D
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]

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. [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]

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References

  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.
  3. 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. Retrieved 5 March 2021.
  4. Chui M (16 November 2020). "Biological E. Limited and Baylor COVID-19 vaccine begins clinical trial in India". Baylor College of Medicine.
  5. 1 2 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.
  8. 1 2 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.