CorbeVax COVID-19 Vaccine Description
Biological E. Limited CorbeVax COVID-19 Vaccine candidate (BioE COVID-19) is based on classical vaccine technology of a protein antigen, SARS-CoV-2 Spike RBD, adsorbed to the adjuvant Alhydrogel (Alum), in combination with another approved adjuvant, CpG 1018.
The RBD of the S1 subunit binds to the Angiotensin-Converting Enzyme-2 (ACE2) receptor on the host cell membrane and facilitates virus entry. RBD protein is expressed in yeast Pichia pastoris and is similar to Bio E's technology for large-scale commercial production of Hep B vaccines.
The Baylor College of Medicine construct “RBD N1C1” was selected as the final vaccine antigen candidate based on its manufacturability due to the yields of protein antigen achieved, ease of process steps, and favorable formulation aspects.
The combination of Alum with Dynavax Technologies Corporation’s CpG with N1C1 antigen elicited a highly synergistic, balanced immune response in preclinical models. Four formulations with these components are currently being evaluated in Phase I/ II clinical study in India to select the final vaccine candidate to be tested in subsequent Phase III trials. Potential advantages of this vaccine candidate include scalability and thermostability, which could make it suitable for deployment at scale in low-resource settings.
“We are delighted with the success of the Phase I/II clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials,” said Ms. Mahima Datla, Managing Director, Biological E. Limited, in a press statement issued on April 24, 2021.
Hyderabad-based Biological E. Limited is a Pharmaceuticals & Biologics Company founded in India in 1953. It is the first private sector biological products company in India and the first pharmaceutical company in Southern India. It supplies its vaccines to over 100 countries, and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio.
CorbeVax COVID-19 Vaccine Indication
CorbeVax COVID-19 Vaccine candidate is indicated to prevent COVID-19, a disease caused by the SARS-CoV-2 beta coronavirus.
Instead of the entire pathogen, subunit vaccines include only the components, or antigens, that best stimulate the immune system. Although this design can make vaccines safer and easier to produce, it often requires the incorporation of adjuvants to elicit a strong protective immune response because the antigens alone are not sufficient to induce adequate long-term immunity, says the U.S. NIH.
CorbeVax COVID-19 Vaccine Price
Biological E’s Corbevax vaccine pricing could be Rs 500 for two doses, The Times of India reported.
CorbeVax COVID-19 Vaccine News
June 10, 2021 - The India Express reported: India has placed an advance order to block 300 million doses of a new Covid-19 vaccine, Corbevax, from Hyderabad-based company Biological E. What is this vaccine and why is it important for India?
June 4, 2021 - Local media reported the Indian government confirmed it would make an advance payment of Rs 1,500 crore to Biological E to reserve 30 crore doses of its under-development Covid-19 vaccine.
April 24, 2021 - Biological E. Limited announced that it had completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization - Subject Expert Committee.
December 29, 2020 - CEPI, the Coalition for Epidemic Preparedness Innovations and Biological E Limited, India (Bio E), announced a collaboration to advance the development and manufacture of Bio E’s COVID-19 subunit vaccine candidate. CEPI will initially contribute up to $5m toward the cost of scaling up the process for manufacturing the vaccine and will potentially explore providing additional funding to Bio E to enable the production of 100 million doses in 2021. The candidate has also received seed funding from the Department of Biotechnology, Government of India.
November 17, 2020 - Biological E. Ltd initiates Phase 1 and 2 clinical trials in India. Biological E’s vaccine candidate includes an antigen licensed from BCM Ventures and an advanced adjuvant CpG 1018, which Dynavax supplies.
CorbeVax COVID-19 Vaccine Clinical Trials
The Phase I/II clinical trial evaluated the safety and immunogenicity of the vaccine candidate in about 360 healthy subjects aged 18-65 years. The schedule consisted of two doses for each participant, administered via intramuscular injection, 28 days apart. Bio E’s novel Covid-19 vaccine was found to be safe, well-tolerated, and immunogenic.
The Phase III clinical study will be conducted in 15 sites across India will further evaluate the immunogenicity and safety of Biological E’s SARS-CoV-2 vaccine for protection against COVID-19 in about 1,268 healthy subjects aged 18-80 years.