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All about CorbeVax® Biological E’s COVID-19 Vaccine

Biological E. Limited CorbeVax® COVID-19 Vaccine (BioE COVID-19, BECOV2D) is based on classical a protein subunit vaccine technology of a protein antigen. In this vaccine, SARS-CoV-2 Spike receptor-binding domain (RBD) is adsorbed to the adjuvant Alhydrogel (Alum), with another approved adjuvant, CpG 1018. CorbeVax uses a harmless piece of the spike protein to stimulate and prepare the immune system for future encounters with the beta coronavirus.

The Biological E. RBD of the S1 subunit binds to the Angiotensin-Converting Enzyme-2 (ACE2) receptor on the host cell membrane and facilitates virus entry. The protein is expressed in yeast Pichia pastoris and is similar to Bio E’s technology for large-scale commercial production of Hep B vaccines.

How is CorbeVax Manufactured?

Baylor College of Medicine developed construct “RBD N1C1” which was selected as the final vaccine antigen candidate based on its manufacturing ability, due to the yields of protein antigen achieved, ease of process steps, and favorable formulation aspects. The vaccine antigen’s initial construct and production process were developed at Texas Children’s Hospital in Houston, Texas, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures. Texas Children’s Hospital CVD received philanthropic support for developing this vaccine from many generous donors across the country, including a significant contribution from The JPB Foundation in May 2020.

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 India’s Phase I/II clinical study to select the final vaccine candidate to be tested in subsequent studies. Potential advantages of this vaccine include scalability and thermostability, which could make it suitable for deployment in low-resource countries.

CorbeVax and the EUAs in India

Biological E. announced on February 21, 2022, that the CorbeVax vaccine received emergency use authorization (EUA) from India’s DCGI for the 12 to 18-year age group and for the 12-14 age group on March 17, 2022. In addition, the Subject Expert Committee (SEC) recommended granting EUA for Corbevax for children in the five to 11 years age group with certain conditions on April 21, 2022. The DCGI initially approved CorbeVax for restricted use in emergencies among adults on December 28, 2021. On June 4, 2022, the DCGI approved CorbeVax as a heterologous COVID-19 booster dose for adults.

As of March 16, 2022, the Company confirmed its capacity to produce 100+ million doses per month. Currently, about 1,500 people work at the manufacturing facilities. In addition, the Company publishes Package Insert, FAQs, and Fact Sheet.

Hyderabad-based Biological E. Limited (BE) 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. BE supplies vaccines to over 100 countries, and its therapeutic products are sold in India and the USA. The company currently has eight WHO-prequalified vaccines in its portfolio. BE started its vaccine manufacturing journey in 1962.

CorbeVax Availability

As of June 11, 2022, the CorbeVax vaccine was available in India and Botswana. BE has supplied about 100 million doses to the Government of India and it has been administered to children, including 17.4 million who have completed the two-dose regimen.

CorbeVax Booster

BE conducted a multicentre Phase III placebo-controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age who were previously vaccinated with two doses of either COVISHIELD or COVAXIN at least 6 months prior to the administering CORBEVAX as a booster dose. The booster dose of CORBEVAX increased the neutralizing antibody titers in the COVISHIELD and COVAXIN groups significantly when compared to the placebo.

In a subset of subjects evaluated for nAb against the Omicron variant, the CORBEVAX booster shot resulted in a significant increase in the nAb titers against the Omicron variant. After the booster dose of CORBEVAX, Omicron nAbs were observed in 91% and 75% of subjects who had received primary vaccination by COVISHIELD and COVAXIN, respectively. The booster dose also resulted in significant Th1 skewed cellular immune response as indicated by cytokine expression analysis post-stimulation of the T-cells.

CorbeVax Omicron BA Sublineages

The SARS-CoV-2 virus has undergone mutations in a short duration. In clinical trials, CORBEVAX-induced immune response demonstrated consistent neutralization of the ancestral SARS-COV-2 strain and the Variants of Concern such as Beta, Delta, and Omicron. Given its recent designation, Omicron/B.1.1.529 therapeutic activity data is currently being reported rapidly. As of June 2, 2022, the U.S. NIH OpenData Portal is working to ingest all applicable in vitro activity data for Omicron, but given the breaking nature of these releases, Omicron data should be interpreted with caution.

CorbeVax Adolescents

According to the India Union Ministry of Health and Family Welfare (MoHFW), as of April 1, 2022, Corbevax is available for adolescents aged 12-14 years and was approved based on its interim safety and immunogenicity data. Corbevax is the only COVID-19 vaccine approved in India for this age group. CorbeVax vaccination appointments in India can be scheduled at this CoWIN weblink. In Madurai, 69,528 children were vaccinated, accounting for 78% coverage for the first dose, as of April 12, 2022. No cases of adverse reactions have been reported.

CorbeVax Indication

The CorbeVax COVID-19 Vaccine candidate is indicated to prevent COVID-19. 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 incorporating adjuvants to elicit a strong protective immune response because the antigens alone are not sufficient to induce adequate long-term immunity, says the US NIH.

CorbeVax Dosage

For eligible children, adolescents, and adults in India, two doses, separated by 28 days, are authorized. According to the Corbevax phase 2/3 clinical trial, 624 children participated. Media reports that efficacy data is pending. The vaccine is stored at 2 to 8 degrees Celsius.

CorbeVax Price

Biological E. Limited announced on May 16, 2022, that it has reduced the price of CORBEVAX from Rs.840 to Rs.250 a dose inclusive of GST, for Private COVID-19 Vaccination Centres. For the end-user, the price would be Rs.400 a dose, including taxes and administration charges.

Source: https://www.precisionvaccinations.com/vaccines/corbevax-covid-19-vaccine

Author

Dr Shilpa Subramanian

Dr. Shilpa Subramanian is a Periodontist and currently manages Global Pharmacovigilance Operations at Indegene Pvt Ltd. She is passionate about staying ahead of the curve in clinical and non-clinical advances in the field of pharma and healthcare.

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