Biological E. Limited (BE) on Saturday announced that it’s COVID-19 vaccine Corbevax has been approved as a booster shot for adults in India. 

It was approved as a regular vaccination, by the DGCI, in December last year. 

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CORBEVAX is a “recombinant protein sub-unit” vaccine made from the receptor biding domain (RBD) of the virus’s surface spike protein and Dynavax’s CpG 1018 adjuvant with alum, which aids the body’s immune reaction against the virus.

Biological E. Limited worked with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas, to produce the vaccine.

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According to B.E, the vaccination will be effective in terms of scalability and affordability, allowing low- and middle-income countries to have long-term access.

CORBEVAX in December had completed two phase III clinical trials involving over 3000 patients ranging in age from 18 to 80 years old across 33 study sites in India. It was discovered that the vaccination was safe, well-tolerated, and immunogenic.

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When measured for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variation in a critical phase III study with an endpoint of immunogenic superiority, CORBEVAX outperformed COVISHIELD vaccination in terms of immune response. A strong Th1 skewed cellular immune response was also induced by CORBEVAXTM immunisation.

Based on the Correlates of Protection assessment completed during Moderna and Astra-Zeneca vaccine Phase III investigations, CORBEVAX nAb GMT against Ancestral-Wuhan strain is suggestive of vaccine effectiveness of more than 90% for prevention of symptomatic infections.

Based on published research, CORBEVAX nAb GMT against the Delta strain has a vaccination efficacy of more than 80% for the prevention of symptomatic infections.

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While neither CORBEVAX nor COVISHIELD caused major side effects, CORBEVAX had 50 percent less side effects than COVISHIELD.

In continuous monitoring of phase II studies, CORBEVAX demonstrated high immune response durability, as seen by a decline in nAb GMT of less than 30% until six months after the second dosage, compared to more than 80% for the majority of vaccinations.