Biological E gets nod to study Corbevax as a booster dose

The Subject Expert Committee has recommended grant of permission to conduct Phase 3 trials under certain conditions

Biological E’s Corbevax has received the go-ahead to conduct trials to find out whether it can be administered as a booster dose. The Subject Expert Committee has recommended grant of permission to conduct Phase 3 trials under certain conditions.

The company is asked to study the administration of booster dose in two cohorts of six and nine months with age-wise categorisation. About 50 per cent should be in the high-risk category or with co-morbidities. The company is expected to extend safety follow-ups of upto nine months after the administration of the booster dose.
Earlier on December 28th, Corbevax received Emergency Use Authorisation from the Drugs Controller General of India (DCGI).

Corbevax is India’s first indigenously developed protein sub-unit vaccine against Covid-19.

Corbevax is a “recombinant protein sub-unit” vaccine, developed from the receptor binding domain (RBD) of the spike protein on the virus’s surface combined with Dynavax’s CpG 1018 adjuvant with alum, which helps the body build the immune response against the virus. The vaccine has been developed by Biological E. Limited in collaboration with Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine (Baylor) in Houston, Texas.

Biological E. Limited's Corbevax has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well tolerated and immunogenic.

In the pivotal Phase III study conducted with an endpoint of immunogenic superiority, Corbevax demonstrated superior immune response in comparison with Covishield vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. The vaccination also generated significant Th1 skewed cellular immune response

Corbevax nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies.

Corbevax nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies.

While none of the subjects who took Corbevax or Covishield had serious adverse events, Corbevax had 50 percent fewer adverse events than Covishield

In the continuous monitoring of phase II studies, Corbevax showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines.

The Government of India, Ministry of Health & Family Welfare said, “We are glad that India has produced yet another Covid-19 vaccine. We believe that this vaccine will address the needs of the world and help the global population fighting against the spread of Covid-19.