Biological E gets DCGI nod for Phase 3 clinical trials of Corbevax as booster dose

Amid the sudden surge in COVID-19 cases due to Omicron and the need for booster doses for better protection, Biological E has been given the nod by the Drug Controller General of India (DCGI) to conduct phase 3 trials of its vaccine Corbevax for booster shots.

Biological E, a Hyderabad-based pharmaceutical company on Tuesday received the emergency-use authorisation for manufacturing and marketing of Corbevax. This is the first indigenously developed receptor-binding domain (RBD) protein subunit vaccine against SARS-CoV-2.

This makes Biological E the second company after Bharat Biotech to conduct clinical trials for booster doses in India. India is rolling out its ‘precaution dose’ to frontline workers and senior citizens with comorbidities from January 10 with Bharat Biotech’s Covaxin.

About Corbevax

Corbevax is a two-dose vaccine which is India’s first indigenously developed protein subunit vaccine.

Receptor-binding domain (RBD) protein subunit vaccines are useful for people with compromised immune systems.

There is no live components due to which there is no risk of vaccine prompting disease and are also considered largely stable.

The vaccine maker Biological E pharmaceutical company plans to deliver more than 1 billion additional doses globally.

After the approval of the vaccine, Biological E’s previous application on using Corbevax for booster shots was also taken up.

Subject Expert Committee recommended granting of permission to conduct proposed phase 3 clinical trials on two conditions.

The first is the administration of booster dose after primary immunization should be studied in two cohorts of six and nine months.

This should be age-wise stratification and include 50% subjects with high risk or comorbidity condition.

The second condition by SEC is that the safety follow-up of Corbevax should be extended to nine months.