Corbevax Vaccine: Biological E gets approval to conduct phase 3 trials of its Covid vaccine as booster dose

Corbevax vaccine news: The Drug Controller General of India has given its approval to Hyderabad-based pharma company Biological E to conduct phase 3 trials of ‘Corbevax’, its COVID-19 vaccine, as a booster dose. The Subject Expert Committee (SEC), after detailed deliberation, recommended granting permission to conduct phase 3 clinical trials of Corbevax.

Hyderabad-based Biological E has become the second company after Bharat Biotech to conduct clinical trials for a booster dose. The company, on the basis of the approvals, has also been generating the data in a systematic manner to study booster dose.

Biological E gets approval to conduct trials of Corbevax as booster dose

Read @ANI Story | https://t.co/bHsOpZDkD0#BiologicalE #COVIDVaccine #COVID19 #Corbevax pic.twitter.com/IhYwXKztgr

— ANI Digital (@ani_digital) December 28, 2021

Corbevax: Clinical trials for booster dose on two conditions

The Subject Expert Committee of India has recommended granting permission to conduct the proposed phase 3 clinical trials of the Corbevax vaccine for boosters on two conditions:

1. The administration of Corbevax booster dose after the primary immunization must be studied in two cohorts of six and nine months with age-wide stratification. It must also include 50 percent of subjects with high risk or comorbidity conditions.

2. The second condition is that the safety follow-up must be extended to a period of nine months.

Corbevax efficacy: How Biological E was permitted to conduct trials for booster dose?

The Subject Expert Committee on December 10, 2021, in its meeting, reviewed the data provided by Hyderabad-based Biological E. The company had presented its revised clinical protocols for the conduct of phase 3 clinical trials to administer booster dose of COVID-19 vaccine that contain receptor-binding domain antigen of SARS-CoV-2.

Biological E had also submitted the six months safety follow-up after the second dose from Phase 1 clinical trials, 90 days of safety data from Phase 2 part, and 60 days of safety data from phase 2/3 and phase 3 active comparator study.

All About Corbevax:

Corbevax vaccine is India’s first indigenously developed protein subunit vaccine against COVID-19. Corbevax approval came after it received Emergency Use Authorisation from DCGI on December 28, 2021.

The vaccine maker company has been planing on delivering more than 1 billion additional doses globally.

Booster dose in India

PM Modi in an announcement on December 25, 2021, informed that the booster dose in India will be available from January 10, 2022, and it will start with the frontline and healthcare workers. With them, those above the age of 60 years with co-morbidities will also be eligible to receive the precautionary dose against COVID-19.