Biological E gets nod to conduct trials of its Corbevax as booster dose
Hyderabad-based Biological E has got the Drug Controller General of India's nod to conduct trials of its vaccine Corbevax as booster shots, news agency ANI reported. This makes Biological E the second company after Bharat Biotech to conduct clinical trials for booster doses. India has already rolled out its plan to administer booster doses, which is being called 'precaution dose' in the country, from January 10. Bharat Biotech's Covaxin will be administered as precaution doses to frontline workers and senior citizens with comorbidities.
The Subject Expert Committee (SEC) recommended granting of permission to conduct proposed phase 3 clinical trials for boosters of biological vaccine subject to the two conditions: The first is that the administration of booster dose after primary immunization should be studied in two cohorts of six and nine months with age-wise stratification and including 50 per cent subjects with high risk or comorbidity condition. The second is that the safety follow-up should be extended to nine months, ANI reported.
On December 10, the committee reviewed the data provided by Biological E, which had presented its revised clinical trial protocol for the conduct of phase 3 clinical trial for the administration of booster dose of COVID-19 vaccine containing receptor-binding domain (RBD) antigen of SARS-CoV-2.
Corbevax, a two-dose vaccine, is India's first indigenously developed protein subunit vaccine which has been included in India's arsenal of vaccines against SARS-CoV-2 on Tuesday after it got the DCGI nod. The vaccine maker company plans to deliver more than 1 billion additional doses globally.