Expert committee allows trial for third dose of Covaxin
The Expert Committee of the country’s drug regulator DCGI has approved a third dose of covaxin to some volunteers in the clinical trial of Covid-19 vaccine to Bharat Biotech.
Bharat Biotech submitted a revised report to the Subject Expert Committee (SECG) of the Drug Controller General of India (SECGI) on a second phase clinical trial to deliver booster doses six months after the second dose.
The SEC said, “The company has reported amending the Phase II clinical trial approved to deliver booster doses six months after the second dose. After detailed deliberations, the committee recommended that the company be allowed to give six micrograms in the booster dose and that the trial should be considered for six months after the third dose. “
Bharat Biotech has also been asked to present primary and secondary targets and various evaluations in the test.
“Accordingly, the company (Bharat Biotech) should introduce a revised clinical trial protocol for evaluation,” the SEC said in its March 23 meeting description.
The SEC said, “After detailed deliberations, the committee recommended that the company may include partners in the age group over 45 years of age and offer free vaccines.”
The SEC further recommended that a protocol for a detailed revised clinical trial, incorporating Brazilian studies with revised statistical evaluation, be introduced to assess the vaccine’s impact.
