Can Covaxin booster dose prolong protection?
In a meeting held on March 24, the Subject Expert Committee of the India drug regulator permitted Bharat Biotech to carry out a phase-2 trial of Covaxin wherein a booster…
Category: DCGI
In a major shift, India fast-tracks restricted use approval for vaccines developed in other countries
The vaccines that would be eligible for the fast-track approval will include those that have been granted an EUA by the US Food and Drug Administration (FDA), European Medicines Agency…
Health Ministry reveals the names of SEC members for vaccine approval
Names of the ten members Dr. Varsha Gupta, Professor, Department of Microbiology, Government Medical College Hospital, Chandigarh; 2) Dr. Archana Thakur, Medical Director, Professor and HOD (Microbiology), G.B. Pant Hospital,…
Should Covaxin trial continue till 130 cases are recorded?
According to details posted on the clinical trial registry, the company had planned to “continue the phase-3 trial until 130 study participants developed PCR-confirmed symptomatic COVID-19 disease during follow-up beginning…
Covaxin should no longer be available in ‘clinical trial mode’
The vaccine efficacy was measured based on symptomatic COVID-19 disease — mild, moderate or severe — two weeks after the second dose. The interim analysis undertaken at the first endpoint…
With two vaccines approved for restricted use, can placebos be used in trials?
In both these cases, the SEC allowed the vaccine manufacturers to use a placebo in the control arm even as two vaccines — Covishield and Covaxin — have been granted…
Causality assessment of COVID-19 vaccine deaths will be made public, says National AEFI Committee advisor
On January 31, when 11 deaths of health-care and frontline workers were reported from across the country following administration of Serum Institute’s Covishield vaccine nearly two-dozen scientists and others wrote…
Updated efficacy results underline the benefits of delaying second dose of Oxford vaccine
The data in the preprint show that vaccine efficacy was high when the interval between the two doses was two months and continued to increase with a longer dose interval.…
