India ill prepared despite lessons learnt in the first wave
Precious time was wasted before critical facilities began to be scaled up to meet the demands of the second wave that is accelerating at an unprecedented speed leading to healthcare…
Category: Clinical trial
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…
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…
SEC allows Bharat Biotech to unblind all participants above 45 years
The Subject Expert Committee (SEC) has permitted Bharat Biotech to unblind all phase-3 trial participants above 45 years and offer the vaccine to those who received a placebo. The reason: vaccines (including Covaxin) are already available under the immunisation programme, and therefore all the eligible age groups should be unblinded for vaccination.
Will intranasal vaccines confer sterilising immunity?
Developed by Washington University School of Medicine in St. Louis, the vaccine has been licensed to Bharat Biotech to carry out human clinical trials, manufacture the vaccine and distribute them…
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…
Vaccinate all above 45 years to avoid vaccine inequities
Roping in the private sector to support the government programme of vaccinating about 270 million people belonging to the two high-risk priority groups can surely speed up vaccination coverage. At…
