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“Considering the emergency and unmet medical need in Covid-19, the SEC on December 27 recommended for grant of permission to manufacture and market the Molnupiravir for restricted use under emergency…
India approved Covishield with an interval of four-six weeks between two doses despite the MHRA approving AstraZeneca with a 4-12 weeks gap and JCVI approving a 12-week prime-boost interval. What…
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…
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…
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,…
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…
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…
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…
Science Chronicle 