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Category: Clinical trial

Posted on January 1, 2022January 1, 2022

The basis on which India approves precaution dose remains unclear

He said the primary focus of the government was on giving a second dose of the vaccine to make people fully vaccinated. “Administering the second dose of COVID-19 vaccine to…

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Posted on December 11, 2021December 12, 2021

Does the Omicron variant make a case for booster doses?

At a recent meeting, the National Technical Advisory Group on Immunisation maintained that it was not recommending a booster dose for any section of the population, priority groups included, in…

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Posted on October 2, 2021

Soon mRNA vaccines for young children who rarely suffer from severe disease

On September 20, Pfizer released details of the trial that showed the vaccine was safe and generated a “robust” antibody response in young children. Going by past experience, the FDA…

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Posted on April 20, 2021

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…

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Posted on April 20, 2021April 20, 2021

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…

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Posted on April 13, 2021April 13, 2021

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…

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Posted on April 1, 2021April 1, 2021

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.

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Posted on April 1, 2021

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…

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