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Wednesday, September 30, 2020

Covaxin gets DSMB nod to continue human trials

Clinical trial sites studying the safety and effectiveness of Covaxin were recently given permission by the Data and Safety Monitoring Board (DSMB) to continue recruiting participants for the trial after it reviewed data from the first 50 participants that were vaccinated, they said.

Written by Prabha Raghavan | New Delhi | July 28, 2020 3:14:03 am
Covaxin’s trials started on July 15, with the All India Institute of Medical Sciences (AIIMS) vaccinating its first set of participants with the candidate. (File)

Indian COVID-19 vaccine candidate ‘Covaxin’ has crossed its first hurdle in its path to a potential launch, with a safety monitoring board allowing clinical trial sites to continue with human trials, three people close to the development confirmed.

Clinical trial sites studying the safety and effectiveness of Covaxin were recently given permission by the Data and Safety Monitoring Board (DSMB) to continue recruiting participants for the trial after it reviewed data from the first 50 participants that were vaccinated, they said.

This means that the board has found the vaccine safe enough to administer in humans at a higher dosage, according to Dr Savita Verma, the principal investigator for the trial taking place at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences in Rohtak. PGIMS had submitted data of around 20 participants for DSMB review and, following the clearance, has screened and vaccinated an additional 15 participants.

“Whenever we give a drug or vaccine for the first time (as part of a trial), we give it at low doses and in a smaller number of individuals because we have to see whether the vaccine will be safe enough to proceed,” Verma told The Indian Express.

“The issue always is that…we don’t know how our body is going to react to something new. So there’s always a chance of a (major) allergic reaction. That is the major concern in any investigator’s mind,” she said.

“So far, we haven’t seen any adverse events or major allergic reactions,” she added. The 20 participants vaccinated in the first set are expected to receive a second dose on July 31, according to her.

“The DSMB’s decision was communicated over email,” said another principal investigator.

Covaxin’s trials started on July 15, with the All India Institute of Medical Sciences (AIIMS) vaccinating its first set of participants with the candidate.

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