Covaxin human trial 2nd phase at PGIMS from today

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Covaxin human trial 2nd phase at PGIMS from today

Sat Singh TNN

Rohtak: 26.07.2020

A week after human trial of Covaxin — the country’s foremost vaccine candidate for Covid-19 — started at Rohtak’s Post-Graduate Institute of Medical Sciences (PGIMS), it got approval from Data Safety Monitoring Board to start the second phase of the trial from Saturday.

The board studied the reports of all people who underwent trial and after satisfaction with the progress, permission was given to initiate the second phase, said Dr Savita Verma, who is also the principal investigator of the study. Covaxin was given to volunteers in Rohtak on July 17 and after it showed no adverse impact the second phase of the trial was given the go-ahead.

Dr Verma said till date PGIMS Rohtak has administered covaxin to 26 subjects.

Covaxin has been developed by the Hyderabad-based pharmaceutical firm Bharat Biotech in collaboration with National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR).

In the second phase, they would conduct trials on more number of subjects upon finding their samples as per criteria but the number is not fixed.

PGIMS pharmacology department professor Ramesh Verma said in the second phase of trial-1, Covaxin would be given to 30 more new subjects and their second dose would follow after two weeks.

The effect of the vaccine are being assessed for two things — generation of antibodies after administration of the vaccine and any adverse reaction caused by it, said the professor.

“All the subjects at PGIMS Rohtak who voluntarily came forward are in the pink of their health and fine,” Dr Verma said, adding that doctors were calling all the people part of the trial twice in the day and inquiring about their health.

On how long it would take to prove the efficacy of the vaccine, Dr Verma said blood samples of the trial subjects would be taken after 28 days to assess how many antibodies they had developed against the coronavirus.

“If the antibodies are produced in good numbers, it would prove that the vaccine is doing its job perfectly. The first part ie it does not have any side effect is also proved with no adverse effect reported so far on the subjects,” the two professors added.

Rohtak has 150 volunteers who want to take part in the trial for the vaccine.

“In the screening process, the volunteers who are healthy and do n’t have chronic illness or diabetes like diseases would be given a chance to be part of the trial process,” they added.