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Friday, February 26, 2021

‘Transparency in Covaxin trial could have built confidence’

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By Ashish Srivastava, (IANS) Dr Vikas Dogra, one of the 3,000 healthcare workers who received the first jab of Covid vaccine ‘Covaxin’ nationwide, told IANS on Saturday that the opaqueness in the data of clinical trials for Covaxin, manufactured by Bharat Biotech, has led to a loss of confidence among the people and healthcare workers.

“The low transparency before the public in clinical trial data has led to low confidence in Covaxin. The firm should have come out with the data it presented for the accelerated approval for emergency use,” he stated.

Dr Dogra also said that the drug regulatory body also should have been more transparent in presenting the evidence which lead to Covaxin’s approval.

“However, I have full faith in Subject Expert Committee (SEC) whose experts recommended it (Covaxin) for the emergency rollout,” he added.

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“Such acts create a perception among the minds of the people. The transparency will eventually overcome the rumours and would enable more confidence in the vaccines,” he said.

He was the first to get the vaccine shot at Rajiv Gandhi Super Speciality Hospital (RGSSH) which is administering ‘Covishield’ to its healthcare workers on the launch of countrywide Covid immunisation programme.

Dr Dogra is the head of department of Pulmonary Medicine at the hospital.

When asked whether he faced any complication post the administration, Dr Dogra said that he didn’t even feel the momentary pain of the injection needle. “I’m absolutely fine. No complications,” he added.

He also appealed to people to come forward without any hesitation and take the vaccine shot.

A countrywide Covid inoculation drive which begun on Saturday is underway at around 3,000 centres. The current beneficiaries of this drive are 1 crore healthcare workers.

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Covaxin has been in the spotlight since it was recommended for restricted emergency use by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). Later, it was approved on January 3 for the rollout in the immunisation programme.

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Its approval for the immunisation programme has drawn flak from public health advocacy groups, researchers, scientists and activists in the domain.

The concern with Covaxin largely remains over its approval for inoculation without the data from phase III clinical trials which determine efficacy of the drug since the trials are still ongoing. So far, any data proving the vaccine’s efficacy has not been published in the public domain, including any results of an interim analysis.

Source: IANS

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