Activist Saket Gokhale on Saturday filed a writ petition against the Drugs Controller General of India seeking the safety and efficacy data submitted by Bharat Biotech for Covaxin. His petition even as the country began using Covishield and Covaxin as part of its pan-India inoculation efforts.
"In the interest of lives of millions of India, we NEED TO know what this data says & why it's being kept secret," he tweeted.
India on Saturday began inoculating citizens in what is being touted as the world's biggest vaccination drive. Earlier this year, the Drugs Controller General of India (DCGI) had approved the emergency usage of two vaccines - Covishield and Covaxin. Around one crore healthcare workers and around two crore frontline workers are first in line for vaccination, followed by people above the age of 50 and those with comorbidities.
But as the government made arrangements for the vaccination drive, many had expressed concern about the use of the indigenously developed Covaxin. Developed by Bharat Biotech in association with ICMR, the vaccine is yet to release third phase clinical trial details. Data from the second phase of trials is currently undergoing peer review.
As the outrage mounted, the government rushed to assure that appropriate precautions had been taken. Union Health Minister Dr Harsh Vardhan had clarified on January 3, the "emergency use authorisation for COVAXIN is differently conditional – in clinical trial mode".
But while the permissions for the two vaccines may be different, later updates indicated that the government was not giving people signing up to get inoculated a choice between the two vaccines.
"The two COVID-19 vaccines approved by the National Regulator are SAFE. 49 eminent scientists and doctors collectively assure in a statement issued today," tweeted the Ministry of Health on January 14.
Another fact of concern, noted by several individuals today is that those taking Covaxin are being asked to sign a separate consent form, acknowledging that the jab is being administered without the phase-3 trial. The form also assured compensation if any adverse effect was found linked to the vaccine.
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