Lawyer and RTI activist Saket Gokhale has filed a writ petition in Bombay High Court against the Drugs Controller General of India (DGCI) requesting for the safety and efficacy data of Bharat Biotech’s Covaxin to be made public.
Gokhale took to Twitter to share about the plea and said, “In the interest of lives of millions of India, we NEED TO know what this data says & why it’s being kept secret.”
India’s Covid-19 vaccination drive kicked off on Saturday and is being termed as the world’s biggest vaccination drive. Healthcare and other frontline workers are the first in line to be vaccinated.
DGCI approved two vaccines earlier this year – Covishield by Serum Institute of India (Oxford-Astrezeneca) and Covaxin by Bharath Biotech. However, the data on Covaxin’s Phase III trials have not been made public.
This raised severe concerns among the public which led to the Union Health Minister Dr. Harshvardhan clarifying that the emergency use authorization for Covaxin is differently conditional.
A press note issued by the Government of India said that Covaxin has been approved for “restricted use in emergency situation.” The press note also states that the Phase III trials are ongoing.
Gokhale in his petition has urged for the details of Phase III trials to be made public and peer-reviewed by scientists and experts.
Further concerns are being raised about the vaccine as several reports suggest that the Covaxin recipients are being made to sign a consent form that states that only Phase I and Phase II trials have been completed.
Bharat Biotech on Saturday said the company will pay compensation to recipients in case of any serious adverse effects experienced after receiving the antidote.
A consent form to be signed by the vaccine recipients said, “In case of any adverse events or serious adverse events, you will be provided medically recognised standard of care in the government designated and authorised centers/hospitals.”
No choice is being given for the recipients between the two vaccines causing further anxiety surrounding the vaccine administration.