Lawyer and activist Saket Gokhale has moved Bombay High Court against the Drug Comptroller General of India seeking directions to publicize the information about the safety and efficacy of the Bharat Biotech’s Covid-19 vaccine “Covaxin”. The phase 3 trial of the vaccine is still is pending.
The petitioner has stated that the information claimed by the company that Covaxin is safe and provides a robust immune response has not been made available to the public even after the vaccinations are about to begin in India from January 16 onwards.
Activist Gokhale has argued that the vaccine is still in phase 3 of the clinical trial and administering this vaccine will lead to a great possibility of harming the life of members of the general public.
He also referred to the press note released by the Government of India dated January 3, 2021, which stated that Covaxin has been approved for restricted use in emergency situations. The press release also claimed that phase 1 and phase 2 of the clinical trial of the vaccine demonstrated that it is safe and provides a robust immune response, while phase 3 trials are still ongoing.
“Thus, from the press release of Respondent, M/s Bharat Biotech’s “Covaxin” has not been granted a full approval but a restricted use approval in clinical trial mode while the company’s phase 3 trials are ongoing. This means that every person that is administered M/s Bharat Biotech’s “Covaxin” will technically be seen as a participant in the company’s Phase 3 trials and monitored accordingly as per the rules of Phase 3 trial process,” the plea states.
Therefore, Gokhale has urged to make the results public for peer review by independent scientists or evaluation by external subject matter experts.
The petition has also raised the point of obtaining consent to receive the Covaxin. He also mentioned the two risks that recipients will be exposed to including either take the vaccine & bear the consequences or remain unvaccinated and make yourself susceptible to a Covid-19 infection.