‘The company has not published the findings and data of their Phase 2 and ongoing Phase 3 trials in any paper’
A plea has been filed before the Bombay High Court on Saturday stating that per the Drugs Controller General of India (DCGI), Bharat Biotech’s vaccine “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 and there is no data made available in the public domain by the DCGI for peer-review by independent scientists.
A Right to Information (RTI) activist Saket Gokhale filed a petition which says: “On January 3, 2021, DCGI issued a press release stating, “Covid-19 vaccines of M/s Serum Institute of India (named “Covishield”) and M/s Bharat Biotech (named “Covaxin”) have been approved for restricted use in emergency situation. The approval was granted based on the recommendations of the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) a division of DCGI.”
“With reference to M/s Bharat Biotech’s vaccine “Covaxin”, the DCGI’s press release stated the company has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on nonhuman primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO,” plea adds.
The petition contends, “The Subject Expert Committee reviewed the data on safety and immunogenicity of M/s Bharat Biotech’s “Covaxin” and recommended it for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue.”
The plea says, “M/s Bharat Biotech have not published the findings and data of their Phase 2 and ongoing Phase 3 trials in any paper.” Mr. Gokhale had also filed a RTI query seeking a reply on, “Copies of safety, efficacy, and all other relevant data submitted by company Bharat Biotech International for its Covid-19 vaccine “Covaxin” to the Drugs Controller General India (DCGI) for approval.”
The RTI also sought a reply on the final report submitted by the subject expert committee (tasked to assess the COVID-19 vaccine approval applications of Covishield and Covaxin, amongst others) to the DCGI. However, Mr. Gokhale did not receive any response, hence the petition.