On Saturday, a plea has been filed before the Bombay High Court by an activist stating that Bharat Biotech Covaxin had not been granted full approval but a restricted use in clinical trials according to the Drugs Comptroller General of India. The Company’s phase 3 trials are ongoing and the DGCI has not made any data available in the public domain for peer- review by independent scientists.
Saket Gokhale, an RTI activist filed a petition that DGCI issued a press release on January 3rd, 2021 stating that vaccines of M/s Serum Institute of India (Covidshield) and M\s Bharat Biotech (Covaxin) is approved for restricted use only in emergency situations.
The approval was granted based on the recommendations of a division of DGCI, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
The plea adds that the DGCIs press release with reference to M/s Bharat Biotech’s vaccine “Covaxin”, stated that the safety and immunogenicity data in animal species like mice, rats, rabbits, etc. have been generated by the company. It has also conducted challenge studies on nonhuman primates and hamsters. All these data have been shared with CDSCO by the firm.
The petitioner contended that
The data on safety and immunogenicity of M/s Bharat Biotech’s “Covaxin” has been reviewed by the subject expert Committee and has recommended it for restricted use only in emergency situations as a precaution in the public interest, to have more options for vaccinations just in case of mutant strains. The clinical trial ongoing by the firm in the country will continue.
The plea complained that the findings and data of phase 2 and ongoing phase 3 trials have not been published anywhere by the M/s Bharat Biotechs. Mr. Gokhale also filed an RTI inquiry seeking a reply on Copies of safety, efficacy, and all other relevant data submitted by the company for its COVID19 vaccine to the DGCA for approval.
It also sought a reply on the final report which was to assess the Covid-19 vaccine approval applications of Covaxin and Covishield against the others. This report was submitted by the Subject expert committee to the DGCI. Since the petitioner did not get any reply on this, he filed the petition.
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