COVAXIN debate: Minister replies on why Bharat Biotech was granted approval for emergency use

The information surfaced during a recent Rajya Sabha session wherein the MoS Health, through a written reply clarified the rush in approval of Covaxin pointing out that the approval in question has been given by the National Regulator based on the recommendations of the Subject Expert Committee functional under Central Drugs Standard Control Organisation (CDSCO).

The Minister was responding to questions raised by Sanjay Singh and others asking whether the Phase-3 trial results of the Covaxin vaccine that was approved recently for emergency uses was not made available, further seeking the basis on which the Government gave the approval.

Responding to the same, Choubey explained that Bharat Biotech International Limited had submitted interim safety and immunogenicity data of Phase I and II clinical trials carried out in the country along with safety data including Serious Adverse Event (SAE) data of the ongoing Phase III clinical trial in the country. The data was reviewed by Central Drugs Standard Control Organisation (CDSCO) in consultation with the Subject Expert Committee (SEC).

The committee noted that this vaccine is Inactivated Whole Virion Corona Virus Vaccine having the potential to target mutated coronavirus strains. The data demonstrated a strong immune response (both antibody as well as T cell) and in-vitro viral neutralization. The ongoing clinical trial is a large trial on 25800 Indian subjects in which all 25800 subjects have already been enrolled.

Moreover, the firm presented the safety and efficacy data from the Non-human primate challenge study also to CDSCO, where the vaccine has been found to be safe and effective.

After detailed deliberations, the SEC recommended a grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.

Based on the recommendations of SEC, CDSCO has granted permission to manufacture COVID-19 vaccine to Bharat Biotech for restricted use in emergency situations in the public interest as an abundant precaution, in clinical trial mode with various conditions/restrictions.

Further, explaining the authority's responsibility in case of any adverse side-effects which come to light post administration of the vaccine, The Minister said, "As a part of the above permission granted by CDSCO, Bharat Biotech is required to submit safety data on Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) with due analysis every 15 days for first two months and monthly thereafter to CDSCO."

He added that CDSCO, in consultation with the Subject Expert Committee, has approved the protocol for rolling out the Whole Virion Inactivated Corona Virus Vaccine (BBV152) in clinical trial mode along with factsheet, informed consent form, and adverse event form.

As per the approval "In case of any serious adverse events, Vaccine recipients will be provided a medically recognized standard of care in the government designated and authorized centers/hospitals. The compensation for the serious adverse event will be paid by the sponsor (BBIL) if the SAE is proven to be causally related to the vaccine. If any Vaccine recipient develops symptoms of COVID-19, Vaccine recipient will be provided a medically recognized standard of care in the government designated and authorized centers/hospitals".