In a major shock to the Hyderabad based-Bharat Biotech, the Government of India has prohibited the administration of Covaxin to those under 18 years of age. The Indian vaccine manufacturer was earlier permitted by the Drugs Controller General of India (DCGI) to administer its doses on all above 12 years of age. The permission was granted to the pharmaceutical firm stating ‘active immunization against the Coronavirus disease (Covid-19) for age above 12 years in 2 doses separated by a time interval of 28 days.’
Bharat Biotech’s Covaxin was also in the spotlight considering the peer vaccine manufacturer Serum Institute of India had received authorization for its vaccine Covishield to be inoculated in citizens only aged 18 years and above. This ‘special’ treatment by the government to the indigenous vaccine manufacturer brought the pharmaceutical firm into the spotlight and was heavily criticized by health activists, researchers, scientists, and subject experts.
Following the growing flak and developing controversy, the authorization was rebuked and was changed to administration to only those above 18 years of age. The controversy surrounding the indigenous vaccine is its efficacy. The efficacy of a vaccine depends on the data provided by the manufacturer from the third stage of clinical trials. To date, no data has been made available to the public domain by Bharat Biotech which is the cause of growing concern in research experts and authorities for its approval as Covid vaccine.
Another roadblock to Covaxin’s authorization was when the trial volunteers from Bhopal Medical College, one of the trial sites for the third stage of a clinical trial of Bharat Biotech’s vaccine, put forth a series of allegations accusing the pharmaceutical company of violating the protocols in conducting the clinical trials.
The volunteers, who were also victims of the unfortunate 1984 Bhopal Gas Tragedy were administered with the doses. The institute was alleged of severe violations of protocol since no follow-up sessions for the adverse symptoms which would have developed after the first dose was conducted and the consent for inoculation was also not considered. This imposed a grave threat to the health of the volunteers.
Meanwhile, a 45-year-old volunteer of the clinical trial from Bhopal died after developing adverse symptoms. The deceased was administered the first dosage on December 21st at People’s Hospital.
Discarding the accusations for neglect, Bharat Biotech in a statement said that after thorough investigations it was found that the cause of death was not the vaccine or placebo. Madhya Pradesh state panel concurring with the pharmaceutical firm ruled out any lapses or faults from the hospital administration in the death.
