One of the top contenders in the race to manufacture Covid-19 vaccine, Bharat Biotech International Ltd has refuted claims of not reporting adverse effect during its coronavirus vaccine trial in August.
The controversy is around the phase 1 trial in August 2020, when a patient was hospitalised after receiving a dose of the covid-19 vaccine Covaxin.
Reacting to media reports that the adverse event during the phase I trials was not reported by Bharat Biotech, the pharmaceutical giant on Saturday confirmed the incident and issued the clarification.
In response to allegations, Hyderabad-based vaccine maker said that the adverse incident was reported by the company within 24 hours.
In a statement on Saturday, Bharat Biotech said, ‘The adverse event during phase I clinical trials in August 2020, was reported to the CDSCO-DCGI, within 24 hours of its occurrence and confirmation.’
The adverse event occurred in a 35-year old participant with no co-morbidities, who was part of Phase 1 trials at a site in western India.
The participant was hospitalised with viral pneumonitis, a couple of days after being administered the vaccine. He was discharged after a week’s stay in the hospital.
According to Bharat Biotech, the adverse incident was probed thoroughly and it was found that the adverse event was not related to the vaccine.
‘All treatment costs for the subject was fully paid for by the sponsor, and the subject is safe,’ Bharat Biotech said.
As per the guidelines laid down by the Centre, all adverse events are to be reported to the site ethics committee, CDSCO-DCGI, data safety monitoring board and sponsors.
It is to be noted that Bharat Biotech and ICMR are working on Covaxin, one of the indigenous coronavirus vaccine candidates.
The Central Drugs Standard Control Organisation (CDSCO) has also given its approval to Bharat Biotech to launch the phase III trials of COVID-19 vaccine candidate.
Bharat Biotech is conducting three-stage clinical trials of Covaxin, a wholly-inactivated novel coronavirus vaccine, in collaboration with apex bio-research agency, the Indian Council of Medical Research.
Bharat Biotech is one of the few companies to conduct human challenge studies at Oxford University, United Kingdom while it’s is also conducting other clinical trials in the US and UK.
‘Bharat Biotech has supplied more than 4 billion doses, to more than 80 countries, with an excellent track report of safety during vaccine development,’ it added.