PUBLICATION OF crucial phase 3 trial data of Bharat Biotech’s Covaxin, which will detail the efficacy of the indigenous Covid vaccine developed by ICMR and Bharat Biotech, will done in the next “7-8 days”, according to Dr V K Paul, who heads the country’s Covid task force.
Paul said the data will be published in a peer-reviewed journal, “go beyond” information submitted so far to the Central Drugs Standard Control Organisation (CDSCO), and reveal findings from “follow-ups” of the clinical trial.
The announcement came on the day the US FDA recommended that Covaxin makers apply for full authorisation instead of seeking Emergency Use Authorisation (EUA), thereby delaying a rollout of the vaccine in that country.
Paul said the US decision will not have any regulatory impact in India. According to the company, regulatory approvals from WHO are expected by July-September 2021. Currently, Covaxin comprises approximately 12 per cent of total vaccines administered in India.
On the US decision, Paul said: “Every country’s regulatory system is different; although some aspects could be the same. The countries have their own parameters and we respect them. Our country’s regulator takes decisions in the same way; the scientific system takes decisions in the same manner. The scientific framework is the same, however, nuancing is based on the context…they have taken a decision, we respect the decision.”
On Covaxin’s phase 3 data, he said: “We have so much data on their safety; we have so much data on their phase 3 trial that has been screened by them, seen by our regulator. I am told that their phase 3 publication could come anytime in the next 7-8 days. This will be beyond what has been shared with the DCGI (Drugs Controller General of India), when they received the licensure; the follow-up (data) will go into a peer-reviewed journal. It will be done objectively.”
The CDSCO had granted permission for emergency use of Covaxin based on phase 1 and phase 2 clinical trials in about 680 participants. Bharat Biotech has also conducted the country’s largest phase 3 clinical trial, with 25,800 participants, to determine the efficacy of the vaccine — interim analysis of phase 3 trials showed efficacy of 78 per cent.
In March, Bharat Biotech had said that its first interim analysis was based on 43 cases, of which 36 cases of Covid9 were observed in the placebo group and seven in the Covaxin group. Additional interim analysis was planned for 87 cases, and the final analysis was planned for 130 cases, the company said. “All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication,” it said.
Bharat Biotech had said that an interim analysis on the safety of the vaccine had “showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups”.
Paul, meanwhile, said that discussions will be held with the experts from the Indian Public Health Association (IPHA), Indian Association of Preventive and Social Medicine (IAPSM), and Indian Association of Epidemiologists (IAE) on their recommendation that “persons who are recovered from natural infections should be low down in priority for vaccination”.
Paul, however, underlined that such decisions are taken by the National Technical Advisory Group on Immunisation in India (NTAGI). “They looked at science and the data available when they took the decision that Covid patients can get vaccinated three months after recovery from illness. If more data becomes available and new suggestions come, they will consider them and deliberate upon them,” he said.