Hyderabad-based Bharat Biotech has submitted data from Phase 3 clinical trials of its COVID-19 vaccine Covaxin to the Drugs Controller General of India (DCGI). NITI Aayog (Health) member VK Paul told several media outlets on Monday that Phase 3 data was submitted to DCGI over the weekend. “It is my understanding that Phase 3 data has already been submitted by Bharat Biotech to the DCGI over the weekend and it is my hope that further processing of the data and requisite meetings would be happening very soon,” VK Paul said in an interview with CNBC-TV18.
Quoting government sources, news agency ANI said that the Central Drugs Standard Control Organization’s Subject Expert Committee will be meeting on Tuesday, June 22, to review the Phase 3 data. “The data has been submitted and I understand that they are working on a manuscript for a peer-reviewed journal or they must be close to submitting such a manuscript to a peer-reviewed journal. So my information is that they have made progress, almost according to the schedule that we talked about. But the significant news is that the Phase 3 data is being submitted to DCGI,” VK Paul said.
He added that this week, Bharat Biotech may also have further discussions with the World Health Organisation on Emergency Use Listing (EUL). As per WHO guidelines, EUL is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies. Bharat Biotech had said last month that it expects approval for its COVID-19 vaccine Covaxin from the World Health Organisation for emergency use listing during July-September this year.
Earlier in April, Bharat Biotech had announced Phase 3 interim analysis results based on more than 87 symptomatic cases of COVID-19. The company said that 127 symptomatic cases were recorded, and showed an estimated vaccine efficacy of 78% against mild, moderate, and severe COVID-19 disease. The manufacturer had earlier said that Phase 3 results will be available in June.
#Coronavirus | '#Bharat Biotech has submitted Phase 3 data to the #DCGI over the weekend,' says Dr VK Paul, Member - Health, NITI Aayog & Head of Natl COVID-19 Taskforce.@ShereenBhan pic.twitter.com/2fwTIB19IX
— CNBC-TV18 (@CNBCTV18News) June 21, 2021
As per Bharat Biotech, the Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days after the second dose.
Raches Ella, who leads the COVID-19 projects at Bharat Biotech, had recently made a series of tweets on the status of the long-awaited results from third phase amid a raging debate on a preprint study which said that while both Covaxin and Covishield showed a good immune response after two doses, Covishield produced more antibodies than Covaxin. He termed Phase 3 trials as the largest efficacy trial conducted in the developing world with a sample size of 25,800.
Earlier this year, when Covaxin was approved for use in India, health experts as well as members of the Congress had questioned why Covaxin was granted authorisation even though no other country has approved a vaccine without the mandatory Phase 3 trials and verification of data.