Bharat Biotech expects peer review of Covaxin's Phase 3 trials data in Q4 2021
Bharat Biotech, which is yet to publish the data of its COVID-19 vaccine Covaxin phase-3, expects a peer review of the jab in two to four months after it was given to scientific journals, said Raches Ella, Project Lead, COVID-19 Vaccine at Bharat Biotech on Wednesday.
In a series of tweets, Ella said there were nine publications on Covaxin so far and the efficacy paper of phase-3 trials would be the tenth one.
To remain unbiased, Bharat/ICMR cannot access any data. Our service provider IQVIA has started the final statistical analysis. After submitting the efficacy and two months of safety to CDSCO (July), it is expected to instantly reach a pre-print server. Peer review takes two to four months, he tweeted.
According to his tweet, as many as 25,800 participants took part in phase-3 trials and there were 30 separate forms pertaining to each volunteer amounting to individual data points of 70.4 lakh.
Image source: Bharat Biotech Twitter page
"The last participant (participant #25,800) received the second dose in mid-March, add two months (based on CDSCO/FDA requirements for 2-months post-dose-2 safety follow-up), and we are in mid-May with sufficient data for quality checks and analysis, he said in another tweet.
Meanwhile, Suchitra Ella, Joint Managing Director of Bharat Biotech, in a tweet, said, Covaxin has reached private hospitals in as many as 28 cities.
Earlier this week, the screening of children for the trial of Covaxin, among those aged between the ages of two and 18, was started at AIIMS, Delhi.
The trial on children had already started at AIIMS Patna to see if the Bharat Biotech jab is suitable for children.
Participants would be given the vaccine after their screening report comes.
The trial is to be conducted on 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
(Disclaimer: Additional background information has been added to this PTI copy for context)