Bharat Biotech expects peer review of Covaxin's Phase 3 trial data in Q4 2021

Hyderabad: 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, Raches Ella Project Lead COVID-19 Vaccines at Bharat Biotech said on Wednesday.

Ph 3 Timelines and reasons to trust the process: Largest efficacy trial conducted in the developing world (sample size=25,800). The last volunteer was vaccinated in Mid March. Mandatory CDSCO/FDA requirement of a 2-month safety follow-up for all volunteers landed us in Mid May⬇️

— Dr. Raches Ella (@RachesElla) June 9, 2021

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 efficacy and 2 months of safety to CDSCO (July), it is expected to instantly reach a pre-print server. Peer review takes 2-4 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.

"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.

Covaxin sent to private hospitals ↔️ https://t.co/HfUlUfR1wx pic.twitter.com/mI1pVMx2OJ

— suchitra ella (@SuchitraElla) June 9, 2021