Bharat Biotech expects peer review of Covaxin's Phase 3 trial data in Q4 2021
Raches Ella, project lead COVID-19 Vaccines at Bharat Biotech said that there were nine publications on Covaxin so far and the efficacy paper on Phase-3 trials would be the tenth one
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.
— suchitra ella (@SuchitraElla) June 9, 2021
The European Union (EU), United Kingdom (UK) and Canada have not included COVAXIN in their approved list of vaccines as it has not been approved by the WHO
The White House said around 19 million will go to UN-backed program COVAX, with approximately 6 million for South and Central America, 7 million for Asia and 5 million for Africa
COVID-19 vaccine: Centre assures 50% more allocation than May, says 12 crore doses will be supplied in June
Of the total, about 6.09 crore doses will be supplied to states and UTs for vaccinating healthcare and frontline workers, and those aged over 45 years