Hyderabad-based vaccine maker Bharat Biotech has lambasted a recent comparative study which gave Serum Institute’s Covishield an advantage over former’s Covaxin and claimed that the report has “a lot of flaws”.
“A recent comparative report on evaluation of immunogenicity responses to spike protein after 1st and 2nd dose of Indian manufactured vaccines study had lots of flaws. The journal that stated comparative report said more antibodies produced by Covishield than Covaxin,” Bharat Biotech said in a statement.
The vaccine making company also clarified that the pan-India study, which accumulated the reactions of healthcare workers who had received both doses of the preventives, was “not a peer-reviewed publication, nor statistically & scientifically designed study.”
Meanwhile, the company also 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.
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.
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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.
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