Bharat Biotech’s COVID-19 vaccine Covaxin completes phase 2/3 kids trials
By Team Newsable | First Published Sep 21, 2021, 5:12 PM ISTChairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said on Tuesday that Covaxin production would touch 55 million doses in October as against 35 million in September.
Hyderabad: Bharat Biotech has completed the Phase 2 and 3 clinical trials of coronavirus vaccine, Covaxin on children in the 2-18 years age group and is expected to submit the data by next week to the DCGI.
Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said on Tuesday that Covaxin production would touch 55 million doses in October as against 35 million in September.
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He also said the Phase 2 trials of the firm’s intranasal vaccine against Covid-19 is expected to be over by next month.
“The paediatric trial we have just completed. The Phase 2/3 is all completed. The data analysis is going on so we will be submitting (data) by next week to DCGI,” Ella said, adding that it was the same product and presentation as the vaccine being administered to adults.
Intranasal immunization can create an immune response in the nose, which is the point of entry for the virus—thereby protecting against the disease, infection, and transmission also, he noted.
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Ella said this on the sidelines of the `Vanijya Saptah-Showcasing the strengths of India as a rising economic force & reinvigorating exports of Telangana’ organised by the department of commerce, Union Ministry of Commerce & Industry, directorate general of foreign trade, Telangana government and Pharmexcil to commemorate as part of the `Azadi ka Amrit Mahotsav' celebrations to commemorate 75 years of independence, PTI report said.
The two-dose Covaxin was administered to 525 children 28 days apart as part of the Phase 2/3 trial. Bharat Biotech had received DGCI’s nod to conduct the children’s trial in May this year.
As per Ella, the intranasal vaccine trials are conducted on three cohorts in which one group is administered Covaxin as the first dose and intranasal as the second. Similarly intranasal-intranasal for the second group and Intranasal- Covaxin for the third cohort, 28 days apart.
He said the trials will be conducted on about 650 volunteers. On the production levels of Covaxin, Ella said 100 million doses per month can be possible if the other manufacturing partners are fully geared up with safety and other parameters are in place.
Dr Ella had earlier indicated that if all goes well the vaccine for kids could be available by October. Covaxin has been developed by Bharat Biotech along with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV)-Pune.
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