NEW DELHI :
Bharat Biotech has completed phase 2/3 trials of its covid-19 vaccine Covaxin on children below 18 years of age, Krishna Ella, Managing Director of the Hyderabad based pharma company said on Tuesday. He was talking to reporters on the side-lines of Pharmaceutical Export Promotion Council (Pharmexcil) Conference being held in Hyderabad on Tuesday.
“The Phase 2/3 clinical trials for pediatric covaxin have completed. We will share all the relevant clinical trial data with the Drugs Controller General of India (DCGI) by next week,” said Ella adding that the data analysis is ongoing which included over 1000 volunteers.
Talking about production of Covaxin, Ella said that the company will scale it up from 3.5 crore doses to 5.5 crore doses in October.
“Production at Bangalore facility is catching up very fast. This month we are supplying 35 million doses next month we will be definitely supplying 55 million doses,” he said hoping that the firm may possibly manufacture 10 crore doses if all safety parameters are in place and manufacturing partners are prepared. Bharat Biotech has partnered with Indian Immunologiclas and Hester Biosciences for to ramp up the production of covaxin.
Ella also said that Bharat Biotech is ready to export Covaxin to other countries while it is in hurry to pitch for overseas markets. Speaking about Bharat Biotech’s much talked about intranasal covid-19 vaccine, Ella said that the Phase 2 trials of the vaccine are expected to be completed by October this year.
“The trials involved 650 volunteers. The trials are being conducted by dividing volunteers into three groups,” said Ella. For the first group, volunteers are administered Covaxin as the first dose and the intranasal vaccine as the second, said Ella adding that that volunteers in the second group get both doses in the form of the intranasal vaccine. The third group, meanwhile, he said, gets intranasal vaccine as the first dose and Covaxin as the second, 28 days apart.
“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,” Ella said.
Meanwhile, the Serum Institute of India (SII) has informed the central government that it will be able to supply around 22 crore doses of Covishield in October. The communication comes a day after the government announced to resume export of surplus Covid vaccines in the coming fourth quarter under the ‘Vaccine Maitri’ programme.
In a communication to the Centre on Monday, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), said the firm has enhanced its production capacity of Covishield and it will be able to supply 21.90 crore doses in October to Government of India and private hospitals. SII has also enhanced the manufacturing capacity of Covishield to more than 20 crore doses per month. “Starting from January 2021, we have supplied 66.33 crore doses of Covishield to MoHFW, Government of India in addition to supply of more than 7.77 crore doses to state governments and private hospitals till 19th September 2021 evening,” the SII said as per sources. Singh futher assured that by December 31, keeping with the timeline, the firm will complete the recent supply order of 66 crore doses.
“At this juncture, I can assure you that by December 31, 2021, we will complete supply of 66 crore doses of Covishield against the recent order and will touch supplies of more than 130 crore doses of Covishield in the year 2021. We are working relentlessly to fulfill our prime minister’s dream for successful completion of world’s largest vaccination drive so that our country overcomes covid-19 pandemic,” the communication stated.
India’s covid-19 vaccination coverage on Tuesday crossed 82 Crore mark.
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