Bharat Biotech said it will share results of the trials with DCGI by next week
Bharat Biotech is to raise Covaxin production from 35 mn to 55 mn doses in October
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NEW DELHI :
Bharat Biotech has completed phase-2 and -3 trials of its covid-19 vaccine Covaxin on children below 18 years of age, Krishna Ella, managing director of the Hyderabad-based pharmaceutical company said on Tuesday.
“The phase-2 and -3 clinical trials for paediatric Covaxin have been completed. We will share all the relevant clinical trial data with the Drugs Controller General of India (DCGI) by next week," Ella told reporters on the sidelines of the Pharmaceutical Export Promotion Council (Pharmexcil) Conference. The trials involve more than 1,000 volunteers, and data generated from them is currently being analysed, he said.
The company will scale up Covaxin production from 35 million doses to 55 million doses in October, Ella said. “Production at the Bengaluru facility is catching up very fast. This month, we are supplying 35 million doses. Next month, we will definitely supply 55 million doses," he said.
The firm could produce 100 million doses if all safety parameters are in place and the manufacturing partners are prepared, Ella said. Bharat Biotech has partnered with Indian Immunologiclas and Hester Biosciences to ramp up production of Covaxin.
The company is also prepared to export the vaccine to other countries, he said.
Ella said the phase-2 trials of Bharat Biotech’s intranasal covid-19 vaccine are expected to be completed by October. “The trials involve 650 volunteers and are being conducted by dividing volunteers into three groups," he said. For the first group, volunteers are administered Covaxin as the first dose and the intranasal vaccine as the second, Ella said. Volunteers in the second group get the intranasal vaccine for both doses. The third group, 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 government that it will be able to supply close to 220 million doses of Covishield in October. This comes a day after the government announced the resumption of export of surplus covid vaccines in the December quarter under the “Vaccine Maitri" programme.
SII has enhanced its production capacity of Covishield to more than 200 million doses per month and will be able to supply about 219 million doses in October to the government of India and private hospitals, Prakash Kumar Singh, director, government and regulatory affairs at the company, informed the government on Monday.
“Starting in January 2021, we have supplied 66.33 crore doses of Covishield to the ministry of health and family welfare, in addition to supplying more than 7.77 crore doses to state governments and private hospitals till 19 September 2021 evening," SII told the government in a communication, according to government officials.
The company will complete the recent supply order of another 660 million doses to the Centre by the 31 December timeframe, Singh said.
“[We] will touch supplies of more than 130 crore doses of Covishield in 2021," SII has said. India’s covid-19 vaccination coverage on Tuesday crossed the 820 million mark.
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