Ocugen Inc. (NASDAQ: OCGN) has announced that its India-based partner Bharat Biotech has finalized Phase 2 and 3 studies of its COVID-19 vaccine candidate, Covaxin, for children between 2 and 18 years. Bharat will submit the vaccine data to DCGI next week.
Bharat completes Covaxin studies in children.
Chairman and managing director of Bharat Krishna Ella said that Covaxin production would reach 55 million doses in October compared to 35 million this month. Ellas added that the phase 2 studies of then intranasal vaccines against COVID-19 will be finalized over the coming month. intranasal immunization creates an immune response within the nose, the entry point of the virus this protecting against infection, transmission, and disease.
Ella said, “Paediatric Covaxin just completed phase 2/3 trials. The data analysis is going on. We will be submitting the data (to the regulator) by next week. The number of subjects ( volunteers) is touching 1000.”
According to Ella, intranasal vaccination trials involve three cohorts, one of which receives Covaxin as the first dose and intranasal as the second. Similarly, the second group received intranasal-intranasal treatment, whereas the third cohort received intranasal-Covaxin treatment 28 days apart. Roughly 650 individuals will participate in the studies. Ella stated that 100 million doses per month of Covaxin might be produced if the other manufacturing partners are fully equipped with safety and other standards in place.
Bharat currently producing 35 million doses
He said, “We are supplying 35 million this month. Next month we will be definitely supplying 55 million doses. Production at Bangalore is catching up very fast.”
Ella said the company is ready to sell Covaxin to other countries if the government allows it. However, it is not in a hurry to explore for international markets. The company’s primary goal is to meet domestic needs. India will resume exporting surplus Covid-19 vaccines in the fourth quarter of 2021 as part of the ‘Vaccine Maitri’ program.
