India’s Biological E. to Begin Phase III Trial of Vaccine
India’s Biological E. Ltd will soon begin its phase III trials of COVID-19 vaccine and plans producing 75 million to 80 million doses a month from August.
The Managing Director, Mahima Datla said the company has developed the vaccine with Baylor College of Medicine in Houston and Dynavax Technologies Corp.
Late last month, it received approval from India’s drug regulator to conduct a Phase III clinical trial which would begin soon.
“Production from August but EUA depends on the government. Will follow their advice and directives,” she said.
Government officials have said the vaccine, which uses the recombinant-protein technology in which a harmless agent is used to stimulate an immune response in cells, could be rolled out in the country from August.
Datla said Biological E. would apply for emergency use authorisation (EUA) for the drug based on government advice.
India, battling the world’s worst jump in coronavirus infections, has partially or fully immunized only about 10% of its 1.35 billion people.
It has administered a total of 163 million doses of the AstraZeneca shot and a domestically made one called Covaxin.