India's Biological E to begin Phase III trial of vaccine, production from August

Published on May 07, 2021 04:07 PM IST

India, battling the world's worst jump in coronavirus infections, has partially or fully immunized only about 10% of its 1.35 billion people.

A nurse takes Covid-19 vaccine at district hospital in Ukhrul, Manipur.(File photo)
A nurse takes Covid-19 vaccine at district hospital in Ukhrul, Manipur.(File photo)
Reuters | , New Delhi

India's Biological E. Ltd will soon start Phase III trials of its COVID-19 vaccine and plans producing 75 million to 80 million doses a month from August, its managing director told Reuters on Friday.

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 Managing Director Mahima Datla said would begin soon.

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.

Production "from August but EUA depends on the government. Will follow their advice and directives," she said in a text message. "75-80 million doses a month from the time of launch."

Datla declined to comment on any firm deal to contract-manufacture the Johnson & Johnson vaccine. She told Reuters in February that Biological E. was looking to make about 600 million doses of the J&J vaccine annually.

J&J said last month it was in talks with India's government to begin a clinical trial of its single-dose shot.

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.

The country has also received doses of the Sputnik V vaccine from Russia though it has not been launched yet in the country. India has also urged Pfizer/BioNTech and Moderna to sell their shots to the country.

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