COVID 19: Hyderabad-based Biological E. to produce J&J vaccine to ramp up supplies

"The infrastructure and plants are completely separate for both the products and we will be producing both and these will be independent of each other," Mahima Datla, managing director of Biological E. told Reuters

She said Biological E. was looking to contract-manufacture about 600 million doses of the J&J vaccine annually. India's government, however, did not factor in any production of J&J this year in the country in a list of likely vaccine output released last week.

J&J confirmed to Reuters that it was working with Biological E. on manufacturing its vaccine.

Last month J&J said that it had sought permission to conduct a local clinical trial in India for its single-dose vaccine. It has not given other details and a spokeswoman for J&J in India did not immediately respond to a request for comment.

Biological E., based in Hyderabad, also plans to produce 75 to 80 million doses of its own vaccine a month from August. The drug has been developed with Baylor College of Medicine in Houston and Dynavax Technologies Corp.

In March, the US said it would finance Biological E.'s efforts to produce at least 1 billion doses of Covid-19 vaccine by the end of 2022.

Reuters reported on Tuesday that India was unlikely to resume major exports of Covid-19 vaccines until at least October as it diverts shots for domestic use, a longer-than-expected delay set to worsen supply shortages from the global COVAX initiative.

Meanwhile, India's drug regulator has accepted the recommendation of the Subject Expert Committee and given a nod to Hyderabad-based Bharat Biotech to conduct phase II/III clinical trial of COVID-19 vaccine Covaxin for children aged 2-18 years. The trails will begin in the next 10-12 days.

This is the first time in India that a COVID-19 vaccine will be tested on children.

The proposal was deliberated during a meeting of the Subject Expert Committee (SEC) on 11 May, the health ministry said last week. On May 13, India had given clearance to conduct trials for the 2-18 age group.

"COVAXIN has been approved by the Drugs Controller General of India (DCGI) for phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days," said Dr. V.K Paul, a member of the NITI Aayog.

The trial will involve 525 subjects at various sites. They will receive two shots of the vaccine injected on day 0 and day 28.