Drug regulator approves Hyderabad-based Biological E's phase I/II trials of Covid vaccine

Biological E has tied up with an undisclosed company and will be conducting the trials. The announcement about the tie up is likely to be made sometime next week about the collaboration, sources told ET.

India’s drug regulator has given approval to Hyderabad based Biological E to start Phase I/II human trials in India for a vaccine against Covid-19.

The Subject Expert Committee (SEC) that advises the Drug Controller General of India (DCGI) on applications seeking permissions for new drugs, clinical trials, vaccines for Covid-19, gave its approval on October 26.

“The firm presented its revised protocol to conduct PhaseI/II clinical trial of SARS-CoV-2 vaccine along with non clinical toxicity data before the committee. After detailed dleiberation, the committee recommended for grant of permission to conduct Phase I/II clinical trial,” said the minutes of the meeting.


Biological E has tied up with an undisclosed company and will be conducting the trials. The announcement about the tie up is likely to be made sometime next week about the collaboration, sources told ET.

This is another boost to the vaccine development in the country. There are three indigenous vaccines for which the clinical trials are undergoing.

The final phase of trials of Serum-AstraZeneca Covishield and Bharat Biotech’s Covaxin will begin soon while Zydus’s vaccine is undergoing Phase II trials.
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Union health minister Harsh Vardhan had a few days ago said the government hopes to administer Covid-19 vaccine to 250 million people in the country by July next year.

Biological E has also tied up with US drug maker Johnson and Johnson. It has got the technology transferred from J&J. J&J has also given manufacturing rights of its SARS-Cov2 vaccine to Biological E, a move that could bring J&J’s vaccine to India by mid 2021.

J&J’s vaccine candidate for SARS-Cov2 works on a platform called the Adenovirus platform which was used to develop the vaccine for Ebola and Zika. The AdVac® and PER.C6® technology uses a piece of SARS-Cov2 virus DNA - specifically, one that codes for the coronavirus "spike" protein that latches on to human cells – that it is placed inside a dead adenovirus. The vaccine candidate hopes to trigger antibody response to the spike protein.

In an earlier interview to ET , Paul Stoffels Chief Scientific Officer of J&J had said that both the companies will look at maximizing the number of dosages and hope to produce up to 400-500 million vaccine doses each year for India.
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