Biological E starts Phase I/II trial, Bharat Biotech to begin Phase III trials for COVID-19

Hyderabad-based Biological E Ltd has begun an adaptive Phase I and II human trials for its COVID-19 vaccine candidate. The firm has already sought approvals from Drugs Controller General of India (DGCI) and expects to get the results back by February, next year.

It is being developed along with Baylor College of Medicine (BCM ventures) in Houston, Texas, and Dynavax Technologies Corp.

According to the press release, the trial will test two doses of the vaccine in around 360 volunteers who are aged between 18 to 65 years. It will be administered via intramuscular injection 28 days apart. Intramuscular injection is a technique used to deliver the vaccine deep into the muscles, allowing it to be absorbed into the bloodstream quickly.

The vaccine will include an antigen form BCM Ventures and Dynavax’s advanced adjuvant CpG 1018. An adjuvant is a substance that increases the potency and regulates the immune responses to an antigen to improve them.

Bharat Biotech’s COVAXIN

On the other hand, Bharat Biotech has also announced that it will soon begin Phase III of its COVID-19 vaccine candidate – COVAXIN. It will involve 26,000 volunteers across India and will be conducted in partnership with the Indian Council of Medical Research (ICMR).

Bharat Biotech is developing the vaccine in partnership with ICMR and the National Institute of Virology (NIV).

According to a press release, COVAXIN has already been tested out in Phase I and II trials with 1000 subjects and has shown promising results.

This trial will be conducted in 22 centres across the country, and participants will receive two intramuscular injections approximately 28 days apart, a press release stated. However, one group will be injected with a placebo, and the other will be injected with the actual vaccine.

According to clinical trial norms, each trial centre has its own ethics committee which monitors the trials conducted at each respective centre and overlooks whether it is meeting the ethics and the study protocol. According to data from the government’s clinical trial registry, eight centres have received their approvals from their respective ethics committees for the clinical trials.

LiveMint reported that Bharat Biotech executive director Sai Prasad said that the company plans to launch the vaccine by June next year unless the government decides to give them emergency use authorisation before that.

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