COVID-19 vaccine | Passed mandated protocols, animal testing and now in clinical development stage: Bharat Biotech's Dr Krishna Ella

Natasha Trivedi

Bharat Biotech chairman and managing director Dr Krishna Ella on July 3 said that the company, which is the first Indian firm to have received approval to begin human trials of its COVID-19 vaccine candidate, had developed the first version of the vaccine within 40 days, after which the pre-clinical trials began.

Hyderabad-based Bharat Biotech, which is one of seven Indian companies involved in the indigenous production of a vaccine for the novel coronavirus, received the green signal from the Central Drugs Standard Control Organisation (CDSCO) to begin human trials of 'Covaxin' last week.

Phase 1 and 2 clinical trials of Covaxin in COVID-19 patients will begin this month. The vaccine candidate was developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) in Pune.

The ICMR has selected 12 institutes across the country to carry out clinical trials of Covaxin and on July 3, urged the chosen clinical trial sites to expedite approvals and complete recruiting for the trails by July 7, as per an internal letter from ICMR to the institutions.

The letter also reportedly said that Covaxin should be "launched for public use" by August 15, however, Bharat Biotech spokespersons refused to comment on the statement.

The letter by ICMR director general Balram Bhargava read, "It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL (Bharat Biotech International Limited) is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project."

Covaxin has been expedited through national regulatory protocols, and subjected to "comprehensive pre-clinical studies" according to the company, which reports that the results are "promising" and "show extensive safety and effective immune responses".

Also Read | Explained: How did Bharat Biotech emerge as dark horse in race for COVID-19 vaccine?

In the past, Bharat Biotech has manufactured the H1N1 vaccine during the swine flu outbreak and has over 140 global patents and 16 vaccines in its portfolio. The most significant of their developments is arguably the rotavirus vaccine Rotavac, a next-gen vaccine against viral gastroenteritis that got pre-approval from the WHO after an Oxford laboratory found it safe and efficacious.

Firstpost spoke to Dr Ella about the development of Covaxin, the estimated cost, and the future course of action regarding the vaccine. Edited excerpts follow:

What was the process of development of the vaccine, what were the various stages before Bharat Biotech approached CDSCO for approval for human trials?

The virus strain was first isolated by the National Institute of Virology, Pune after it was collected by ICMR. This isolated strain was then used to develop a vaccine candidate at Bharat Biotech.

Upon receipt of the virus strain from the NIV Pune, Bharat Biotech was able to quickly layout the GMP (good manufacturing practices) protocols for the manufacture of the vaccine candidate. Bharat Biotech took to develop the first set of GMP batches within 40 days and upon completion, the pre-clinical trials commenced.

COVAXIN™ was evaluated in animals on Schedule Y Guidelines (Schedule Y defines the clinical trials as the requirements and guidelines for import and manufacture of new drugs for sale or for clinical trials. It describes the details of the application process for conducting clinical trials; responsibilities of the sponsor, investigators and the guidelines of India's Independent Ethics Committee) and the World Health Organisation.

COVAXIN™ was reported to be safe and immunogenic in all animals. We have now moved forward towards the clinical development of this vaccine.

What does the vaccine contain?

COVAXIN™ is an inactivated vaccine developed on a Vero-cell platform. Inactivated vaccines have a well-proven and accepted track record.

What are you expecting the vaccine to do based on your clinical trials so far? What are some of the key findings of the vaccine from your trials?

Upon receipt of the virus strain from the NIV Pune, Bharat Biotech was able to quickly layout the GMP protocols for the manufacture of the vaccine candidate. Bharat Biotech took to develop the first set of GMP batches within 40 days and upon completion, the pre-clinical trials commenced. COVAXIN™ was evaluated in animals on Schedule Y Guidelines from India and WHO Guidelines. COVAXIN™ was reported to be safe and immunogenic in all animals. We have now moved forward towards the clinical development of this vaccine.

Is it likely to be more effective in some people than others? How long is the vaccine likely to be effective?

Conventionally, inactivated vaccines have been around for decades. Numerous vaccines such as seasonal influenza, polio, pertussis, rabies, and Japanese Encephalitis use the same technology to develop inactivated vaccines. Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves the immune system as a dead virus and mounts an antibody response towards the virus.

Which authority might be likely to decide the cost of the vaccine? If it's Bharat Biotech, what is the estimated cost?

As a socially inclined organisation and a company that is focussed on public health, we endeavour to deliver world-class vaccines at affordable prices. We have done this earlier and we hope to achieve the same even for COVAXIN™. We must say that it is too early to make any statement regarding the price.