Too early to announce COVAXIN launch date

Dr Krishna Ella, chairman and managing director of Bharat Biotech


He is of humble origins. The man on whom India has pinned its hopes for a Covid-19 vaccine. Dr Krishna Ella’s parents were farmers in Thiruttani, Tamil Nadu; Ella learnt the basics of biotechnology from his family farm.

Young Ella wanted to become a farmer. However, he took up a job in Bayer to support his family economically. Scholarships enabled him to pursue his master’s at the University of Hawai’i and his PhD at the University of Wisconsin-Madison. He also had a stint at the Medical University of South Carolina, Charleston, as a teacher and researcher.

With well-equipped labs and funding opportunities, the US has been a dreamland for researchers. Yet, Ella chose to return to India.

In 1996, he founded Bharat Biotech in Hyderabad. The lab had a modest beginning. The biotech research and development park known as Genome Valley, one of his dream projects, was commissioned in 1999. Genome Valley is now home to more than 100 biotech companies including Bharat Biotech.

Ella is passionate about making the impossible possible. The vaccines developed by Bharat Biotech speak volumes about the man and his mission. The hepatitis-B vaccine is the cheapest in the world, costing just 04 per dose. ROTAVAC, the first indigenous vaccine against rotavirus infections, has also been a real game changer. Other vaccines being developed by Bharat Biotech include the ones against zika, chikungunya and malaria. The company is poised to become the world’s largest supplier of rabies vaccine.

The first phase of human trials of Bharat Biotech’s vaccine against Covid-19—COVAXIN—has begun. The sites for the trials include Chennai, Delhi, Hyderabad, Mumbai, Patna, Rohtak and Vishakhapatnam. The results of the animal trials are quite promising.

COVAXIN is India’s top contender in the Covid-19 vaccine race. It competes with around 100 other vaccine candidates from different countries at different stages of development. Russian scientists have claimed that they will launch the world’s first Covid-19 vaccine in August, which has led to intensified competition among vaccine researchers. Excerpts from an interview:

When can we expect the launch of COVAXIN?

It is too early to remark on this, as we are in the beginning phase of human trials. Only after the safety data is established and upon receiving regulatory approvals will we be able to decide to move into the course of licensure.

What are the features of COVAXIN?

COVAXIN is an inactivated vaccine developed on a Vero-cell [a lineage of cells used in cell cultures] platform. Inactivated vaccines have a well-proven and accepted track record.

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

Will it be an oral vaccine?

It will be an injectable vaccine.

Tell us about your research journey.

The vaccine strain was first isolated from the National Institute of Virology (NIV), Pune. It was further developed into a vaccine candidate at Bharat Biotech.

Upon receipt of the virus strain from the NIV, Bharat Biotech was able to quickly lay out the good manufacturing practice (GMP) protocols for the manufacture of the vaccine candidate. Bharat Biotech developed the first set of GMP batches within 40 days, and upon completion, the pre-clinical trials commenced. COVAXIN was evaluated in animals following the Schedule Y guidelines [established under Drugs and Cosmetics Act, 1945] and World Health Organization guidelines. COVAXIN was reported to be safe and immunogenic in all animal trials. We have now moved forward towards the clinical development of this vaccine.

How big is your study group? Is it difficult to find volunteers for the human trials?

Right now, we are also awaiting ethical committee approvals from various institutions. Some of them have already come.

Enrolment of the cohort for the phase-1 is underway. We will be following a statistically-derived number of subjects required for the human clinical trials. The trial will be a multi-centre study in multiple cities across India.

At what price will the vaccine be sold?

As a socially-inclined organisation, we endeavour to deliver world-class vaccines at affordable prices. We have done this earlier and we hope to achieve the same for COVAXIN. It is too early to make any statement regarding price.

Vaccine race

As on July 14, the WHO has listed 23 vaccine candidates in different phases of

clinical evaluation stage (human trials)

Phase III

Fully assess efficacy, effectiveness and safety; involves up to 3,000 participants Candidates in

phase III: 2 Developers: Sinovac (China), University of Oxford/AstraZeneca (United Kingdom)

Phase II

Assess efficacy and side effects; several hundred participants Candidates in phase II: 2 Developers:

CanSino Biological Inc./Beijing Institute of Biotechnology (China), Moderna/NIAID (United States)

Phase I

Tests on 20 to 80 healthy volunteers; assess safety Candidates (phase I and II combined): 8 [Bharat Biotech belongs to this phase] Candidates in phase I: 11

Pre-clinical evaluation:

Evaluates test results in animal models Candidates in pre-clinical evaluation stage: 140

*Russia’s vaccine candidate that claims completion of human trials is still in phase 1

Source: WHO