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Tuesday, December 07, 2021

Explained: Covaxin’s road to recognition

WHO emergency use licence is an acknowledgement of Bharat Biotech's research credentials, and paves the way for Covaxin's deployment elsewhere. With demand set to grow, production too will need to rise.

Written by Amitabh Sinha | Glasgow |
Updated: November 9, 2021 2:49:35 pm
Covaxin Vaccination, WHO Approval on CovaxinCovaxin Covid-19 Vaccination: Vials of Covaxin lie on a table at the venue of a vaccination drive in Guwahati. (AP Photo: Anupam Nath, File)

The World Health Organization (WHO) has granted an emergency use licence (EUL) to Bharat Biotech’s Covaxin, a move that ends months of suspense over the fate of a Covid-19 vaccine that has had a tumultuous journey since the beginning of its development last year. The vaccine was approved for use in India under emergency use authorisation since January this year. But in the absence of an EUL by WHO, it wasn’t considered valid by many countries.

The EUL, the first to any vaccine developed in India, is an acknowledgment of the research credentials of the Hyderabad-based company. More importantly, it paves the way for its widespread distribution around the world. It also brightens the chances for the company’s vaccine for children —India’s first for the age group 2-18 — although that will have to be appraised separately.

The developer

Bharat Biotech was one of two Indian companies to have decided to develop a vaccine for Covid-19, immediately after the pandemic started spreading in India, the other being Ahmedabad-based Zydus. Bharat Biotech was selected the Indian Council of Medical Research (ICMR) for a partnership in the development of this vaccine, although the role of the government research organisation was restricted mainly to supplying virus samples. Most of the research and development, as well as investments, came from the Hyderabad-based company.

Bharat Biotech was no stranger to vaccine development and manufacturing. At the time it ventured into Covid19 vaccine, it already had 15 other vaccines for different diseases in the market, including the rotavirus vaccine that was developed after a decade of research. Its typhoid vaccine, based on an innovative technology and commercialized three years ago, is the only one in the world that provides long-term immunity against the disease. The typhoid vaccine is also approved by the WHO for global use.

Yet, when it came to the Covid-19 vaccine, the company opted for a traditional and time-tested technology, unlike the fancier technologies that several foreign companies were using. It uses a dead pathogen to trigger an immune response. This is considered a safer approach, one that has less chance of causing side-effects, compared to vaccines that use live inactivated pathogens or their proteins or genetic material.

The controversies

Bharat Biotech’s approach received the support of the scientific community, but two moves by the government led to the vaccine coming under attack, not just from scientists but also from the general public, and also resulted in scepticism in India and abroad. The first was the revelation, in early July, that ICMR director general Balram Bhargava had directed the hospitals chosen for the trials to “fast-track all approvals related to clinical trials” apparently because “it was envisaged to launch the vaccine for public health use latest by August 15, 2020”.

In effect, Bhargava seemed to be saying this vaccine could be cleared within a month and a half, when normally it takes several years to approve a vaccine. The directive gave the impression that the government was ready to push a vaccine without adequate safety trials, compromising the health and lives of people.

That directive was withdrawn but the impression persisted, and gained strength six months later when Covaxin was given emergency use authorisation without even interim results from phase III trials. At that time, in January this year, Covid-19 cases were declining consistently, and the demand for vaccines was not immediate, and interim results from phase-III trials were only a few weeks away. Once again, it created an impression that the government was making undue interventions to push Covaxin.

Covaxin Vaccination, WHO Approval on Covaxin Covaxin Covid-19 Vaccination: A woman is vaccinated against Covid-19 in India during the pandemic.

Its performance

Despite the avoidable controversies, the vaccine itself did quite well when deployed. Its safety and efficacy were at par with that of other vaccines available in the market. Along with Covishield, the vaccine developed by Oxford University and AstraZeneca and produced in India by Serum Institute of India, Covaxin played a key role in the fight against the pandemic in India.

The big difficulty, after Covaxin’s clearance and deployment, has been Bharat Biotech’s inability to significantly ramp up production as planned. Covaxin barely accounts for 11% of all doses that have been given in India till now, although that itself means over 10 crore doses.

The WHO licence

The emergency use licence from WHO was needed not just for Indians wanting to travel, but also for Covaxin’s deployment in other countries. Wednesday’s approval opens the way for Covaxin to be included on the COVAX platform that is used to distribute vaccines to low- and middle-income countries where very few Covid-19 vaccines are available now. COVAX is being operated by WHO along with a few other international agencies to ensure equitable and affordable distribution of Covid-19 vaccines.

The recognition also gives a boost to Covaxin’s use among the younger population. The vaccine has recently been approved for in India among people between the ages of 2 and 18 after successful trials in these age groups. No other vaccine in the world has been approved for children below five. Vaccination among younger children is still to start in India.

The WHO EUL has now put the ball back in Bharat Biotech’s court. It is the company’s turn to ramp up production to satisfy the demand that is expected to go up sharply now.

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