Covaxin: How India-made Covid-19 vaccine managed to get WHO approval and what it means

The World Health Organization’s (WHO) emergency-use licence to Bharat Biotech’s Covaxin recently ended months of suspense over the fate of the vaccine’s tumultuous journey that began since its development phase last year. India approved the vaccine for emergency use in January. But in the absence of an emergency-use licence from WHO, many countries refused to consider it as valid.

The emergency-use licence, the first to a vaccine developed in India, acknowledges the Hyderabad-based company’s research credentials. It also paves the way for the vaccine’s worldwide distribution and brightens the chances for the company’s vaccine for children, which will be appraised separately.

Bharat Biotech
Hyderabad-based Bharat Biotech was among two Indian companies — the other being Ahmedabad-based Zydus — to start development on a Covid-19 vaccine immediately after the pandemic began to spread in India. The Indian Council of Medical Research (ICMR) selected Bharat Biotech for a partnership to develop the vaccine. The role of the government research organisation was restricted to mainly supplying virus samples. Most of the research and development and investment was made by the company.

Bharat Biotech is familiar with vaccine development and manufacture. It already had 15 other vaccines for various diseases by the time it ventured into Covid-19 vaccine. These include the rotavirus vaccine, developed after a decade-long research. The company’s typhoid vaccine, based on innovative technology and commercialised three years ago, is the only vaccine that provides long-term immunity. The typhoid vaccine is approved for global use by the WHO.

The company, however, opted for a traditional technology for the Covid-19 vaccine, using a dead pathogen to trigger an immune response. This is seen as a safer approach and with lower chances of side-effects.

Controversy
Bharat Biotech received support from the scientific community for its approach. However, the vaccine came under attack for two government moves, resulting in scepticism. The first was the revelation that ICMR Director General Balram Bhargava had directed the hospitals where the trials were taking place to fast-track approvals related to the clinical trials, ostensibly because it aimed to launch the vaccine for the general public by Independence Day 2020.

Bhargava’s direction meant the vaccine could get clearance within a month and a half, when it takes years to get approval. The directive gave the impression that the government was willing to push the vaccine without complete safety trials.

Six months later, Covaxin was granted emergency-use authorisation without the Phase III trial interim results. At that time, in January, Covid-19 cases were on the decline, demand was not immediate, and the interim results were just weeks away. Again it created the impression that the Centre was making a push for Covaxin with undue interventions.

Performance
Despite the controversies, the vaccine did well when deployed. Its efficacy and safety were at a par with other available vaccines. Covaxin, along with Covishield — developed by AstraZeneca and Oxford University and produced by the Serum Institute of India for the domestic market — played a major role in the country’s fight against the pandemic.

The difficulty after Covaxin’s clearance and deployment was Bharat Biotech’s inability to ramp up production. Covaxin accounts for barely 11% (roughly 10 crore) of doses administered in India till now.

WHO licence
Covaxin needed WHO’s emergency-use licence not only for Indians wanting to travel but also for its deployment in other countries. The approval on Wednesday paves the way for Covaxin to be on the COVAX platform, used to provide Covid-19 vaccines to low- and middle-income countries.

The recognition also boosts Covaxin’s use among India’s younger population. The vaccine was recently approved for use among children aged between 2 and 18 in India after successful trials. No other vaccine has been granted approval for children below five.

The WHO emergency-use licence puts the ball back in the court of Bharat Biotech. It is now the company’s turn to increase production and satisfy the demand that is expected to rise sharply.