Bharat Biotech’s perception battle

For 65-year-old Brazilian President Jair Bolsonaro, Bharat Biotech International Ltd (BBIL) is like a knight in shining armour. The man, who faced a barrage of criticism for his inept handling of the Covid-19 pandemic, heaved a sigh of relief on January 12 as BBIL signed an agreement with São Paulo-based Precisa Medicamentos for the supply of Covaxin, a Covid-19 vaccine indigenously developed in India, to Brazil.

After a technical visit to BBIL’s Genome Valley facility in Hyderabad on January 7-8, the firm's pharmaceuticals director, Emanuela Medrades, was swayed by the efficacy and production quality of the vaccine. “There are excellent outcomes in clinical trials, which will be published soon. Bharat Biotech has exceeded our expectations, demonstrating quality and safety at the level of the largest vaccine suppliers in the world,” Medrades said.

Precisa Medicamentos, a family-run private company, is buying 12 million doses on behalf of the Brazilian government “over a period of time”. The price at which BBIL has signed the deal is under wraps. The supply of vaccines will be prioritised for the public market, through direct procurement by the government of Brazil, BBIL said in a statement, adding that the vaccine roll-out will be subject to approval by Brazil's health regulator, ANVISA. At present, the Indian government doesn’t allow exports to private markets abroad nor in the domestic market.

The Covaxin deal brings solace to Brazil which has ratcheted up the second highest death toll of over 200,000, after the U.S. The Latin American country has already reported over 8 million cases and is in the throes of a second wave. Bolsonaro—who once joked on Twitter that vaccination would be required only for his dog, and earned public ire—has struggled to get the country's vaccination campaign off the ground.

The Brazilian recognition for the vaccine has come as a big win for Krishna Ella, the chairman and managing director of BBIL. For the Hyderabad-headquartered BBIL, which is fighting a perception battle in the country, it couldn’t have come at a better time, say industry officials.

An elated Ella said Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist. “We are happy to note that vaccines innovated in India are able to address the public health needs of Brazil,” he said.

BBIL knew it was in for a windfall in December 2020, soon after a team of 70 ambassadors and high commissioners representing countries from Asia, Africa, North America and South America visited its facility in Genome Valley. Subsequently, Nasdaq-listed Ocugen signed a deal with BBIL to co-develop Covaxin for the U.S. market.

In response to a questionnaire from Fortune India, Ella said, “Our goal is to provide global access to populations that need it [the vaccine] the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist.” He, however, refused to answer all other queries.

As India gears up for the world’s biggest vaccination campaign, BBIL is ready to fight all odds and script another success story. The vaccine maker, which worked in close association with the National Institute of Virology (NIV) under the aegis of Indian Council of Medical Research (ICMR), the state-run medical research organisation, for the development and roll-out of the vaccine, received emergency use authorisation (EUA) approval from the Drugs Controller General of India (DCGI), on January 3.

Around a week later, on January 11, the Indian government signed a purchase agreement with BBIL for 3.85 million doses at ₹295 per dose (excluding tax). BBIL has committed another 1.65 million for free, bringing down the effective cost of the vaccine to ₹206 per dose, according to the health ministry. BBIL is also believed to have committed to supply an additional 4.5 million doses, for which the price per dose is unknown.

BBIL began dispatching vaccines from Wednesday (January 13) via Hyderabad’s Rajiv Gandhi International Airport. These are being sent to 11 cities across the country.

“At present, our BSL-3 [biosafety level 3] facility in Hyderabad has an annual capacity of 200 million doses of Covaxin. We are in the process of setting up a new facility with a capacity of 100 million. The other two facilities in Bengaluru and Ankleshwar (in Gujarat) have a combined capacity of 500 million for Covaxin,” said an official from the PR company representing BBIL.

Ever since the public announcement of the vaccine, it was muddied in an array of controversies.

On July 2, 2020, ICMR director general Dr. Balram Bhargava wrote to all the 12 trial sites that all clinical trials had to be completed before August 15 when it would be launched publicly. Immediately, medical experts and virologists had raised concerns as to how all three phases of the trial could be crunched into a month’s time. Some experts, however, said in a pandemic, emergency-use approval could be given if data from the first two trial phases is compelling enough, of course with riders related to additional data and adverse event reports.

The ICMR’s insistence came despite a BBIL application to the Clinical Trials Registry-India (CTRI) that estimated 15 months for phase 1 and 2 trials, including a month for phase 1 alone. The application showed its plans to complete the enrolment of trial participants by July 13, but the ICMR chief had directed the sites to complete enrolment by July 7. As per reports, Bhargava had also written to Ella, asking him to fast-track clinical trials.

A few days later, ICMR said in a statement that it had not set an August 15 deadline for the vaccine, seeking to allay a controversy over setting a hurried target for the drug. It added that its aim was to complete trials quickly but it didn’t mean to predate the launch.

BBIL faced several odds when some of the 12 clinical trial sites failed to get an adequate number of participants. Subsequently, health activists also raised a hue and cry over the absence of consent from trial participants at People's College of Medical Sciences & Research Centre, Bhopal. The allegation was refuted by the college as well as BBIL. Rajesh Kapur, vice chancellor of Peoples’ University, said on January 6 that the participants in the trial were given consent forms only if they asked for them.

There was also confusion over the use of Covaxin among minors of 12 years and above. Suchitra Ella, joint managing director of BBIL, had stated in December that as of now the clinical trials of Covaxin have been authorised by DCGI to be conducted on 18-plus age group, meaning “primarily for adults right now”.

“Nowhere in the world the vaccine has been tried and tested on children yet. The vulnerable population immediately in front of us is the older population, the ageing population. Children may come at a later stage when WHO and other agencies look at it,” she had said.

On January 4, Ella hit out at comments suggesting that his vaccine was “safe like water”, and said that their phase 3 efficacy data, likely to be out by February or March, will silence all critics. Though he did not take any names, Ella’s remarks appeared to be in response to a statement by Adar Poonawalla, chief of BBIL’s rival, Serum Institute of India. Poonawalla had said that apart from their vaccine, only two others—Pfizer and Moderna—had passed all the scientific evaluations, while the others were “safe like water”, meaning their effectiveness had not yet been evaluated.

A day later, Poonawalla and Ella called a truce and issued a joint statement pledging their commitment to supply Covid-19 vaccines to India and the world. “Both companies respect the great work being carried out by each other and put behind us the miscommunication and misunderstanding caused during the past week. We are fully aware of the importance of vaccines for people and countries alike, we hereby communicate our joint pledge to provide global access for our Covid-19 vaccines," Poonawalla and Ella said in the joint statement, emphasising “their combined intent to develop, manufacture, and supply Covid-19 vaccines for India and globally”.

A senior official from Mumbai-based Bharat Serums and Vaccines Ltd, who refused to be named, said there are a few issues at Bharat Biotech over approval-related protocols and publication of the efficacy data. “The company will need to sort them out as quickly as possible,” he said.

The Indian Medical Association (IMA) has, meanwhile, endorsed Covaxin along with Covishield, manufactured by Serum Institute of India in collaboration with the University of Oxford and AstraZeneca. “These are our Indian vaccines. Good protective levels of antibodies have been found to develop with the two vaccines against the current strain and new mutated strains. These vaccines are practically easy to store and use in Indian conditions,” said IMA while strongly recommending the two vaccines.

IMA has also requested all its 350,000 members in 1,800 local branches to voluntarily come out to get vaccinated first to show the world that these vaccines are safe and efficacious. “We stand with the scientists to endorse the safety and efficacy of both these vaccines, so public awareness and countering with myths on vaccine percolating in social media shall be our priority. Our modern medicine doctors will vouch for the safety, quality and professionalism in this difficult time and support the emergency approval for the usage of vaccines,” said IMA in its statement.

For BBIL, a startup that began on a shoestring budget in 1996, every challenge is an opportunity.

With a diversified product portfolio in its kitty, BBIL is known for its successful rotavirus vaccine and typhoid vaccine. The company, which came into existence in 1996, has so far produced vaccines for rabies, polio, Japanese encephalitis and H1N1 influenza.

“In 1996, I started conceptualising a Hepatitis vaccine, when I was working on a yeast molecular gene and had the expertise of taking the gene out of yeast and putting it back. During that period, there was a substantial demand for medicine in India. So, I set up a small lab in Hyderabad with the medical equipment I had brought along with me in my 40-foot container and started producing the protein,” Ella said.

He started Bharat Biotech with a total cost of ₹12.5 crore. “Within three years, in January 1999, the then-President A.P.J. Abdul Kalam launched our first Hepatitis vaccine. We went on to supply several million doses for the national immunisation programme to the government of India at ₹10 per dose,” Ella said.

This was a huge milestone as BBIL became the first company in the world to produce the world's first caesium-free Hepatitis B vaccine at an affordable price when the vaccine was sold by a multinational at ₹1,400 per dose.

Having delivered more than 4 billion doses of vaccines worldwide, BBIL continues its journey amid challenges. It developed vaccines for influenza H1N1, polio, rotavirus, Japanese encephalitis, rabies, chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for typhoid. The 2019 acquisition of Chiron Behring (the makers of the Chirorab vaccine) has now positioned BBIL as the largest rabies vaccine manufacturer in the world.

Over the last two-and-a-half decades, BBIL has established a track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, four bio-therapeutics, registrations in more than 116 countries, and WHO pre-qualifications.

If all goes well, the Covid-19 vaccine can be another feather in its cap.