When Bharat launched Rotavac, two years ago, it was a dollar a dose. Also, the cheapest in comparison with what competitors GlaxoSmithKline (GSK) and Merck were selling in India. It was developed with support from the Indian and the US governments and non-government organisations including the Bill and Melinda Gates Foundation (BMGF). It couldn’t have been better timed because a year later, the Modi government included the rotavirus vaccine in the Universal Immunisation Programme (UIP) in four states—Andhra Pradesh, Haryana, Himachal Pradesh and Odisha. Rotavirus diarrhoea kills between 80,000 to 100,000 children every year.
Meanwhile, slowly and steadily, Serum had been developing a different product, more in tune with the global market. For two dollars a dose, Serum’s Rotasiil offers higher stability, a longer shelf life and reduced wastage with its small doses. No less importantly, it has pushed the government to change its ways of buying from the industry as the vaccine demand for the UIP soars.
More vaccine quantities and the number of children being immunised, up from 65% to 90% by 2020, under the new plan, have been like a booster dose for the Indian vaccine makers. The guaranteed minimum of 40% to the second lowest bidder is a turning point. The current UIP budget of Rs 1000 crore for 2017-18 will see nearly twice the number of suppliers for different vaccines, the credit for which goes to two companies—Bharat and Serum.
The hare & the tortoise
The story of Rotavac’s development started in 1985. A new strain of the virus was isolated at the All India Institute of Medical Sciences (AIIMS) in Delhi, says a member of the National Technical Advisory Group on Immunisation (NTAGI), which informs decision making in the UIP. What followed was unconventional. Global health charities supported molecular biologist Krishna M Ella, who founded Bharat in 1996 to develop vaccines in India. Along with other products, he slowly developed Rotavac, India’s first indigenous rotavirus vaccine, which, for that matter, was also India’s first locally developed novel vaccine. It was effective but, more importantly, inexpensive.
Rotavac took over 20 years to develop. In 2009, Serum, which mostly supplied generic vaccines for global immunisation programmes, began working on its own rotavirus vaccine. Eight years later, it licensed Rotasiil in India.
How did Serum take less time and develop a more stable vaccine?
Gagandeep Kang, a clinician scientist at the Christian Medical College and Hospital in Vellore, who was involved with the testing of both Rotavac and Rotasiil, says it was because of the experience that had already been achieved in Rotavac’s development process.
Although Rotavac’s development was a longer process, chiefly owing to finding partners, funding and the right trial design, there was no unreasonable delay, says Kang. In fact, it was only in 1997-98 that Bharat was identified as the industrial partner to manufacture the vaccine. Further, international non-government organisation PATH, which was a partner in Rotavac’s clinical development, was more experienced when it supported Serum with Rotasiil, she points out.
The motivation in the development of the two vaccines was also different as the vaccine-procuring landscape had evolved. High heat stability and shelf life were not priorities while developing Rotavac, notes Kang. With Rotasiil, Serum specifically focused on the fact that vaccines lose their efficacy if left at very high or low temperatures. Kang believes, a country with inadequate cold storage facilities could consider Rotasiil for its heat stability.
Whatever its reasons, Serum is not worried about finding a market.
In December 2016, the Drug Controller General of India (DCGI) approved Rotasiil. The vaccine also found itself eligible for the latest bidding round for 14.5 million doses of rotavirus, floated by the ministry of health.
When the rules of the race change
For now, Serum may have scored a win over Bharat. Rotasiil can be stored for 24 months at 37°C and for 6 months at 40°C. Whereas Bharat’s Rotavac, if not frozen at -20°C, can be stored at 5°C ±3°C for six months. Serum claims to have another advantage over Rotavac.
“Bharat Biotech’s rotavirus vaccine was initiated as a collaborative project with the DBT (Department of Biotechnology), PATH, BMGF, etc. It had the advantage of being the first company to launch an indigenous rota vaccine in India,” says SK Bahl, a director at Serum. He wouldn’t comment further on the competitor’s product. Serum, he says, worked diligently on its own vaccine, which underwent various phases of clinical trials in India and abroad.