Ready to challenge GlaxoSmithKline and Merck, India's Bharat Biotech has won WHO prequalification for its rotavirus vaccine Rotavac. The designation means international agencies can purchase the cheaper vaccine for use in developing countries, helping to expand access around the globe.
At $1 per dose or $3 per course, the Bharat vaccine comes at a discount to Glaxo's Rotarix and Merck's RotaTeq, which cost $4.02 and $9.60 per course, respectively, according to UNICEF and Gavi, the Vaccine Alliance.
Bharat believes it can reduce its price by another 30% "based on the procurement of [approximately] 100 million doses" to low-income countries, managing director Dr. Krishna Ella said in a statement.
Bharat launched the vaccine—a result of an international collaboration including groups such as the NIH, CDC, PATH, Gates Foundation and more—in India back in 2014. The company said it has delivered 35 million doses there as part of a national campaign that kicked off in 2016.
In all, partners invested $200 million in the development of Rotavac, according to the company.
While WHO prequalification will likely mean significant demand for the vaccine, Bharat Biotech says its manufacturing systems are ready for the challenge. The company's site in Hyderabad can produce 200 million doses per year and "is a scalable model ready to meet global demand," according to a press release.
Half a million children under five die each year from vaccine-preventable rotavirus infections, according to WHO; most live in low-income countries. Rotavirus is the most common cause of severe diarrhoeal disease in the world.
Even though the field is experiencing an increase in competition with the new WHO prequalification, it might soon see another player in the Serum Institute of India. That vaccine firm has an approved option that's heat stable, a feature that would mean fewer logistical requirements in low-income countries.
According to Gavi, that vaccine is expected to win WHO prequalification this year and costs $5.58 or $4.65 depending on whether it's ordered with one dose in a vial or two doses per vial.