NEW DELHI :
Bharat Biotech International on Tuesday launched a new variant of its rotavirus vaccine, Rotavac 5D, a smaller dosage form of its earlier oral immunisation shot that can be stored at a relatively higher temperature.
Available in a 0.5 ml dosage, Rotavac 5D can be stored at 2-8 degree Celsius for up to 24 months, and can be administered in five drops. Rotavac 5D is also stable at 37 degree Celsius for seven days.
In contrast, the earlier version, Rotavac is available in 2.5 ml vial per dose and has to be stored at -20 degree Celsius.
The vaccine stability, combined with its small cold chain footprint, enables its use in low resource settings and outreach programs, the company said in a release.
Rotavac 5D will be priced about 25% higher than Rotavac, a company official said, but did not give details on the pricing due to competition issues.
Bharat Biotech had invested $20 million for the development of Rotavac, over and above the $165 million it invested for the original version.
The original Rotavac was made part of the Indian immunization program in 2016 after it received regulatory approval in 2014.
Bharat Biotech also said it has supplied over 100 million doses of Rotavac globally since its launch.
The company has around 60-70% market share for rotavirus vaccines in India, a company official said. Competitors to Bharat Biotech’s Rotavac are GlaxoSmithKline’s Rotarix, Merck’s RotaTeq and Serum Institute of India’s Rotasil.
The Bharat Biotech vaccine’s newer variant, Rotavac 5D, however, will not be part of the Indian immunization scheme as the Indian government has said it has enough storage at -20 degree Celsius and does not need vaccines at a relatively higher temperature as of now, the company’s chairman and managing director Krishna Ella said.
In India, the company plans to target private hospitals for supply of the vaccines, as well as export to countries in Africa and Asia.
For vaccines, it is important that they are stored at the right temperature as exposure to temperatures outside the specified range may result in reduced vaccine potency or increased risk of vaccine-preventable diseases. In the worst case, the vaccines can even cause diseases it is supposed to immunize against.
Globally, rotavirus causes approximately 200,000 deaths and about 2 million hospitalizations annually, mostly in low-income countries.