Almost four years after India got its first indigenously made Rotavac vaccine to combat severe diarrhoea causing rotavirus, Vice President M Venkaiah Naidu on Tuesday launched vaccine's newer variant, Rotavac 5D, a smaller dosage and low cost cold chain footprint form of its earlier oral immunisation shot.
Globally, Rotavirus disease burden is estimated at 200,000 deaths and about 2 million hospitalizations annually, mostly in low-income countries. While child deaths from rotavirus have more than halved since 2000, almost half of the deaths each year occur in just four countries: India, Pakistan, Nigeria and the Democratic Republic of Congo, according to the WHO.
Sharing the details of the new variant at a press conference here, Bharat Biotech Chairman Dr Krishna Ella said that 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, he said.
"During clinical trials, we realised that nearly 20 per cent of the children were not able to swallow an entire of 2-2.5 ml, and they spit it out. The nurses were in a quandary so as to whether the dose should be re-administered or not. We advised the nurses against delivering double doses. Eventually we packed the dose in a smaller quantity," said Dr Ella on the need to have a new version.
A baby requires three doses of the vaccine at sixth, tenth and fourteenth week after birth. In the private set-ups both Rotavac and Rotavac 5D are expected to cost between Rs 900-Rs 1100 per dose, ten times higher than what is being made available to the Governments.
Dr Ella said that Rotavac 5D is now available for sale, having received commercial license in India where it plans to tap private hospitals for supply of the vaccines, as well as export to countries in Africa and Asia.
However, Rotavac 5D, will not be part of the Indian immunization scheme. "The Government has said it has enough storage at -20 degree Celsius and does not need vaccines at a relatively higher temperature as of now", Dr Ella said. The company has supplied over 100 million doses of Rotavac globally since its launch. The original Rotavac was made part of the Indian immunization program in 2016 after it received regulatory approval in 2014.
The company had invested USD 20 million for the development of Rotavac, over and above the USD165 million it invested for the original version.