Hyderabad-based Bharat Biotech launched its advanced version of rotavirus vaccine – Rotavac 5D, to tackle viral diarrhoea, on Tuesday. While all other variants of rotavirus vaccine manufactured by competitors are at 2-2.5 ml per dose, Bharat Biotech has concentrated the larger dose into 0.5 ml quantity, an official from the company said.

“During clinical trials, we realized 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 the official.

Also, dosages of 2-2.5 ml occupy larger storage space as compared to multi-dose vials packing 0.5 ml doses. “For example, Ghana has decided to switch over to Rotavac 5D to save storage space. Countries in Africa, South America and Central Asian countries have expressed interest in the newer vaccine,” said the official.

Newer Rotavac version

The current Rotavac vaccine, also manufactured by Bharat Biotech and catering to 80 per cent of the Indian government’s need, requires to be stored at -20 degree celsius, which is the same as temperature that needs to be maintained in cold chain for oral polio vaccine. The newer Rotavac 5D will, however require between two to eight degrees celsius storage temperature, which is the normal refrigeration temperature. “Most vaccines be it pentavalent, HPV (for cervical cancer), pneumococcal (for pneumonia) or injectible polio vaccine are stored between two-eight degrees celcius. So that is the latest choice,” said the company official.

While Rotavac is being supplied to the government at less than ₹70 per dose, the price for Rotavac 5D is slated to be slightly higher at close to ₹105 per dose. 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 being pegged at over ten times costing between ₹900-₹1100 per dose.

The Hyderabad-based facility of Bharat Biotech has the joint capacity to manufacture up to 200 million doses of both Rotavac and Rotavac 5D. While the newer Rotavac 5D was licensed in India in August earlier this year, the government is currently dependent on the older Rotavac vaccine of the company as of now. “We will supply the government whatever they requisite for in the tender,” the official said.

Currently the company is not looking at supplying the vaccine in the US, UK or Europe as that will require additional clinical trials on local population, for which massive resources will have to be invested. “We do not have those many resources to expand into western markets as of now,” said the official.

In 1980s, increasing number of child deaths were attributed to the rotavirus vaccine manufactured by Pfizer – 'Rotashield,' due to a condition that vaccinated babies developed known as Intussusception, said M Santosham, Professor (Paediatrics) at US-based John Hopkins University. “Intussusception entails prolapsing of one section of intestine into another causing a blockage. While it happens in normal case with babies too, increasing number of cases were found to be associated with the vaccine in 1980s, following which the US rolled back the vaccine,” said Santosham. The safety of vaccines has massively improved now, he further said.

Between 2011 to 2013, Bharat Biotech tested Rotavac on approximately 6,800 children. “None of the Intussusception cases happened in the first 21 days after giving vaccine to the babies. In the vaccinated arm though there were eight cases, while in the placebo arm there were three cases. Because the vaccinated arm was double the placebo arm, there is no significant difference in the case of Intussusceptions and the association to vaccination was ruled out,” the official said.

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