INTERVIEW: Hilleman CEO On $1 Rotavirus Vaccine Challenges

India’s Hilleman Laboratories has developed a new low-cost vaccine for rotavirus that it sees able to compete with the $1 a dose pricing of Rotavac, a rival product from Bharat Biotech International Ltd.

"It is possible to scale the vaccine production to a point where the prices can be brought down to $1 a dose. That's certainly possible. The Bharat Biotech vaccine, in some ways, is the most basic of basic rotavirus vaccines. The price can be matched if the other products are actually scaled," Gill told PharmAsia News’s sister publication Scrip Intelligence in an interview in Mumbai.

Hilleman is a joint venture between Merck & Co. Inc. and Wellcome Trust.

Gill, though, explained that at lower scales, it may be a "little difficult" to achieve that price level given that Hilleman's rotavirus vaccines and other products have other attributes, such as thermo-stability or multiple different sero groups, or a dry formulation prepared to a liquid formulation, which may add to the cost.

The Rotavac vaccine originated from an attenuated strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86, and the project has involved multiple partners including India's Department of Biotechnology (DBT), Bharat Biotech (an Indian firm), the US National Institutes of Health, the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and the non-governmental organization PATH.

Rotavac was recently in the spotlight after a public interest lawsuit - since dismissed - flagged concerns over the allegedly higher risk of intussusception that may potentially be associated with the Indian vaccine.

Gill said it is unfortunate that the debate on Rotavac is ongoing primarily because, rotavirus induced diarrhea kills so many children and the longer the vaccine is delayed, more children will suffer and die.

"I think the clinical trials have been conducted in a very clear and robust fashion…the data that I have seen would suggest that perhaps there are no long term concerns with this vaccine, but it still has to be tested. I hope this debate can be resolved and this vaccine can be brought to people as quickly as possible."

Safe And Stable

Gill explained that the Hilleman rotavirus vaccine has the advantage that its active ingredient has proven to be "completely safe", with no reported cases of intussusception with the bulk antigen. In addition, the design of the vaccine includes five different serotypes of rotavirus, which means it can address rotavirus infections from multiple different serotypes.

"We have a very stable formulation, which in a country like India - large, diverse, heterogeneous - from an implementation perspective it's a much easier vaccine to implement," he explained.

The Hilleman boss underscored that the thermostability profile of the product is such that it has the potential to be completely "kept out" of the cold chain.

"We tested it at 45 degrees Celsius for 10 months and it's stable."

Hilleman is at the "cusp" of initiating clinical trials with its rotavirus vaccine, though Gill explained that the active ingredient in the vaccine – bulk antigen - is derived from a previous vaccine that has been licensed almost 10 years.

"So there is a huge amount of safety and efficacy data. What that allows us to do is go through some pretty rapid assessment of safety of our formulation and then use an immunobridging strategy to gain registration."

He hopes to have trials "wrapped up" in two-three years, if all goes well.

Hilleman, which on Oct. 26 announced the publication of an original scientific report in the Royal Society of Chemistry Advances Journal on the synthesis of a meningitis vaccine for Neisseria meningitidis sero group X, is also developing a Hib vaccine.

Mosquirix

The Hilleman CEO also believes that GlaxoSmithKline PLC's Mosquirix, the world's first malaria vaccine, should be allowed to roll out alongside an almost "parallel assessment" of the effectiveness, instead of the currently recommended approach of the World Health Organization advisory group.

On Oct. 23, the WHO said that the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) recommended pilot implementations of GSK's vaccine in a limited number of African nations, before considering a wider scale-up.

These pilot implementations could pave the way for wider deployment of the vaccine in three to five years, if safety and effectiveness are considered acceptable.

Gill said that rather than engaging in additional testing, the "right thing" to do will probably be to roll out the vaccine in a phased manner.

"Go to most endemic areas where the burden of the disease is highest and roll out the vaccines in those areas, because it does work; it is protective. And then use perhaps those roll out situations to gather additional data.

“I would rather that there is a roll out and almost a parallel assessment of the effectiveness of the vaccine only because the burden of disease is very high…lots of people are dying."

GSK CEO Sir Andrew Witty had earlier noted that while Mosquirix - also known as RTS,S - on its own is not the "complete answer" to malaria, its use alongside those interventions currently available, such as bed nets and insecticides, would provide a very "meaningful contribution" to controlling the impact of malaria on children in those African communities that need it the most.

(This article is also published in Scrip Intelligence. PharmAsia News brings selected complementary coverage from our sister publications to subscribers.)