As vaccine production in India has hit manufacturing roadblocks over the past few years, GlaxoSmithKline (GSK) has signed a joint venture to begin development of a six-in-one pediatric vaccine.
The joint venture with Indian vaccine developer Biological E seeks to launch a first of its kind vaccine that will combine GSK’s injectable polio vaccine with Biological E’s pentavalent vaccine for diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type b. The new vaccine is expected to enter Phase I development by 2015.
The aim is to enable fewer injections and improve compliance in immunisation schedules. The liquid formulation of the vaccine also means it will not require any additional ingredients or materials before its use, GSK says.
“We expect to leverage this partnership to accelerate the development of the hexavalent vaccine and make [GSK’s injectable polio vaccine] accessible for developing countries in the post eradication phase for polio,” Vijay Kumar Datla, chairman of Biological E., said.
Both companies will make a “small initial cash investment” in the joint venture to cover start-up costs and other development costs will be split between them, according to GSK.
The joint venture comes as Biological E opened a $61m vaccine and biopharmaceutical manufacturing campus in 2009. The campus was built in conjunction with the Indian government.
India’s Investment in Vaccines
The GSK venture also comes at a time when India is looking to ramp up its investment in vaccine development. In May, the government announced an investment of $37m to bring the country’s vaccine plants up to cGMP compliance.
The investment is intended to help vaccine development at sites in Chennai and Coonoor almost four years after the Drugs Controller General of India suspended the manufacturing licenses of four vaccine makers after they failed to meet GMP requirements in 2008. The suspension of licenses caused shortages and public outcry.
But it’s difficult to gauge how the GSK joint venture will impact future vaccine production in India.
“At this stage, it is too early to speculate on the potential impact on sales,” a GSK spokesman told In-Pharmatechnologist.com. “The [joint venture] is a demonstration of our commitment to global public health and, in this particular case, the WHO’s polio eradication strategy.”