Merck JV, Hilleman Laboratories Form Collaboration To Fast-Track Oral Cholera Vaccine
Hilleman Laboratories, a vaccine developer and manufacturer based in New Delhi, has signed a Memorandum of Understanding (MoU) with ICD DR, B and Incepta Vaccine to expedite clinical trials and eventual marketing for a new oral cholera vaccine, Business Standard reports.
The three companies will lend their individual expertise to the development process. Hilleman will further develop the compound through its preclinical stages. ICDR,B will research potential candidates, and with the help of Incepta’s manufacturing capabilities, will produce the necessary quantities of the drug necessary for pre-clinical and clinical trials.
The CDC reports there are two existing cholera vaccines currently in use: Dukoral, manufactured by SBL vaccines, and ShanChol, manufactured by Shantha Biotec in India. Only Dukoral is pre-qualified by the WHO and licensed for use in 60 countries.
Current cholera vaccines are two-dose, requiring weeks between injections. Even when the dosing is complete, protection is incomplete and only lasts for a short time. These shortcomings, in addition to the indelible problems of injectable vaccines in low-income nations, have steered vaccine research towards oral alternatives.
Oral vaccines are advantageous for a few reasons. They’re more chemically stable and easier to transport and store; they circumvent the problem of needle-transferred infection; and they are usually much cheaper to produce.
However, scientists have been hard at work to address inherent drawbacks. Stomach acid in the GI track, for instance, often breaks the vaccine down in the stomach before the immune system has a chance to respond. As a result, very few oral vaccines have been approved for human use.
Hilleman Laboratories, a joint venture from U.S.-based Merck and Wellcome Trust, is a non-profit based in India dedicated to addressing the gaps in vaccine availability and the shortcomings of existing treatments. Their research focuses on thermostability, ease-of-administration, reduced footprint, and affordability.
According to Hilleman, many of today’s existing vaccines were developed and manufactured for citizens in industrialized nations and often prove ineffective in the areas of the world where they are most needed.
Davinder Gill, CEO of Hilleman, explains, “We are sensitive to the fact that cholera is endemic in developing nations, especially in the Bengal delta and sub-Saharan Africa.”
Business Standard projects 30 million doses of a cholera vaccine will be needed in 2016, and that number might increase to 200 million by 2025. This is a demand that current manufacturers of existing vaccines might not be able to meet, though Gill remains confident Hilleman will be able to contribute sufficiently following this new collaboration agreement with ICD DR, B and Incepta Vaccine.