Takeda Pharmaceuticals entered into an agreement with India’s Biological E Limited in June to produce low-cost vaccines for low income countries. Under the deal, Japan’s largest drug maker agreed to share the rights of the company’s bulk production technology used in its proprietary measles and acellular pertussis vaccines to Biological E. Takeda would, as per the terms of the deal, also provide technical services such as support in infrastructure review, training for production and quality control. Biological E, a privately held vaccines and biologics company located in Hyderabad of south India, will fund and conduct development activities for vaccine combos utilizing Takeda’s measles and pertussis vaccine technologies, besides scaling up production. BE gets the rights to commercialize combinations made out of two vaccines such as measles-rubella (MR) and diphtheria, tetanus and acellular pertussis (DTaP) in India, China and a number of public markets worldwide. Takeda has been looking out for vaccine partners from India for quite some time. Clearly, the idea is to get into more developing economies through affordable vaccines.

India, the generic powerhouse, is emerging as a sought-after location for sourcing low-cost vaccines. Vaccines made in India are already an integral part of immunization programs the world over through UN agencies. Indian companies supply about 60% of vaccines for Global Alliance for Vaccines and Immunization (GAVI), the non-profit organization.

The USP of Indian vaccine makers, however, is not limited to making basic vaccines more affordable through extremely low costs. They also try out simple and cost-effective technologies to improvise the vaccines. It could be tweaking the formulation a bit to make the vaccine withstand possible adversities in hostile climates to ensure efficacy. Or, at times, they may work around an injectable vaccine to produce an oral equivalent to help enhance compliance, and so on.

Phase III data from a heat stable rotavirus vaccine from Serum Institute of India (SII), has come out recently. The results of the study conducted in 7,500 infants across 6 Indian sites demonstrated that Rotasiil’s efficacy was comparable to the performance of the leading RotaTeq and Rotarix brands in Bangladesh and in some African countries, according to the study published in the journal Vaccine.

The oral vaccine used in the Niger study was stored at less than 25°C and transported for vaccination at ambient temperature. Studies have shown that Rotasiil is stable for two years at 37°C. This lends a unique edge to Rotasiil over the competitor products as costly cold chain requirement still pose a tough challenge in several parts of the world.

SII, the world’s largest vaccine maker by number of doses produced, is currently in the process of gathering additional data from a separate Phase III study in India for WHO prequalification.
Cyrus Poonawalla Group, the promoters of SII, acquired Nanotherapeutics Bohumil s.r.o of Czech Republic in May. The company said it would utilize the 150,000-square foot BSL-3 capable manufacturing facility to produce inactivated polio vaccine, for which there is presently a global shortage.

Bharat Biotech, which has rolled out a live attenuated oral rotavirus vaccine in India, announced results from a study using its Typbar TCV, a conjugated typhoid vaccine, in The Lancet. A “controlled human infection model” study carried out at Oxford University found the vaccine prevents up to 87% of infections.

Based in the Genome valley of Hyderabad, Bharat Biotech is presently evaluating several vaccines including candidates for chikungunya and Zika viruses.

In a related development, New Delhi-based Hilleman Laboratories, a joint-venture of MSD and Wellcome Trust, received a 6 million krona Indo-Swedish grant in September for making an affordable single strain whole cell-B subunit oral cholera vaccine. The vaccine development is jointly funded by the Department of Biotechnology, Government of India and Vinnova, the Swedish Governmental Agency for Innovation Systems.

An affordable, simplified oral cholera vaccine would make mass vaccination a reality in cholera endemic areas due to ease of manufacturing and low cost, thereby improving vaccine affordability and accessibility, Hillman Laboratories said.

Hilleman Labs, which is also developing a thermostable oral rotavirus vaccine, has shigella vaccine and a low-cost meningococcal conjugate vaccine in its pipeline.

Bigger players, meanwhile, have started listing the vaccine business as one of their potential growth engines for the future.

With nine approvals and 18 in the pipeline, Zydus Cadila, for instance, is betting big on the company’s vaccine division. In its latest tech tie-up, the Ahmedabad based firm joined hands with Russian company Pharm Aid Ltd. for the knowhow on varicella vaccine production.

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S. Harachand
Contributing Editor

S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com