Bharat Biotech's Zika, Chikungunya vaccines to enter Phase II trials; focus now on private label market

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Vaccine maker Bharat Biotech International said two of its vaccines against Zika and Chikungunya will be entering phase-II clinical trials, where they will be tested on humans for safety and efficacy.

So far there are no vaccines in the world against Zika and Chikungunya.  Both are viral diseases and spread primarily by mosquito bites.

“We are ready for phase-II trials,” said GVJA Harshvardhan, Director at Bharat Biotech.

“In the first phase, the vaccine was tested on healthy volunteers to determine the safety,” Harshvardhan added.

It takes around 10 to 15 years to complete all three phases of clinical trials of a vaccine before it can get marketing licensing. Phase-II trial takes around two years and the vaccine has to be tested on 200-300 patients.

“Clinical trials require a lot of money, and the risk of failure is high,” Harshvardhan said.

Bharat Biotech mitigates the risk of failure associated with R&D through research grants and supply commitments from funding agencies, governments and partnerships.

The Hyderabad-headquartered company had successfully developed and launched vaccines for Japanese Encephalitis, Rotavirus and Typhoid. So far the company has invested around $200 million on vaccine development.

Zika vaccine

Bharat Biotech surprised the world when it announced in February 2016 that it had developed two Zika vaccine candidates, one of them is an inactivated vaccine or that contains inactivated virus.

The company also said it was probably the first in the world to file for a global patent for Zika Vaccine candidates.

Apart from Bharat Biotech, globally several drugmakers including Inovio Pharmaceuticals, Cerus Corporation, Immunovaccine are in the race to develop a vaccine for Zika.

Zika virus, transmitted through the aedes aegypti mosquito, causes fever, skin rashes, conjunctivitis, muscle and joint pain. Zika infections during pregnancy have been linked to miscarriage and can cause microcephaly, a potentially fatal congenital brain condition.

In the backdrop of Zika outbreaks in India starting Ahmedabad in 2017, Indian Council for Medical Research (ICMR), according to media reports announced undertaking phase-II trial of the Bharat Biotech’s vaccine.

Chikungunya vaccine

Bharat Biotech’s Chikungunya vaccine is in for development for some time. It completed Phase I in January 2018.

It takes a lot of time in getting regulatory approvals, identifying right contract research organisation (CRO) and hospitals, before we administer a trial, Harshvardhan said.

Chikungunya is associated with fever and joint pains is rarely fatal, but patients face the issue of mobility for some time.

Private market focus

Founded by yeast molecular biologist Krishna Ella, Bharat Biotech generates revenues like most other Indian vaccine makers, from public health vaccination and immunisation contracts, launched governments of emerging countries and multilateral agencies like United Nations International Children's Emergency Fund (Unicef).

But with rising competition from Chinese and South Korean vaccine makers and lower price realisations, Bharat Biotech is focusing on private label market where the margins are healthy, but barriers are high.

The private market involves brand building and reaching out to doctors through a dedicated sales force, requiring a lot of investment on the front end, over and above the spend on research and development and manufacturing of vaccines.

To mitigate this Bharat Biotech has entered into a licensing arrangement with US drug major Abbott to distribute its influenza, typhoid and rotavirus diarrhea vaccines in India.

The company maintains its own sales force to market its other vaccines, and is also looking for partners in other countries to distribute its vaccines.