NEW DELHI - India's Bharat Biotech International Ltd. has announced what it called two "promising" potential vaccine candidates to protect against the mosquito-borne Zika virus which has been declared an international public health emergency and said it was seeking global patents for the vaccines.

The privately held firm said in a statement it believed it was "probably" the first company in the world to seek a global patent for a vaccine against the virus, which has been tentatively linked to a steep rise in babies in South America born with microcephaly, a serious condition characterized by a small head and brain.

The virus also is suspected of causing a rare illness known as Guillain-Barre syndrome that can lead to temporary paralysis.

“Currently, our efforts are towards scale-up and characterization of the vaccine product," said Krishna Ella, co-founder and chairman of Bharat Biotech.

He added that the Hyderabad-based company, which makes vaccines for polio, hepatitis and H1N1 among other illnesses, hopes "to announce the arrival of ZikaVac [vaccine] to the world as early as possible," without specifying a time-frame.

Ella said the company has two candidate vaccines in development against Zika, one of which is an inactivated vaccine that has reached preclinical testing. A recombinant vaccine using the surface antigens of the virus is also being developed, he added.

"Our interest in Zika virus, an obscure virus when we started the project a year ago, was that the clinical features at an early stage of infection are indistinguishable from that of dengue and chikungunya,” said Ella.

Increasingly Crowded Race

Bharat Biotech, which said it had invested over $150m since its launch in 1996 to build a portfolio of vaccines, joins a crowded race to develop a Zika vaccine that now involves drug companies from around the world. But Ella said the company believes it has "an early mover advantage."

Scientists, however, say that as little is known about the virus, first discovered in 1947, developing a vaccine could take several years, if not longer. French drug-maker Sanofi's newly approved dengue vaccine was more than two decades in the making, they note.

Because earlier outbreaks of Zika, mainly in equatorial regions of Africa and Asia, caused mild, flu-like symptoms, there had been little focus on isolating a vaccine. But now some 1.5 million Brazilians are believed to have contracted the virus since last May, and health authorities in the US and many other countries are scaling up their research as Zika looms as a global emergency.

The World Health Organization warns there could be three to four million Zika cases in the Americas alone over the coming year.

Earlier this week, Sanofi announced it would leverage research it carried out to create its pioneering vaccine to combat dengue fever, caused by a virus which is part of the same family as Zika, to try and develop a product to tackle the explosively spreading virus.

US biotech company NewLink Genetics Corp. has said it too is working on a Zika vaccine, while Merck & Co. Inc., Pfizer Inc. and Johnson & Johnson have said they're considering how they might be able to take the fight against the virus forward.

Meanwhile, Asia's largest drug firm, Takeda Pharmaceutical Co. Ltd. in Japan, also says it is looking at early-stage work on a potential Zika vaccine, and Australian company Sementis Ltd. is working in collaboration with the University of South Australia.

Preparing For Spread

Bharat Biotech’s Ella said, “The first thing is to be prepared for the worst.” No cases of Zika have been reported in India but experts worry it could spread fast in the country of 1.25 billion people where the Aedes mosquitoes that transmit the virus thrive amid crowded cities, poor sanitation and humid monsoons.

Other mosquito-borne illnesses, such as dengue, are endemic in India and the day-biting Aedes mosquito can breed in a pool of water as tiny as a bottle cap.

Considering that women of child-bearing age and pregnant women are the prime target group for a Zika virus vaccine, "We consider safety as the overriding factor in development of a new vaccine for this virus," said Dr. Sumathy K., Bharat Biotech's research director.

"The vaccine methods developed early on, before the devastating consequences of the epidemics in Brazil came to light, provided us a push to accelerate vaccine development," he added. Despite lacking knowledge on viral pathogenesis and the immune correlates required for protection, "an early start in vaccine development has nevertheless provided a fair advantage to face the eventuality of an epidemic outbreak in the region," Sumathy said.

Bharat Expertise

Bharat Biotech, which is developing vaccine candidates against chikungunya, chandipura, human papillomavirus and Ebola, comes to its Zika vaccine quest with some notable achievements under its belt, and is one of a clutch of Indian firms now beginning to make inroads into original medical discovery and development.

Last year, it launched a three-dose rotavirus vaccine, Rotavac, which became India’s first home-made vaccine to prevent the potentially lethal diarrhea that claims the lives of 100,000 children below five in the country every year, according to the World Health Organization. The product was offered at $1/dose to low-income countries.

Its chikungunya vaccine is entering Phase I trials shortly, while its typhoid conjugate vaccine Typbar TCV has been successfully commercialized.

Bharat Biotech specializes in the R&D, manufacturing and marketing vaccines and biotherapeutics, with a core focus on developing novel solutions for region-specific neglected diseases, and has the first Indian biopharma facility to be approved by the Korean Food and Drugs Administration.

It holds a 50-patent portfolio and says it has delivered more than three billion doses of vaccines to over 65 countries to tackle infections and neglected diseases in children and adults.

India’s Bharat Enters Zika Fray With Two Vaccine Candidates

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