Hyderabad-based Bharat Biotech has filed for global patent of two vaccine candidates – a recombinant vaccine and an inactivated vaccine – for Zika virus.
The company announced that it could make available the inactivated vaccine in two years if the Indian Government fast-tracked the regulatory approvals once the pre-clinical trials proved to be successful.
Addressing a press conference here on Wednesday, Krishna Ella, Chairman and Managing Directorof the company, said that Bharat Biotech was probably the first in the world to file for global patent for the two promising Zikavac vaccine candidates.
While the recombinant vaccine might take time, the pre-clinical testing of the inactivated vaccine inanimals would be completed in five months.
He said that the company had invested over $ 150 million since its inception to build its portfolio of vaccines, which included Rotovac (rotavirus vaccine) and Typbar TCV, typhoid conjugate vaccine. He said that a patent was also filed for Chikungunya vaccine, which would be entering Phase-1 trials shortly.
Bharat Biotech Director R & D Sumathy said that work on Zika vaccine project was started in 2014 and the patent was filed in July 2015. She said that Zika fever was an unmet healthcare need in India and other countries and the potential for Zika virus epidemic was high.
Mr. Krishna Ella said the normal process for a vaccine to get commercialised would take seven years, including the clinical trials.
However, he said that the Zikavac vaccine could be made available if the Indian Government declares national emergency and moves aggressively in regulatory approvals. He said that women would be the prime target group for the vaccine, followed by adults of both the genders since the virus causes Guillain-Barre syndrome in them.
A Bharat Biotech press release said that the WHO just announced a disease linked to the Zika virus in Latin America poses a global public health emergency requiring a united response.
Zika is now present in 23 countries. Brazil, the hardest-hit country, has reported around 3,500 cases of the devastating birth defect called microcephaly. The Zika virus is spread by mosquitoes of the Aedes genus, which can breed in a pool of water as small as a bottle cap and usually bite during the day.
Indian biotechnology company Bharat Biotech said on Wednesday it was working on two possible vaccines to fight the Zika virus, which has been linked to birth defects in thousands of babies in Brazil.
The virus is spreading rapidly in the Americas, and WHO officials on Tuesday expressed concern that it could hit Africa and Asia as well. No vaccine has been developed so far.
One of the possible vaccines is “recombinant”, which means it is created by genetic engineering, while the other was “inactivated”, and will enter pre-clinical trials in animals in two weeks, BharatBiotech managing director Krishna Ella told Reuters.
An inactivated vaccine is created by killing a pathogen in a way that its ability to replicate is destroyed, but the immune system can still recognise it.
Bharat Biotech’s announcement came a day after France’s Sanofi said it had launched a project to develop a Zika vaccine. On Wednesday, Japanese drugmaker Takeda Pharmaceutical also said it was investigating the possibilities of developing a vaccine for the disease.
Privately held Bharat Biotech, based in Hyderabad, said it started work on the Zika virus a year ago, while developing vaccines for chikungunya and dengue. Zika is closely related to dengue and is spread by the same species of mosquito.
Bharat Biotech sells its vaccines for polio, hepatitis B, H1N1 and rabies, among others, to more than 65 countries, according to its website.
“They’ve got a lead, essentially … it’s certainly not a vaccine yet,” said Soumya Swaminathan, the Director General of the Indian Council of Medical Research (ICMR), the apex body for biomedical research in India, funded by the health ministry.
Swaminathan said it was premature to comment on the two vaccine candidates, but the ICMR had put together a group of experts to examine their validity.
No cases of the virus have been detected in India yet, but the health ministry on Tuesday issued guidelines on the disease, including an advisory that travel to affected countries be postponed or cancelled. (Source: Pharma Tips)