Vaccines manufacturer, Bharat Biotech, on Wednesday, announced a breakthrough in developing the world’s first Zika vaccine. The Hyderabad-based company has submitted two vaccine candidates —— one inactivated and one recombinant —— to the Indian government.
The company maintain that pre-clinical studies will be concluded in the next five months, after which the process for regulatory approval will commence.
An inactivated vaccine is when the disease-causing microbe is killed, typically, using chemicals, heat, or radiation. Such a vaccine is more stable and safer than live vaccines. A recombinant vaccine is a vaccine produced through recombinant DNA technology. This involves inserting the DNA encoding an antigen (such as a bacterial surface protein) that stimulates an immune response.
Zika virus disease is an emerging viral disease transmitted through the bite of an infected Aedes mosquito, which also transmits diseases like dengue and chikungunya. World Health Organization has reported 22 countries and territories in Americas from where local transmission of Zika virus has been reported. Microcephaly in the newborn and other neurological syndromes (Guillain Barre Syndrome) have been found temporally associated with Zika virus infection.
Speaking exclusively to The Hindu, Dr. Krishna Ella, Chairman and Managing Director of the company said that one the two candidates is in advanced stage of development and can be ready soon. “In the coming two weeks, we will be able to start animal tests in one of the two candidates. Since this is a pandemic situation, we are hoping that the Indian government will move quickly of giving requisite approvals for the trials,” said Dr Ella.
Bharat Biotech has submitted necessary information to Indian Council of Medical Research (ICMR) four days ago. The company is now looking to seek Prime Minister Narendra Modi’s approval to expedite regulatory clearances. “When Ebola vaccine candidates were being discussed, the company had skipped phase 2 trials and went on to phase three with a small sample size. Given the urgency of the situation, something of that sort will be required,” he added. Currently, getting regulatory approvals takes for conducting clinical trials in India can take up to 6-8 months.
Bharat Biotech filed patents for both vaccine candidates in July 2015, Dr Ella informed. He said that since the company already worked on chikungunya, this was the next logical step. “At the time we started working on the Zika vaccine, there was not a market incentive or any demand for it- largely because the symptoms are mild. But we were already working in chukungunya and our hypothesis was that the same vector transmits this disease as well, so we thought we need to look at this aspect as well,” he added.
The earlier version of the report said that "Bharat Biotech can manufacture up to one million doses of the vaccine in the next four months." This is incorrect. The regulatory approval will be granted only after the pre-clinical studies conclude, which according to the company will take another 5 months. The error is regretted.