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 maintains that if clinical trials go as per plans and
regulatory approvals are swift, Bharat Biotech can manufacture up to one
million doses of the vaccine in the next four months.
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
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 hindu-
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