Vaccines
manufacturer, Bharat Biotech, 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.
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,”
Source: The Hindu
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