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Proceedings
India’s leading research and development organization, the Scientific and Industrial Research Council (CSIR), which is currently testing a “reused” vaccine against Covid-19 in a Phase 2 trial, hopes to obtain approval from the drug controller for wider use. Against the pandemic in just 30 days from now, the scientist coordinating the effort said Saturday.
CSIR is currently testing Cadila Pharmaceuticals’ “Sepsivac” against COVID-19.
This treatment was developed as a result of a partnership between CSIR and Cadila Pharmaceuticals many years ago. This immunotherapy treatment, which increases “innate immunity”, was initially approved by the General Drug Controller of India (DCGI) for gram negative sepsis which is a disease caused by bacteria.
But scientists discovered that the pathological symptoms of this disease and Covid-19 were quite similar. And given the urgency of finding a solution to the rapidly increasing number of Covid-19 cases worldwide, the scientists considered trying the treatment against the current pandemic caused by the SARS-CoV-2 virus.
CSIR was approved to test “Sepsivac” against Covid-19 in a phase 2 clinical trial about 10 days ago. The trial is being conducted in 50 patients at the Indian Institute of Medical Sciences (AIIMS), New Delhi, AIIMS Bhopal and the Graduate Institute of Medical Education and Research (PGIMER), Chandigarh.
“We expect the results of this Phase 2 trial within 30-45 days from now. And if the results are encouraging, we will seek approval from the drug controller due to an emergency and continue with the Phase 3 trial. That’s right as it happens. “Ram Vishwakarma, Director of Integrative Medicine (Council for Scientific and Industrial Research), Jammu, told IANS.
Vishwakarma said that once it is applied, drug controller approval is expected to come quickly, as it is an emergency situation.
So if the Phase 2 trial shows that “Sepsivac” is effective against Covid-19, the world can have a vaccine against the disease as soon as within a month, at least for emergency use.
Meanwhile, Vishwakarma reported that CSIR also obtained approval to conduct the “Sepsivac” Phase 3 clinical trial against Covid-19.
“Phase 3 trials will be conducted on 1,100 people: 600 will be those who tested positive but not symptomatic, and 500 will be those who are out of hospital,” said Vishwakarma.
How does Sepsivac work?
It contains mycobacterium w (Mw), an immunomodulator, which is a non-pathogenic mycobacterium.
“Normally, when you develop a vaccine, you grow the body and kill it. It’s called heat killed. Here heat kills bacteria. It’s a standard vaccine concept,” said Vishwakarma, adding that the bacteria are produced by fermentation.
“The treatment we are testing against Covid-19 is designed to improve innate immunity, which is very critical. People with weak innate immunity will get the infection faster,” he said.
Vishwakarma explained that it is a non-specific vaccine that could be used to heal and protect people. He explained that there are generally three types of vaccines.
“There are therapeutic vaccines, where they are administered as a medicine to cure. There are prophylactic vaccines, which are administered to people to protect them. And there are some that have both properties, which are called immunomodulators.”
“Sepsivac will be an immunomodulator, which will have both a protective and a therapeutic effect,” he said.
Vishwakarma hopes that phase 2 clinical trials of treatment will provide positive results. And because the drug is already in use to treat sepsis or septic shock, “human safety is already guaranteed,” he said, adding that it will be applicable to all age groups.
“We keep our fingers crossed and hope for the best,” said Vishwakarma.
Since developing a vaccine against a new disease takes time, researchers around the world are rushing to reuse existing drugs, vaccines against the disease.
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