Serum Institute has received necessary regulatory approval from the Review Committee on Genetic Manipulation (RCGM) of India's Department of Biotechnology (DBT) for manufacturing Codagenix's COVID-19 vaccine candidate. It is one of the first to use a weakened version of the coronavirus, unlike other vaccine candidates.
Union health minister Harsh Vardhan on Thursday said that COVID-19 vaccine may be available in India by first half of 2021
Serum Institute of India has started manufacturing a COVID-19 vaccine candidate developed by Codagenix Inc. Dubbed the DX-005, the coronavirus vaccine has completed pre-clinical animal studies. The drug maker aims to initiate phase I clinical trial of its COVID-19 vaccine in the United Kingdom by the end of 2020, according to a statement by the US drugmaker.
"Today marks an important step in our efforts to advance the development of CDX-005," said Dr J Robert Coleman, chief executive officer (CEO) of Codagenix, adding that with Serum Institute's financial and technical support, it expects to get the vaccine into the clinic before the end of 2020.
The American company has tied up with the Serum Institute of India, which is currently the largest vaccine-maker by number of doses produced in the world.
According to claims made by the vaccine maker, the pre-clinical study has showed promising results. "Pre-clinical testing of a single, intranasal dose of CDX-005 in animals has yielded encouraging safety and efficacy signals," it said.
How does CDX-005 work?
CDX-005 was engineered using a proprietary software that induced mutations in the virus genome. "These mutations result in a live-attenuated vaccine that is non-pathogenic yet has the potential to stimulate a robust T cell and antibody immune response that mimics that of the wild-type virus," said the CEO.
Explaining further how it Codagenix's COVID-19 vaccine will work differently than other vaccine candidates, Coleman said that using a weakened version of the viral strain could prove more effective than other methods being used, "such as mRNA or virus-like-particle candidates, which only target the spike protein, or the adenovirus vectored approaches that could cause off-target effects." Since it administrated intra-nasally rather than via an injection this allows for more efficient, patient-friendly administration, he added.
According to the statement by Codagenix, the Serum Institute has received necessary regulatory approval from the Review Committee on Genetic Manipulation (RCGM) of India's Department of Biotechnology (DBT) for manufacturing Codagenix's COVID-19 vaccine.
Serum Institute will begin manufacturing for large-scale safety and efficacy studies as well as preparing to meet global vaccine supply requirements, said Codagenix.
Source - MoneyControl
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