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.
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.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
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.