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
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
Serum Institute Of India sends out Covishield vaccine - Consignment of Covishield Vaccine arrived in Delhi, Chennai, Kolkata, Guwahati, Shillong, Ahmedabad, Hydrabad, Vijayawada, Bhubaneswar, Patna, Bengaluru, Lucknow, Chandigarh
Serum Institute of India launches India’s first fully indigenously developed pneumococcal vaccine, 'PNEUMOSIL'
Oxford COVID-19 vaccine: Serum Institute likely to submit final Covishield trial data within 10 days
SII’s Adar Poonawalla on Covid vaccine, pricing and rollout at Hindustan Times Leadership Summit 2020
COVISHIELD Completes Enrolment of Phase III clinical trials under partnership of ICMR and Serum Institute of India
Government Secures Vaccine Supplies For Half Of The Indian Population From Serum Institute And Novavax
IAVI, Merck, and Serum Institute of India Join Forces to Develop Monoclonal Antibodies for COVID-19 and Ensure Prompt and Equitable Global Access
Serum Institute Of India Takes A Multipronged Approach In Quest To Produce World’s First Covid-19 Vaccines
Serum Institute of India to produce up to an additional 100 million covid 19 vaccine doses for india and low and midle income countries in 2021
Adar Poonawalla CEO of Serum Institute of India, the world’s largest vaccine manufacturer, explains the timing, challenges & cost of vaccinating the world against COVID-19
Serum Institute looking for a $1 billion shot to fight covid, talks on with Blackstone, KKR and others
Serum Institute of India Says Covid Vaccine Likely to Be Ready by End of 2020, Final Pricing in 2 Months
Serum institute of india to produce up to 100 million covid-19 vaccine doses for india and low-and middle-income countries as early as 2021
50% of our Covid vaccines will be for India, people won't have to buy them, govts will pay: Adar Poonawalla
AstraZeneca vaccine's success in early human trials, Will Begin AstraZeneca Vaccine Trial in India After Applying for Licence Next Week, Says Serum Institute
Serum Institute of India CEO: ‘We plan to make millions of doses of Covid vaccine over three months’:’
New supply agreement between UNICEF and Serum Institute of India makes pneumococcal conjugate vaccine available at US$2.00 per dose, a 43 % reduction from the Gavi price at the start of the Advance Market Commitment
Serum Institute confident of manufacturing Covid vaccine’s 100 million doses if trials establish efficacy
Serum Institute’s Journey To Success | ET NOW Covid-19 vaccine possible by Q2 of 2022: Adar Poonawalla
Adar Poonawalla discusses Serum Institute's progress in the global battle against COVID-19 with Shereen Bhan, CNBC-TV18
Adar Poonawalla talks with Aabha Bakaya about the success story of Serum Institute of India. Tune in to know all about the journey of the company.
Bill Gates confers Indian Council of Medical Research "Lifetime Achievement Medal" on Dr. Cyrus Poonawalla
Dr. Cyrus Poonawalla conferred with 'Lifetime Achievement Award’ by the Asian Business Leadership Forum
Dr. Cyrus Poonawalla conferred with the prestigious honorary degree by the University of Oxford, U.K.