The study will assess the safety, tolerability and
immunogenicity of the vaccine
Vaccine Discovery Programme supported by the
Department of Biotechnology, Govt. of India under the National Biopharma
Mission, implemented by BIRAC moves into clinical trials
BIRAC has announced that ZyCoV-D, the plasmid DNA
vaccine designed and developed by Zydus and partially funded by the Department
of Biotechnology, Government of India has initiated Phase I/ II clinical trials
in healthy subjects, making it the first indigenously developed vaccine for
COVID-19 to be administered in humans in India.
The adaptive Phase I/II dose escalation,
multi-centric study will assess the safety, tolerability and immunogenicity of
the vaccine. The human dosing of the vaccine marks a key milestone since the
launching of the accelerated vaccine development programme for COVID-19 in
February 2020.
Dr. Renu Swarup, Secretary, DBT and
Chairperson, BIRAC said, “The Department of Biotechnology Government of India
has partnered with Zydus to address rapid development of an indigenous vaccine
for COVID-19 under the National Biopharma Mission. This partnership with Zydus
is to serve the country’s need for a vaccine to fight the dreaded pandemic
which has put a billion people at risk. Such research endeavours will help the
country to develop preventive strategies for future disease outbreaks as well
and exemplifies the government’s focus on creating an ecosystem that nurtures
and encourages new product innovation to make real and measurable changes to
issues most relevant to our society.”
She also mentioned that, “This is an important
milestone for AtmaNirbhar Bharat as Zydus begins human clinical trials for the
indigenously developed vaccine. We hope, that the vaccine continues to show
positive outcomes as it has done so far in the pre-clinical phase where it was
found to be safe, immunogenic and well tolerated. This will be a big leap
forward for Indian scientific research.”
Speaking on the development, Chairman of Zydus
Cadila, Mr. Pankaj R. Patel said, “This is a very important step in our fight
against this pandemic and one that will help the nation combat this healthcare
challenge. We are thankful to BIRAC and the Department of Biotechnology,
Government of India for their support in our quest to provide a safe and
efficacious vaccine to prevent COVID 19.”
About ZyCoV-D
In the pre-clinical phase, the vaccine was found to
elicit a strong immune response in multiple animal species like mice, rats,
guinea pigs and rabbits. The antibodies produced by the vaccine were able to
neutralize the wild type virus in virus neutralization assay indicating the
protective potential of the vaccine candidate. No safety concerns were observed
for the vaccine candidate in repeat dose toxicology studies by both
intramuscular and intradermal routes of administration. In rabbits, up to three
times the intended human dose was found to be safe, well tolerated and
immunogenic.
With ZyCoV-D, the Company has successfully
established the DNA vaccine platform in the country using non-replicating and
non-integrating plasmid carrying the gene of interest making it very safe.
Further, no vector response and with absence of any infectious agent, the
platform provides ease of manufacturing the vaccine with minimal biosafety
requirements (BSL-1). The platform is also known to show much improved vaccine
stability and lower cold chain requirements making it easy for transportation
to remotest regions of the country. Furthermore, the platform can be rapidly
used to modify the vaccine in couple of weeks in case thevirus mutates to
ensure that the vaccine still elicits protection.
About National Biopharma Mission, DBT:
The Industry-Academia Collaborative Mission of
Department of Biotechnology (DBT), Govt of India for accelerating discovery
research to early development for Biopharmaceuticals approved by the Cabinet
for a total cost US$ 250 million and 50% co-funded by the World Bank is being
implemented at Biotechnology Research Assistance Council (BIRAC). This program
is dedicated to deliver affordable products to the nation with an aim to
improve the health standards of India’s population. Vaccines, medical devices
and diagnostics and biotherapeutics are few of its most important domains,
besides, strengthening the clinical trial capacity and building technology
transfer capabilities in the country.
About BIRAC:
Biotechnology Industry Research Assistance Council
(BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise,
set up by Department of Biotechnology (DBT), Government of India as an
Interface Agency to strengthen and empower the emerging Biotech enterprise to
undertake strategic research and innovation, addressing nationally relevant
product development needs. To find out more visit https://birac.nic.in
About Zydus
Zydus Cadila is an innovative, global
pharmaceutical company that discovers, develops, manufactures and markets a
broad range of healthcare therapies, including small molecule drugs, biologic
therapeutics, and vaccines.
(For Further Information: Contact Communication
Cell of DBT/BIRAC
@DBTIndia
@BIRAC_2012Courtesy: pib.gov.in
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