Krishna Shriram Dhanasekaran
As a Pharm.D graduate I'm keen in writing content and creating deliverables for regulatory submissions, with a comprehensive knowledge on study designs, regulatory guidelines like ICH-GCP, NDCT Rules 2019, Medical device regulations and requirements like Protocol development, ICF and a strong knowledge on history & development of Clinical Research process.
COVAXIN TO BE TESTED INTRADERMALLY: BHARAT BIO-TECH BAGS DCGI APPROVAL
27 August 2020
Hyderabad based BHARAT BIO-TECH is on trials for its COVAXIN in collaboration with Indian Council for Medical Research (ICMR).
Now the Drug Controller General of India (DCGI) has given the approval to Bharath Biotech for the conduction of phase I & II trials for COVAXIN through intradermal vaccine delivery alike BCG and Rabies vaccines.
It is the first Indian company to experiment the potential Corona Vaccine through both intra-dermal and intra-muscular routes.
Intra-dermal vaccine delivery involves administration of vaccine through the dermis or epidermis of the skin.
A senior doctor at AIIMS told that, "The dermis and epidermis of human skin are rich in antigen-presenting cells, suggesting that delivery of vaccines to these layers is more efficient and induce protective immune responses with smaller amounts of vaccine antigen."
Anant Bhan, a researcher in global health, bioethics and health policy and former president of International Association of Bioethics told "the intradermal method could lower the required dose administered to an individual and decrease the per injection cost."
However, Bhan cautioned that clinical trials are required to see if the intradermal method generates an immune response comparable to the intramuscular method.
Source: The Economic Times, The Print
So if the COVAXIN appears to be safe and effective via intradermal vaccine delivery, it will be a vaccine that requires low dose to produce effective response at a lower cost.
As of now Oxford's (ChAdOx1) vaccine is in advance in its trials after Russia's SPUTNIK 5 vaccine which is probably considered to be safe in humans.
So Oxford - Astra Zeneca's COVISHIELD is expected to be the first intra-muscular Corona virus vaccine to be launched after its clearance of Phase 3 trials.
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