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Expert panel of India's drug regulator mulling Bharat Biotech's nasal vaccine trial proposal


coronavirus.
Days after getting the Drugs Controller General of India s nod for restricted emergency use of India s first indigenously-made
coronavirus vaccine, Bharat Biotech had applied to the drug regulator for permission to start Phase 1 and 2 trials of their nasal coronavirus vaccine.
The nasal vaccine is different from the intramuscular vaccine which recently got approval, as it is non-invasive, needle-free, doesn t require trained healthcare workers, eliminates needle-associated risks, suits children and adults and has scalable manufacturing.
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Clinical trials of Bharat Biotech s BBV154 - a novel adenovirus vectored intranasal vaccine for coronavirus will be conducted at various locations, a top source privy to the development told IANS. The vaccine will be single-dosed. ....

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Serum Institute, Codagenix initiate Ph 1 dosing of COVI-VAC vaccine


Serum Institute, Codagenix initiate Ph 1 dosing of COVI-VAC vaccine
Serum Institute, Codagenix initiate Ph 1 dosing of COVI-VAC vaccine
12 January 2021 | News
Phase 1 trial will evaluate a total of 48 volunteers at multiple dose levels to determine the safety and tolerability COVI-VAC
Source credit: Shutterstock
US based Codagenix Inc and the Serum Institute of India Pvt Ltd (SII) have announced that the first patient has been dosed in the Phase 1 clinical trial of COVI-VAC, a single-dose, intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19.  
Designed as a randomised, double-blinded, placebo-controlled dose-escalation study, the Phase 1 trial will evaluate a total of 48 volunteers at multiple dose levels to determine the safety and tolerability COVI-VAC. In addition, the study will evaluate the vaccine s ability to provoke an immune response – measuring neutralising antibodies, mucosal immunity in the airway ....

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