iNCOVACC (codenamed BBV154) is an
intranasal
Nasal administration, popularly known as snorting, is a route of administration in which drugs are insufflation (medicine), insufflated through the nose. It can be a form of either topical administration or systemic administration, as the drugs t ...
COVID-19 vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 ( COVID19).
Knowledge about the structure and fun ...
candidate developed by
Bharat Biotech
Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company based in Hyderabad, which is engaged in drug discovery, drug development, and the manufacture of vaccines, biotherapeutics, pharmaceuticals and health ...
,
American company Precision Virologics and the
Washington University School of Medicine
Washington University School of Medicine (WashU Medicine) is the medical school of Washington University in St. Louis, located in the Central West End neighborhood of St. Louis, Missouri. Founded in 1891, the School of Medicine shares a ca ...
in
St Louis
St. Louis ( , sometimes referred to as St. Louis City, Saint Louis or STL) is an Independent city (United States), independent city in the U.S. state of Missouri. It lies near the confluence of the Mississippi River, Mississippi and the Miss ...
,
Missouri
Missouri (''see #Etymology and pronunciation, pronunciation'') is a U.S. state, state in the Midwestern United States, Midwestern region of the United States. Ranking List of U.S. states and territories by area, 21st in land area, it border ...
, United States.
History
Clinical trials
Phase I trials
On recommendation by the Subject Expert Committee (SEC) under the Indian drug regulator, the company conducted
phase 1 clinical trial
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...
s using 75 volunteers and submit safety and
immunogenicity
Immunogenicity is the ability of a foreign substance, such as an antigen, to provoke an immune response in the body of a human or other animal. It may be wanted or unwanted:
* Wanted immunogenicity typically relates to vaccines, where the injecti ...
data for the committee's consideration before it proceeds to the second phase of the trial.
Phase II and III trials
On 12 August 2021, after evaluating the results of phase I trial data, the drug regulator approved for phase II/III randomized trials that involves evaluation of the immunogenicity and safety of
Covaxin
Covaxin (list of pharmaceutical compound number prefixes, development name, BBV152) is a Inactivated vaccine, whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Res ...
with BBV154 in healthy volunteers.
Authorizations
India
On 24 December 2022, the Government of India approved the intranasal vaccine for inclusion in the vaccination programme as a booster dose for those above 18 years of age.
References
External links
Bharat Biotech's Intranasal Vaccine for COVID-19: Everything we know so far about BBV154''firstpost.com''
Adenoviridae
Clinical trials related to COVID-19
Indian COVID-19 vaccines
Viral vector vaccines
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