BBV154 Intranasal SARS-CoV-2 Vaccine Description For 2022
Bharat Biotech's BBV154 is a novel replication-deficient adenoviral vector-based (expressing a stabilized spike protein). BBV154 is an intranasal vaccine that stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T cell responses. Immune responses at the site of infection (in the nasal mucosa) – are essential for blocking both infection and transmission of COVID-19.
Non-invasive, Needle-free, enabling ease of administration as it does not require trained health care workers.
The Drugs Controller General of India (DCGI) in January 2022 permitted Bharat Biotech to conduct a phase 3 randomized, multi-centric examination to consider the immunogenicity and security of the booster dose. However, as of March 11, 2022, India's DCGI had not approved the intranasal vaccine for COVID-19, BBV154 developed by the Hyderabad primarily based firm, Dr. Sanjay Rai, Professor on the Centre for Community Medicine at AIIMS, New Delhi, instructed PTI.
India-based Bharat Biotech is a pioneering biotechnology company known for its world-class R&D and manufacturing capabilities. BBIL has in-licensed technology from Washington University in St Louis, USA. Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a broad product portfolio of more than 16 vaccines, four bio-therapeutics, registrations in more than 123 countries, and the World Health Organization Pre-qualifications.
BBV154 Intranasal SARS-CoV-2 Vaccine Indication
BBV154 is indicated to prevent illness caused by the SARS-CoV-2 beta coronavirus. The intranasal immunization of ChAd-SARS-CoV-2-S can create an immune response in the nose, the virus's point of entry, thereby protecting against disease, infection, and transmission.
Mice, Hamsters, and macaques were immunized with a single dose of ChAd-SARS-CoV-2-S conferred superior protection against the SARS-CoV-2 virus challenge. In addition, post-challenge with SARS-CoV-2, viral clearance was observed in both lower and upper airways in all these animal models. Please find more information on the Hamster, Mice, and Rhesus macaques studies.
BBV154 Intranasal SARS-CoV-2 Vaccine News For 2021 - 2022
March 11, 2022 - Local media reported AIIMS would start the booster dose trial of the intranasal COVID-19 vaccine candidate. The booster dose might be given to those who previously received Covaxin or Covishield no less than five months in the past; however, no more than seven months.
January 28, 2022 - The Company Tweeted it had received authorization to proceed with a phase 3 clinical study. The Company will conduct the trials at nine study centers, including the All India Institute of Medical Sciences sites.
August 13, 2021 - Bharat Biotech's intranasal vaccine is the first nasal vaccine that has received regulatory approval for Phase 2 trials. This is the first of its kind COVID-19 nasal vaccine to undergo human clinical trials in India. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.
August 11, 2021 - Scientists debate the potential benefits of intranasal COVID-19 vaccines.
March 6, 2021 - Bharat Biotech's intranasal COVID-19 vaccine clinical trial begins in Hyderabad, India.
January 26, 2021 - A non-peer-reviewed animal study. Summary: A single intranasal dose of ChAd-SARS-CoV-2-S induced neutralizing antibodies and T cell responses and limited or prevented infection in the upper and lower respiratory tract after the SARS-CoV-2 virus challenge. This single intranasal dose vaccine confers protection against SARS-CoV-2 in non-human primates; it is a promising candidate for limiting SARS-CoV-2 infection and transmission in humans.
BBV154 Intranasal SARS-CoV-2 Vaccine Clinical Trial
Clinical Trial NCT04751682: Safety and Immunogenicity of an Intranasal SARS-CoV-2 Vaccine (BBV154) for COVID-19 - Last Update Posted on June 21, 2021
The study is designed to evaluate the safety, reactogenicity, and immunogenicity of three groups of healthy volunteers who receive either a single intranasal dose (Vaccine on Day 0 and placebo on Day 28) or a two-dose (vaccine on days 0 and 28) of BBV154 vaccine or placebo (on Day 0 and day 28). A total of 175 subjects will be enrolled in a 2:2:1 ratio and conducted in a double-blinded manner.
Phase 1 Clinical trial has been completed in age groups ranging ≥from 18 to ≤60 years. The Company reports that the vaccine doses administered to healthy volunteers in the Phase I clinical trial have been well tolerated. In addition, no serious adverse events were reported. Previously, the vaccine was found safe, immunogenic, and well-tolerated in the pre-clinical toxicity studies. In addition, the vaccine elicited a high level of neutralizing antibodies in animal studies.