BBV154 Intranasal SARS-CoV-2 Vaccine Description
Bharat Biotech's BBV154 is a 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) – 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.
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 wide product portfolio of more than 16 vaccines, 4 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. Thus, intranasal immunization of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the virus's point of entry, thereby protecting against disease, infection, and transmission.
BBV154 Intranasal SARS-CoV-2 Vaccine News
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 intranasal single dose (Vaccine on Day 0 and placebo on Day 28) or two-dose (vaccine on Day 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 Phase I clinical trial have been well tolerated. No serious adverse events were reported. Previously, the vaccine was found safe, immunogenic, and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralizing antibodies in animal studies.