The COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside the United States, is a whole-virion inactivated COVID-19 vaccine candidate that applies the same vero cell manufacturing platform used in the production of polio vaccines for decades. It has been granted Emergency Use Listing by the World Health Organization, based on a submission by partner, Bharat Biotech.
Unique to COVAXIN™ (BBV152) is its novel, Algel-IMDG (TLR 7/8) adjuvant, which together with the inactivated virus is designed to elicit an immune response against multiple antigens (S1, N and RBD) and generate memory T cell responses against several epitopes. IMDG is a novel immunomodulator developed in collaboration with the National Institutes of Health. It can be stored at 2-8 °C for up to two years, and is stable for six months at room temperature (25°C).
COVAXIN™ (BBV152) was co-developed with Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
COVAXIN™ (BBV152) is a two-dose vaccine given at Days 0 and 28. COVAXIN™ (BBV152) demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 77.8% with efficacy against severe COVID-19 disease alone of 93.4%. Adverse events reported were similar to placebo, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events. It is under clinical investigation in the U.S. for use in adults 18+ based on a Phase 3 clinical trial conducted in India and whose results were published in The Lancet.
An additional study has shown how the candidate vaccine generates neutralizing antibodies against the Omicron and Delta variants.
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A novel adenovirus vectored COVID-19 vaccine, specifically designed to generate local mucosal immunity in the nasopharyngeal region. Data indicates the vaccine can generate neutralizing IgG, mucosal IgA ,and T cell responses, which is essential for reducing infection and transmission of COVID-19. This approach represents a potential universal booster, regardless of previous COVID-19 vaccination.
OCU500 is unique from any other COVID-19 vaccine (including AAV, mRNA and Protein subunit) as it incorporates two mutations into the spike protein that enhances antibody response.
Other features include:
- Needle-free administration
- Potential for increased compliance
- Scalable manufacturing
- Stored and shipped at standard refrigerated conditions
- Potential to develop multi-strain and variant specific versions