iNCOVACC® COVID-19 Vaccine May 2023
Bharat Biotech's iNCOVACC® (BBV154, ChAd36-SARS-CoV-S) is a novel replication-deficient adenoviral vector-based (expressing a stabilized spike protein) vaccine. iNCOVACC 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 (nasal mucosa) are essential for blocking infection and transmission of the SARS-CoV-2 coronavirus that causes COVID-19.
In preclinical research, mice, Hamsters, and macaques were immunized with a single dose of ChAd-SARS-CoV-2-S, which 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.
iNCOVACC 0.5 ml vaccine contains NLT 5x1010 particles per mL, including excipients such as Tris (pH 7.4), Sodium Chloride, Magnesium Chloride, Glycerol, and Polysorbate- 80. In addition, the non-invasive, needle-free vaccination enables ease of administration as it does not require trained healthcare 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. As a result, Washington University in St. Louis, Missouri, announced on September 7, 2022, that the nasal COVID-19 vaccine was approved in India based on its technology. Furthermore, on November 28, 2022, Bharat Biotech announced its iNCOVACC had become the world's first intranasal Covid-19 vaccine to receive emergency use authorization (EUA) from CDSCO India, as a primary vaccine as well as a heterologous booster for those who have received two doses of another vaccine. Both the EUAs have been granted for those aged 18 years and above.
On December 27, 2022, @BharatBiotech tweeted that iNCOVACC® is now available on CoWin throughout India. On February 6, 2023, @BharatBiotech tweeted, 'the first shipments of iNCOVACC were dispatched to various locations across India.' In addition, the Company posted an informational video on February 20, 2023.
India-based Bharat Biotech is a pioneering biotechnology company known for its R&D and manufacturing capabilities. BBIL has in-licensed technology from Washington University. Bharat Biotech has established a global track record of innovation with more than 145 international patents, a broad product portfolio of more than 16 vaccines, four bio-therapeutics, registrations in more than 123 countries, and World Health Organization (WHO) Pre-qualifications.
iNCOVACC Availability May 2023
The TOI reported on May 15, 2023, with thousands of doses available; only 700 doses have been consumed in Maharashtra. On April 24, 2023, Mumbai News reported two lakh doses of iNCOVACC were recently delivered to districts and corporations. The Times of India reported on April 14, 2023, the local government has begun ordering iNCOVACC vaccines for local use. About 3 lakh doses were distributed to local hospitals in February 2023.
iNCOVACC (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 entry point, thereby protecting against disease, infection, and transmission. India approved iNCOVACC for people aged 18 and above. It can be administered as a precaution to adults who have taken two doses of either Covaxin or Covishield vaccines.
Research published eBioMedicine - The Lancet on December 19, 2022, explained why people who have had COVID-19 are at risk for reinfection. The decline in nasal IgA responses nine months after infection and the minimal impact of subsequent vaccination may explain the lack of long-lasting nasal defense against reinfection and the limited effects of vaccination on transmission. These findings highlight the need to develop vaccines that enhance nasal immunity.
The U.S. NIAID wrote on December 8, 2022, As the SARS-CoV-2 virus has evolved, so has scientists' knowledge of how to manage its spread and severity. Importantly, scientists have learned that the virus first infects the nose and throat before sometimes spreading to the lungs, where severe COVID-19 can develop. But the nose and throat are difficult destinations for the SARS-CoV-2 antibodies that develop in the blood after a vaccine is injected into the arm or leg – making those hard-to-reach areas targets for better vaccines.
iNCOVACC® is administered through the nose as a 2-dose series, 4 four weeks apart. A total of 8 drops (0.5 mL per dose), four drops are administered into each nostril.
iNCOVACC will be first available in private hospitals for Rs 800, excluding GST. In April 2023, iNCOVACC was priced at Rs 325/dose for large-volume procurement by state governments and the government of India.
Ocugen, Inc. Agreement
On September 28, 2022, Ocugen, Inc. announced it entered into an exclusive license agreement with Washington University for the rights to develop, manufacture, and commercialize its proprietary, intranasally delivered COVID-19 vaccine in the U.S., Europe, and Japan.
iNCOVACC News 2023
March 27, 2023 - @BharatBiotech tweeted about the increasing number of COVID-19 cases in India.
February 27, 2023 - Local media reported iNCOVACC had been well received in India.
January 26, 2023 - The Company reported iNCOVACC was available and would be distributed in February 2023.
December 19, 2022 - Co-senior author of a new study, Dr. Lance Turtle, Senior Clinical Lecturer at the University of Liverpool and Consultant in Infectious Diseases at Liverpool University Hospitals, said: "Our study suggests that this first-line defense immunity is separate from other immune responses, and although it is increased by vaccination and infection, it only lasts for about nine months. Nonetheless, booster vaccines can increase it slightly and otherwise significantly impact other areas of immunity, effectively protecting against severe disease and death, so remain very important."
November 28, 2022 - iNCOVACC intranasal Covid-19 vaccine received approval for a primary and heterologous booster.
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 India's first COVID-19 nasal vaccine to undergo human clinical trials. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vector vaccine.
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 upper and lower respiratory tract infection 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.
iNCOVACC Clinical Trial
iNCOVACC has conducted various clinical studies:
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 conduct a double-blind study.
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 preclinical toxicity studies. In addition, the vaccine elicited high neutralizing antibodies in animal studies.