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India’s 1st needle-free intranasal COVID-19 vaccine get emergency use approval from DCGI

India’s 1st Intranasal COVID-19 vaccine: Bharat Biotech has received emergency use authorization for India’s 1st needle-free intranasal COVID-19 vaccine. DCGI granting approval for the first intranasal vaccine comes as a major milestone in India’s fight against the COVID-19 pandemic. The news about Bharat Biotech getting emergency use approval for its needle-free COVID-19 vaccine was confirmed by Union Health Minister Mansukh Mandaviya. As of now, the Drugs Controller General of India (DCGI) has approved the intranasal vaccine for restricted emergency use in those aged above 18 years.

The intranasal vaccine developed by India’s Pharma Major Bharat Biotech has been named ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine. As per the statement issued by Health Minister, the development of the intranasal vaccine shows how India has harnessed its science, research and development (R&D), and human resources in the fight against COVID-19.

Bharat Biotech’s Intranasal Vaccine

Unlike Serum Institute’s COVISHIELD and Bharat Biotech’s COVAXIN, which were intravenous in nature; the new vaccine developed by Hyderabad-based Pharmacy Firm is intranasal and can be delivered in a needle-free manner. The new vaccine named ChAd36-SARS-CoV-S COVID-19 can be delivered through the nasal route, making it a safer and more effective option. The company’s official website mentions that “An intranasal vaccine 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.”

The development of an intranasal vaccine to fight the COVID-19 virus is significant because similar to influenza, COVID-19 infection also passes through thenose and mouth route into the lungs. Therefore, having an intranasal vaccine provides mucosal immunity by using the same use the same nasal (drop) route, used by the virus.

  • Needle-Free Administrationeliminates needle injury and infection risk
  • Trained Healthcare workers are not required for administration
  • Higher compliance and suitable for use in children as well as adults
  • Easy to deploy for mass immunization campaigns
  • Production can be scaled up relatively easily, to meet global demand

According to the details shared by Hyderabad-based Pharma major, clinical trials of the intranasal vaccine were completed by about 4,000 volunteers. No side effects or adverse reactions were reported from its usage in any of the undertrial patients. As part of the Phase III trials, Bharat Biotech held two separate trials i.e., one as a primary dose for people who have not received any other vaccine so far and another as a booster dose for those who have received two doses of two commonly administered Covid vaccines in India. In both trials, the company found the vaccine efficacy to be “well-tolerated and immunogenic in subjects”.

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