Clinical trials for nasal COVID-19 vaccine complete: Bharat Biotech
What's the story
The phase 3 clinical trials of Bharat Biotech's COVID-19 nasal vaccine have been completed, according to Dr. Krishna Ella, the company's Chairman and Managing Director. The company will submit its data to the Drugs Controller General of India (DCGI) next month. "If everything's okay, we'll get permission to launch, and it will be the world's first clinically proven nasal COVID-19 vaccine," he reportedly stated.
Context
Why does this story matter?
Experts say nasal COVID-19 vaccines could be a game-changer in the global fight against the COVID-19 pandemic. They are reportedly easier to store, can be transported without refrigeration, and also remove injury risks that are associated with needle-based vaccines. Dr. Soumya Swaminathan, the chief scientist at the World Health Organization (WHO), had earlier described such treatments as a "second generation" of coronavirus vaccines.
Statement
Statement of Dr. Ella over the development
In a recent interview with ANI, Dr. Ella stated, "We just completed a clinical trial. Data analysis is going on. Next month, we will submit the data to the regulatory agency." Dr. Ella was speaking at Viva Technology 2022 in Paris, where India was named country of the year. Notably, intranasal vaccines reportedly have the potential to prevent new COVID-19 variants like Omicron.
Context
DCGI granted Bharat Biotech permission to perform trials in January
India's drug controller granted Bharat Biotech permission to perform standalone phase 3 trials of its COVID-19 nasal vaccine in January 2022. In addition, the DCGI's Subject Expert Committee (SEC) gave Bharat Biotech's "in-principle" approval for the "phase 3 booster dose study" for its first-of-its-kind intranasal COVID-19 vaccine and requested that it to submit protocols for approval a few weeks ago.
Fact
How does an intra-nasal vaccine work?
According to Bharat Biotech's website, "An intra-nasal vaccine stimulates a broad immune response neutralizing IgG, mucosal IgA, and T cell responses and creates an immune response at the site of infection (in the nasal mucosa) essential for blocking both infection and transmission of COVID-19." In India, Bharat Biotech is the second organization to apply for the phase 3 test of the third dose.
Quote
Booster is miracle dose for every vaccination: Dr. Ella
While highlighting the importance of the COVID-19 booster dose, Dr. Ella stated, "I always say...booster dose is a miracle dose for every vaccination. Even in children, two doses don't give much immunity, but the third dose gives an amazing response... The same thing is for adults also." "The third dose is very important for adults," he added, stating that COVID-19 can't be eradicated.