Abstract

REGULATORY REQUIREMENTS FOR MARKETING AUTHORIZATION OF NASAL VACCINES FOR COVID CONTROL IN MAJOR COUNTRIES LIKE USA, EU, INDIA

Y. Ratna Sindhu* and Kundeti Naga Chaitanya

ABSTRACT

Nasal inhaled therapeutics and vaccination can be a potent alternative for COVID-19 therapeutics and management in the developing world. Research to develop low-cost, easy-to-use nasal spray vaccines with readily available materials and facilities is encouraged to this aim. Nasal spray vaccines based on traditional and complementary medicines, such as GSE, algae-isolated carrageenan, and Yogurt-fermenting Lactobacillus, are promising and under active development. There is a compelling need to develop an effective delivery system to target formulations at the ACE2-rich regions to achieve optimal outcomes for both adults and children, health (as a prophylactic), and disease (as a therapeutics). This need is particularly pressing in a context that emerging SARS-CoV-2 variants may evade current vaccines and develop resistance to existing therapies. This need is more real than ever by affecting each one of us considering the increasing confirmed cases in children and the devastating outbreak waves in India and many other countries around the world.

Keywords: Nasal vaccines, Marketing Authorization, USA, EU, India.