1. NAME OF THE MEDICINAL PRODUCT

Proprietary Name: COVOVAX™

Non-Proprietary Name:

COVID-19 Vaccine, Adjuvanted 2023-2024 Formula
(SARS-CoV-2 rS Protein (COVID-19) Nanoparticle Vaccine, Omicron XBB.1.5 variant)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

These are multidose vials which contain 5 doses of 0.5 ml per vial.

One dose (0.5 ml) contains 5 micrograms of the SARS-CoV-2 (Omicron XBB.1.5) spike protein^* and is adjuvanted with Matrix-M.

Adjuvant Matrix-M containing per 0.5 ml dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract.

^*produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.

The other ingredients are Disodium hydrogen phosphate heptahydrate, Sodium dihydrogen phosphate monohydrate, Sodium chloride, Polysorbate 80 and Water for injections.