Novavax COVID-19 vaccine for adolescents gets emergency use authorization in India
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Novavax COVID-19 vaccine for adolescents gets emergency use authorization in India
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Novavax COVID-19 vaccine for adolescents gets emergency use authorization in India
On March 24, Novavax and the Serum Institute of India (SII) announced that the Directorate General of Drug Control of India (DCGI) has granted Novavax an Emergency Use Authorization (EUA) for Novavax’s COVID-19 pneumonia protein vaccine for use in India over 12 years old (inclusive) 18 years old The following youth population.
The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the Covovax™ brand and is the first protein-based vaccine approved for this age group in India.
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An observer-blind, randomized, controlled phase 2/3 study was conducted in a total of 460 Indian adolescents over 12 years and under 18 years to evaluate the safety and immunogenicity of Covovax. The study showed that Covovax was well tolerated and had a reliable safety profile.
In addition, the data indicate that Covovax is immunogenic in the adolescent population 12 years of age and older, and up to and including 18 years of age. The authorization in India is also based on the PREVENT-19 pivotal Phase 3 pediatric extension trial using NVX-CoV2373 in adolescents over 12 years of age and under 18 years of age in the United States, the results of which were announced in February.
Covovax is the fourth vaccine to receive an EUA from the DCGI for adolescents 12 years and older. The safety and efficacy of Covovax in adolescents under 12 years of age have not been established; however, studies are currently underway to evaluate Covovax in India in the age groups of 7+, 12+ and 2+, 7+ age groups Safety and Immunogenicity.
DCGI originally awarded an EUA to Covovax in December for people 18 and older. In addition, Covovax is listed on the World Health Organization’s Emergency Use List (EUL) and has EUA authorizations for Indonesia, the Philippines and Bangladesh.
Novavax COVID-19 vaccine for adolescents gets emergency use authorization in India
(source:internet, reference only)
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